1
Question IX.Aa.
Question text:
Introduction
IX.a) Current provisions of Directive 86/609/EEC
Member States shall, as far as possible, recognise the validity of data generated elsewhere,
unless further testing is necessary to protect public health and safety.
IX.b) Current situation in Member States
No specific instruments apart from ethical evaluation are employed at the Member States to
reduce duplication of testing. Retesting is a legal requirement for general medical products for
human and veterinary use. The only instruments possibly contributing to a reduction of
duplication in this area are Mutual Recognition Agreements between exporting countries and
the EU. However these instruments only cover specific issues and are thus not able to abolish
the requirement to test all products coming from that exporting country. For vaccines there is
an option for Member States to retest, which 10 – 15 Member States actually use.
IX.c) Trends and implications
One of the leading principles of the Three Rs is to avoid unnecessary testing on animals.
However, due to the different laws, administrative procedures in authorisation and inspection
arrangements in the Member States, it cannot be excluded, that duplication of testing may
occur. First evidence shows, that in Europe approximately 160.000 animals are subject to
duplication in regulatory testing each year.
2
IX.d) Problem dimension
Currently, there is no harmonised approach in Europe to ensure an effective exchange of
relevant information and data regarding animal experiments. Authorisation and inspection
bodies as well as researchers do not have the necessary overview of objectives and results of
all experiments carried out each year on more than 10 million animals in the EU 25 alone.
Although it can be argued that scientists usually have an excellent overview of the literature
within their respective fields of specialisation, negative results (although equally valuable),
however, are usually not reported. Only 25% of all Member States have currently a system of
automatic data collection in place.
IX.e) Potential solutions
A significant reduction of duplication in regulatory testing would require changes in numerous
legislative requirements at Member State level. This policy approach, however, cannot be
addressed by a revision of the given horizontal Directive. Compulsory authorisation of projects
and ethical evaluation aims partly to address this problem. However, these are discussed in
detail elsewhere in the questionnaire.
In view of this situation, the general approach of a revised Directive regarding the reduction of
duplication could be setting-up a centralised EU-wide database collecting information on
project authorisation and scientific results in each Member State.
The database could also provide a discussion platform where scientists and inspectors could
exchange their experiences, problems and good practices. As far as possible, information on
3rd countries should be collected. This could contribute in increasing the knowledge,
especially in basic research, and provide more transparency on “negative results”, not
systematically published so far.
The database would not be made public but be restricted to scientists and inspectors only.
Do you support this overall analysis?
Statistics:
3
83 respondents stated that they support the preliminary analysis.
23 respondents stated that they have no opinion in relation to this question.
101 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.Aa.
ness
the
organisation
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
Establishing such a database is not supported by a cost-benefit analysis, as the costs would be high
chair of lab.
and benefits minimal. See comments on 1.1 below.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
4
User of animals - Local; National
Dezentrale
Biomedizinische public sector
Einrichtungen
der Med.
Universität Wien
yes
Gesellschaft zur User of animals - National
Förderung der public sector
biomedizischen
Forschung
No Proof of reproducibility of results is imperative in natural science.
The organisation at IX.e) Potential solutions
Avoidance of duplication is only possible for safety testing (REACH).
is
representative
for the field at
the respective
activity level.
Hannover
Medical School
No, not easily practicable
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
User of animals - Local; Regional; Hannover
public sector
National
Medical School possible for safety testing (REACH).
currently ranks
highest with
respect to
research
activities and
aquired
research grants
5
Hans J. Hedrich User of animals - Local; Regional; I am currently No Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
President of the possible for safety testing (REACH).
public sector
National;
European
European
College of
Laboratory
Animal Medicine
(ECLAM) and
Vicepresident
Gesellschaft zur
Förderung der
Biomedizinische
n Forschung
Prof. Dr. R.
Nobiling,
University of
Heidelberg
User of animals - Regional;
public sector
National;
European;
Worldwide
Timo Nevalainen User of animals - Local
public sector
Biomed research Proof of reproducibility of results and including control groups is imperative in science. However, this
is not a duplication of experiments or projects. This can exluded in a well organized scientific
at Univ.
community Duplication, however, can and should be avoided in primary safety testing (e.G. REACH).
