EN Official Journal of the European Union L 106/17

COUNCIL JOINT ACTION 2008/307/CFSP

of 14 April 2008

in support of World Health Organisation activities in the area of laboratory bio-safety and bio-security in the framework of the European Union Strategy against the proliferation of Weapons of Mass Destruction

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 14 thereof,

Whereas:

(1) On 12 December 2003, the European Council adopted the EU Strategy against the Proliferation of Weapons of Mass Destruction (hereinafter referred to as the EU Strategy), Chapter III of which contains a list of measures to combat such proliferation.

(2) The European Union is actively implementing the EU Strategy and is giving effect to the measures listed in Chapter III thereof, in particular those related to the reinforcement of the Biological and Toxin Weapons Convention (hereinafter referred to as the BTWC), including support for the national implementation of the BTWC through, inter alia, Council Joint Action 2006/184/CFSP of 27 February 2006 in support of the Biological and Toxin Weapons Convention, in the framework of the EU Strategy against the Proliferation of Weapons of Mass Destruction (1) and the EU Action Plan on biological and toxin weapons, complementary to the EU Joint Action in support of the BTWC (2).

(3) On 20 March 2006, the Council of the European Union adopted Common Position 2006/242/CFSP relating to the 2006 Review Conference of the Biological and Toxin Weapons Convention (BTWC) (3), with the objective of further strengthening the universality of the BTWC and promoting a successful outcome of the Review Conference (hereinafter referred to as the Sixth Review Conference). At the Sixth Review Conference, held in December 2006, the EU promoted full compliance with the provisions of the BTWC by all States Parties and the strengthening, where necessary, of national implementation measures, including penal legislation, and the control over pathogenic micro-organisms and toxins in the framework of the BTWC. The EU also put forward working papers, including on bio-safety and bio-security.

(4) The Sixth Review Conference reaffirmed the commitment of States Parties to take the necessary national measures under Articles I, III and IV of the BTWC in order to ensure the safety and security of microbial or other biological agents or toxins in laboratories and other facilities, and during transportation, as well as to prevent unauthorised access to and removal of such agents and toxins. The Conference also urged States Parties with relevant experience in legal and administrative measures for the implementation of the provisions of the BTWC to provide assistance on the request of other State Parties. The Conference encouraged such assistance on a regional basis.

(5) The Sixth Review Conference decided to discuss, in 2008, and promote common understanding and effective action on, inter alia, national, regional and international measures to improve bio-safety and bio-security, including laboratory safety and security of pathogens and toxins.

(6) The Sixth Review Conference also noted, in the context of Article VII of the BTWC, that the States Parties’ national preparedness contributes to international capabilities for responding to, investigating and mitigating outbreaks of disease, including those due to alleged use of biological or toxin weapons.

(7) The Sixth Review Conference encouraged the States Parties, in the context of Article X of the BTWC, to continue strengthening existing international organisations and networks, in particular those of the World Health Organisation (WHO), the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE) and the International Plant Protection Convention (IPPC), called upon States Parties to continue supporting and/or improving national and regional capacities to survey, detect, diagnose and combat infectious diseases and also other possible biological threats, and urged States Parties in a position to do so to continue supporting, directly as well as through international organisations, capacity-building activities in States Parties in need of assistance in the fields of surveillance, detection, diagnosis and combat of infectious diseases, and related research.

(8) On 15 June 2007, the International Health Regulation (hereinafter referred to as the IHR) entered into force. It regulates the movement and control of and response to outbreaks of infectious diseases regardless of their origin, and requires the WHO Member States to build-up core capabilities in laboratory and surveillance to allow for the implementation of the IHR. The WHO Secretariat is committed to supporting WHO Member States to implement their IHR national plans through the WHO headquarters and regional offices, including the WHO Office in Lyon. The WHO bio-risk reduction management programme provides guidance on how laboratories should operate through normative guidelines, workshops and training on bio-safety practices, laboratory bio-security and codes of conduct for responsible life science research. It has also a role in establishing UN guidelines on the transportation of infectious substances. Under the IHR, public health laboratories have a role in being prepared to address biological, chemical, radiological and nuclear threats. The definitions for bio-safety and laboratory bio-security are encompassed in the WHO Laboratory Bio-safety Manual, third edition (2004) and the Bio-risk Management, Laboratory Bio-security Guidance (2006).

