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
Date: 2008-04-14
Institutions: Council of the European Union
Subjects: World Health Organisation, biological weapon, international security, non-proliferation of arms, weapon of mass destruction

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III

(Acts adopted under the EU Treaty)

ACTS ADOPTED UNDER TITLE V OF THE EU TREATY

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)

(2)

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
III of which contains a list of
Strategy), Chapter
measures to combat such proliferation.

thereof,

referred to as

The European Union is actively implementing the EU
Strategy and is giving effect to the measures listed in
in particular those related to the
Chapter III
the Biological and Toxin Weapons
reinforcement of
the BTWC),
Convention (hereinafter
implementation of
including support
the BTWC through,
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).

inter alia, Council

for the national

(3)

On 20 March 2006, the Council of the European Union
adopted Common Position 2006/242/CFSP relating to
the Biological and
the 2006 Review Conference of
Toxin Weapons Convention (BTWC) (3), with the

(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.

objective of further strengthening the universality of the
BTWC and promoting a successful outcome of
the
Review Conference (hereinafter referred to as the Sixth
the Sixth Review Conference,
Review Conference). At
the EU promoted full
held in December 2006,
compliance with the provisions of
the BTWC by all
States Parties and the strengthening, where necessary,
of national
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.

implementation measures,

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 administra-
tive 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.

and promote

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

common understanding

the BTWC,

The Sixth Review Conference also noted, in the context
the States Parties’
of Article VII of
national
international
to
preparedness
investigating and miti-
capabilities for responding to,
gating outbreaks of disease,
including those due to
alleged use of biological or toxin weapons.

that
contributes

(4)

(5)

(6)

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(7)

(8)

(FAO),

and the

the World Organisation

The Sixth Review Conference encouraged the States
in the context of Article X of the BTWC, to
Parties,
strengthening existing international organi-
continue
sations and networks,
in particular those of the World
Health Organisation (WHO), the Food and Agriculture
for
Organization
Animal Health (OIE)
Plant
Protection Convention (IPPC), called upon States Parties
to continue supporting and/or improving national and
and
regional
capacities
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.

to survey, detect, diagnose

International

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
in laboratories and other
facilities, including during transportation as appropriate, in
order to prevent unauthorised access to and removal of
such agents and toxins;

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.

in

The WHO bio-risk

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
is
implementation of
the IHR. The WHO Secretariat
committed to supporting WHO Member States
to
implement their IHR national plans through the WHO
including the WHO
headquarters and regional offices,
Office
reduction
Lyon.
management programme provides guidance on how
laboratories should operate through normative guidelines,
practices,
workshops
laboratory bio-security
for
responsible life science research.
It has also a role in
establishing UN guidelines on the transportation of
the IHR, public health
infectious
laboratories have a role in being prepared to address
biological, chemical,
threats.
The definitions
for bio-safety and laboratory bio-
security are encompassed in the WHO Laboratory Bio-
third edition (2004) and the Bio-risk
safety Manual,
Management, Laboratory Bio-security Guidance (2006).

radiological and nuclear

substances. Under

and codes of

bio-safety

conduct

training

and

on

(9)

implementation of

The
Joint Action shall be
this
performed in accordance with the Financial and Admin-
istrative 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:

To achieve the objectives referred to in paragraph 1, the
following

introduce projects

consisting of

the

2.
EU shall
measures:

laboratory managers/staff at

(a) organisation of outreach workshops, consultations and
training for competent authorities in the relevant sectors
and for
the national, sub-
levels, aiming at a deeper under-
regional and regional
standing 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

The Presidency, assisted by the Secretary-General/High
1.
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.

Article 1

1.
For the purpose of giving immediate and practical appli-
cation to the relevant elements of the EU Strategy, the EU shall

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.

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The

Presidency,

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

SG/HR,

the

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.

endeavour

The Commission shall

4.
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.

to conclude

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 implemen-
tation of this Joint Action.

Article 5

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

its

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

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ANNEX

DESCRIPTION OF THE PROJECTS TO BE FINANCED

1. General objectives

The overall objective of this Joint Action is to support, through the projects described below, the implementation of
the BTWC, in particular those aspects that relate to the safety and security of microbial or other biological agents
and 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.

It is also to contribute to raising awareness of bio-risk management practices and to promote, especially through
Project 2, the harmonisation of good national
laboratory practices and biological agent response with overall
national biological preparedness.

2.

Project-based specific objectives

The projects described below will address three areas of major concern in the accidental and deliberate spread of
diseases:

1. The risk of terrorists or other criminals having access to dangerous biological pathogens/toxins. The intention of
terrorists to acquire and to use the disease as a weapon must be contained. Such events as the anthrax spore-
laden letters in the US in 2001 have the potential to create huge political and economic disturbances.