Heidelberg is
Top - ranked
Yes
There is already EU-funded ECVAM, not to mention association based structures. Another important
point is that verification and confirmation of experimental results is inherent to good science, thus
should not be regarded as duplication.
User of animals - Local; Regional; Yes, guess so ... I cannot understand why and how - at all - this kind of "EU database" might solve the problem of
Torgny
National
duplication (in regulatory testing).
Jeneskog, Umeå public sector
University,
Sweden
6
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 001)
yes
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
User of animals - Local; Regional; XXX
(Name
public sector
National;
confidential European;
Respondent 002)
Worldwide
See 1.11
User of animals - Local; Regional; Yes
(Name
public sector
National
confidential Respondent 003)
It is not clear that there is a problem with duplication of testing as pharmaceuticals are patented and
this prevents duplicate research by another company. There is limited re-testing for shipment of
vaccines between member states which could be addressed. There is no evidence that a EU-wide
database would be beneficial and could generate a huge burden. There are opportunities for
focussed databases, such as that for vehicles, which is being developed by the Industry/Animal
welfare dog minimisation project team. For the background to this initiative, which could have
positive welfare benefits and ensure no duplication takes place with these materials see Smith D et
al, ILAR Journal 43, S39-S42, 2002
User of animals - Worldwide
(Name
public sector
confidential Respondent 005)
there are others Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).
7
User of animals - National
(Name
public sector
confidential Respondent 009)
The easiest way to reduce duplication is to allow test results from one country for the same purposes
Yes, we are
representing all to other EU countries. In this way control is exercised at the level of the regulatory authorities, not
the investigators.
physiological
researchers in
the
Netherlands; we
have about 300
members
User of animals - Worldwide
(Name
public sector
confidential Respondent 010)
One of several
global
pharmaceutical
companies
It is unclear what the 160,000 animals refer to. There is some replication necessary for safety
reasons. Concerning the nonregulatory situation: There is clear need to replicate results. Reliability
and reproducibility are crucial for medical ethics to assure quality. Research has to deal with species
and strain differences. In this respect the public opinion is often misled. The impact of data bases is
grossly overestimated. The EU contributes a decreasing share of scientific results globally. More
results are being generated in US and increasingly in Asian countries, esp. China. Many results would
be outdated at time of publication. Results from pharmaceutical industry would hardly contribute to
decrease animal numbers since companies typically work on patentable compounds.
User of animals - Not applicable
(Name
public sector
confidential Respondent 018)
we are a
medical
university.
absolutely not. Duplication is important for good science. Scientific studies are not often duplicated
exactly. There is no question that duplication, reproduction is absolutely critical for science.
User of animals - Not applicable
(Name
public sector
confidential Respondent 022)
yes
] Replication of experiments is the fundament of science. Attempts to prevent duplication can be
considered as a serious threat to produce solid and replicable scientific results
8
User of animals - Local; National
(Name
public sector
confidential Respondent 023)
Avoidance of duplication is possible in regulatory testing. In basic research proof of reproducibility by
There are
several central others is a necessity! A database open to all scientists of Europe is in fact a public database which can
cause problems with animal activists.
laboratory
animal facilities
at Austrian
universities
User of animals - Local
(Name
public sector
confidential Respondent 025)
representative
Proof of reproducibility is imperative in natural science. Duplication might be avoidable in safety
testing.
User of animals - Local
(Name
public sector
confidential Respondent 032)
yes
No. This is an idealise view concerning this topic. In reality it will not work (see below). How does the
database know who is a scientist. There might be also animal right activists who are claiming that
they do scientific work.
User of animals - National
(Name
public sector
confidential Respondent 041)
no
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).
User of animals - National
(Name
public sector
confidential Respondent 042)
yes
Bureaucratic centralized regulation of research goes AGAINST the essence of free research. It is not
for the regulator do decide which research is worth wile, but to the scientist. I strongly oppose
centralized control.