(9) The implementation of this Joint Action shall be performed in accordance with the Financial and Administrative Framework Agreement (hereinafter referred to as ‘the Framework Agreement’) concluded between the European Commission, on the one hand, and the UN, on the other hand, which sets out a framework for the UN and the European Commission for enhancing their cooperation, including operational partnership,

HAS ADOPTED THIS JOINT ACTION:

Article 1

1. For the purpose of giving immediate and practical application to the relevant elements of the EU Strategy, the EU shall contribute to the implementation of decisions made by the States Parties at the Sixth Review Conference of BTWC, with the following objectives:

(a) ensuring the safety and security of microbial or other biological agents or toxins in laboratories and other facilities, including during transportation as appropriate, in order to prevent unauthorised access to and removal of such agents and toxins;

(b) promoting bio-risk reduction practices and awareness, including bio-safety, bio-security, bioethics and preparedness against intentional misuse of biological agents and toxins, through international cooperation in this area.

2. To achieve the objectives referred to in paragraph 1, the EU shall introduce projects consisting of the following measures:

(a) organisation of outreach workshops, consultations and training for competent authorities in the relevant sectors and for laboratory managers/staff at the national, sub-regional and regional levels, aiming at a deeper understanding of bio-risk reduction practices and their effective implementation in laboratories and other facilities, including during transportation as appropriate;

(b) assistance to a selected country to review public health response capacity in the context of enhancing national biological preparedness, to develop and implement a bio-risk reduction management plan, particularly concerning laboratory practice and safety, and to harmonise it with integrated national preparedness plans, and to strengthen the performance and sustainability of national laboratories by connecting them with regional and international networks.

A detailed description of these projects is set out in the Annex to this Joint Action.

Article 2

1. The Presidency, assisted by the Secretary-General/High Representative (hereinafter referred to as the SG/HR), shall be responsible for the implementation of this Joint Action. The Commission shall be fully associated.

2. The technical implementation of the measures referred to in Article 1(2) shall be carried out by the WHO, which includes the WHO Office in Lyon.

The WHO shall perform its tasks under the control of the SG/HR assisting the Presidency. For this purpose, the SG/HR shall enter into the necessary arrangements with the WHO.

3. The Presidency, assisted by the SG/HR, and the Commission shall keep each other regularly informed about the implementation of this Joint Action, in conformity with their respective competences.

Article 3

1. The financial reference amount for the implementation of the measures referred to in Article 1(2) shall be EUR 2 105 000, to be funded from the general budget of the European Union.

2. The expenditure financed by the amount stipulated in paragraph 1 shall be managed in accordance with the Community procedures and rules applicable to the general budget of the European Union.

3. The Commission shall supervise the proper management of the expenditure referred to in paragraph 2, which shall take the form of a grant. For this purpose, the Commission shall conclude a financing agreement with the WHO. The financing agreement shall stipulate that the WHO is to ensure that the visibility of the EU contribution is appropriate to its size, including by participation of EU experts.

4. The Commission shall endeavour to conclude the financing agreement referred to in paragraph 3 as soon as possible after the entry into force of this Joint Action. It shall inform the Council of any difficulties in that process and of the date of conclusion of the financing agreement.

Article 4

The Presidency, assisted by the SG/HR, shall report to the Council on the implementation of this Joint Action on the basis of quarterly reports prepared by the WHO. These reports will form the basis for the evaluation carried out by the Council. The Commission shall be fully associated. It shall report to the Council on the financial aspects of the implementation of this Joint Action.

Article 5

This Joint Action shall enter into force on the day of its adoption.

It shall expire 24 months after the date of conclusion of the financing agreement referred to in Article 3(3), or six months after the date of its adoption if no financing agreement has been concluded by then.

Article 6

This Joint Action shall be published in the Official Journal of the European Union.

Done at Luxembourg, 14 April 2008. For the Council The President I. JARC

(1) OJ L 65, 7.3.2006, p. 51.

(2) OJ C 57, 9.3.2006, p. 1.

(3) OJ L 88, 25.3.2006, p. 65.