The EU Framework Programme for Research and Innovation

HORIZON 2020
Gain of function / Dual use:
EU perspective
Ruxandra Draghia-Akli, MD, PhD
Health Director
DG Research & Innovation
European Commission
National Academies of Sciences,
Engineering and Medicine
International Symposium on Gain of Function research
10-11 March 2016, Washington DC
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Content

Horizon 2020: the EU's Research and Innovation programme

EU funded GoF/Dual Use Research of Concern (DURC)

Horizon 2020 Ethics

GoF/DURC research: dialogue with stakeholders in the EU

GoF/DURC research: response from the European Commission

Examples of policies on GoF/DURC research in Member States

Horizon 2020
The European Union programme for research and innovation for
2014-2020 with a budget of 79 billion

Rationale: R&D is increasingly complex, interdisciplinary, costly,

requiring critical mass

Europe = 28 countries: need for increased collaboration

Overarching ambition of Horizon 2020:
Respond to the economic crisis to invest in jobs and growth
Address peoples concerns about their livelihoods, safety and environment
Strengthen the EUs global position in research, innovation and technology

EU: 3/4 of US total for federally

funded R&D

Horizon 2020 budget breakdown

The EU R

SocietalChallenge1(SC1):
Health,Demographicchangeand
Wellbeing

EUR:7.4billion

EU funded GoF/DURC research

The purpose of EU R&D is always civil/health use military (or
malevolent) use is if at all unintentional by-product

No specific call for proposals on GoF, rather (in health):

strengthen research on prediction, identification, modelling and

surveillance of newly emerging infectious diseases in humans, and

identify factors promoting the emergence of pathogens with human

pandemic potential from pathogens with a zoonotic background and

related prevention strategies

In FP7 Health and H2020 Societal Challenge 1 Health, dual use research is
exceedingly rare (FP7: 3 out of > 1000 projects)

EU funded GoF/DURC research

FP7 Health projects with GoF components
EMPERIE (European Management Platform for Emerging and Reemerging Infectious Disease Entities, 2009-2014)
PREDEMICS (Preparedness, Prediction and Prevention of Emerging
Zoonotic Viruses with Pandemic Potential using Multidisciplinary
Approaches, 2011-2016)
ANTIGONE (Anticipating the Global Onset of Novel Epidemics, 20112016)
FP7 Health projects in security research with dual use items
AntiBotABE (Neutralizing antibodies against botulinum toxins A,B,E,
2010-2015)
TIRAMISU (Humanitarian Demining Toolbox, 2012-2016)
H2020: Currently no projects with GoF research
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Horizon 2020 - Ethics

During proposal preparation, applicants are asked:

if their proposal has an exclusive civilian focus on research
if their research uses or produces goods or information that will
require export licenses in accordance with legislation on dual
use items

Ethical screening, for each successful proposal:

at least 2 ethical experts with a variety of different backgrounds e.g.

law, philosophy, medicine, biology, read the proposal

Full ethical assessment:

reviewed by at least 5 ethical experts for all proposals containing
potential dual use

Horizon 2020 Ethics

At the end of the whole process, the ethics report

states:

clearance no action

no clearance project not funded

conditional clearance - changes to be made to the description of work

(e.g. requirements for permits, follow-up, ethical audits)

The Horizon 2020 model grant agreement has an optional article to

ensure that activities involving dual-use goods comply with EU, national
and international law and have an export licence, if applicable.

GoF/DURC research: dialogue with

stakeholders in the EU
EU 28 Member States

Subsidiarity principle: national research funding = national responsibility

EU-wide regulation of 'export control' policy of intangible technology

transfer (EU and national licenses)

EU Scientific Communities

EU Society for Virology: common policy for scientific research and

publications

Foundation for Vaccine Research: comprehensive risk-benefit

assessment of GoF

European Academies Science Advisory Council (EASAC): working group

established in autumn 2014 to explore consensus on key questions:
identify further GoF issues and clarify options for policy development
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EU perspective on stakeholders' views

The EU acknowledges the need to improve awareness and best practice

among members of the scientific community and to promote an underlying
culture of responsibility given the potential for accidental release and misuse

Welcomes the European Academies Science Advisory Council (EASAC)

working group recommendations:

Research applications should explain and justify their GoF experiments, discuss

the benefits and risk, indicate the biosafety category and assess GoF study
proposals on a case-by-case basis

Appropriate guidance on biosafety and biosecurity for research applications and

evaluations should be given and all Member States should have a clear national
advisory approach

An international forum is needed to sustain dialogue between the life sciences and
policy-making communities, and with other stakeholder involvement

Academies of science play a continuing role in promoting and increasing

understanding of biosafety and biosecurity norms

Information on procedures already in place in Member States should be collected

and collated

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Examples of national policies: United Kingdom

In research institutions, scientists must:

Assess the risks of their experiments
Ensure training and have the equipment/facilities suitable for safe experimentation
(biosafety legislation in UK: control of hazardous substance, GMOs, specified Animal
Pathogen Order, ...)
Submit their research proposals to the local Biological Safety Committee

Biological Safety Committee:

Members with appropriate knowledge, expertise, and experience to assess the
proposal
For work requiring highly secure facilities: the proposal, with the recommendations of
the Biological Safety Committee, must be submitted to the senior management of the
institution.

Accepted proposals are submitted to the Health & Safety Executive by

the establishments Biological Safety Officer, as a "Notification of
Intention to Conduct Individual Contained Use Activities"
The Health & Safety Executive reviews the application and gives permission to proceed
Experiments must be done by experienced, trained scientists following safety
procedures. If possible, vaccination should be considered; available therapies made
accessible
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Examples of national policies: The Netherlands

The responsibility lies first with the researchers/institutes:

Special facilities, procedures applicable, training of staff are supervised by
the biosafety office
All research proposals are first submitted to the biosafety office who looks at
the wild type pathogens (ARBO rules) and to GMOs (GMO Decision)
Staff has a biosafety and biosecurity training updated annually

The proposals are checked by the inspection services of the Ministry:

A permit must be obtained from the Ministry before starting work
In difficult cases there are formal scientific opinions, which are made public
and receive a formal permit from the Ministry based on WHO guidelines
All ethical requirements are assessed by Ethical Review Committees
Vaccination is compulsory, when effective vaccines are available

The government has a "Biosecurity Office" has which can be consulted

by researchers/institutions

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Examples of national policies: France

Supervision by the National Agency for Safety of the Drug and Health

products (ANSM)
Persons who conduct operations involving the use of human pathogens or
toxins on the toxic micro-organisms list must hold an authorisation issued by
ANSM
The control on the use of toxic micro-organisms to ensure the safety and
security related to their detention and use is managed by ANSM

Limitation/control of access to foreign persons in 'sensitive'

laboratories:
Decree (n 2011-1425 November 2, 2011 on the protection of the scientific
and technical potential of the nation replacing the inter-ministerial
instruction No. 486 of 1993
Legislation on "good practices to guarantee biosecurity, on the list of microorganisms and toxins, on information related to the authorisations,
competences and qualifications for holders of an authorisation"

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Learn more:

All about ethics in Horizon

2020: visit our website

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