9
User of animals - National
(Name
public sector
confidential Respondent 046)
yes
First need is the definition of a negative result, to prove the absence of effect is the most difficult
task in science. Results are based on statistical approach which can prove that groups are different or
that they are not different. Inclusion of negative results in a database also needs a peer review
process for the insurance of their validity. Data which are not validated could not be useful for
rejection of a procedure. Research project are subjected to peer review by scientific expert. During
this review, it is necessary to prove that the project is new and has not been previously done. So
there is a control based on scientific up to date information done by experts in the field of interest.
Creating a database with validated date conduct to a duplication of these evaluations and waste of
time and money.
User of animals - Regional;
(Name
public sector
National
confidential Respondent 047)
yes
see 1.11
User of animals - Local
(Name
public sector
confidential Respondent 048)
Not applicable, I This will be impractical
am not an
organisation
User of animals - Local; Regional;
(Name
public sector
National;
confidential European;
Respondent 050)
Worldwide
No. The issues here are fundamentally political and will not be assisted by a bureaucratic solution.
yes, we are a
major EU HEI for What is at stake here is whether the judgment of medical doctors in one country is trusted by doctors
in another. This is not just an EU problem.
biomedical
research
User of animals - National
(Name
public sector
confidential Respondent 053)
Some smaller
institutes exist
in the
Netherlands
I think this would only be relevant for regulatory testing. For all other experiments the complications
with confidentiality issues would be tremendous, except when dealing with obsolete results. The gain
for basic science projects would be small, and be outweighed entirely by the additional costs.
User of animals - National
(Name
public sector
confidential Respondent 054)
yes
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).
10
User of animals - Local; Regional;
(Name
public sector
National;
confidential European;
Respondent 069)
Worldwide
It is a
University, the
question is
meaningless
This is an example of an unnecessary layer of bureaucracy, which would add both financial and
temporal constraints beyond its benefits. The current level of duplication identified is low, and
unlikely to rise.
Bayer
HealthCare
organisation is
representative
for the field
The publication of results from animal experiments in an EU-wide internet-based data platform is
often impossible as the data are confidential (e.g. in industry). However, it exists already discussion
forums in the internet addressing questions to animal studies (confirmed by login and authentication).
Results from basic research are publicized on international conferences and publications in
international reviewed journals. These results are publishable only one-time. Thus, there is no
benefit to establish an additional discussion platform to prevent duplications of animal studies.
Thre are other
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
This analysis confirms, as have others http://www.apgaw.org/userimages/Vaccinetesting.pdf that
national governments and the EU cause duplication of regulatory testing. It then says it cannot do
anything about this, so proposes the burden of a database to addresses it own deficiencies. This is
entirely unreasonable
User of animals - Worldwide
private sector
GlaxoSmithKline User of animals - Worldwide
private sector
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
See 1.1
No - ABPI and
EFPIA repesent
the
pharmaceutical
industry in
UK/EU
sanofi pasteur
R&D
User of animals - Worldwide
private sector
Vaccine field
Based on previous experiences of central database, those systems are not efficient with limited (no)
added-value. Worldwide harmonization of regulations might be more effective to limit duplication of
studies.
11
User of animals - National
(Name
private sector
confidential Respondent 071)
yes
The setting of such a database seams to be the solution, but I am not sure if there is so much
duplication in research. EU- wide database for all results will be very compact and needs high effort
to keep the data updated. Regulations, Agreements between MS could be more effective than such a
database. There are also existing databases in EUROPE, like REACH.
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is Experience with Industry projects designed to create databases of this type show that it is extremely
difficult and represent a significant challenge. The contents of the database could rapidly extend to
the largest
pharmaceutical intellectual property that would need to be excluded.
company in
Europe and
ranks third
worldwide
User of animals - Worldwide
(Name
private sector
confidential Respondent 074)
Yes
Very bureaucratic and do not address the problem in paragraph b), c) and d).