2. A considerable increase in new laboratories in general, but in particular in high-level containment laboratories
which lag behind in respecting adequate bio-safety and bio-security standards. In recent years, a considerable
number of countries, including countries which have limited resources, have allocated funds to construct high
level containment laboratories. While this should allow the country’s scientists to gain experience in the handling
of dangerous pathogens like the SARS coronavirus, or viral hemorrhagic fever viruses, it may also bring about
risks, especially in countries which are not able to reserve sufficient funds for the long-term maintenance of their
facilities and do not provide adequate training for staff.

3. The occurrence of

laboratory incidents and accidental releases of highly dangerous bio-materials due to
inadequate bio-safety and bio-security practices in laboratories and other facilities, and lack of compliance
with the UN infectious substance packaging and shipping regulations. Three separate SARS laboratory
accidents in Asia in 2003 and 2004 and the recent death from laboratory acquired Ebola haemorrhagic fever
infection in Russia as well as deficiencies in bio-safety practices leading to laboratory acquired infections
(tularemia and meliodosis) in the US are examples demonstrating the associated risks involved in inadequate
bio-safety and laboratory bio-security,
through
management practices and the training of staff irrespective of the type of laboratory environment (human,
animal or agricultural) in which the worker operates.

the improvement of which requires stronger commitment

2.1. Project 1: Promotion of bio-risk reduction management through regional and national outreach

P u r p o s e o f

t h e p r o j e c t

The purpose of this project is to encourage States to assume responsibility for developing programmes to avoid
accidental exposure or release and to prevent deliberate misappropriation or misuse of bio-agents in the laboratories.
The project will
involve national health policy makers as well as laboratory managers and laboratory staff to
encourage their commitment to a bio-safety/bio-security culture. The project will also contribute to the development
of bio-risk reduction programmes at national, regional and international levels, including through the networking of
laboratories and through a harmonised bio-safety and laboratory bio-security definition in the countries of the
region, with the aim of promoting transparency and commitment to bioethics (including the promotion of non-
proliferation). Particular attention will be given to cross-sector networking between public health and other sectors
such as animal health and the environment, to ensure a coordinated and comprehensive approach to bio-risk
reduction.

R e s u l t s o f

t h e p r o j e c t

(i) Regions and countries will become engaged in active dialogue on the issues related to the safety and security of

dangerous bio-agents and toxins in laboratories and other facilities.

(ii) Existing laboratory bio-safety and bio-security practices will be mapped.

(iii) The development of national plans will be supported, in particular in compliance with IHR, pathogen regu-
lations and control measures to enhance safety and security in the handling of highly infectious materials.

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(iv) Training curricula will be developed, designed to keep policy makers, laboratory managers and laboratory staff
include bio-ethics and the promotion of the Codes of

(They will

engaged in bio-risk reduction practices.
Conduct).

(v) Means will be provided for connecting national stakeholders among themselves and with international organi-
sations (including the FAO, the OIE and the IPPC), so as to sustain their activities and help them become
responsible global partners in regional professional societies and international networks.

D e s c r i p t i o n o f

t h e p r o j e c t

(a) Regional outreach workshops to raise bio-risk reduction management awareness and to envisage concrete

country-focused operational initiatives in the field of bio-safety and bio-security

In 2006, the WHO organised bio-risk reduction management awareness-raising workshops in Central and South
America, Eastern Mediterranean countries and English-speaking African countries. It will complete this first
general awareness-raising cycle of outreach in the remaining regions, and will ensure a follow-up to these
efforts through more focused outreach to respond to specific needs of the countries in the selected regions,
including on bio-ethics and the Codes of Conduct. In order to avoid duplication of effort and to coordinate and
harmonise approaches, the WHO will consult with relevant stakeholders and donors (international actors and
non-governmental organisations) on the ongoing projects and needs for assistance.

Five regional workshops are planned, which may target the following regions: sub-Saharan Africa, South
America, South and Southeast Asia, East Asia/Western Pacific, Central Asia and Eastern European countries
(including Russia).

(b) Consultations with relevant competent authorities to commit them to bio-risk reduction management in the

health sector

The WHO will consult with the competent authorities in the relevant sectors and with the managers of the
reference libraries to encourage their commitment to bio-risk reduction management. At least four visits are
planned. The countries to be visited will be selected through a consultation process within the Steering
Committee, and the selection of the countries will reflect their commitment to the implementation of the
non-proliferation policy.

(c)

In-depth topic specific workshops on bio-risk reduction practices

The WHO will arrange at least two regional workshops to discuss specific topics aimed at deepening the
understanding of the elements of bio-risk reduction practices, with health policy makers as well as laboratory
managers and staff. Issues relating to legislation and management will be addressed, as well as how to plan for
sustainability of the programmes through networks, seminars and professional societies. The seminars will target
primarily Eastern Mediterranean and Eastern European countries, or other countries relevant for the selection
process in Project 2.

