working to reduce the use of animals in scientific research · Delivery Plan ‘Working to reduce...

Working to reduce the use of animals in scientific research

Delivery Report

2

Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report

Acknowledgements

© Crown copyright 2015

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated.

To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information

Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].

Where we have identified any third party copyright information you will need to obtain permission from the copyright

holders concerned.

This Delivery Report describes the progress made on actions set out in the Delivery Plan published on 7 February

2014. The Report has been prepared by the Home Office (HO), the Department for Business, Innovation and Skills

(BIS) and the Department of Health (DH). It includes substantial contributions from other government departments

including the Department for Environment, Food and Rural Affairs (Defra), the Foreign & Commonwealth Office

(FCO) and the Food Standards Agency (FSA), and from government agencies including Public Health England

(PHE), the Medicines and Healthcare Products Regulatory Agency (MHRA), the Veterinary Medicines Directorate

(VMD), the Animal & Plant Health Agency (APHA), the Food and Environment Research Agency (Fera), the Centre

for Environment, Fisheries and Aquaculture Science (Cefas) and the Health and Safety Executive (HSE). The

Research Councils have also contributed significantly to this work.

We recognise in particular the major contribution made to the implementation of the Delivery Plan by the National

Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs).

ISBN: 978-1-78246-731-1


3

Foreword

In February 2014, the Government published its Delivery Plan ‘Working to reduce the use of animals in scientific research’1. In this Delivery Report we summarise progress since that publication.The Delivery Plan brought together new and existing initiatives, through a science-led approach, for promoting the widespread adoption of scientific and technological advances which present significant opportunities to replace animal use, to reduce the number of animals used and to refine the procedures involved so as to find additional ways to minimise suffering of animals used in scientific research – the 3Rs. The Plan also proposed ways in which the UK would increase openness and transparency.Since the Plan was published, a wealth of significant new research and knowledge dissemination on the 3Rs has been completed. It includes the launch of the first products from the NC3Rs open innovation programme CRACK IT, a £4m competition run by Innovate UK and the NC3Rs to fund the commercialisation of non-animal technologies, and the publication of important new studies on veterinary and human vaccine testing by Defra and Public Health England which have identified scope to reduce the numbers of animals used in developing vaccines. New joint working by the RSPCA and the Home Office has additionally produced refined testing models to reduce animal suffering.We have taken major steps to encourage greater international adoption of 3Rs techniques, including a ground-breaking programme of knowledge-sharing with regulators and life science associations in China led by the Animals in Science Regulation Unit. In addition, we have published collaborative research across the global life sciences sector led by the NC3Rs and the

UK’s Medicines and Healthcare Products Regulatory Agency to minimise the use of recovery animals in pharmaceutical development.The use of animals in scientific research rightly attracts considerable attention and scrutiny. The public is entitled to know why such research is carried out, how animal welfare needs are addressed and what steps are being taken to reduce dependence on animal-based research. We are therefore delivering on our commitments to increase openness in the use of animals for research in the UK. In particular, we have consulted on options to reform section 24 of the Animals (Scientific Procedures) Act 1986 to allow greater access to animal research information. Greater openness brings increased opportunities to explain why the carefully regulated use of animals in scientific research remains of vital importance in improving our understanding of human and animal disease, and in ensuring the safety of new medicines.The UK is a global leader in the 3Rs and the concerted efforts underpinning the Delivery Plan have provided a new platform and new tools to accelerate the domestic and international uptake of scientifically valid alternatives in research and safety testing. Ongoing scientific and technological advances will provide many further opportunities to reduce our dependence on animal-based testing. We will build on the momentum generated and cross-sector relationships developed through this Plan’s implementation to ensure that the UK stays at the forefront of global efforts to find and use alternatives to animal testing, while continuing to make clear the important benefits that animal research brings to society.

1 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/277942/bis-14-589-working-to-reduce-the-use-of_animals-in-research.pdf

The Rt Hon Lynne Featherstone MP

Minister for Crime Prevention

Home Office

George Freeman MP

Minister for Life Sciences

Dept for Business, Innovation & Skills,

& Dept of Health

4



5

Contents

Acknowledgements ....................................................................................................................2

Foreword ....................................................................................................................................3

Contents .....................................................................................................................................5

Introduction .................................................................................................................................7

Progress on the three strategic objectives .................................................................................8

Strategic Priority 1 .....................................................................................................................8

Strategic Priority 2 ...................................................................................................................10

Strategic priority 3 ....................................................................................................................12

Tables .......................................................................................................................................15

Glossary ...................................................................................................................................34

6



7

The Government is clear that science has a major role

to play in developing new technologies and approaches

that wherever possible replace, reduce and refine

the use of animals in scientific research (the ‘3Rs’).

Breakthroughs in areas such as tissue engineering,

stem cells and computer modelling have opened up

significant opportunities to reduce our reliance on

animal research models. Government departments,

agencies and other publicly funded bodies with a role

in life sciences research have an important part to play

in helping find and seize these new opportunities, and

to share knowledge in this area both in the UK and

internationally.

The Government is also committed to increasing

openness and transparency in animal research,

by giving the public new tools and opportunities to

understand how and why such research is carried out,

and to scrutinise the steps being taken to minimise

suffering and find alternatives.

The Delivery Plan, published on 7 February 2014, set

out three strategic priorities in meeting the Coalition

Government’s commitment to work to reduce the use of

animals in scientific research:

● advance the use of the 3Rs within the UK;

● use international leadership to influence the uptake

and adoption of 3Rs approaches globally; and

● promote an understanding and awareness of

animals where no alternatives exist.

In Sections 1, 2 and 3 of this report, we describe the

progress that has been achieved in pursuing these

three core objectives, including new initiatives that have

been launched since the original Plan was published. In

the tables at the end of the report we provide updates

on each specific action.

The Plan has been implemented through a partnership

comprising:

● relevant central government departments and non-

ministerial departments including the Home Office,

BIS, Defra, the Department of Health, the Foreign

Office and the Food Standards Agency;

● the National Centre for the 3Rs (NC3Rs); and its

main funders, the Medical Research Council (MRC)

and the Biotechnology and Biological Sciences

Research Council (BBSRC); and

● agencies, including Public Health England (PHE),

the Medicines and Healthcare Products Regulation

Agency (MHRA), the Health and Safety Executive

(HSE), the Food and Environment Research Agency

(Fera), the Animal & Plant Health Association

(APHA), the Centre for Environment, Fisheries

and Aquaculture Science (Cefas), the Veterinary

Medicines Directorate (VMD) and Innovate UK

(formerly the Technology Strategy Board).

The partnership has brought together expertise,

knowledge and data-sharing around a common set

of priorities and provides a strong platform to identify

further opportunities

to implement the

3Rs in the UK and

overseas. It has

also helped drive a

more proactive and

consistent approach

in communicating

with the public

about the use of

animals in scientific

research.

Introduction

Working to reduce the use of animals in scientific research

ASRU Delivery Plan final artwork.indd 1 04/12/2013 17:53

8


PROGRESS ON THE THREE STRATEGIC OBJECTIVES

Strategic Priority 1 Advancing the use of the 3Rs in the UK

Overview and summary progress on actions (for a detailed breakdown see Tables, Strategic Priority 1)

The UK has strength and depth to support the delivery

of 3Rs approaches through the NC3Rs, other funders

and the regulatory framework but also strongly

supported by researchers and organisations in the life

sciences sector.

The NC3Rs’ mission is to replace, refine and reduce the

use of animals in research. Building on their ten-year

history, they not only lead the UK science community

in developing and sharing 3Rs techniques and practice

here but show strong international leadership in the

field. The various programmes and initiatives funded

by the NC3Rs have both identified problems and found

innovative solutions to shape changes in policy, practice

and regulations through science-led approaches. The

recent publication of the NC3Rs’ vision for the next ten

years is a holistic approach focusing on five inter-related

areas: Practice, Procedures,

People, Places and Policy2.

It is not only the 3Rs that are

important. The Government

recognises that innovative

approaches to research can

open up new fields of study in

areas where animal methods

have limits, and in doing

so find improved methods

for answering scientific

questions that could lead to

a real reduction in the use of

animals in the longer term.

Such innovation is being

backed by Innovate UK, working with the NC3Rs and

the Research Councils, through the funding (£3m

committed) last year of business-led feasibility studies

into Non-Animal Technologies (NATs). Innovate UK

has now announced a new £6m funding competition

in this area which opens on 23 March3 and is working

in parallel with partners, including the NC3Rs and

Research Councils, to produce a NATs Roadmap for the

UK. The Roadmap will provide a focus for supporting

and increasing the scale and impact of NATs activities in

the UK research and industry base, and develop routes

to commercialisation and adoption of the NATs products

and services generated.

The Home Office Animals in Science Regulation Unit

(ASRU – the regulator) has delivered new Guidance

and a Code of Practice with increased emphasis on the

3Rs during 2014. ASRU continues to engage across the

spectrum of stakeholders, through proactive stakeholder

2 http://www.nc3rs.org.uk/our-vision3 https://interact.innovateuk.org/-/developing-non-animal-technologies

9


meetings, consultation and presentations

at a range of national fora, to disseminate

the 3Rs and promote leading practice to

improve animal welfare within the regulatory

framework.

Case study examples from the Delivery Plan

Action 1.1 (1) Publication of the review of the NC3Rs’ pharmaceutical industry collaborations

The NC3Rs published its ten-year review of

working with more than 40 pharmaceutical

and biotechnology companies and

regulatory agencies from the UK, elsewhere

in Europe and the USA, fostering a

cross-company approach to the 3Rs.

The NC3Rs is a trusted partner for data-

sharing with companies providing extensive

non-clinical and clinical data-sets from

historic compounds and those currently

in development. The NC3Rs works with

companies to interrogate and analyse data

and rationalise the requirement for in vivo

studies to deliver 3Rs impacts. Through

its collaborations the NC3Rs has sought

to build evidence bases that could not be

achieved by any one company alone.

Action 1.8 Updated requirements for applications which include animal research

The Medical Research Council and the Biotechnology

and Biological Sciences Research Council (MRC

and BBSRC) have produced updated guidance on

their expectations for applicants and reviewers in

relation to the use of animals in bioscience research.

The emphasis is on improving the information on

experimental design and the 3Rs. As part of the process

of implementing this, a workshop was held jointly with

NC3Rs in September 2014 to promote the importance

of improved scrutiny of experimental design in the

peer review process, including representatives from

charitable funders.

Further actions supplementing the Delivery Plan

Frozen Embryo and Sperm Archive

There has been a steady increase in usage of the

Frozen Embryo and Sperm Archive (FESA) at MRC

Harwell, part of the European Mutant Mouse Archive,

both for archiving stocks and in requests for distribution.

Improved techniques have led to a shift from freezing

embryos towards freezing sperm, which reduces the

numbers of mice necessary per strain for archiving and

recovery.

10


Strategic Priority 2 Influencing the uptake and adoption of 3Rs approaches globally


The UK’s commitment and development of 3Rs

approaches places it in a strong position to spread

best practice and influence overseas. Our vision for

the continued development of non-animal technologies

provides a bright future for predictive test systems that

supports both the drive for animal welfare and a thriving

life sciences community that uses animals only where

there are no validated alternatives. Furthermore, the

UK seeks to give companies with high ethical standards

greater opportunities to trade in growing markets that

currently require the use of questionable animal tests in

order to market their products. The UK also continues to

support the UK life sciences industry through working to

harmonise international regulatory testing requirements.

Through the Delivery Plan we have made significant

progress against our objectives, in particular by:

● supporting the NC3Rs’ international initiatives;

● engaging with other countries to promote

harmonisation of global regulatory standards which

use alternatives wherever possible;

● providing an evidence base for where changes

would be beneficial to international regulations

which require animal use; and

● working to end unnecessary animal testing for

cosmetics globally.

Case study examples from the Delivery Plan

Actions under 2.1 Joint international leadership by the NC3Rs and MHRA

In addition to engagement with specific countries on

the 3Rs, the UK has helped lead discussions in OECD

and other international fora to secure agreement to

new validated alternatives to animal testing. The tables

with this report describe joint international leadership

by the NC3Rs and the MHRA to identify opportunities

to reduce the use of animals in safety pharmacology

studies and to minimise the use of recovery animals

in pharmaceutical studies. The UK also played a key

part in discussions that led to the OECD publishing two

new Test Guidelines on human health hazard endpoint

skin sensitisation that are expected to replace gradually

animal tests required in this area.

The Government and its partner agencies have taken

new action to promote the 3Rs within Europe. For

example, the NC3Rs carried out a detailed programme

of knowledge-sharing with the Italian Ministry of Health

and the Lombardy Regional Government. This is

helping lead to the creation of a panel of scientists that

can advocate the use of the 3Rs in Italy.

Action 2.4 Cosmetics alternatives and Action 2.5 Developing Delivery Plan priorities into an effective international communication and influencing strategy

The UK and EU have banned animal testing of

cosmetics. However, 80% of other countries have not.

There is therefore significant scope to reduce global

testing on animals through the UK showing global

leadership and influence. This will, in turn, deliver

economic benefits for the UK by opening up foreign

cosmetics markets to ethically produced UK cosmetic

products.

This priority has a particular focus on China where

animal testing is mandated for cosmetics imported

from the EU and elsewhere. Through this work we

support a drive to further incorporate 3Rs techniques

into frameworks, thus encouraging the move towards

greater acceptance of non-animal data and the opening

up of markets to trade.

11


China has relaxed the requirements for animal data

on domestically produced cosmetics so that there

is no longer a mandate to provide such data as

long as an adequate risk assessment can be made

based on other data. However, there is still work to

be done both to apply this to cosmetics produced

outside China (e.g. in the UK) and to up-skill Chinese

regulators and cosmetics producers to be able to

perform such risk assessments. We are supporting

China in this endeavour alongside our partners in the

EU Commission and the European trade association,

Cosmetics Europe.

The Home Office Animals in Science Regulation Unit,

and BIS have hosted a visit to the UK by a senior

delegation of officials from the China Food & Drug

Administration (CFDA) to discuss ways

in which human safety of cosmetics and

medicines can be assured through rigorous

risk assessments which do not include

unnecessary animal data. Their programme

included visits to: the NC3Rs; Huntingdon

Life Sciences; the Association of the British

Pharmaceutical Industry (ABPI); Unilever;

Walgreens Boots Alliance; and meetings

with the EU Commission and Cosmetics

Europe as well as UK government teams.

The visits demonstrated best practice in

cosmetic and pharmaceutical safety testing

and showcased UK expertise in the 3Rs

with a particular focus on non-animal testing

methods.

UK government officials, in partnership with

the Chinese Association for Laboratory

Animal Sciences (CALAS), held a scene-

setting seminar in Beijing to explore

opportunities for UK–China cooperation

in the development of standards for the

welfare of research animals and their

ethical use in China. This is important to

create an ethical framework within which

UK scientists can collaborate with partners

in China on a compatible basis. A further

UK–China Seminar is planned for 2015 to support the

further development of current voluntary standards

for research animal care, welfare and ethical use to

become mandatory national standards in China.

We have also engaged with other countries that

mandate testing for cosmetics, including Brazil, where

we are encouraging a new domestic political initiative

to legislate against the unnecessary use of animals in

testing cosmetics and also the acceptance of safety

data which has been produced overseas, such as in

the UK. As the third largest consumer of cosmetics in

the world, Brazil has the potential to deliver the great

reductions in animal testing.