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
no comment
User of animals - Worldwide
(Name
private sector
confidential Respondent 076)
Yes
There are no evidence that a centralized data base would result in a reduction of “duplication” of
experiments, since there are no sound data indicating duplication of experiments today. Private
institutions will not perform research studies in areas protected by patents of competitors, e.g.
pharmaceutical industry will not do pharmacological studies in areas of patents of others and will
perform extensive analysis of patent situation simply for economic reasons. Researchers in public and
private institutions active in a field are generally well linked to their colleagues also working in the
field and since many animal experiments are highly specialized, the benefit of a such a database is
questionable. The efforts for setting up and maintaining such a database will be remarkably high.
Therefore, a proper analysis of the actual benefits to be expected is needed first.
12
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
no comment
User of animals - Worldwide
(Name
private sector
confidential Respondent 084)
yes
Because it is impossible to give a valid definition who is a scientist, how will this designation be
awarded
User of animals - Not applicable
(Name
private sector
confidential Respondent 085)
In the private sector, confidentiality of data might limit feasibility of this EU database
Also other
biotech
companies have
similar animal
facilities
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many
other such
organisations in
Europe
The key issue for duplication is not duplication of licences but duplication of data sets for regulators.
The proposal is not appropriate for matters relating to the protection of intellectual property. In the
pharmaceutical industry minor chemical differences in compounds are subject to protection of
intellectual property due to their potential to dramatically increase efficacy and or safety
parameters. The implementation of such unrefined proposals would bring intolerable risk to the
operation of drug discovery paradigms in the pharmaceutical industry. It may also be helpful to better
define replication versus duplication (see report of Nuffield Council on Bioethics, report titled “Ethics
of Research Involving Animals”, p 264,
279,www.nuffieldbioethics.org/go/ourwork/animalresearch/introduction). and whether the
screening of distinct chemical entities in a particular animal model would be considered as
duplication of testing.
User of animals - Worldwide
(Name
private sector
confidential Respondent 087)
No
If there are EU Directives which may result in duplicate testing it is these which should be changed,
not the system which authorises tests. Publication of negative results for education of others should
be recognised as a good thing and encouraged.
13
User of animals - Worldwide
(Name
private sector
confidential Respondent 090)
Yes
It is difficult to understand how this proposed system will be administered to attempt to avoid
duplication of animal experiments. Supplying information to a central database will be problematic
as details of experiments are usually commercially sensitive. Drug companies will not want to supply
information to such a database as this may give their competitors an advantage. The situation will
undoubtedly encourage industrial espionage. It will also be very costly to administer, which will, in
turn, favour larger establishments.
User of animals - Worldwide
(Name
private sector
confidential Respondent 091)
YES (Safety
Assessment)
It is being assumed that there is a problem with duplication of testing. This is not the case. There is
limited retesting (eg batch release for polio testing). ICH and mutual recognition agreements would
be more useful than any database.
User of animals - Worldwide
(Name
private sector
confidential Respondent 092)
No welfare effect of a central database - scientific DBs already available
Global
pharmaceutical
research and
development
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
see answers below
User of animals - Worldwide
(Name
private sector
confidential Respondent 098)
Representative
For the safety assessment of new drug, retesting is only limited to satisfy ICH requirements, and to
support/compare new data generated "in-house". The large amount of variables still present at
individual Research Centers prevent the possibility to generally adopt data obtained at other
facilities. Different perspectives might be adopted for the assessment of the existing chemicals, but
these have to be consistent within the REACH Program.
User of animals - Worldwide
(Name
private sector
confidential Respondent 099)
yes
It is being assumed that there is a problem with duplication of testing. This is not the case. There is
limited retesting (eg batch release for polio testing). ICH and mutual recognition agreements would
be more useful than any database.
14
User of animals - Worldwide
(Name
private sector
confidential Respondent 102)
no
For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to
nearly everybody. Then, intellectual property protection rights will be violated. In addition, lots of
people will have to collect data and put them into the database. Why is this only aiming at an EU
wide database? Experiments are performed globally! The prerequisite is, that duplication of animal
experiments is really an issue. For our sectors and the entire industry this is not true! In the
agrochemical sector as well as in the pharmaceutical sector every company is working on their own
active compounds without overlaps. For chemicals, avoiding duplication of experiments is already a
prominent part of REACH (information exchange fora must be formed and testing proposals must be
submitted to the agency). Overall, this will have a high negative impact on European research and
industry and this cannot be the goal. Setting up such a database is neither feasible nor reasonable.