2.2. Project 2: Strengthening the security and laboratory management practices against biological risks (a demonstration model for

countries)

P u r p o s e s o f

t h e p r o j e c t

(i) To map and assess public health response capacity, in particular in respect of biological agents and toxins, in the
context of enhancing national biological preparedness by connecting the health sector with the sectors of foreign
affairs, justice, environment, commerce, agriculture (and animal health), intelligence.

(ii) To develop a forum to keep the relevant national actors informed and connected with regard to public health

preparedness and response capacity.

(iii) To develop a bio-risk reduction management plan, particularly concerning laboratory practice and safety, and to

harmonise it with integrated national preparedness plans.

(iv) To implement the national bio-risk reduction management plan, in particular concerning laboratory practice and

safety.

(v) To map and strengthen the performance, capacity and sustainability of national laboratories by connecting them

with regional and international laboratory networks.

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R e s u l t s o f

t h e p r o j e c t

(i) The programme of the selected country will be strengthened, to minimise biological risks.

(ii) Among national stakeholders, there will be improved understanding of and trust created in the role of the public

health sector in biological incident response.

(iii) The bio-laboratory component will be connected with national stakeholders in biological incident response.

(iv) Improved laboratory safety, quality and performance.

(v) Continuance of recognised laboratory quality and connectivity will be assured through regional and international

validation.

(vi) The country will be provided with meeting laboratory core capacity in compliance with the IHR.

D e s c r i p t i o n o f

t h e p r o j e c t

For the purposes described above, the project will be implemented over an appropriate period which requires a long-
term commitment by both the applicant country and the EU. The project will be implemented in phases. An EU-
sponsored seconded expert should be appointed as a country project leader.

Preparatory phase

The WHO will
identify a number of candidate countries for the project, with a view to recommending to EU
Member States a suitable candidate through the Steering Committee. The selection criteria will reflect as a priority
non-proliferation concerns. The WHO and the Presidency, assisted by the SG/HR, will conduct exploratory
discussions with the candidate countries. Based on the progress of those discussions, the WHO will conduct
preliminary country pre-assessment visits, relevant for the next phase of the project. The WHO will appoint a
project officer, who shall be a national of one of the EU Member States.

As a result of this preparatory process, a memorandum of understanding will be signed by the EU (represented for
this purpose by the Presidency, assisted by the SG/HR), the WHO and the selected country.

Assessment phase

In the assessment phase, the WHO will conduct an assessment of national biological activities and assets in the
selected country, and will assist with their harmonisation with national preparedness for and response to biological
incidents. This will include the completion of the bio-incidents evaluation exercise and of the coordination plan to
inform all stakeholders of the status of national preparedness against biological incidents, and the initiation of the
harmonisation of public health responsibilities in the national preparedness plan for biological threats and/or
incidents as well as public health emergencies of international concern.

Technical assistance phase

In this phase, the aim is to strengthen laboratory practices to respond to a public health event of international
concern and to ensure that laboratory performance is safe and its results are validated at the national, regional and
international levels. To achieve these goals, training will be provided for the responsible stakeholders in the public
health area and in the biological response. Laboratory infrastructure plans will be developed and country bio-safety
professionals will be connected with international networks, including through participation in the annual meetings
and conferences of the international bio-safety associations.

Evaluation phase

The WHO will prepare, on a quarterly basis and in cooperation with the selected country, reports evaluating the
implementation of national biological preparedness plans as well as national laboratory performance from the bio-
safety and bio-security perspective, and will forward these evaluation reports to the Presidency, assisted by the
SG/HR, and to the Commission.

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3. Duration

The total estimated duration of the implementation of this Joint Action is 24 months.

4.

Beneficiaries

The beneficiaries are States Parties to the BTWC or States which have initiated the ratification/accession process. The
Joint Action targets primarily countries and regions which are vulnerable because of unsafe practices in biological
laboratories, contributing to an increased risk of the loss, theft and misuse of high-consequence micro-organisms and
their products.

5.

Implementing entity

The Presidency, assisted by the SG/HR, is responsible for the implementation and supervision of the implementation
of the Joint Action. The Presidency is to entrust the technical implementation to the WHO.

The projects will be implemented by WHO staff in cooperation, as appropriate, with (experts from) WHO Member
States,
in particular the EU Member States. Where recruiting new staff for the implementation of the project,
preference should be given to nationals of the EU Member States. The implementation of the Joint Action will
be supervised by a Steering Committee consisting of representatives of the WHO, the EU Presidency assisted by the
SG/HR and the Commission. The Steering Committee will hold meetings as necessary, but at least twice a year, in
order to review progress and to discuss issues relating to implementation. This is to ensure harmonisation of the
overall project implementation and evaluation reports. The Steering Committee will also serve as a mechanism for
the selection of countries for Project 1(b) and Project 2.