12


Strategic priority 3 Promoting an understanding and awareness about the use of animals where no alternatives exist


The Government is committed to promoting a culture of

openness and transparency around the use of animals

in scientific research. Openness is crucial to help people

understand, and challenge if they wish, the reasons for

animal research where no validated alternatives exist,

and to demonstrate more widely the many safeguards in

place to minimise suffering. Public trust in the regulatory

system depends in large part on people feeling that they

have the ability to get answers to their questions and

to explore any concerns. Being able and willing to talk

openly about the use of animals also helps signal to

global industry and academia that the UK remains one

of the best places for high quality life sciences research.

To understand public opinion in this area and gauge

the success of new approaches on openness, the

Government continues to commission an independent

opinion poll on public attitudes to animal research.

Results from the latest poll in March 2014 indicate that

around two-thirds of the public continue to accept the

use of animals in medical research where there are no

alternatives. At the same time, the poll suggested that

more could be done to increase public understanding

around animal research. For example, only three in

ten respondents said that they felt “well informed”

about the use of animals in research, while a similar

proportion still believed that animal testing is allowed

for cosmetics, despite this having been banned in the

UK for over a decade. The poll clearly indicates the

need for openness and transparency to place public

understanding on a firm footing to inform well-evidenced

public debate on the issues. Since that poll was carried

out, a number of new initiatives on openness and

transparency have been launched, as summarised

below.

Action 3.3 Concordat on openness and transparency

In May 2014, the life sciences sector launched a

landmark ‘Concordat on openness and transparency in

UK animal research’4. The Concordat has been signed

by 86 organisations working across the UK life sciences

sector, including major pharmaceutical companies

and contract research organisations, UK universities

engaged in animal research and the UK’s medical

research charities. It commits each organisation to the

following four pledges.

● To be clear about when, how and why they use

animals in research.

● To enhance their communications with the media

and the public about their research using animals.

● To be proactive in providing opportunities for the

public to find out about research using animals.

● To report on progress annually.

4 http://www.understandinganimalresearch.org.uk/policy/concordat-openness-animal-research/

13


5 http://www.ucl.ac.uk/animal-research http://www.cam.ac.uk/research/research-at-cambridge/animal-research http://www.cardiff.ac.uk/research/our-research-environment/integrity-and-ethics/animal-research http://www.bristol.ac.uk/university/governance/policies/animal-policy.html

6 https://www.gov.uk/government/publications/compliance-investigations-by-the-animals-in-science-regulation-unit

The Concordat puts the UK life sciences sector at

the head of global efforts to increase openness and

transparency in animal research. Every signatory

organisation has given a clear commitment both to

facilitate greater scrutiny of their animal research and

to be visibly accountable by reporting annually on their

progress towards implementing the Concordat.

Its publication has already led directly to a number of

new initiatives on public engagement, including the

development of new websites5 and outreach activities

by, among others, University College London, the

University of Cambridge, the University of Bristol and

Cardiff University. Signatories are also taking steps to

engage directly with the public and the media, to explain

why they use animals in research and the measures

in place to ensure animal care and welfare. This more

accountable approach to the use of research animals

is intended to give members of the public a clearer idea

of the work carried out in animal research facilities, as

well as stimulate discussion and challenge. A progress

report on implementation of the Concordat is due to

be published in June 2015, and will include measures

taken to promote greater public dialogue about the

use of animals in research, as well as to invite greater

accountability.

Action 3.4: Review of section 24 of the Animals (Scientific Procedures) Act 1986

As we committed to in the Delivery

Plan, the Government has held

a full public consultation on

options to reform section 24 of the

Animals (Scientific Procedures)

Act 1986 (ASPA). Section 24

currently places a blanket ban on

the disclosure of any information

provided to the regulator or

those involved in animal research in confidence. The

Government recognises that this is out of step with

wider policy on openness and transparency. Last year’s

consultation document set out a preferred government

option of moving to more open disclosure of information

while retaining statutory prohibitions on the disclosure

of sensitive information, including that which could

prejudice intellectual property rights or compromise

personal safety.

Further actions supplementing the Delivery Plan objectives on openness

Publication of investigation reports

Further to the Delivery Plan, the Home Office has, in

2014, started publishing anonymised summaries of

reports where there has been a substantial investigation

by the regulator6. The Home Office has routinely

reported high-level summaries of all cases of non-

compliance in the ASRU Annual Report for several

years. However, these reports are in addition to the

usual reporting to help ensure that all stakeholders

can learn from the outcomes of these investigations

as early as possible and enable them to address any

potential weaknesses. In addition, the reports provide

14


the public with an insight into this work. In determining

which investigation reports to publish, the Home Office

have applied a public interest test. In the interests of

transparency, we expect that a decision to not publish

an investigation report to be the exception.

Publication of actual severity data pilot7

The recently transposed EU Directive (2010/63/EU)

requires the collection of data on the actual severity

of procedures. Each animal that undergoes scientific

procedures must be allocated a severity classification

indicating the level of harm actually suffered due to

those procedures. As an aid to ensuring a smooth

implementation of the new requirement for reporting

actual severity, a pilot study was carried out over a

two-month period in August and September 2013. The

data collected were a sample and not intended to be

entirely representative of the distribution of procedures

performed in the UK; however, it provided a preliminary

snapshot of the distribution of actual severity.

A prospective classification that predicts the likely

harms is assessed by inspectors and is used as part

of the harm–benefit analysis of a proposed project.

The intention behind introducing recording actual

rather than just prospective harm is primarily to

increase transparency on the real harms of animal use.

Collecting these data will also have the potential to aid

in the targeting of refinement initiatives by identifying

areas of high severity.

The results showed that 5% of the 35,409 procedures

reported were determined to be sub-threshold, 81.5%

were reported as mild, 11% were reported as moderate

and only 2% were reported as severe. Just over 1%

were non-recovery procedures. The severe procedures

involved mainly mice, rats and fish. Severe outcomes

were reported for both basic and applied research

procedures, and also for routine production, but not for

regulatory testing.

This information is now formally collected in the UK,

and in the rest of the EU for the first time for procedures

completed from January 2014 onwards. It will be

published for the first time later in 2015.

7 https://www.gov.uk/government/publications/animals-in-science-regulation-unit-annual-report-2013


15

In this section we describe each of the actions set out

in the Delivery Plan and provide a detailed report on

progress.

In the Delivery Plan we described a wide range of

measures to promote the 3Rs, both within the UK and

internationally. The Plan also provided opportunities

for researchers and industry to address the 3Rs in

their work. The actions included existing programmes

and also sought to foster new, specifically targeted,

programmes.

As in the Delivery Plan, the Delivery Report tables in

this section consider progress on delivery against each

of our three strategic priorities:

Strategic Priority 1 – a domestic programme which

focuses on advancing the use of the 3Rs within the UK;

Strategic Priority 2 – an international programme

aimed at influencing the uptake and adoption of 3Rs

approaches globally; and

Strategic Priority 3 – a programme aimed at promoting

an understanding and awareness about the use of

animals where no alternatives exist.

Tables

16


Stra

tegi

c Pr

iorit

y 1:

Adv

anci

ng th

e us

e of

the

3Rs

dom

estic

ally

by

putti

ng th

em a

t the

hea

rt o

f sci

ence

-led

prog

ram

mes

.

Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

1.1

Nat

iona

l Cen

tre

for t

he R

epla

cem

ent,

Ref

inem

ent a

nd

Red

uctio

n of

Ani

mal

s in

R

esea

rch

prog

ram

mes

(NC

3Rs)

1) P

ublic

atio

n of

the

seco

nd re

view

of t

he N

C3R

s re

sear

ch p

ortfo

lio b

y N

ovem

ber 2

013.

- Rec

eive

d po

sitiv

ely

by s

take

hold

ers

and

sect

or.

- Enh

ance

d un

ders

tand

ing

by s

take

hold

ers

and

publ

ic o

f hig

h-qu

ality

rese

arch

fund

ed

by th

e N

C3R

s an

d th

e an

imal

wel

fare

, sc

ient

ific

and

soci

etal

ben

efits

of t

his.

Com

plet

ed.

2) L

aunc

h of

the

NC

3Rs

Exp

erim

enta

l Des

ign

Ass

ista

nt o

nlin

e re

sour

ce.

Ear

ly u

ptak

e an

d us

e by

rese

arch

co

mm

unity

and

impr

oved

und

erst

andi

ng

of th

e 3R

s be

nefit

s to

goo

d ex

perim

enta

l de

sign

.

The

beta

test

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is n

ow c

ompl

ete

and

the

syst

em

is b

eing

am

ende

d fro

m s

take

hold

er fe

edba

ck. T

he

Exp

erim

enta

l Des

ign

Ass

ista

nt w

ill b

e la

unch

ed in

20

15.

3) C

RA

CK

IT: T

he 2

013

CR

AC

K IT

Cha

lleng

es

com

petit

ion

cons

ists

of f

ive

Cha

lleng

es id

entif

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join

tly b

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e N

C3R

s an

d in

dust

ry s

pons

ors

who

pr

ovid

e in

-kin

d co

ntrib

utio

ns in

clud

ing

data

, ac

cess

to c

ompo

unds

, val

idat

ion

stud

ies,

etc

. C

RA

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IT C

halle

nges

is a

mile

ston

e-dr

iven

fu

ndin

g co

mpe

titio

n fro

m th

e N

C3R

s w

hich

is

desi

gned

to (i

) min

imis

e th

e us

e of

ani

mal

s in

re

sear

ch; a

nd (i

i) su

ppor

t the

dev

elop

men

t of

mar

keta

ble

prod

ucts

and

/or i

mpr

oved

bus

ines

s pr

oces

ses.

The

tota

l bud

get f

or th

e 20

13 ro

und

of C

RA

CK

IT C

halle

nges

is a

ppro

xim

atel

y £7

m.

Con

tract

s aw

arde

d to

add

ress

the

chal

leng

es.

The

2014

Pha

se 1

aw

ards

for p

roof

-of-c

once

pt s

tudi

es

have

bee

n m

ade

for t

he th

ree

CR

AC

K IT

Cha

lleng

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– th

ese

focu

s on

toxi

city

end

-poi

nts

and

we

have

sp

onso

rs (w

ho p

rovi

de in

-kin

d co

ntrib

utio

ns) f

rom

the

phar

mac

eutic

al a

nd c

hem

ical

sec

tors

. The

Pha

se 2

w

inne

rs w

ill b

e de

cide

d in

Jul

y 20

15.

4) S

trate

gic

awar

d: Im

agin

g te

chno

logy

de

velo

pmen

t for

the

3Rs

– th

e N

C3R

s ha

ve

rece

ntly

ann

ounc

ed a

stra

tegi

c fu

ndin

g ca

ll to

sup

port

high

-qua

lity

rese

arch

pro

posa

ls

to a

ddre

ss g

enui

ne te

chno

logi

cal c

halle

nges

in

pre

clin

ical

imag

ing

whi

ch, i

f sol

ved,

wou

ld

adva

nce

scie

nce

and

the

3Rs.

The

tota

l bud

get

for t

his

stra

tegi

c ca

ll is

£1m

.

Awar

ds m

ade.

Th

e su

m o

f £1.

5 m

illio

n ha

s be

en in

vest

ed in

five

im

agin

g pr

ojec

ts w

ith c

o-fu

ndin

g fro

m th

e E

ngin

eerin

g an

d P

hysi

cal S

cien

ces

Res

earc

h C

ounc

il (E

PS

RC

).

5) D

isea

se m

odel

s –

the

NC

3Rs

are

deve

lopi

ng

a pr

ogra

mm

e of

wor

k, b

ased

on

prev

ious

ex

perie

nce,

focu

sing

on

dise

ase

mod

els

and

effic

acy

test

ing.

Thi

s in

clud

es d

isea

se a

reas

su

ch a

s as

thm

a, e

pile

psy

and

pain

, and

they

are

w

orki

ng w

ith th

e A

BP

I to

secu

re fu

ndin

g to

lead

on

this

. An

initi

al p

riorit

y is

can

cer m

odel

s.

Eng

agin

g an

d bu

ildin

g re

latio

nshi

ps w

ith

the

canc

er re

sear

ch c

omm

unity

in a

pply

ing

the

3Rs

to th

eir r

esea

rch.

A w

orks

hop

was

hel

d in

Feb

ruar

y 20

15 c

over

ing

prec

linic

al o

ncol

ogy

rese

arch

mod

els.

The

out

put o

f w

orks

hop

will

info

rm N

C3R

s’ fu

ture

pla

ns in

onc

olog

y su

ch a

s re

sear

ch in

vest

men

t.

17

Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi

tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

1.2

Impr

oved

reso

urce

sh

arin

g in

clud

ing

outc

omes

of r

esea

rch,

re

sour

ces,

ani

mal

s an

d da

ta

(NC

3Rs

with

MR

C a

nd

BB

SRC

)

Exa

mpl

es o

f ong

oing

wor

k in

clud

e:- R

ecen

tly la

unch

ed N

C3R

s In

frast

ruct

ure

for

Impa

ct (I

fL) s

chem

e.- S

hare

d A

gein

g R

esea

rch

Mod

els

(ShA

RM

–

Bio

repo

sito

ry o

f age

d m

ouse

tiss

ues)

.- A

vaila

bilit

y of

Non

Hum

an P

rimat

e tis

sue

from

C

entre

for M

acaq

ues

(CFM

).- E

nhan

ced

arch

ivin

g of

ani

mal

mod

els

in

acad

emia

.- C

oord

inat

ed m

ouse

phe

noty

ping

of g

enet

ical

ly

alte

red

anim

als

(IMP

C).

- The

NC

3Rs

and

fund

ers

are

cons

ider

ing

way

s to

enh

ance

dat

a-sh

arin

g an

d pu

blic

atio

n of

ne

gativ

e re

sults

.

Four

Infra

stru

ctur

e fo

r Im

pact

pro

ject

s aw

arde

d to

talli

ng £

1.3m

.Th

ere

has

been

a s

tead

y in

crea

se in

usa

ge o

f th

e Fr

ozen

Em

bryo

and

Spe

rm A

rchi

ve (F

ES

A) a

t M

RC

Har

wel

l, pa

rt of

the

Eur

opea

n M

utan

t Mou

se

Arc

hive

, bot

h fo

r arc

hivi

ng s

tock

s an

d in

requ

ests

fo

r dis

tribu

tion.

Impr

oved

tech

niqu

es h

ave

led

to a

sh

ift fr

om fr

eezi

ng e

mbr

yos

tow

ards

free

zing

spe

rm,

whi

ch re

duce

s th

e nu

mbe

rs o

f mic

e ne

cess

ary

per

stra

in fo

r arc

hivi

ng a

nd re

cove

ry. A

wor

ksho

p w

as

held

in F

ebru

ary

2015

that

bro

ught

toge

ther

fund

ers,

pu

blis

hers

and

sci

entis

ts to

dis

cuss

the

impa

ct o

f pu

blic

atio

n bi

as o

n an

imal

rese

arch

1.3

Post

grad

uate

3R

s tr

aini

ng

(NC

3Rs)

PhD

stu

dent

ship

sch

eme

as p

art o

f the

NC

3Rs

stra

tegy

to e

mbe

d th

e 3R

s in

the

train

ing

and

deve

lopm

ent o

f sci

entis

ts fr

om th

e st

art o

f the

ir ca

reer

s. T

o da

te 3

7 aw

ards

in to

tal h

ave

been

m

ade.

Impr

oved

trai

ning

on

proj

ect d

esig

n fo

r P

hD s

tude

nts.

In D

ecem

ber 2

014

an

awar

d w

as g

iven

to a

furth

er

coho

rt of

ten

PhD

stu

dent

ship

s to

talli

ng £

900,

000.

Tw

o of

the

awar

ds a

re fo

r pro

ject

s to

refin

e ro

dent

mod

els

of s

troke

.