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
It is being assumed that there is a problem with duplication of testing. This is not the case. There is
limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would
be more useful than any database. Reference documents: EFPIA impact assessment on data bases of
experiments and our discussion on who should have access to data and specificity of pharmaceutical
research + pilot project on data sharing. Please do not forget requirement to publish data under
REACH.
User of animals - Worldwide
(Name
private sector
confidential Respondent 106)
Yes
Duplication may be a problem in basic research where negative results are hard to publish. In
regulatory testing, duplicate experiments will be avoided for economic reasons already. However,
management of well-run database will be very cost-intensive.
User of animals - National
(Name
private sector
confidential Respondent 110)
representative
For basic research such a data bank would only be accepted if intellectual property issues are
included. Furthermore, a very actual database must be available. If the data are more than 3 month
behind, nobody would use it. For regulatory sensitive data and animal studies a data base could be
helpful.
User of animals - Worldwide
(Name
private sector
confidential Respondent 198)
The proposed solutions do not address the issues identified in paragraphs b. c and d.
Don't
understand this
question
15
Animal
Procedures
Committee
(APC)
Public authority National
Public authority National
Coordination
group for
laboratory
animal activities
The APC provide
independent
advice to UK
Government on
the use of
animals in
scientific
procedures. The
APC consider
science,
industry and
animal welfare.
Members are
from a variety
of backgrounds.
Scientists will necessarily go to great lengths to avoid duplication for very practical reasons. The
availability of any tool to assist in this should be welcomed. Fundamental research, however, may be
less amenable to use in a straightforward database and the use of systematic review/meta-analysis
techniques in animal-based research should be promoted and encouraged to avoid duplication.
Statistical techniques to allow for publication bias may already be available to counter the effects of
non-publication of negative results. No reference is given for the statement in IXc: “First evidence
shows, that in Europe approximately 160.000 animals are subject to duplication in regulatory testing
each year.” However, if the EC were successful in addressing this specific issue, it may be a more
effective way of reducing the number of animals used in procedures than introducing a database.
Yes
There is already EU-funded ECVAM, not to mention association based structures. Another important
point is that verification and confirmation of experimental results is inherent to good science, thus
should not be regarded as duplication.
For funded research, the best way to avoid duplication is the grant review process. For competitive
DR Achim Klug, Public authority Worldwide; Not Deutsche
applicable
Forschungsgeme funding, one will not be able to get grants for something that has already be done. Again, grant
Ludwig
inschaft - DFG reviewers (peer reviewers) are usually much more competent at determing this issue than any other
Maximilians
governmental regulatory agency even under the most ideal circumstances could.
University
Munich
16
Francois
Lachapelle
INSERM
Public authority National
BEA du CNRS, de establishing such a database will be extermly time consuming and wont'be supported by the scientific
l'INRA, du CEA community
Prof. Dr. Bernd
Hoffmann,
Justus-LiebigUniversität
Giessen
Public authority National;
European
similar to other Most duplication occurs in industry based research. Succesful attempts have been made to decrease
universities
animal experiments. I dont think that another substantial progress can be made. Since has to publish
which inherently is against duplication. Above all, published data can also be used for registration
purposes.
Public authority Local
(Name
confidential Respondent 115)
yes
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).
Public authority Local
(Name
confidential Respondent 116)
yes
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).Proof of reproducibility of results is imperative in natural science.
Avoidance of duplication is only possible for safety testing (REACH).
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
The reasons are given below.
Public authority National
(Name
confidential Respondent 118)
Yes
Neither science nor business works in this way. Who should read it? Companies do not publish these
data either.
Public authority Local; Regional no
(Name
confidential Respondent 119)
This will be ineffective but very bureaucratic
17
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use. It is not clear how any mandated use of such a database would be monitored, or how its
value and impact would be judged. It is also important to appreciate that data is often owned by
those who commission testing – and not the test labs themselves. What is needed in the context of
regulatory testing is, though other directives, better promotion of data-sharing, and mutual
acceptance of data.
