EN Official Journal of the European Union L 310/13

COUNCIL DECISION 2013/668/CFSP

of 18 November 2013

in support of World Health Organisation activities in the area of biosafety and biosecurity 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 Articles 26(2) and 31(1) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

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

(2) The Union is actively implementing the EU Strategy and is giving effect to the measures listed in Chapter III thereof, in particular those related to reinforcement, implementation and universalisation of the Convention on the prohibition of the development, production and stockpiling of bacteriological (biological) and toxin weapons and on their destruction (BTWC).

(3) At the Sixth (2006) and Seventh (2011) Review Conferences of the BTWC the Union 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.

(4) On 14 April 2008, the Council adopted Joint Action 2008/307/CFSP (1). That Joint Action was successfully implemented by the World Health Organisation (‘WHO’) until 31 December 2011.

(5) On 11 December 2008, the Council adopted the ‘New lines of Action’ to strengthen the EU Strategy. Chapter IV of the EU Strategy sets out the Union’s support for a coordinated and complementary approach to biosafety and biosecurity problems guaranteeing optimal management, in particular of biological risks and threats.

(6) On 18 July 2011, the Council adopted Decision 2011/429/CFSP (2) setting out the Union’s support for the development of national regulatory frameworks, in particular on biosafety and biosecurity.

(7) The Seventh 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 their transportation, as well as to prevent unauthorised access to such agents and toxins and their unauthorised removal. 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 States Parties. The Conference encouraged such assistance on a regional basis.

(8) The Seventh 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 the alleged use of biological or toxin weapons.

(9) The Seventh 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 WHO, the Food and Agriculture Organisation (FAO), the World Organisation for Animal Health (OIE) and the International Plant Protection Convention (IPPC).

(10) On 15 June 2007, the International Health Regulation (‘the IHR’) entered into force. It regulates the movement and control of outbreaks of infectious diseases, and the response thereto, regardless of their origin, and requires the WHO Member States to build-up core capabilities in laboratory and surveillance in the field of public health against infectious diseases 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. The WHO biorisk reduction management programme provides guidance on how laboratories should operate through normative guidelines, workshops and training on biosafety practices, laboratory biosecurity and codes of conduct for responsible life science research. It also has 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 biosafety and laboratory biosecurity are encompassed in the WHO Laboratory Biosafety Manual, 3rd edition (2004) and the Biorisk Management, Laboratory Biosecurity Guidance (2006).

(11) The WHO is the only implementing agency with the expertise, deep knowledge, personnel, structure and resources to implement the projects and activities foreseen in this Council Decision.

(12) The Commission is entrusted with the supervision of the proper implementation of the Union’s financial contribution,

HAS ADOPTED THIS DECISION:

Article 1

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

— 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 such agents and toxins and their unauthorised removal,

— promoting biorisk reduction practices and awareness, including biosafety, biosecurity, bioethics and preparedness against intentional misuse of biological agents and toxins, through international cooperation in this area.

2. The projects corresponding to measures of the EU Strategy, are those that aim at the:

— promotion of laboratory biorisk management through national and regional outreach,

— development of national laboratory biorisk management strategies to counter biological risks (a demonstration model for countries).

A detailed description of those projects is set out in the Annex.

Article 2

1. The High Representative of the Union for Foreign Affairs and Security Policy (‘the HR’) shall be responsible for the implementation of this Decision.

2. The technical implementation of the activities referred to in Article 1 shall be entrusted to the WHO. It shall perform its task under the responsibility of the HR. For this purpose, the HR shall enter into the necessary arrangements with the WHO.

Article 3

1. The financial reference amount for the implementation of the projects referred to in Article 1(2) shall be EUR 1 727 000.

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

3. The Commission shall supervise the proper management of the expenditure referred to in paragraph 1. For that purpose, it shall conclude a financing agreement with the WHO. The financing agreement shall stipulate that the WHO is to ensure the visibility of the Union’s contribution, commensurate to its size.

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 Decision. It shall inform the Council of any difficulties in that process and of the date of conclusion of the financing agreement.

Article 4

The HR shall report to the Council on the implementation of this Decision on the basis of regular reports prepared by the WHO. Those reports shall form the basis for the evaluation carried out by the Council. The Commission shall provide information on the financial aspects of the projects referred to in Article 1(2).

Article 5

1. This Decision shall enter into force on the date of its adoption.

2. This Decision shall expire 24 months after the date of the conclusion of the financing agreement referred to in Article 3(3). However, it shall expire 6 months after its adoption if the financing agreement has not been concluded by that time.

Done at Brussels, 18 November 2013. For the Council The President C. ASHTON

(1) 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 (OJ L 106, 16.4.2008, p. 17).

(2) Council Decision 2011/429/CFSP of 18 July 2011 relating to the position of the European Union for the Seventh Review Conference 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 (BTWC) (OJ L 188, 19.7.2011, p. 42).