Stra

tegi

c P

riorit

y 1

18


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

1.4

Incr

ease

the

impa

ct o

f H

ome

Offi

ce in

spec

tors

an

d ot

her r

egul

ator

s in

th

e di

ssem

inat

ion

of 3

Rs

adva

nces

and

adv

ise

abou

t im

plem

enta

tion

(HO

and

MH

RA

)

Enh

ance

d di

ssem

inat

ion

of th

e 3R

s th

roug

h co

ntin

ued

deve

lopm

ent o

f exp

ert k

now

ledg

e ne

twor

ks (i

nter

nal H

O In

spec

tora

te a

ctiv

ities

w

orki

ng w

ith o

ther

s e.

g. N

C3R

s) a

nd e

xter

nally

w

ith li

cens

ees

thro

ugh:

- pub

licat

ion

of G

uida

nce

on th

e op

erat

ion

of th

e A

ct w

ith in

crea

sed

emph

asis

on

3Rs

and

harm

–be

nefit

ass

essm

ent;

- out

reac

h ac

tiviti

es a

ttend

ing

and

spea

king

at

mee

tings

and

con

fere

nces

; and

- reg

ular

dis

cuss

ions

with

new

and

exi

stin

g lic

ense

es.

i) G

uida

nce

to n

ew re

gula

tions

pub

lishe

d in

clud

ing

sign

ifica

nt m

ater

ial o

n 3R

s an

d ha

rm–b

enef

it as

sess

men

t.ii)

Insp

ecto

rate

hav

e fo

rmal

ised

a

stra

tegy

for i

nter

nal k

now

ledg

e tra

nsfe

r.

iii) I

nspe

ctor

ate

have

form

alis

ed a

stra

tegy

fo

r dis

sem

inat

ion

of 3

Rs

info

rmat

ion

and

impl

emen

tatio

n w

ith li

cens

ees.

iv) C

ontin

uatio

n of

Con

tinuo

us P

rofe

ssio

nal

Dev

elop

men

t act

iviti

es a

nd n

etw

orki

ng w

ith

rele

vant

sta

keho

lder

s.

i) G

uida

nce

com

plet

ed.

ii) Im

prov

ed k

now

ledg

e tra

nsfe

r and

dis

sem

inat

ion

of 3

Rs

info

rmat

ion

bein

g de

velo

ped

as p

art o

f a

tech

nolo

gy re

set p

rogr

amm

e to

be

deliv

ered

late

201

5.iii

) A re

view

of t

he in

spec

tion

proc

ess

has

emer

ging

fin

ding

s to

adv

ance

them

atic

insp

ectio

n to

dev

elop

w

ider

eng

agem

ent w

ith s

peci

alis

t gro

ups,

NC

3Rs

and

licen

sees

to p

rom

ote

cons

iste

nt le

adin

g pr

actic

e.iv

) Ong

oing

incl

udin

g at

tend

ance

at N

C3R

s w

orks

hops

, ext

erna

l sta

keho

lder

mee

tings

(LA

SA

, LA

VA, I

nter

natio

nal N

euro

logy

and

Imm

unol

ogy

Con

fere

nces

) and

EU

Com

mis

sion

wor

ksho

ps.

Incr

ease

d re

quire

men

t to

appl

ican

ts fo

r new

M

arke

ting

Aut

horis

atio

ns to

dem

onst

rate

ab

senc

e of

a s

uita

ble

non-

anim

al te

st b

efor

e an

aut

horis

atio

n ba

sed

on a

n an

imal

test

will

be

appr

oved

. Wor

king

with

the

Hom

e O

ffice

, MH

RA

to

pur

sue

man

ufac

ture

rs w

ith e

xist

ing

Mar

ketin

g A

utho

risat

ions

to v

alid

ate

non-

anim

al te

sts

for

thei

r pro

duct

, par

ticul

arly

whe

re th

e an

imal

test

is

sev

ere,

or w

here

ano

ther

man

ufac

ture

r of a

si

mila

r pro

duct

has

val

idat

ed a

non

-ani

mal

test

.

i) N

ew M

arke

ting

Aut

horis

atio

ns b

ased

on

non-

anim

al te

sts

bein

g ap

prov

ed.

ii) W

aivi

ng o

f app

licat

ion

fee

by c

lass

ifyin

g su

ch a

cha

nge

as a

Typ

e 1

varia

tion

to th

e M

arke

ting

Aut

horis

atio

n.iii

) Non

-ani

mal

test

s fo

r exi

stin

g M

arke

ting

Aut

horis

atio

ns b

eing

sub

mitt

ed.

The

Med

icin

es a

nd H

ealth

care

Pro

duct

s R

egul

ator

y A

genc

y (M

HR

A) h

as c

ontin

ued

to w

ork

with

com

pani

es

to d

evel

op a

nim

al a

ltern

ativ

es a

nd h

ighl

ight

s an

y su

ch

poss

ibili

ties

whe

n as

sess

ing

doss

iers

.Stra

tegi

c P

riorit

y 1

19


1 ht

tp://

jour

nals

.lww

.com

/sho

ckjo

urna

l/Abs

tract

/pub

lisha

head

/Ref

inem

ent_

of_A

nim

al_M

odel

s_of

_Sep

sis_

and_

Sep

tic.9

8571

.asp

x2

http

://w

ww

.fram

e.or

g.uk

/wp-

cont

ent/u

ploa

ds/2

014/

09/R

SP

CA

-Roa

d-M

ap.p

df

Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

1.5

Ref

inem

ent o

f mod

els

(RSP

CA

with

HO

)

(Cef

as w

ith N

C3R

s)

Wor

k to

refin

e th

e m

ost s

ever

e m

odel

s to

av

oid

or re

duce

ani

mal

suf

ferin

g. M

odel

s to

be

cons

ider

ed in

clud

e:

- Exp

erim

enta

l Aut

oim

mun

e E

ncep

halo

mye

litis

(E

AE

);- S

eizu

res;

- Rhe

umat

oid

arth

ritis

; and

- Sep

sis.

- Rep

orts

on

each

of t

he s

elec

ted

topi

cs

prep

ared

and

pub

lishe

d.

- Rec

omm

enda

tions

pro

mul

gate

d.

Rhe

umat

oid

arth

ritis

repo

rt co

mpl

eted

and

sub

mitt

ed to

A

rthrit

is R

esea

rch

& T

hera

py, c

urre

ntly

with

revi

ewer

s.

Rep

ort p

rom

oted

via

pos

ter a

t RU

S-L

AS

A-IC

LAS

by

HO

I co-

auth

or, f

urth

er p

rom

otio

n by

Roy

al S

ocie

ty fo

r th

e P

reve

ntio

n of

Cru

elty

to A

nim

als

(RS

PC

A) p

lann

ed

whe

n re

port

is in

pre

ss1 .

The

RS

PC

A al

so d

evel

oped

an

d pu

blis

hed

a ‘R

oad

Map

’ tow

ards

end

ing

seve

re

suffe

ring

in 2

0142 :

This

pro

vide

s ge

neric

gui

danc

e in

the

form

of a

se

ries

of p

ract

ical

ste

ps th

at e

stab

lishm

ents

can

ta

ke to

iden

tify

and

impl

emen

t app

roac

hes

to e

nabl

e th

em to

wor

k to

war

ds e

ndin

g th

e us

e of

mod

els

and

proc

edur

es th

at c

an c

ause

sev

ere

suffe

ring.

RS

PC

A pl

ans

for w

ork

on s

ever

e su

fferin

g fo

r 201

5:• T

wo

furth

er E

WG

s w

ill b

e es

tabl

ishe

d in

201

5 w

ith th

e ai

m to

com

plet

e gu

idan

ce fo

r pub

licat

ion

in e

arly

201

6.• T

he ‘R

oad

Map

’ app

roac

h w

ill b

e de

velo

ped

furth

er,

incl

udin

g th

e pr

oduc

tion

of a

reso

urce

pac

k th

at c

an b

e im

plem

ente

d at

est

ablis

hmen

ts.

• An

onlin

e re

sour

ce to

pro

vide

pra

ctic

al g

uida

nce

on

refin

ing

and

avoi

ding

pro

cedu

res

that

cou

ld c

ause

se

vere

suf

ferin

g is

cur

rent

ly a

t the

pla

nnin

g st

age.

Stra

tegi

c P

riorit

y 1

20


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

i) M

easu

res

take

n to

elim

inat

e de

ath

as a

n en

d-po

int i

n fis

h di

seas

e st

udie

s to

redu

ce s

uffe

ring.

Th

is re

pres

ents

bet

wee

n 76

% a

nd 9

4% o

f the

fis

h w

ork

of th

e N

atio

nal R

efer

ence

Lab

orat

ory.

ii) R

efin

emen

t of t

he F

ish

Sex

ual D

evel

opm

ent

Test

(FS

DT)

for d

etec

ting

early

life

-sta

ge e

ffect

s an

d po

tent

ial a

dver

se c

onse

quen

ces

of p

utat

ive

endo

crin

e di

srup

ting

com

poun

ds o

n se

xual

de

velo

pmen

t (C

efas

– fu

ndin

g fro

m N

C3R

s).

The

deve

lopm

ent o

f mol

ecul

ar m

arke

rs fo

r st

ickl

ebac

k en

docr

ine

func

tion

and

prot

ocol

s fo

r st

udyi

ng b

ehav

iour

of t

he a

nim

als

to fa

cilit

ate

a de

crea

se in

use

of s

tickl

ebac

ks.

iii) N

C3R

s’ fu

ndin

g to

exa

min

e in

dica

tors

of f

ish

wel

l-bei

ng.

i) A

ctiv

e ev

alua

tion

of d

iffer

ent w

ays

to re

duce

ani

mal

suf

ferin

g an

d an

imal

nu

mbe

rs u

sed.

The

new

pro

ject

lice

nce

for t

his

wor

k do

es n

ot in

clud

e de

ath

as a

n en

d-po

int.

ii) H

as re

sulte

d in

a 2

5% to

50%

redu

ctio

n in

the

num

ber o

f fis

h ne

eded

for t

his

test

. A

calc

ulat

ion

of th

e nu

mbe

r of c

hem

ical

s re

quiri

ng F

SD

T te

stin

g in

Eur

ope

alon

e sh

ows

that

use

of s

tickl

ebac

ks in

this

test

w

ill re

sult

in a

bout

90,

000

few

er fi

sh b

eing

sa

crifi

ced.

iii) P

roje

ct re

port

dem

onst

ratin

g be

tter f

ish

wel

fare

in e

xper

imen

tal s

yste

ms,

but

als

o m

ore

wid

ely

in fa

rmed

fish

in a

quac

ultu

re.

i) U

nder

wat

er c

amer

as h

ave

been

est

ablis

hed

in

30 ta

nks.

Thi

s is

giv

ing

a cl

ear p

ictu

re o

f ani

mal

be

havi

our,

clin

ical

sig

ns a

nd w

elfa

re w

ithou

t the

nee

d to

dis

turb

the

fish

unne

cess

arily

for c

heck

s. F

ish

that

ar

e di

spla

ying

sig

ns o

f mor

bidi

ty c

an b

e re

mov

ed

befo

re th

ey d

ie, s

ubst

antia

lly re

duci

ng th

eir s

uffe

ring.

ii) T

he re

finem

ent o

f the

test

is c

ompl

ete

and

it is

now

ava

ilabl

e fo

r use

. The

new

mod

el s

peci

es

(stic

kleb

acks

) is

now

in th

e re

gula

tory

gui

delin

e (T

G23

4).

iii) T

his

is in

the

mid

dle

of th

e ex

perim

enta

l pha

se.

Pre

limin

ary

resu

lts in

dica

te th

at s

mal

l cha

nges

in th

e aq

uaria

mak

e la

rge

diffe

renc

es to

fish

beh

avio

ur. T

he

aim

is to

link

this

with

mar

kers

in th

e w

ater

that

can

be

mea

sure

d no

n-in

vasi

vely.

1.6

“Act

ual S

ever

ity”

repo

rtin

g in

Ann

ual

Stat

istic

s on

Use

of

Ani

mal

s in

Sci

ence

(HO

)

Impl

emen

t ret

rosp

ectiv

e re

porti

ng o

f the

“Act

ual

Sev

erity

” of a

ll sc

ient

ific

proc

edur

es o

n pr

otec

ted

anim

als

in li

ne w

ith th

e D

irect

ive

(201

0/63

/EU

). Th

is w

ill e

nabl

e us

to b

ette

r und

erst

and:

- lev

els

of o

vera

ll an

imal

suf

ferin

g in

term

s of

nu

mbe

rs o

f ani

mal

s ex

perie

ncin

g ea

ch c

ateg

ory

of s

ever

ity –

sub

-thre

shol

d, m

ild, m

oder

ate

or

seve

re;

- whi

ch p

roce

dure

s ar

e m

ost s

ever

e an

d in

whi

ch

spec

ies;

and

- whe

ther

3R

s im

plem

enta

tion

is h

avin

g an

im

pact

on

redu

cing

ove

rall

seve

rity.

i) C

ompl

etio

n an

d re

view

of p

ilot t

rial f

or

retro

spec

tive

(act

ual)

seve

rity

repo

rting

.ii)

Dev

elop

men

t of G

uida

nce

on re

cord

ing

Act

ual S

ever

ity.

iii) C

omm

ence

pro

ject

to m

ap p

heno

typi

ng

of G

A m

ouse

stra

ins

to a

ctua

l sev

erity

ca

tego

ries

com

men

ced

(with

ext

erna

l st

akeh

olde

rs e

.g. M

RC

Har

wel

l).iv

) Com

plet

ion

of a

naly

sis

of p

ilot d

ata

for

limite

d pu

blic

atio

n.v)

Pub

licat

ion

of fi

rst c

ompl

ete

year

of

retro

spec

tive

actu

al s

ever

ity d

ata.

vi) P

rovi

sion

of c

ompl

ete

year

dat

a to

the

EU

Com

mis

sion

.

i) C

ompl

eted

and

pub

lishe

d in

the

AS

RU

Ann

ual

repo

rt.3

ii) G

uida

nce

on A

ctua

l Sev

erity

pub

lishe

d on

the

Hom

e O

ffice

web

site

4

iii) P

heno

typi

ng p

roje

ct w

orks

hop

with

MR

C H

arw

ell

held

with

Hom

e O

ffice

Insp

ecto

rs. A

SR

U in

tend

to

publ

ish

mat

eria

l in

2015

as

a to

ol fo

r est

ablis

hmen

ts to

en

sure

effe

ctiv

e br

eedi

ng p

ract

ices

, spe

cific

ally

for G

A

anim

als.

iv) P

ilot d

ata

publ

ishe

d in

201

3 A

nim

als

in S

cien

ce

Reg

ulat

ion

Uni

t (A

SR

U) a

nnua

l rep

ort.

Firs

t ful

l yea

r da

ta to

be

publ

ishe

d in

Jul

y 20

15.

1.7

Cap

ture

of

info

rmat

ion

on s

cien

tific

ou

tput

s re

leva

nt to

3R

s an

d th

e im

plem

enta

tion

of 3

Rs

adva

nces

(MR

C a

nd B

BSR

C)

Res

earc

h C

ounc

ils to

impr

ove

the

capt

ure

of

info

rmat

ion

on s

cien

tific

out

puts

rele

vant

to 3

Rs

and

the

impl

emen

tatio

n of

3R

s ad

vanc

es in

fu

nded

pro

ject

s.D

ata

on 3

Rs

impl

emen

tatio

n an

d re

leva

nt

outp

uts

capt

ured

via

the

intro

duct

ion

of

new

que

stio

ns in

the

Res

earc

h C

ounc

ils’

com

pute

rised

dat

a-ga

ther

ing

syst

ems.