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
see 1.11
Public authority National;
(Name
European;
confidential Worldwide
Respondent 128)
Although we are
a smaller
University,
about half of
the research
groups involving
animal
experiments
belong to
leading
institutions in
their field.
Proof of reproducibility of results is imperative to science. "Replication in science … is a way of being
sure that something really exists." (Giles, 2006, "The trouble with replication", Nature 442: 344-347).
This implies that scientists have to be able to replicate experiments from other groups. Avoidance of
duplication is only possible for safety testing.
Public authority National
(Name
confidential Respondent 129)
representative
Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only
possible for safety testing (REACH).
18
1.Animal Aid
Other
National
There should be a statutory obligation to avoid any duplication. To suggest that it would be too
Other
organisations do complex to introduce such legislation represents a lack of compassion and a disregard for the
suffering of fellow sentient beings. A regime that permits duplication is an affront to the Universal
exist
Declaration of Animal Rights (proclaimed in Paris on 15 October 1978 at the UNESCO headquarters,
and made public in 1990).
Biosciences
Federation
Other
National;
European
There are other We cannot see how these suggestions could be workable. First, recent UK history of the development
of major national databases has shown that they are very expensive, fraught with technical problems
relevant
and rarely fit for purpose. Second, the results would need to identify the research group, which is
organisations
not acceptable for security reasons. Third, issues of IP protection would obstruct the objective, as if
competitors in a particular research field are doing similar research they are not going to release
information to the other side An objective and evidence-based cost-benefit analysis would need to be
undertaken before these proposal should be taken forward.
COST Action B24 Other
“Laboratory
Animal Science
Welfare” http://biomedic
um.ut.ee/costb
24
European
No
Medical
University of
Vienna
Other
Local; Regional; Research in
Medicine
National;
European;
Worldwide
No. This is an idealised view concerning this topic. In reality it will not work (see below). How does
the database know who is a scientist. There might be also animal right activists who are claiming that
they do scientific work. And there is already EU-funded ECVAM, not to mention association based
structures. Another important point is that verification and confirmation of experimental results is
inherent to good science, thus should not be regarded as duplication.
see 1.11.
19
National Centre Other
for the
Replacement,
Refinement and
Reduction of
Animals in
Research
National
Representative
Much duplication of animal testing is imposed under EU regulations. A more profitable way of
achieving a reduction in animal use would be to address this issue. A database may be onerous and
too simplistic to be cost effective on any large scale. Systematic reviews and meta-analyses may be
more productive.
Royal
Netherlands
Akademie of
Arts and
Sciences
Other
National
Yes,
representative
of the scientific
community
To our knowledge this database is not a feasible option in basic research. For a start, it would give
scientists extra administrative tasks. Secondly, in basic research it is very important to perform
experiments yourself, even if they have already been performed elsewhere. Testing conditions might
differ substantially, so one prefers not to rely on someone else’s results. Next to that, we are worried
about privacy matters. It is not guaranteed that people with false intentions will not abuse the
information available.
TNO Quality of
Life (The
Netherlands)
Other
National;
Worldwide
Yes
A central european database is not achievable and meaningfull, because of: - compulsary input of
data, including negative results, and keeping the data base up to date will lead to bureaucracy - for
regulatory test data compound names are often propriety; under REACH lower tier test data will
probably be publicly available in IUCLID V - several large databases on Alternatives are already
available (e.g. ECVAM)
National
I am the chair of It is a nice, naiv, unrealistic idea.
the Hungarian
Scientific
Ethical
Committeeon
Animal
Experimentation
Other
(Name
confidential Respondent 138)
20
Other
(Name
confidential Respondent 140)
Local
Benefits would not justify costs. Effectiveness of such a body is questionnable.
We are
relatively small
in terms of
usage but our
operational
organisation is
typical
Other
(Name
confidential Respondent 141)
Not applicable
other
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by
duplicate work
Other
(Name
confidential Respondent 144)
National
Yes
It is not the case that there is a problem with duplication of testing. As a result, ICH and mutual
recognition agreements would be of more use than a database.
Other
(Name
confidential Respondent 157)
Worldwide
pharmaceutical When intellectual property right and personal confidentiality are secured, such database cannot lead
industry
to an exchange of data between experimentators and many data would be excluded from such
database. Therefore, the costs of such database would not be in proportion of the very limited gain,
if any.
Other
(Name
confidential Respondent 199)
European
yes
These findings assume that there is a problem with duplication of testing. This is not the case. ICH
and mutual recognition agreements would therefore be more useful than a database.
21
British Heart
Foundation
Nongovernmental
organisation
National
An EU register os experiments for regulatory testing could be useful, but a register for all
We are a
experiments would be very expensive, difficult to analyse for duplication, and would not lead to
medical
significant reduction in animal use.
research
charity, of
which there are
many in the UK
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
The Introduction focuses on duplication in specific aspects of regulatory testing whilst neither fully
addressing this issue nor fully addressing the issue of duplication in basic and applied research which
is equally important. Some means of preventing duplication is essential, and its cost would be
outweighed by the benefits in terms of a) reducing the impact of science on animals and b) economic
benefits. A single centralised database may not be the best, or only, answer to address duplication in
different areas of research and testing. Different strategies are likely to be required in different
sectors of regulatory testing and to cover basic research. The problems of duplication, and possible
solutions in basic and applied research, should be assessed separately.
22
Nongovernmental
organisation
European
Establishing such a database is not supported by a cost-benefit analysis, as the costs would be high
FELASA
and benefits minimal. See comments on 1.1 below.
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
Gesellschaft für NonVersuchstierkun governmental
de - Society for organisation
Laboratory
Animal Science
(GV-SOLAS)
National;
European
Yes
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
No. This is an idealise view concerning this topic. In reality it will not work (see below). How does the
database know who is a scientist. There might be also animal right activists who are claiming that
they do scientific work.
23
PETA Europe
Ltd.
Nongovernmental
organisation
Stichting EDEV - Nongovernmental
Een DIER Een
organisation
VRIEND
The
Physiological
Society
Nongovernmental
organisation
Worldwide
both
The impact is not neutral because it will reduce animal use and has the potential to improve science.
A statutory obligation to avoid duplication should be required. Regulatory testing can and should also
be included. In some instances, sharing of information about failed/negative studies could lead to a
reduction in animal use and improved science if more effective non-animal methods are introduced.
Repetition of flawed animal research is also less likely to happen, resulting in better use of research
funding. The additional cost of setting up the system will be outweighed by the financial benefits,
and in any event measures to improve animal welfare should always be introduced regardless of cost,
in line with the EU commitment to the 3Rs.
National;
European
We cooperate
with animal
organisations
within the
ECEAE
This database shoul be public, why not?
Worldwide
Many other
Learned
Societies aer
also
representative
We cannot see how these suggestions could be workable. The work to get all data into a consistent
searchable format would be enormous. To be useful, the results would need to identify the research
group, which, as indicated elsewhere, is not feasible on security grounds. Issues of IP protection
would obstruct the objective. The central support needed would be considerable and ongoing to
maintain the database. An objective and evidence-based cost-benefit analysis would need to be
undertaken before such a proposal should be taken forward. In any case, any major duplication of
basic research is weeded out on cost grounds and during peer review of project proposals, and, as
indicated, regulatory duplication cannot be improved by such means.
24
The Royal
Society
Nongovernmental
organisation
National
Yes. The Royal
Society is the
independent
scientific
academy of the
UK dedicated to
promoting
excellence in
science. The
Society plays an
influential role
in national and
international
science policy
Whilst we support the principle of avoiding duplication by setting up an EU wide database where
negative data could be published, we believe that there is a risk that the costs and resources required
will not be proportional to the benefits to be gained from it. The time and resources need to get all
data into a consistent searchable and useful format would be enormous. There are also issues of
security, confidentiality and IP protection.
UK Laboratory
Animal Science
Association
(LASA)
Nongovernmental
organisation
National
LASA represents
animal user
community in
academic,
government &
industry sectors.