Enc

oura

gem

ent o

f oth

er c

harit

able

fund

ers

to d

o lik

ewis

e.

i) S

ucce

ssfu

l col

lect

ion

of c

aptu

red

data

.ii)

Pub

licat

ion

of a

naly

sis

of d

ata

colle

cted

.iii

) Oth

er m

ajor

cha

ritab

le fu

nder

s of

ani

mal

re

sear

ch a

ble

to c

olle

ct c

ompa

rabl

e da

ta.

A ne

w s

et o

f que

stio

ns a

bout

the

3Rs

has

been

in

trodu

ced

into

Res

earc

hfis

h, th

e on

line

syst

em

for c

olle

ctin

g in

form

atio

n on

rese

arch

out

puts

, ou

tcom

es a

nd im

pact

, and

rese

arch

ers

fund

ed b

y M

edic

al R

esea

rch

Cou

ncil

(MR

C),

Bio

tech

nolo

gy a

nd

Bio

logi

cal S

cien

ces

Res

earc

h C

ounc

il (B

BS

RC

) and

so

me

med

ical

cha

ritie

s s

ubm

itted

dat

a fo

r the

firs

t tim

e in

Nov

embe

r 201

4. T

he fi

rst a

naly

sis

of d

ata

on

impl

emen

tatio

n of

the

3Rs

and

outp

uts

rele

vant

to th

e 3R

s w

ill b

e av

aila

ble

in 2

015.

Stra

tegi

c P

riorit

y 1

3 ht

tps:

//ww

w.g

ov.u

k/go

vern

men

t/pub

licat

ions

/ani

mal

s-in

-sci

ence

-reg

ulat

ion-

unit-

annu

al-r

epor

t-201

34

http

s://w

ww

.gov

.uk/

gove

rnm

ent/u

ploa

ds/s

yste

m/u

ploa

ds/a

ttach

men

t_da

ta/fi

le/2

7601

4/N

otes

Act

ualS

ever

ityR

epor

ting.

pdf

21


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

1.8

Upd

ated

requ

irem

ents

fo

r app

licat

ions

whi

ch

incl

ude

anim

al re

sear

ch

(MR

C a

nd B

BSR

C)

Res

earc

h C

ounc

ils to

issu

e up

date

d re

quire

men

ts a

nd g

uida

nce

for a

pplic

atio

ns

whi

ch in

clud

e re

sear

ch in

volv

ing

the

use

of

anim

als.

Ens

ure

that

eve

ry re

sear

ch p

rogr

amm

e an

d pr

ojec

t pro

posa

l rec

eive

s ef

fect

ive

scru

tiny

befo

re it

is fu

nded

and

that

opp

ortu

nitie

s to

im

plem

ent s

cien

tific

adv

ance

s to

repl

ace,

redu

ce

or re

fine

anim

al u

se a

re n

ot m

isse

d.

i) D

rafti

ng a

nd is

suin

g of

new

gui

danc

e.ii)

Eva

luat

ion

of im

pact

of n

ew g

uida

nce.

Med

ical

Res

earc

h C

ounc

il (M

RC

) and

Bio

tech

nolo

gy

and

Bio

logi

cal S

cien

ces

Res

earc

h C

ounc

il (B

BS

RC

) ha

ve is

sued

revi

sed

guid

ance

for a

pplic

ants

abo

ut

info

rmat

ion

that

mus

t be

prov

ided

in p

ropo

sals

in

volv

ing

the

use

of a

nim

als.

A w

orks

hop

was

hel

d jo

intly

with

NC

3Rs

for B

oard

and

Pan

el m

embe

rs

in S

epte

mbe

r 201

4 to

pro

mot

e th

e im

porta

nce

of

impr

oved

scr

utin

y of

exp

erim

enta

l des

ign

in th

e pe

er

revi

ew p

roce

ss.

1.9

Hig

hlig

ht o

n ‘A

nim

al

Wel

fare

: Mea

sure

s an

d as

sess

men

t’

(BB

SRC

and

NC

3Rs)

Dis

sem

inat

ion

even

t: B

BS

RC

join

t hig

hlig

ht

with

NC

3Rs

on ‘A

nim

al W

elfa

re: M

easu

res

and

asse

ssm

ent’.

16 p

roje

cts

fund

ed to

talli

ng n

early

£5.

8m.

BB

SR

C w

orki

ng w

ith N

C3R

s to

ens

ure

that

ou

tput

s ar

e ca

ptur

ed a

nd d

isse

min

ated

to

ensu

re b

ette

r mon

itorin

g an

d as

sess

men

t of

wel

fare

in th

e fu

ture

.D

isse

min

atio

n ev

ents

dur

ing

the

cour

se o

f th

e pr

ogra

mm

e.

Pla

ns fo

r dis

sem

inat

ion

even

t in

sprin

g 20

15.

1.10

Vet

erin

ary

vacc

ine

test

ing

(VM

D a

nd D

efra

)

Rev

iew

of b

atch

test

ing

of b

iolo

gica

ls s

uch

as

vete

rinar

y va

ccin

es.

Iden

tific

atio

n of

are

as fo

r pos

sibl

e re

plac

emen

t in

the

batc

h te

stin

g of

vac

cine

s, e

spec

ially

are

as

of s

uch

test

ing

invo

lvin

g an

imal

s w

here

the

repl

acem

ent o

f the

test

wou

ld h

ave

the

bigg

est

impa

ct in

redu

cing

num

ber o

f ani

mal

s us

ed.

A re

port

setti

ng o

ut th

e nu

mbe

r of a

nim

als

used

dur

ing

in-p

roce

ss a

nd fi

nal p

rodu

ct

test

ing

of b

atch

es o

f vac

cine

s re

leas

ed b

y th

e V

MD

.

A re

port

was

pub

lishe

d in

Apr

il 20

14 e

liciti

ng

cons

ider

able

inte

rest

am

ong

vete

rinar

y m

edic

ines

re

gula

tors

thro

ugho

ut E

urop

e. A

sho

rt pr

esen

tatio

n w

as g

iven

to th

e Im

mun

olog

ical

Wor

king

Par

ty o

f the

C

omm

ittee

for M

edic

inal

Pro

duct

s fo

r Vet

erin

ary

Use

(C

VM

P) a

nd a

pos

ter a

bout

the

repo

rt pr

esen

ted

at

the

50th

Ann

iver

sary

Con

fere

nce

of th

e E

urop

ean

Dire

ctor

ate

for t

he Q

ualit

y of

Med

icin

es (E

DQ

M).

In

2014

, fur

ther

pre

sent

atio

ns w

ere

give

n to

the

Eur

opea

n M

edic

ines

Age

ncy

Ad

Hoc

Joi

nt E

xper

t Gro

up o

n th

e 3R

s an

d at

a V

eter

inar

y Va

ccin

es c

onfe

renc

e in

B

russ

els.

Stra

tegi

c P

riorit

y 1

22


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

1.11

Hum

an V

acci

ne

test

ing

(PH

E)

Dev

elop

men

t of 3

Rs

tech

niqu

es fo

r use

in

hum

an v

acci

ne d

evel

opm

ent.

i) W

orki

ng w

ith a

cade

mic

and

clin

ical

par

tner

s to

de

velo

p a

BC

G m

odel

that

allo

ws

asse

ssm

ent

of e

ffica

cy o

f nov

el T

B v

acci

nes

whi

ch re

fine

the

use

of a

nim

al m

odel

s.ii)

Act

ivel

y de

velo

ping

cel

l-bas

ed a

ssay

s fo

r the

ch

arac

teris

atio

n of

the

man

ufac

turin

g pr

oces

s an

d th

e ba

tch

rele

ase

of th

e pr

oduc

t, ev

alua

ting

the

pote

ntia

l to

repl

ace

toxi

city

rele

ase

test

s.

i) Th

is m

odel

has

the

pote

ntia

l to

refin

e th

e cu

rren

t tes

t to

allo

w fu

rther

dev

elop

men

t to

take

pla

ce a

t hum

an c

linic

al tr

ials

sta

ge.

ii) If

dev

elop

ed, t

he T

oxin

Neu

tralis

atio

n A

ssay

test

will

repl

ace

the

curr

ent p

oten

cy

test

resu

lting

in a

redu

ctio

n in

the

num

bers

of

ani

mal

s us

ed a

nd th

e se

verit

y of

the

test

ing.

i) Th

e us

e of

adv

ance

d lu

ng im

agin

g, in

non

-hum

an

prim

ates

, has

led

to th

e es

tabl

ishm

ent o

f mor

e re

fined

ef

ficac

y st

udie

s fo

r TB

vac

cine

s an

d th

erap

eutic

s by

redu

cing

the

chal

leng

e do

se th

at n

eeds

to b

e gi

ven.

Thi

s ha

s re

sulte

d in

less

dis

ease

sev

erity

and

sh

orte

ning

the

time

take

n to

dem

onst

rate

effi

cacy

, in

add

ition

to a

redu

ctio

n in

the

num

ber o

f ani

mal

s us

ed. F

urth

erm

ore,

fund

ing

has

been

pro

vide

d fo

r the

de

velo

pmen

t of a

wel

fare

ass

essm

ent s

yste

m th

at w

ill

quan

tify

refin

emen

t stra

tegi

es. T

his

will

be

publ

ishe

d in

due

cou

rse.

Sof

twar

e w

ill b

e la

unch

ed to

allo

w th

e re

sear

ch c

omm

unity

to a

pply

the

wel

fare

ass

essm

ent

in a

use

r-fri

endl

y m

anne

r.ii)

The

in v

itro

com

pone

nt o

f the

ass

ay (T

oxin

ne

utra

lisat

ion

assa

y) h

as b

een

deve

lope

d an

d va

lidat

ed. T

he d

evel

opm

ent o

f the

in v

ivo

com

pone

nt

is n

ear c

ompl

etio

n an

d th

e va

lidat

ion

will

be

com

plet

ed

this

yea

r. Th

is w

ill th

en le

ad to

a re

duct

ion

in b

oth

the

num

ber a

nd s

ever

ity o

f ani

mal

pro

cedu

res

requ

ired

for

the

batc

h re

leas

e as

says

.

1.12

Dev

elop

men

t of n

on-

anim

al te

chno

logi

es

(TSB

and

NC

3Rs)

Tech

nolo

gy S

trate

gy B

oard

(TS

B) d

evel

opm

ent

of n

on-a

nim

al te

chno

logi

es.

Com

petit

ion

to fu

nd e

arly

sta

ge fe

asib

ility

stu

dies

in

vest

igat

ing

nove

l non

-ani

mal

tech

nolo

gies

to

impr

ove

prod

uct d

evel

opm

ent a

cros

s a

rang

e of

in

dust

ries.

Up

to £

4 m

illio

n fu

ndin

g av

aila

ble.

Indu

stry

and

sec

tor i

nfor

med

of c

ompe

titio

n in

aut

umn

2013

and

aw

ards

mad

e in

201

4.O

utpu

t fro

m th

e fu

nded

stu

dies

will

be

nove

l non

-ani

mal

tech

nolo

gies

that

pr

oduc

e ap

proa

ches

that

are

‘fit

for

purp

ose’

.

Bus

ines

s-le

d fe

asib

ility

stu

dies

wer

e fu

nded

und

er

the

first

non

-ani

mal

tech

nolo

gies

cal

l (In

nova

te U

K’s

em

ergi

ng te

chno

logi

es a

nd in

dust

ries

prog

ram

me)

. Th

e to

tal b

udge

t was

£4

mill

ion

with

fund

ing

from

In

nova

te U

K, t

he N

atio

nal C

entre

for t

he R

epla

cem

ent,

Ref

inem

ent a

nd R

educ

tion

of A

nim

als

in R

esea

rch

(NC

3Rs)

, Eng

inee

ring

and

Phy

sica

l Sci

ence

s R

esea

rch

Cou

ncil

(EP

SR

C),

Bio

tech

nolo

gy a

nd

Bio

logi

cal S

cien

ces

Res

earc

h C

ounc

il (B

BS

RC

) and

D

efen

ce S

cien

ce a

nd T

echn

olog

y La

bora

tory

(Dst

l). A

ro

ad m

ap fo

r the

non

-ani

mal

tech

nolo

gies

pro

gram

me

is b

eing

pre

pare

d fo

r pub

licat

ion

by In

nova

te U

K w

ith

inpu

t fro

m N

C3R

s an

d ot

her e

xper

t gro

ups.

Con

sorti

a w

orks

hops

wer

e he

ld in

thre

e lo

catio

ns in

the

UK

th

roug

hout

Feb

ruar

y 20

15.

Stra

tegi

c P

riorit

y 1

23


5 ht

tps:

//ww

w.g

ov.u

k/re

sear

ch-a

nd-te

stin

g-us

ing-

anim

als

6 ht

tp://

ww

w.h

se.g

ov.u

k/re

ach/

reso

urce

s/18

anim

alte

stin

g.pd

f 4

Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

1.13

Ens

ure

gove

rnm

ent

depa

rtm

ents

and

ag

enci

es c

onsi

der t

he

3Rs

whe

n co

mm

issi

onin

g or

fund

ing

rese

arch

in

volv

ing

anim

als

(GC

S an

d C

SAs)

Gov

ernm

ent C

hief

Sci

entis

t and

Dep

artm

enta

l C

hief

Sci

entif

ic A

dvis

ers

(CS

As)

to e

nsur

e th

at g

over

nmen

t dep

artm

ents

and

age

ncie

s co

nsid

er th

e 3R

s w

hen

com

mis

sion

ing

or fu

ndin

g re

sear

ch in

volv

ing

anim

als.

Com

mitm

ent f

rom

dep

artm

ents

and

thei

r ag

enci

es o

n th

e 3R

s in

clud

ing

polic

y st

atem

ents

ov

erse

en b

y th

e C

SA

s.

i) A

ll go

vern

men

t dep

artm

ents

incl

udin

g

DH

, MoD

, Def

ra, H

O, B

IS a

nd a

genc

ies

have

sta

tem

ents

on

thei

r web

site

s.

Sta

tem

ent u

ploa

ded

on G

ov.U

K, l

inke

d to

all

rele

vant

D

epar

tmen

ts th

at re

gula

te o

r fun

d re

sear

ch in

volv

ing

anim

als,

incl

udin

g H

ome

Offi

ce, D

H, B

IS, D

efra

and

M

oD.5

1.14

“M

inim

isat

ion

of

anim

al te

stin

g” le

afle

t

(Def

ra a

nd H

SE)

As

UK

Com

pete

nt A

utho

rity

for R

EA

CH

, D

efra

and

HS

E a

lread

y pr

oduc

e a

leaf

let

entit

led

“Min

imis

atio

n of

ani

mal

test

ing”

. Thi

s is

a p

opul

ar p

ublic

atio

n an

d pr

ovid

es a

brie

f su

mm

ary

of th

e op

portu

nitie

s th

at a

re a

vaila

ble

to R

EA

CH

regi

stra

nts

to m

inim

ise

the

amou

nt o

f an

imal

test

ing

need

ed to

com

ply

with

RE

AC

H

regi

stra

tion.

This

initi

ativ

e w

ill e

nsur

e ne

w in

form

atio

n ab

out a

dvan

ces

in in

vitr

o te

stin

g, p

artic

ular

ly

of ir

ritan

ts, i

s co

mm

unic

ated

to U

K-b

ased

dut

y ho

lder

s.

i) U

pdat

e th

e pu

blic

atio

n “M

inim

isat

ion

of a

nim

al te

stin

g” w

hich

is p

opul

ar a

nd

effe

ctiv

e in

pro

mot

ing

the

3Rs

in th

is a

rea.

ii) E

ncou

rage

the

Eur

opea

n C

hem

ical

s A

genc

y (E

CH

A) t

o si

mila

rly u

pdat

e its

gu

idan

ce in

this

are

a fo

r tho

se w

ith

regi

stra

tion

dutie

s in

201

8.

The

revi

sed

leaf

let h

as b

een

publ

ishe

d by

the

RE

AC

H

UK

Com

pete

nt A

utho

rity.

6

Stra

tegi

c P

riorit

y 1

24


Stra

tegi

c Pr

iorit

y 2:

Influ

enci

ng th

e up

take

and

ado

ptio

n of

3R

s ap

proa

ches

glo

bally

Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

2.1

NC

3Rs

inte

rnat

iona

l sc

ienc

e-le

d pr

ogra

mm

es

2.1.

1 H

uman

tiss

ues

and

phar

mac

eutic

al

deve

lopm

ent

prog

ram

mes

(NC

3Rs

and

MH

RA

)

NC

3Rs/

MH

RA

join

t wor

king

gro

up o

n hu

man

tis

sue

for s

afet

y ph

arm

acol

ogy

– Jo

int

wor

king

gro

up to

gen

erat

e an

evi

denc

e ba

se

to s

uppo

rt th

e us

e of

hum

an ti

ssue

to re

duce

an

imal

s in

saf

ety

phar

mac

olog

y st

udie

s. T

he

grou

p co

nsis

ts o

f 25

phar

mac

eutic

al c

ompa

nies

, co

ntra

ct re

sear

ch o

rgan

isat

ions

, aca

dem

ics

and

regu

lato

rs fr

om th

e U

K, E

urop

e an

d U

SA

. Thi

s fo

rms

the

basi

s of

a w

ider

pro

gram

me

of w

ork

on th

e us

e of

hum

an ti

ssue

for b

asic

and

app

lied

rese

arch

, inc

ludi

ng in

the

area

s of

ast

hma

and

pain

.

An

evid

ence

bas

e is

dev

elop

ed to

su

ppor

t the

use

of h

uman

tiss

ue to

re

duce

the

use

of a

nim

als

in s

afet

y ph

arm

acol

ogy

stud

ies.

Dat

a ha

ve b

een

colle

cted

on

hum

an ti

ssue

-bas

ed

assa

ys fo

r saf

ety

phar

mac

olog

y st

udie

s an

d ha

ve s

how

n th

at th

e us

e of

hum

an ti

ssue

is li

mite

d; m

ainl

y fo

cuse

d on

car

diov

ascu

lar a

ssay

s an

d w

ider

use

is in

hibi

ted

by

conc

erns

abo

ut th

e re

gula

tory

acc

epta

bilit

y of

the

data

ge

nera

ted.

Acc

ess

to ti

ssue

is a

pro

blem

. The

dat

a ar

e be

ing

prep

ared

for p

ublic

atio

n. A

n on

line

hub

to s

uppo

rt hu

man

tiss

ue u

se fo

r saf

ety

phar

mac

olog

y st

udie

s w

ill

be la

unch

ed in

201

5 to

pro

mot

e be

tter a

cces

s to

tiss

ue

and

stan

dard

ope

ratin

g pr

oced

ures

for a

ssay

s.

NC

3Rs/

MH

RA

join

t wor

king

gro

up o

n re

cove

ry

anim

als

in p

harm

aceu

tical

dev

elop

men

t –

Join

t wor

king

gro

up to

con

side

r pot

entia

l op

portu

nitie

s fo

r min

imis

ing

the

use

of re

cove

ry

anim

als

(rat

s, d

ogs

or n

on-h

uman

prim

ates

) in

phar

mac

eutic

al d

evel

opm

ent.

The

grou

p co

nsis

ts

of 3

2 ph

arm

aceu

tical

com

pani

es, c

ontra

ct

rese

arch

org

anis

atio

ns a

nd re

gula

tors

from

the

UK

, Eur

ope

and

US

A, i

nclu

ding

the

FDA

.

Pot

entia

l opp

ortu

nitie

s ar

e id

entif

ied

to

min

imis

e th

e us

e of

reco

very

ani

mal

s in

ph

arm

aceu

tical

stu

dies

.

Ana

lysi

s ha

s be

en c

ondu

cted

on

data

for 2

59 s

tudi

es

and

137

com

poun

ds to

exp

lore

whe

ther

the

use

of

reco

very

ani

mal

s ca

n be

redu

ced.

Rec

over

y an

imal

s ar

e us

ed to

det

erm

ine

whe

ther

any

adv

erse

effe

cts

obse

rved

are

reve

rsib

le. T

he d

ata

anal

ysis

has

sho

wn

that

it is

pos

sibl

e to

redu

ce th

e us

e of

reco

very

ani

mal

s by

66%

in s

tudi

es to

sup

port

first

-in-h

uman

clin

ical

tria

ls,

avoi

ding

the

use

of th

ousa

nds

of a

nim

als

wor

ldw

ide.

It

has

show

n th

at w

here

reco

very

ani

mal

s ar

e ne

eded

it is

no

t nec

essa

ry to

incl

ude

them

for a

ll do

se g

roup

s or

all

stud

ies.

The

dat

a an

alys

is w

as p

ublis

hed

in th

e jo

urna

l R

egul

ator

y To

xico

logy

and

Pha

rmac

olog

y in

201

4.

25


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

2.1.

2 C

hem

ical

saf

ety

prog

ram

me

(NC

3Rs,

HSE

and

PH

E)

NC

3Rs

wor

king

gro

up o

n th

e fix

ed

conc

entr

atio

n pr

oced

ure

(che

mic

al s

afet

y)

– Th

is w

orki

ng g

roup

sup

ports

the

inte

rnat

iona

l ad

optio

n of

the

fixed

con

cent

ratio

n pr

oced

ure

(FC

P) f

or a

cute

inha

latio

n to

xici

ty te

stin

g. T

he

NC

3Rs

is w

orki

ng w

ith in

hala

tion

toxi

city

exp

erts

fro

m c

ontra

ct re

sear

ch o

rgan

isat

ions

, aca

dem

ia,

and

othe

r gov

ernm

ent b

odie

s, to

mak

e th

e FC

P

mor

e ob

ject

ive

to e

ncou

rage

wid

er a

dopt

ion

of

the

appr

oach

acr

oss

Org

anis

atio

n fo

r Eco

nom

ic

Co-

oper

atio

n an

d D

evel

opm

ent (

OE

CD

) Mem

ber

Sta

tes.

Obj

ectiv

e sc

orin

g sy

stem

to e

ncou

rage

w

ider

ado

ptio

n of

FC

P ac

ross

OE

CD

m

embe

r sta

tes.

Focu

s ha

s be

en g

iven

on

build

ing

a ca

se fo

r evi

dent

to

xici

ty in

stea

d of

dea

th o

f the

ani

mal

s as

the

end-

poin

t fo

r inh

alat

ion

toxi

city

stu

dies

. Evi

dent

toxi

city

is k

ey to

th

e FC

P bu

t the

re a

re c

once

rns

from

som

e co

untri

es

abou

t how

to re

cogn

ise

it. E

vide

nt to

xici

ty is

def

ined

as

the

clin

ical

sig

n(s)

that

pre

dict

sev

ere

toxi

city

or d

eath

at

the

next

hig

hest

dos

e us

ed. A

naly

sis

on in

hala

tion

toxi

city

dat

a w

as c

ondu

cted

on

188

subs

tanc

es a

t tw

o or

m

ore

conc

entra

tions

. The

re is

evi

denc

e to

sup

port

the

use

of e

vide

nt to

xici

ty a

nd p

repa

ratio

ns a

re n

ow in

pla

ce

for p

ublic

atio

n an

d fo

r dis

cuss

ion

at th

e O

EC

D. T

his

is

inte

rnat

iona

l par

ticip

atio

n fro

m re

gula

tors

and

CR

Os

from

Nor

th A

mer

ica,

Eur

ope

and

Kor

ea.

2.2

Rev

iew

of O

ECD

Tes

t G

uide

lines

2.2.

1 Sy

stem

atic

revi

ew o

f O

ECD

Tes

t Gui

delin

es to

ad

dres

s 3R

s.

(Def

ra a

nd P

HE)

Sys

tem

atic

revi

ew o

f Org

anis

atio

n fo

r Eco

nom

ic

Co-

oper

atio

n an

d D

evel

opm

ent (

OE

CD

) Tes

t G

uide

lines

(TG

s) to

add

ress

3R

s.In

liai

son

with

indu

stry

par

tner

s as

wel

l as

regu

lato

ry a

utho

ritie

s, w

e w

ill re

view

TG

s w

here

a

pote

ntia

l to

repl

ace,

redu

ce o

r ref

ine

anim

al

stud

ies

is id

entif

ied.

Cur

rent

wor

k is

on

skin

and

ey

e se

nsiti

satio

n an

d irr

itatio

n (s

ee a

lso

Act

ion

1.14

). P

ropo

sed

addi

tiona

l wor

k is

on

the

acut

e de

rmal

toxi

city

. All

are

area

s w

here

the

a re

view

of

the

prot

ocol

s w

ould

not

onl

y ad

dres

s 3R

s bu

t pr

ovid

e an

adv

ance

in s

cien

ce.

i) A

dopt

ion

of T

G u

nder

revi

ew T

G43

0 an

d TG

431

– S

kin

irrita

tion

and

corr

osio

n.ii)

Sub

mit

prop

osal

to O

EC

D fo

r rev

iew

of

the

use

of b

oth

gend

ers

in th

e ac

ute

derm

al to

xici

ty a

ssay

(TG

402)

.iii

) Com

men

ce re

view

of d

ata

for t

he

use

of b

oth

gend

ers

in th

e ac

ute

derm

al

toxi

city

ass

ay (T

G40

2).

A pr

opos

al to

upd

ate

TG40

2 ha

s be

en a

ccep

ted

by

the

OE

CD

. Dat

a ha

ve b

een

gath

ered

to s

uppo

rt th

e re

duct

ion

in th

e us

e of

ani

mal

s fo

r acu

te d

erm

al to

xici

ty

test

. A

repo

rt w

ill b

e su

bmitt

ed to

OE

CD

in A

pril

2015

. W

orki

ng w

ith S

wis

s O

EC

D p

artn

ers

to a

men

d TG

203

(Fis

h A

cute

Tox

icity

Tes

t) to

redu

ce n

umbe

rs o

f fis

h an

d pr

omot

e ea

rly te

rmin

atio

n fo

r mor

ibun

d in

divi

dual

s,

thus

avo

idin

g un

nece

ssar

y su

fferin

g. P

ropo

sal t

o be

co

nsid

ered

furth

er a

t OE

CD

Nat

iona

l Co-

ordi

nato

rs

mee

ting

in A

pril

2015

.

2.2.

2 R

epro

duct

ive

toxi

colo

gy (E

OG

RTS

)

(Def

ra a

nd H

SE)

The

Ext

ende

d O

ne G

ener

atio

n R

epro

duct

ive

Toxi

city

Stu

dy (E

OG

RTS

) offe

rs a

muc

h m

ore

flexi

ble

stud

y de

sign

than

the

tradi

tiona

l tw

o-ge

nera

tion

appr

oach

(OE

CD

TG

416)

. The

E

OG

RTS

has

bee

n sh

own

to g

ener

ate

suffi

cien

t in

form

atio

n fo

r reg

ulat

ory

purp

oses

with

out t

he

man

dato

ry p

rodu

ctio

n of

a s

econ

d ge

nera

tion.

Th

e E

OG

RTS

use

s ab

out h

alf t

he n

umbe

r of

anim

als

– re

duci

ng fr

om 2

,600

to 1

,400

rats

per

te

st. I

t was

ado

pted

by

the

OE

CD

into

its

test

gu

idel

ines

in 2

009.

i) In

ass

ocia

tion

with

com

pete

nt

auth

oriti

es fr

om o

ther

key

EU

Mem

ber

Sta

tes,

to p

rom

ote

the

adop

tion

of th

e E

OG

RTS

in th

e E

U.

ii) T

o co

mpl

ete

the

proc

ess

by a

chie

ving

ad

optio

n of

the

EO

GR

TS in

the

RE

AC

H

Test

Met

hods

Reg

ulat

ion.

Agr

eem

ent h

as b

een

reac

hed

at th

e R

EA

CH

Arti

cle

133

Com

mitt

ee o

n re

visi

ons

to th

e R

EA

CH

info

rmat

ion

anne

xes

to a

ccom

mod

ate

the

Ext

ende

d O

ne G

ener

atio

n R

epro

duct

ive

Toxi

city

Stu

dy (E

OG

RTS

) (O

EC

D T

G44

3).

Form

al a

dopt

ion

is d

epen

dent

on

the

polit

ical

pro

cess

es.

Stra

tegi

c P

riorit

y 2

26


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

2.3

Influ

ence

regu

lato

ry

fram

ewor

ks w

hich

requ

ire

anim

al te

stin

g

2.3.

1. A

dver

se O

utco

me

Path

way

s fo

r che

mic

als

(PH

E an

d D

efra

)

Adv

erse

Out

com

e Pa

thw

ays

– In

tern

atio

nal

Dev

elop

men

t of N

ew A

ppro

ache

s to

Che

mic

als

Test

ing.

His

toric

ally,

iden

tifyi

ng a

dver

se e

ffect

s of

ch

emic

als

has

relie

d on

usi

ng la

rge

num

bers

of

anim

als

to te

st th

eir t

oxic

ity, o

ne b

y on

e. If

we

coul

d id

entif

y th

e ch

ain

of li

nked

eve

nts

from

an

initi

al c

hem

ical

impa

ct a

t the

mol

ecul

ar le

vel

to re

spon

ses

at h

ighe

r bio

logi

cal l

evel

s, w

e m

ight

be

able

to u

se in

vitr

o te

chni

ques

suc

h as

ge

nom

ics

to p

redi

ct im

pact

s up

to th

e le

vel o

f an

orga

nism

or e

ven

popu

latio

ns. T

his

wou

ld o

ffer

way

s of

redu

cing

the

need

for t

ests

usi

ng in

tact

an

imal

s, a

s w

ell a

s sp

eedi

ng u

p th

e as

sess

men

t of

che

mic

als.

The

con

cept

of A

dver

se O

utco

me

Pat

hway

s (A

OP

s) o

ffers

a m

echa

nist

ic w

ay to

de

scrib

e su

ch a

seq

uent

ial c

hain

of c

ausa

lly

linke

d ev

ents

. In

2012

, the

OE

CD

laun

ched

a

new

pro

gram

me

to d

evel

op A

OP

s, in

whi

ch th

e U

K is

col

labo

ratin

g.A

ppro

pria

te A

OP

s to

be

valid

ated

and

in

corp

orat

ed in

to O

EC

D T

est M

etho

ds to

olki

t as

qui

ckly

as

poss

ible

, via

out

puts

of U

K-

fund

ed re

sear

ch m

ade

avai

labl

e to

the

OE

CD

pr

ogra

mm

e.

Thre

e re

leva

nt p

roje

cts

are

unde

rway

:i)

UK

–Jap

an c

olla

bora

tive

proj

ect –

C

ritic

al re

view

of k

ey k

now

ledg

e ga

ps to

su

ppor

t AO

Ps

for O

EC

D te

st g

uide

lines

fo

r aqu

atic

org

anis

ms.

Del

iver

y of

crit

ical

re

view

of k

ey k

now

ledg

e ga

ps to

sup

port

AO

Ps

for O

EC

D te

st g

uide

lines

for

aqua

tic o

rgan

ism

s de

liver

ed b

y U

K a

nd

Japa

n.ii)

Def

ra-fu

nded

pro

ject

(Cra

nfie

ld

Uni

vers

ity) –

In S

ilico

Pre

dict

ions

of

In v

ivo

Toxi

city

: Are

inte

rspe

cies

ex

trapo

latio

ns o

ff ta

ngen

t? F

inal

repo

rt pu

blis

hed

on a

ccur

acy

of in

ter-

spec

ies

extra

pola

tions

of i

n si

lico

pred

ictio

ns o

f in

vivo

toxi

city

.iii

) Def

ra-fu

nded

pro

ject

(Cef

as,

Uni

vers

ities

of B

irmin

gham

and

Li

verp

ool)

– Th

e us

e of

sys

tem

s to

xico

logy

to re

cons

truct

mol

ecul

ar

AO

Ps

– ca

n ch

emic

al m

ixtu

re to

xici

ty

be p

redi

cted

to a

id e

nviro

nmen

tal r

isk

asse

ssm

ent a

nd re

gula

tion?

Fin

al

repo

rt pu

blis

hed

on th

e us

e of

sys

tem

s to

xico

logy

to re

cons

truct

mol

ecul

ar

AO

Ps.

Pub

lic H

ealth

Eng

land

(PH

E) i

n co

llabo

ratio

n w

ith

inte

rnat

iona

l par

tner

s is

taki

ng fo

rwar

d a

larg

e pi

ece

of w

ork

to im

prov

e in

vitr

o m

etho

ds in

toxi

city

test

ing

for g

enot

oxic

and

non

-gen

otox

ic c

arci

noge

ns. T

his

is a

lo

ng-te

rm p

roje

ct w

hich

will

lead

to re

duct

ion

in a

nim

al

test

ing

and

impr

ovem

ents

in te

stin

g st

rate

gies

.

Stra

tegi

c P

riorit

y 2

27


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

2.3.

2 A

ppro

ache

s fo

r ph

arm

aceu

tical

s

(MH

RA

and

VMD

)

Har

mon

isat

ion

of a

ppro

ache

s w

ithin

re

gula

tory

fram

ewor

ks:

- Har

mon

ise

appr

oach

es w

ith re

spec

t to

the

3Rs,

and

pro

mot

e th

eir u

ptak

e in

pha

rmac

eutic

al

deve

lopm

ent.

- Con

tribu

te to

ong

oing

exp

lora

tion

of a

ltern

ativ

es

to u

sing

ani

mal

s in

test

ing

of h

azar

dous

m

ater

ials

.S

uppo

rt th

e ha

rmon

isat

ion

of g

loba

l reg

ulat

ory

stan

dard

s. U

nles

s al

l reg

ulat

ors

acce

pt a

n al

tern

ativ

e to

an

anim

al te

st, t

he a

nim

al te

st

wou

ld s

till b

e ca

rrie

d ou

t by

indu

stry

to e

nsur

e w

ides

prea

d m

arke

ting

– es

sent

ially

per

form

ing

to th

e ‘lo

wes

t com

mon

dom

inat

or’ (

and

high

est

anim

al u

se) d

espi

te b

ette

r and

mor

e ec

onom

ic

test

s be

ing

avai

labl

e.

Con

tinue

to w

ork

with

oth

er re

gula

tory

age

ncie

s to

inte

rpre

t IC

H (I

nter

natio

nal C

onfe

renc

e on

H

arm

onis

atio

n of

Tec

hnic

al R

equi

rem

ents

for

Reg

istra

tion

of P

harm

aceu

tical

s fo

r Hum

an U

se)

and

VIC

H (V

eter

inar

y IC

H) f

lexi

bly,

esp

ecia

lly in

lig

ht o

f em

ergi

ng m

arke

ts w

hich

are

kno

wn

to b

e le

ss fl

exib

le.

Con

tinue

to in

sist

on

adhe

renc

e of

OE

CD

Goo

d La

bora

tory

Pra

ctic

e (G

LP) r

equi

rem

ents

to a

void

du

plic

atio

n of

stu

dies

, esp

ecia

lly im

porta

nt fo

r em

ergi

ng m

arke

ts w

hich

are

not

par

ty to

the

Mut

ual A

ccep

tanc

e of

Dat

a pr

oced

ures

. P

rovi

de a

cha

lleng

e to

indu

stry

for a

lread

y au

thor

ised

pro

ject

s an

d hi

ghlig

ht w

here

they

are

pe

rform

ing

unne

cess

ary

anim

al te

stin

g an

d se

t ou

t our

exp

ecta

tions

for c

hang

e.

i) M

HR

A en

gage

d at

Eur

opea

n an

d w

ider

in

tern

atio

nal l

evel

s w

ith p

harm

aceu

tical

re

gula

tors

to p

rom

ote

the

upta

ke o

f the

3R

s an

d ha

rmon

ise

appr

oach

es a

t all

stag

es o

f pha

rmac

eutic

al d

evel

opm

ent.

ii) M

HR

A en

cour

agin

g th

e us

e of

mul

tiple

en

d-po

ints

in o

ne s

tudy

to w

ork

to

redu

ce th

e us

e of

ani

mal

s –

an e

xam

ple

wou

ld b

e in

clud

ing

geno

toxi

city

test

ing

in

anim

als

in o

ther

toxi

city

stu

dies

.iii

) VM

D a

nd M

HR

A in

fluen

cing

the

deve

lopm

ent a

nd re

visi

on o

f Eur

opea

n P

harm

acop

oeia

mon

ogra

phs

such

that

, w

here

ver f

easi

ble,

test

ing

in a

nim

als

is

repl

aced

or r

emov

ed o

r ref

ined

. (Th

is

crea

tes

a w

ider

out

reac

h th

an s

impl

y th

e E

U a

s m

ore

coun

tries

are

sig

ned

up to

th

e ph

arm

acop

eia.

)iv

) VM

D p

artic

ipat

ing

in th

e C

XM

P 3R

s gr

oup

whi

ch is

inte

nded

to id

entif

y an

d pr

ogre

ss a

reas

for r

egul

ator

y ch

ange

w

hich

can

ena

ble

redu

ced

test

ing

in

anim

als.

v) V

MD

and

MH

RA

activ

ely

chal

leng

ing

indu

stry

for a

lread

y au

thor

ised

pro

ject

s an

d hi

ghlig

htin

g w

here

they

may

be

perfo

rmin

g un

nece

ssar

y an

imal

test

ing.

S

ettin

g ou

t our

exp

ecta

tions

for c

hang

e.vi

) Def

ra p

roje

ct to

revi

ew a

ccur

acy

of

inte

r-sp

ecie

s ex

trapo

latio

ns o

f in

silic

o pr

edic

tions

of i

n vi

vo to

xici

ty.

i) M

HR

A st

aff h

ave

been

eng

aged

at E

U S

afet

y W

orki

ng

Par

ty a

nd In

tern

atio

nal I

CH

leve

l pro

mot

ing

the

3Rs

in

new

/revi

sed

guid

elin

es.

MH

RA

staf

f als

o di

scus

sed

the

3Rs

with

del

egat

es fr

om C

hina

’s F

DA

.ii)

MH

RA

staf

f hav

e be

en in

volv

ed w

ith th

e re

visi

on o

f E

U a

nd In

tern

atio

nal g

uide

lines

pro

mot

ing

mul

tiple

end

-po

ints

in o

ne s

tudy

. M

HR

A st

aff h

ave

also

pro

mot

ed th

is

view

in s

cien

tific

adv

ice

mee

tings

with

pha

rmac

eutic

al

com

pani

es a

nd a

cade

mic

gro

ups.

iii) R

equi

rem

ent f

or a

saf

ety

test

to b

e ca

rrie

d ou

t in

the

targ

et s

peci

es fo

r eac

h ba

tch

of v

eter

inar

y va

ccin

es

prod

uced

has

bee

n de

lete

d fro

m th

e E

urop

ean

Pha

rmac

opoe

ia –

this

requ

irem

ent h

as n

ow b

een

dele

ted

from

all

mar

ketin

g au

thor

isat

ions

sav

ing

appr

oxim

atel

y 5,

000–

6,00

0 an

imal

s pe

r yea

r.Ve

terin

ary

Inte

rnat

iona

l Con

fere

nce

on h

arm

onis

atio

n (V

ICH

) is

wor

king

on

guid

elin

es fo

r wai

ving

bat

ch s

afet

y te

sts

for v

eter

inar

y va

ccin

es. T

his

will

not

affe

ct th

e E

U

beca

use

the

requ

irem

ent f

or th

ese

test

s ha

s al

read

y be

en re

mov

ed fr

om th

e E

urop

ean

Pha

rmac

opoe

ia, a

nd

cons

eque

ntly

from

all

vacc

ines

aut

horis

ed in

the

EU

, but

sh

ould

eve

ntua

lly re

duce

the

num

ber o

f ani

mal

s us

ed

for t

his

purp

ose

wor

ldw

ide.

Hum

ane

end-

poin

ts h

ave

been

intro

duce

d in

to th

e ‘ra

bies

vac

cine

s (i

nact

ivat

ed) f

or v

eter

inar

y us

e’

mon

ogra

ph a

long

with

an

alte

rnat

ive

batc

h po

tenc

y te

st b

ased

on

sero

logi

cal r

espo

nses

inst

ead

of v

irule

nt

chal

leng

e. U

ptak

e of

this

alte

rnat

ive

met

hod

has

been

sl

ow b

ecau

se o

f the

nee

d fo

r pro

duct

-spe

cific

val

idat

ion.

Stra

tegi

c P

riorit

y 2

28


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

iv) T

he g

roup

has

revi

ewed

all

Com

mitt

ee fo

r Med

icin

al

Pro

duct

s fo

r Vet

erin

ary

use

(CV

MP

) and

Com

mitt

ee fo

r M

edic

inal

Pro

duct

s fo

r Hum

an u

se (C

HM

P) g

uide

lines

w

ith a

vie

w to

redu

cing

reco

mm

ende

d an

imal

num

bers

an

d re

mov

ing

unne

cess

ary

anim

al te

sts.

Fol

low

ing

this

re

view

, one

gui

delin

e on

vet

erin

ary

vacc

ines

is to

be

with

draw

n an

d a

revi

sed

vers

ion

of a

gui

delin

e re

mov

ing

the

optio

n fo

r in

vivo

test

s, a

t the

requ

est o

f JE

G 3

Rs,

is

bein

g pr

esen

ted

to C

VM

P fo

r end

orse

men

t.Ve

terin

ary

vacc

ines

aut

horis

ed v

ia th

e E

urop

ean

cent

ralis

ed p

roce

dure

are

bei

ng re

view

ed w

ith a

vie

w to

id

entif

ying

ani

mal

test

ing

proc

edur

es th

at m

ight

be

able

to

be

mod

ified

or r

epla

ced

acco

rdin

g to

3R

s pr

inci

ples

. Th

is is

ong

oing

.v)

The

Vet

erin

ary

Med

icin

es D

irect

orat

e (V

MD

) has

pu

blis

hed

a re

port

on a

nim

al u

sage

dur

ing

qual

ity

cont

rol t

estin

g of

vet

erin

ary

vacc

ines

dur

ing

2007

to

2012

and

hav

e gi

ven

pres

enta

tions

on

this

at t

he J

EG

3R

s m

eetin

g an

d th

e Ve

terin

ary

Vacc

ines

con

fere

nce.

Th

is h

as e

nabl

ed th

e id

entif

icat

ion

of v

acci

nes

that

re

quire

the

use

of p

artic

ular

ly la

rge

num

bers

of a

nim

als

to b

e id

entif

ied,

faci

litat

e m

onito

ring

trend

s an

d ev

alua

te

the

impa

ct o

f oth

er in

itiat

ives

, suc

h as

cha

nges

to

Eur

opea

n P

harm

acop

oeia

mon

ogra

phs.

As

a re

sult

of th

e ab

ove

men

tione

d st

udy,

clo

strid

ial

vacc

ines

hav

e be

en id

entif

ied

as u

sing

par

ticul

arly

larg

e nu

mbe

rs o

f ani

mal

s. T

he V

MD

has

writ

ten

to a

ll of

the

man

ufac

ture

rs o

f vet

erin

ary

clos

tridi

al v

acci

nes

aski

ng

abou

t pla

ns fo

r ref

inin

g th

e m

etho

ds to

redu

ce th

e nu

mbe

rs o

f ani

mal

s us

ed o

r to

repl

ace

them

by

in v

itro

met

hods

.

Stra

tegi

c P

riorit

y 2

29


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

2.3.

3. P

rom

ote

3Rs

in

food

saf

ety

regu

latio

n

(FSA

and

Cef

as fo

r Mou

se

bioa

ssay

repl

acem

ent)

(FSA

for o

ther

op

port

uniti

es)

Upt

ake

of 3

Rs

and

rese

arch

/risk

ass

essm

ent

to p

rom

ote

alte

rnat

ives

.- P

rom

ote

upta

ke o

f 3R

s in

food

saf

ety

regu

latio

n an

d su

ppor

t tes

ting

requ

irem

ents

in th

e U

K a

nd

EU

.- P

rom

ote

and

supp

ort r

esea

rch

and

risk

asse

ssm

ent t

o un

derp

in a

dopt

ion

of a

ltern

ativ

es

to a

nim

al-b

ased

test

ing

for f

ood

safe

ty w

here

this

ca

n be

don

e w

hile

mai

ntai

ning

an

adeq

uate

leve

l of

con

sum

er p

rote

ctio

n.

Key

opp

ortu

nitie

s ex

ist:

- rep

lace

mou

se b

ioas

say

in te

stin

g fo

r she

llfis

h bi

o to

xins

(i a

nd ii

).- c

ontin

ue to

enc

oura

ge th

e E

urop

ean

Com

mis

sion

and

oth

er M

embe

r Sta

tes

to

cons

ider

the

3Rs

prin

cipl

es w

hen

dete

rmin

ing

the

need

for a

nim

al s

tudi

es in

the

risk

asse

ssm

ent o

f G

enet

ical

ly M

odifi

ed O

rgan

isim

s (G

MO

s) (i

ii).

- eng

agem

ent w

orld

wid

e w

ith fo

od ri

sk

asse

ssm

ent a

nd re

gula

tory

bod

ies

to d

evel

op

and

harm

onis

e ap

proa

ches

and

to re

flect

thes

e an

d th

e 3R

s in

new

or u

pdat

ed fo

od re

gula

tions

an

d te

stin

g re

quire

men

ts. U

nles

s al

l reg

ulat

ors

acce

pt a

n al

tern

ativ

e to

an

anim

al te

st, t

he a

nim

al

test

may

stil

l be

carr

ied

out b

y in

dust

ry to

ens

ure

wid

espr

ead

acce

ss to

mar

kets

des

pite

bet

ter a

nd

mor

e ec

onom

ic te

sts

bein

g av

aila

ble

(iv).

- con

side

r the

mos

t app

ropr

iate

mea

ns o

f ge

nera

ting

data

on

appr

oved

food

che

mic

als,

in

clud

ing

hum

an s

tudi

es w

here

thes

e ar

e et

hica

l an

d ap

prop

riate

(v).

- cle

ar g

uida

nce

on th

e re

quire

men

ts fo

r au

thor

isat

ion

of n

ovel

food

s an

d pr

oces

ses

(vi).

i) S

ucce

ssfu

l rep

lace

men

t of m

ouse

bi

oass

ay in

con

trols

on

shel

lfish

toxi

ns

in U

K.

ii) S

eek

com

mitm

ent f

rom

Com

mis

sion

to

ensu

re o

ther

EU

Mem

ber S

tate

s re

plac

e m

ouse

bio

assa

y.iii

) Key

opp

ortu

nitie

s to

influ

ence

in

clud

e w

hen

the

EU

FP

7 “G

RA

CE

” pr

ojec

t com

es to

frui

tion,

and

whe

n th

e C

omm

issi

on’s

two-

year

feed

ing

stud

y w

ith G

M m

aize

is c

ompl

eted

.iv

) FS

A an

d its

inde

pend

ent s

cien

tific

ad

viso

ry c

omm

ittee

s ar

e en

gage

d at

EU

an

d w

ider

inte

rnat

iona

l lev

els,

incl

udin

g st

rong

eng

agem

ent w

ith th

e E

FSA

, th

e C

omm

issi

on, J

EC

FA a

nd C

odex

A

limen

tariu

s.v)

Pro

duci

ng th

e m

ost a

ppro

pria

te

mea

ns to

gen

erat

e da

ta o

n ap

prov

ed

food

che

mic

als,

incl

udin

g hu

man

stu

dies

w

here

thes

e ar

e et

hica

l and

app

ropr

iate

.vi

) FS

A pr

ovid

e cl

ear g

uida

nce

to

indu

stry

on

the

requ

irem

ents

for

appl

icat

ions

for a

utho

risat

ion

of n

ovel

fo

ods

and

proc

esse

s on

whe

re a

nim

al

test

ing

is a

nd is

not

nec

essa

ry fo

r ap

prov

al.

i) an

d ii)

The

mon

itorin

g of

she

llfis

h to

xins

for o

ffici

al

cont

rol p

urpo

ses

in th

e U

K u

ses

anal

ytic

al c

hem

istry

m

etho

ds. T

here

was

no

repo

rted

use

of m

ouse

bi

oass

ays

in th

e la

test

per

iod

for w

hich

Hom

e O

ffice

st

atis

tics

on a

nim

al u

se a

re a

vaila

ble.

EU

Mem

ber

Sta

tes

have

als

o m

oved

the

maj

ority

or a

ll of

thei

r te

stin

g to

the

anal

ytic

al c

hem

istry

met

hods

and

it is

an

ticip

ated

that

this

will

repl

ace

the

mou

se b

ioas

say

in

the

few

rem

aini

ng la

bora

torie

s sh

ortly

.iii

) The

GR

AC

E p

roje

ct is

due

to fi

nish

in N

ovem

ber

2015

. Onc

e th

e fin

al re

port

and

reco

mm

enda

tions

are

pu

blis

hed

the

Com

mis

sion

has

mad

e a

com

mitm

ent

to re

view

the

nece

ssity

for m

anda

tory

90-

day

feed

ing

stud

ies

as p

art o

f the

risk

ass

essm

ent f

or G

MO

s.

FSA

will

of c

ours

e re

min

d th

e C

omm

issi

on o

f thi

s co

mm

itmen

t whe

n th

e tim

e co

mes

.7

It is

of n

ote

that

a n

ewer

EU

-fund

ed re

sear

ch p

roje

ct

calle

d G

-Tw

YS

T, w

hich

sta

nds

for,

‘GM

Tw

o Ye

ar S

afet

y Te

stin

g’, i

s lo

okin

g at

long

er-te

rm s

afet

y te

stin

g fo

r G

MO

s. T

his

proj

ect l

asts

for f

our y

ears

and

doe

s no

t en

d un

til A

pril

2018

. No

info

rmat

ion

is y

et a

vaila

ble,

bu

t it i

s po

ssib

le th

e C

omm

issi

on m

ay s

eek

to d

elay

a

deci

sion

on

anim

al te

stin

g un

til th

is p

roje

ct is

co

mpl

eted

.8

iv) F

ood

Saf

ety

Age

ncy

(FS

A) s

uppo

rted

by it

s in

depe

nden

t sci

entif

ic a

dvis

ory

com

mitt

ees

cont

inue

s to

hav

e st

rong

eng

agem

ent w

ith E

urop

ean

Food

S

afet

y A

utho

rity

(EFS

A),

the

Com

mis

sion

, Joi

nt E

xper

t C

omm

ittee

on

Food

Add

itive

s (J

EC

FA) a

nd C

odex

A

limen

tariu

s. F

SA

cont

inue

s to

cha

mpi

on p

ropo

rtion

ate

and

appr

opria

te te

stin

g w

hich

mai

ntai

ns a

dequ

ate

cons

umer

pro

tect

ion.

7 ht

tp://

ww

w.g

race

-fp7.

eu/c

onte

nt/p

roje

ct (n

ote

web

link)

8 ht

tp://

ww

w.g

-twys

t.eu/

Stra

tegi

c P

riorit

y 2

30


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

v) H

isto

rical

ly F

SA

have

use

d hu

man

stu

dies

to

inve

stig

ate

issu

es w

ith a

ppro

ved

food

che

mic

als

whe

neve

r app

ropr

iate

e.g

. with

caf

fein

e an

d pr

egna

ncy

and

to in

vest

igat

e al

lege

d si

de e

ffect

s of

asp

arta

me

and

that

this

app

roac

h w

ill c

ontin

ue to

be

embe

dded

in

thei

r fut

ure

scie

nce

stra

tegy

vi)

Reg

ardi

ng n

ovel

fo

ods,

we

plan

to c

onsu

lt th

e A

CN

FP a

t the

nex

t C

omm

ittee

mee

ting

on 2

9 A

pril

rega

rdin

g gu

idan

ce to

ap

plic

ants

for m

inim

isin

g th

e us

e of

ani

mal

s in

the

risk

asse

ssm

ent o

f nov

el fo

ods.

The

gui

danc

e w

ill d

raw

at

tent

ion

to th

e st

atut

ory

requ

irem

ents

for a

nim

al te

stin

g in

the

regu

latio

ns a

nd h

ighl

ight

are

as id

entif

ied

whe

re

alte

rnat

ives

are

acc

epta

ble.

2.4

Cos

met

ics

alte

rnat

ives

(BIS

and

indu

stry

with

su

ppor

t fro

m H

O a

nd

FCO

– s

ee a

lso

2.5

belo

w)

Wor

k pl

an b

eing

dev

elop

ed to

influ

ence

oth

er

non-

EU

cou

ntrie

s in

usi

ng a

ltern

ativ

es to

ani

mal

te

stin

g in

brin

ging

cos

met

ics

to m

arke

t (se

e al

so 2

.5 b

elow

) Con

side

r opt

ions

of h

ow th

e E

U s

yste

m (r

elia

nce

on in

gred

ient

saf

ety)

cou

ld

be a

dapt

ed fo

r thi

rd c

ount

ries

such

as

Chi

na to

fa

cilit

ate

trade

.

i) P

aper

dev

elop

ed.

ii) O

utlin

e of

geo

grap

hies

and

type

s of

te

st w

here

we

thin

k th

ere

is re

dund

ant

anim

al te

stin

g to

targ

et fo

cus.

iii) O

ptio

ns fo

r rev

isin

g (p

ossi

bly

base

d on

the

EU

mod

el) i

nclu

ding

opp

ortu

nitie

s fo

r ref

orm

iden

tifie

d (e

.g. i

n C

hina

).

Hom

e O

ffice

Offi

cial

s ho

sted

a v

isit

by a

sen

ior

dele

gatio

n of

offi

cial

s fro

m th

e C

hina

Foo

d &

Dru

g A

dmin

istra

tion

(CFD

A) t

o di

scus

s w

ays

in w

hich

hu

man

saf

ety

can

be a

ssur

ed th

roug

h rig

orou

s ris

k as

sess

men

ts w

hich

do

not i

nclu

de u

nnec

essa

ry a

nim

al

data

. Dem

onst

rate

d w

as b

est p

ract

ice

in c

osm

etic

saf

ety

test

ing

and

show

case

of U

K e

xper

tise

in th

e 3R

s w

ith

a pa

rticu

lar f

ocus

on

non-

anim

al te

stin

g m

etho

ds. T

he

prog

ram

me

incl

uded

vis

its to

the

Nat

iona

l Cen

tre fo

r th

e 3R

s (N

C3R

s); U

nile

ver;

Wal

gree

ns B

oots

Alli

ance

; an

d m

eetin

gs w

ith th

e E

U C

omm

issi

on a

nd C

osm

etic

s E

urop

e as

wel

l as

UK

gov

ernm

ent t

eam

s.H

avin

g es

tabl

ishe

d a

cons

ortiu

m w

ith th

e co

mpa

nies

(U

nile

ver,

Wal

gree

ns B

oots

Alli

ance

, L’O

real

, and

P

roct

or &

Gam

ble)

and

UK

, EU

and

Chi

nese

trad

e as

soci

atio

ns (C

TPA

, Cos

met

ics

Eur

ope

and

CA

FFC

I) an

d in

par

tner

ship

with

the

EU

Com

mis

sion

(DG

E

nter

pris

e) a

wor

ksho

p w

as p

lann

ed fo

r Mar

ch 2

015

in B

eijin

g to

exp

lain

the

prin

cipl

es o

f saf

ety

risk

asse

ssm

ents

with

indu

stry

-led

exam

ples

. As

the

UK

/EU

is

a w

orld

lead

er in

this

fiel

d an

d is

stro

ngly

pos

ition

ed

to s

uppo

rt C

hina

in d

evel

opin

g th

e sk

ills

to c

arry

out

and

ev

alua

te s

afet

y ris

k as

sess

men

ts a

mon

g bo

th it

s S

ME

s an

d its

regu

lato

rs th

roug

h th

e de

velo

pmen

t of a

Ris

k A

sses

smen

t Tra

inin

g P

rogr

amm

e de

sign

ed fo

r Chi

na.

The

wor

ksho

p is

the

first

sta

ge in

the

proc

ess

that

will

co

ntin

ue fr

om A

pril

2015

onw

ards

.

Stra

tegi

c P

riorit

y 2

31


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

2.5

Dev

elop

ing

Act

ion

Plan

prio

ritie

s in

to a

n ef

fect

ive

inte

rnat

iona

l co

mm

unic

atio

n an

d in

fluen

cing

str

ateg

y

(FC

O, H

O a

nd B

IS-S

IN)

Usi

ng B

IS-S

IN G

loba

l Par

tner

ship

Fun

d, to

su

ppor

t a U

K c

olla

bora

tion

with

Chi

na (e

.g.

Chi

nese

Ass

ocia

tion

for L

abor

ator

y A

nim

al

Sci

ence

– C

ALA

S) f

or a

two-

day

sem

inar

, fun

ded

join

tly b

y U

K G

over

nmen

t and

the

rele

vant

ph

arm

aceu

tical

and

cos

met

ics

indu

strie

s, fo

r in

vite

d ex

perts

(gov

ernm

ent,

acad

emia

and

in

dust

ry) f

rom

Chi

na a

nd o

vers

eas

(UK

/EU

/US

) to

be h

eld

in B

eijin

g.

i) O

rgan

ise

sem

inar

in B

eijin

g to

sup

port

deve

lopm

ent o

f sta

ndar

ds fo

r ani

mal

ca

re, w

elfa

re a

nd e

thic

al u

se in

rese

arch

.ii)

Wor

k to

war

ds e

ndor

sem

ent o

f CA

LAS

st

anda

rds

by C

hine

se a

utho

ritie

s.iii

) Ini

tiate

a d

ialo

gue

on h

arm

onis

ing

phar

mac

eutic

al s

afet

y te

stin

g gu

idel

ines

an

d de

velo

p a

forw

ard

plan

.iv

) Exp

lore

a s

trate

gy to

cea

se a

nim

al

test

ing

of c

osm

etic

s in

Chi

na w

here

ver i

t is

not

sci

entif

ical

ly n

eces

sary

.

A st

rong

wor

king

rela

tions

hip

with

the

Chi

nese

A

ssoc

iatio

n fo

r Lab

orat

ory

Ani

mal

Sci

ence

s (C

ALA

S)

has

been

est

ablis

hed.

In M

arch

201

4 U

K g

over

nmen

t of

ficia

ls, w

ith C

ALA

S, h

eld

a sc

ene-

setti

ng s

emin

ar in

B

eijin

g th

at m

appe

d ou

t opp

ortu

nitie

s fo

r UK

–Chi

na

co-o

pera

tion

in th

e de

velo

pmen

t of s

tand

ards

for t

he

wel

fare

of r

esea

rch

anim

als

and

thei

r eth

ical

use

in

Chi

na.

Sup

port

has

been

giv

en to

CA

LAS

in d

evel

opin

g an

imal

w

elfa

re a

nd e

thic

al re

sear

ch s

tand

ards

and

it w

as

dem

onst

rate

d, th

roug

h vi

sits

to th

e U

K, h

ow th

ese

can

be m

ade

com

para

ble.

A fa

mili

aris

atio

n ex

erci

se w

ith

our r

egul

ator

y sc

hem

e de

mon

stra

ted

our a

ppro

ach

to d

evel

opin

g st

anda

rds

in th

e U

K. A

s pa

rt of

this

th

e de

lega

tion

visi

ted

both

indu

stry

and

aca

dem

ic

esta

blis

hmen

ts to

see

sta

ndar

ds b

eing

impl

emen

ted

in

prac

tice.

In p

artn

ersh

ip w

ith C

ALA

S a

sec

ond

UK

–Chi

na S

emin

ar

has

been

org

anis

ed to

be

held

in M

arch

201

5 w

hich

will

su

ppor

t the

furth

er d

evel

opm

ent o

f cur

rent

vol

unta

ry

stan

dard

s fo

r res

earc

h an

imal

car

e, w

elfa

re a

nd e

thic

al

use

to b

ecom

e m

anda

tory

nat

iona

l sta

ndar

ds in

Chi

na.

Inte

rnat

iona

l lob

byin

g, in

fluen

cing

and

evi

denc

e-ga

ther

ing

com

mun

icat

ions

man

aged

by

FCO

S

cien

ce a

nd In

nova

tion

Net

wor

k, in

par

tner

ship

w

ith B

IS a

nd H

ome

Offi

ce le

ads,

thro

ugh

the

FCO

glo

bal s

truct

ure.

Inte

rnat

iona

l Act

ion

Pla

n pr

iorit

ies

deliv

ered

: Del

iver

y P

lan

partn

ers

with

an

inte

rnat

iona

l com

pone

nt to

thei

r ac

tivity

abl

e to

acc

ess

FCO

net

wor

k ef

ficie

ntly

/effe

ctiv

ely

with

tim

ely

inpu

t of

inte

rnat

iona

l fee

dbac

k an

d ev

iden

ce a

s re

quire

d.

The

Hom

e O

ffice

, in

colla

bora

tion

with

indu

stry

and

the

Eur

opea

n C

omm

issi

on, i

s cr

eatin

g S

cien

ce In

nova

tion

Net

wor

k (S

IN) t

oolk

it. O

nce

deve

lope

d th

is w

ill b

ecom

e th

e to

ol w

hich

the

Sci

ence

and

Inno

vatio

n N

etw

ork

in

FCO

pos

ts w

ill u

se to

pro

mot

e bo

th a

nim

al w

elfa

re a

nd

its b

enef

icia

l im

pact

s to

hum

an w

ell-b

eing

. The

pla

n is

to

targ

et E

mba

ssie

s, in

clud

ing

Bra

zil,

Indi

a an

d Ta

iwan

, w

ho c

an ta

ke o

n th

e w

ork

of e

ngag

ing

on th

e 3R

s re

gard

ing

cosm

etic

s te

stin

g to

a lo

cal l

evel

. B

razi

l is

the

wor

ld’s

third

larg

est c

osm

etic

s m

arke

t. D

iscu

ssio

ns h

ave

been

initi

ated

to s

uppo

rt pr

opos

ed

legi

slat

ion

whi

ch w

ill b

an a

nim

al te

stin

g of

fini

shed

co

smet

ic p

rodu

cts

and

prom

ote

acce

ptan

ce o

f ove

rsea

s (e

.g.U

K) g

ener

ated

non

-ani

mal

test

dat

a.

Stra

tegi

c P

riorit

y 2

32


Title

/lead

org

anis

atio

n(s)

Act

ions

pub

lishe

d in

the

Del

iver

y Pl

anM

easu

res

of s

ucce

ss a

nd k

ey

mile

ston

es p

ublis

hed

in th

e D

eliv

ery

Plan

Prog

ress

3.1

Impr

ovin

g pu

blic

un

ders

tand

ing

of a

nim

al

rese

arch

(BIS

)

Impr

ovin

g pu

blic

und

erst

andi

ng o

f the

con

text

of

anim

al re

sear

ch a

nd th

e lic

ensi

ng fr

amew

ork.

- Rev

iew

the

resp

onse

s to

ani

mal

rese

arch

qu

estio

ns c

onta

ined

with

in th

e P

ublic

Atti

tude

s S

urve

y 20

14 m

anag

ed b

y S

cien

ce a

nd S

ocie

ty

and

IPS

OS

Mor

i.- O

ffice

of L

ife S

cien

ces

(OLS

) lea

ding

Pol

l on

anim

al re

sear

ch.

Pre

viou

s po

lls (B

IS) s

how

an

enha

nced

pub

lic u

nder

stan

ding

of

the

regu

lato

ry fr

amew

ork

with

in

whi

ch a

nim

als

are

used

in th

e U

K.

i) 20

14 p

oll l

aunc

hed.

ii) E

vide

nce

of e

nhan

ced

publ

ic

unde

rsta

ndin

g th

roug

h ne

w p

oll

resu

lts.

In M

arch

201

4 B

usin

ess

Inno

vatio

n an

d S

kills

(BIS

) ran

tw

o pa

ralle

l pub

lic o

pini

on s

urve

ys o

n th

e us

e of

ani

mal

s in

sc

ient

ific

rese

arch

. One

sur

vey

was

exa

ctly

the

sam

e as

the

prev

ious

iter

atio

n (O

ct 2

012

– th

e te

nth

wav

e of

rese

arch

in

this

ser

ies)

and

a n

ew s

urve

y w

ith s

ome

addi

tiona

l qu

estio

ns a

nd u

pdat

ed la

ngua

ge.

The

surv

ey in

dica

ted

that

aro

und

two-

third

s of

the

publ

ic

cont

inue

to a

ccep

t the

use

of a

nim

als

for m

edic

al re

sear

ch

whe

re th

ere

is n

o va

lidat

ed a

ltern

ativ

e. T

he re

sear

ch a

s a

who

le p

rovi

des

an e

vide

nce

base

for f

utur

e po

licy

and

enga

gem

ent a

nd to

pro

vide

evi

denc

e fo

r the

sec

tor t

o un

derp

in th

eir p

ublic

eng

agem

ent.9

3.2

Incr

ease

d tr

ansp

aren

cy

abou

t act

ual s

ever

ity

(HO

)

Dis

aggr

egat

ion

of d

ata

to re

port

proc

edur

es

acco

rdin

g to

thei

r act

ual s

ever

ity.

Mor

e cl

early

sep

arat

e th

e nu

mbe

r of p

roce

dure

s as

soci

ated

with

the

bree

ding

of n

on-h

arm

ful

GM

ani

mal

s (in

volv

ing

no s

uffe

ring)

from

pai

nful

pr

oced

ures

in a

nim

als.

Bet

ter i

nfor

m th

e pu

blic

ab

out w

hat a

nim

al re

sear

ch c

ompr

ises

(lar

gely

m

ild o

r sub

-thre

shol

d) a

s w

ell a

s to

iden

tify

the

mos

t sev

ere

proc

edur

es a

nd d

evel

op w

ays

to

redu

ce th

at s

ever

ity.

i) C

ompl

etio

n an

d re

view

of p

ilot t

rial

for r

etro

spec

tive

(act

ual)

seve

rity

repo

rting

.ii)

Dev

elop

men

t of g

uida

nce

on

reco

rdin

g ac

tual

sev

erity

.iii

) Pub

licat

ion

of fi

rst c

ompl

ete

year

of

retro

spec

tive

actu

al s

ever

ity d

ata.

iv) P

rovi

sion

of c

ompl

ete

year

dat

a to

the

EU

Com

mis

sion

.

i) A

n ac

tual

sev

erity

pilo

t stu

dy w

as c

arrie

d ou

t ove

r a tw

o-m

onth

per

iod

in A

ugus

t and

Sep

tem

ber 2

013.

The

resu

lts

wer

e pu

blis

hed

in th

e 20

13 A

SR

U a

nnua

l rep

ort.10

ii) T

he re

sults

of t

he p

ilot i

nfor

med

the

deve

lopm

ent o

f gu

idan

ce o

n ac

tual

sev

erity

, pub

lishe

d on

the

Hom

e O

ffice

w

ebsi

te.11

iii) T

he fi

rst c

ompl

ete

year

of d

ata

will

be

publ

ishe

d as

par

t of

the

Ann

ual S

tatis

tics

on th

e us

e of

Ani

mal

s in

Sci

entif

ic

Pro

cedu

res

in 2

015.

iv) T

he fi

rst c

ompl

ete

year

of d

ata

will

be

subm

itted

to th

e E

urop

ean

Com

mis

sion

whe

n av

aila

ble.

Stra

tegi

c Pr

iorit

y 3:

Pro

mot

ing

an u

nder

stan

ding

and

aw

aren

ess

abou

t the

use

of a

nim

als

whe

re n

o al

tern

ativ

es e

xist

9 ht

tps:

//ww

w.g

ov.u

k/go

vern

men

t/pub

licat

ions

/pub

lic-a

ttitu

des-

to-s

cien

ce-2

014

10 h

ttps:

//ww

w.g

ov.u

k/go

vern

men

t/pub

licat

ions

/ani

mal

s-in

-sci

ence

-reg

ulat

ion-

unit-

annu

al-r

epor

t-201

3 (p

age

12)

11

http

s://w

ww

.gov

.uk/

gove

rnm

ent/p

ublic

atio

ns/a

nim

als-

in-s

cien

ce-r

egul

atio

n-un

it-an

nual

-rep

ort-2

013

33


tle/le

ad o

rgan

isat

ion(

s)A

ctio

ns p

ublis

hed

in th

e D

eliv

ery

Plan

Mea

sure

s of

suc

cess

and

key

m

ilest

ones

pub

lishe

d in

the

Del

iver

y Pl

an

Prog

ress

3.3

Con

cord

at o

n O

penn

ess

and

Tran

spar

ency

(Aca

dem

ia, i

ndus

try,

hea

lth

char

ities

, fun

ders

, etc

.)

Con

cord

at o

n O

penn

ess

and

Tran

spar

ency

to

be m

ore

open

abo

ut th

e w

ays

in w

hich

ani

mal

s ar

e us

ed in

sci

entif

ic, m

edic

al a

nd v

eter

inar

y re

sear

ch in

the

UK

.- C

onco

rdat

on

Ope

nnes

s ab

out a

nim

al

rese

arch

agr

eed

betw

een

maj

or fu

nder

s,

rese

arch

org

anis

atio

ns a

nd in

dust

ry.

- IP

SO

S M

OR

I rep

ort o

n S

cien

cew

ise

supp

orte

d pu

blic

dia

logu

e se

ssio

ns w

ill d

eter

min

e pu

blic

ex

pect

atio

ns o

f ope

nnes

s, tr

ansp

aren

cy a

nd

com

mun

icat

ion

to in

form

the

deve

lopm

ent o

f the

C

onco

rdat

on

the

use

of a

nim

als

in re

sear

ch.

i) P

ublic

atio

n of

dec

lara

tion

on

open

ness

.ii)

Pub

licat

ion

of C

onco

rdat

.iii

) Ann

ual m

onito

ring

show

s pr

ogre

ss in

impl

emen

tatio

n.iv

) Pol

ls s

how

incr

ease

d pu

blic

un

ders

tand

ing

of th

e ro

le o

f ani

mal

re

sear

ch.

The

Con

cord

at w

as p

ublis

hed

in M

ay 2

014

and

sign

ed b

y 86

com

pani

es, u

nive

rsiti

es, m

edic

al re

sear

ch c

harit

ies

and

othe

r org

anis

atio

ns a

cros

s th

e U

K li

fe s

cien

ces

sect

or. I

t pu

ts th

e U

K li

fe s

cien

ces

sect

or a

t the

hea

d of

glo

bal e

fforts

to

incr

ease

ope

nnes

s an

d tra

nspa

renc

y in

ani

mal

rese

arch

. E

very

sig

nato

ry o

rgan

isat

ion

has

give

n a

clea

r com

mitm

ent

both

to fa

cilit

ate

grea

ter s

crut

iny

of th

eir a

nim

al re

sear

ch

and

to b

e vi

sibl

y ac

coun

tabl

e by

repo

rting

ann

ually

on

thei

r pr

ogre

ss to

war

ds im

plem

entin

g th

e C

onco

rdat

. Ins

titut

ions

in

volv

ed in

ani

mal

sci

ence

con

tinue

to s

ign

up to

the

Con

cord

at. A

‘one

yea

r on’

sto

ck ta

ke is

inte

nded

sho

rtly

to e

nsur

e si

gnat

orie

s ha

ve m

ade

clea

r ste

ps to

war

ds

impl

emen

tatio

n.

3.4

Rev

iew

of s

ectio

n 24

of

ASP

A

(HO

)

The

Gov

ernm

ent t

o re

view

sec

tion

24 o

f the

A

nim

als

(Sci

entif

ic P

roce

dure

s) A

ct 1

986

(AS

PA).

Sec

tion

24 p

rovi

des

for t

he p

rote

ctio

n of

in

form

atio

n, g

iven

in c

onfid

ence

, in

conn

ectio

n w

ith re

gula

tory

act

iviti

es u

nder

AS

PA. A

bre

ach

of s

ectio

n 24

can

resu

lt in

crim

inal

san

ctio

ns.

The

infle

xibl

e co

nfid

entia

lity

requ

irem

ents

of

sect

ion

24 a

re n

ow o

ut o

f ste

p w

ith g

over

nmen

t po

licy

on o

penn

ess

and

trans

pare

ncy

and

with

th

e ap

proa

ch ta

ken

in o

ther

legi

slat

ion,

suc

h as

the

Free

dom

of I

nfor

mat

ion

Act

(FO

IA).

The

inte

ntio

n is

to d

esig

n a

mor

e fle

xibl

e fra

mew

ork

that

will

pro

tect

pro

prie

tary

righ

ts, i

ntel

lect

ual

prop

erty

and

per

sona

l saf

ety,

pro

vide

gre

ater

tra

nspa

renc

y to

ass

ist p

ublic

und

erst

andi

ng,

and

not h

arm

the

com

petit

iven

ess

of th

e U

K in

th

e lif

e sc

ienc

es.

i) P

ublic

con

sulta

tion

on o

ptio

ns fo

r re

visi

on o

f sec

tion

24 c

omm

ence

d.ii)

Res

pons

e to

pub

lic c

onsu

ltatio

n re

view

ed a

nd p

refe

rred

opt

ion

prep

ared

.iii

) Pro

cess

es fo

r leg

isla

tive

chan

ges

(as

need

ed) p

ursu

ed le

adin

g to

re

visi

on o

f sec

tion

24.

The

publ

ic c

onsu

ltatio

n on

opt

ions

for t

he re

view

of s

ectio

n 24

was

pub

lishe

d an

d fo

ur b

road

opt

ions

wer

e of

fere

d.

Thes

e ra

nged

from

the

com

plet

e re

peal

of t

he s

ectio

n th

roug

h to

no

chan

ge. A

lmos

t 5,0

00 re

spon

ses

wer

e re

ceiv

ed, t

he m

ajor

ity th

roug

h th

e on

line

surv

ey s

yste

m.

Alm

ost w

ithou

t exc

eptio

n, re

spon

dent

s ex

pres

sed

a de

sire

fo

r inc

reas

ed o

penn

ess

and

trans

pare

ncy

in th

is fi

eld

whi

lst

reco

gnis

ing

the

need

to p

rote

ct th

e id

entit

ies

of p

eopl

e an

d pl

aces

as

wel

l as

info

rmat

ion

that

is a

cade

mic

ally

or

com

mer

cial

ly s

ensi

tive.

Fur

ther

dis

cuss

ions

with

st

akeh

olde

rs h

ave

refin

ed th

e pr

opos

als

and

we

will

revi

sit

thes

e in

the

next

Par

liam

ent.

Stra

tegi

c P

riorit

y 3

34


Glossary

3Rs The principles of replacement, reduction and refinement – an ethical framework for conducting scientific experiments using animals humanely

AHVLA Animal Health & Veterinary Laboratories Agency, an executive agency of Defra

ASPA Animals (Scientific Procedures) Act 1986 (as amended in 2012)

ASRU Animals in Science Regulation Unit, a unit of the Home Office responsible for regulating the use of animals in research under ASPA

AWERB Animal Welfare and Ethical Review Body, a requirement of each research establishment licensed under ASPA

BBSRC Biotechnology & Biological Sciences Research Council, an executive NDPB of BIS investing in bioscience research and training in the UK

BIS Department for Business, Innovation and Skills

Cefas Centre for Environment, Fisheries & Aquaculture Science, an executive agency of Defra

CFDA The Food and Drug Administration responsible for registration, including pharmaceuticals, medical devices and cosmetics, in China

Defra Department for Environment, Food and Rural Affairs

DH Department of HealthECHA European Chemicals Agency responsible for

the REACH RegulationEOGRTS Extended One-Generation Reproductive

Toxicity Study FCO Foreign & Commonwealth Office Fera Food & Environment Research Agency, an

executive agency of DefraFRAME Fund for the Replacement of Animals in

Medical ExperimentsFSA Food Standards Agency, a non-ministerial

department responsible for food safety and food hygiene across the UK

GA Genetically altered (applied to animals)GO-Science The Government Office for Science

which works within BIS and supports the Government Chief Scientific Adviser

HSE Health & Safety Executive, an executive NDPB of the Department for Work & Pensions and the UK competent authority for REACH

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

in vitro research using methods in components of an organism (e.g. tissue culture, cells, subcellular extracts or purified molecules)

in vivo research using methods within a whole, living organism, usually an animal

MHRA Medicines and Healthcare Products Regulatory Agency, an executive agency of DH responsible for registration of human medicines, vaccines and other healthcare products in the UK

MRC Medical Research Council, an executive NDPB of BIS which aims to improve human health by supporting research in medical sciences

NC3Rs The National Centre for the Replacement, Refinement & Reduction of Animals in Research

NDPB Non-departmental public bodyOECD Organisation for Economic Co-operation and

DevelopmentPHE Public Health England, an executive agency

of DH which aims to protect and improve human health in the UK

REACH Registration, Evaluation, Authorisation & restriction of Chemicals, an EU regulation which addresses the potential impact of chemicals on human health and the environment

RSPCA Royal Society for the Prevention of Cruelty to Animals – a UK charity which aims to reduce the suffering of animals used in research

TSB Technology Strategy Board, an executive NDPB sponsored and funded by BIS

UFAW Universities Federation for Animal Welfare – an internationally recognised, independent, scientific and educational animal welfare charity which first promoted the concept of the 3Rs

US FDA US Food and Drug Administration, an operating division of the US Department of Health & Human Services responsible for ensuring that human and animal pharmaceuticals, medical devices and cosmetics in the USA are safe and effective

VICH The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

VMD Veterinary Medicines Directorate, an executive agency of Defra responsible for registration of veterinary medicines, vaccines and other animal health products in the UK

35


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