We disagree that there is a problem with duplication of testing. Active pharmaceuticals are patented
and this prevents duplicate research by another company. There is limited re-testing for shipment of
vaccines between member states which could be addressed. There is no evidence that a EU-wide
database would be beneficial and could generate a huge burden. There are opportunities for
focussed databases, such as that for vehicles, which is being developed by the Industry/Animal
welfare dog minimisation project team. For the background to this initiative, which could have
positive welfare benefits and ensure no duplication takes place with these materials see Smith D et
al, ILAR Journal 43, S39-S42, 2002
Non(Name
governmental
confidential Respondent 164) organisation
National
yes
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
25
Non(Name
governmental
confidential Respondent 166) organisation
National
NO OTHER
RELEVANT
ORGANISATION
The proposal is not precise enough, especially regarding the content of the database (validation
process mandatory)
Non(Name
governmental
confidential Respondent 167) organisation
National
YES
The setting up of an centralizes EU-data base seem impracticable.
Non(Name
governmental
confidential Respondent 171) organisation
Worldwide
No other
organisations
Whilst we would support the principles behind setting up a database to share information at the EU
level, we believe that the resource requirement necessary to establish such a complex system is out
of proportion to the benefits to be gained from it. Any such system would be too cost prohibitive and
difficult to run. It would take an enormous amount of time and resources to turn the information into
searchable data that would be useful to the research community. Issues of security, confidentiality
and IP protection would also prove problematic.
Non(Name
governmental
confidential Respondent 174) organisation
Worldwide
-
-
Non(Name
governmental
confidential Respondent 175) organisation
National
yes
The database does not help. It would be very demanding and costly to keep it updated.
Breeder of
(Name
animals
confidential Respondent 182)
Worldwide
Representative
These platforms already exists on the scientific level. Thus a duplication of experiments is excluded.
Further database will only increase cost and work.
26
(Name
confidential Respondent 188)
Regional;
National
Not applicable: Although the concept of an EU wide database for this purpose is reasonable, the practical problems
related to collecting, uploading, storage in a meaningful and retrievable manner and maintenance
response is
personal opinion (ensuring database is up to date) seem impossible to overcome without extensive resources.
based on
personal
expertise
(Name
confidential Respondent 189)
National;
European
There are other Duplication resulting from regulatory requirements should be addressed by the relevant regulatory
organisations
authorities, and will not be solved by the proposed database.
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
see below
27
Question IX.1.1.
Question text:
Preliminary assessment shows an overall neutral impact of this element: A centralised EUwide database can help to prevent duplication of testing by providing neutral, timely and
comprehensive information about all non-confidential authorised projects in Europe. This can
increase both animal welfare and the quality of science, and could make research funding go
further as it would avoid having to carry out those experiments that do not need to be
duplicated.
However, the resource requirements for establishment, administration and maintenance of
such a database coupled with challenges for timely availability of information to ensure
usefulness could reduce the efficiency of this option
Do you support this overall analysis? Yes/No/No opinion
Statistics:
114 respondents stated that they support the preliminary analysis.
39 respondents stated that they have no opinion in relation to this question.
65 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.1a.
ness
the
organisation
28
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
chair of lab.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
The cost-benefit analysis does not support the establishment of a centralised database. True
duplication is a very rare event, extremely so in the industrial sector owing to differences in
molecular structure of compounds and in formulations and excipients. This analysis is supported by
the UK Home Office, based on detailed inspections and licensing system in place in that country.
Such a database would therefore have a minimal effect on reduction in animal use. There would also
be considerable concern at possible disclosure of information that could be of benefit to competitors,
and this could lead to a movement of research outside Europe.
User of animals - Local; National
Dezentrale
Biomedizinische public sector
Einrichtungen
der Med.
Universität Wien
yes
No increase in animal welfare expected
Gesellschaft zur User of animals - National
Förderung der public sector
biomedizischen
Forschung
The organisation at 1.2 and 1.4
databases exist.
is
representative
for the field at
the respective
activity level.
No No welfare effect of central database, sufficient assessable scientific
29
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 001)
yes
User of animals - Local; Regional; XXX
(Name
public sector
National;
confidential European;
Respondent 002)
Worldwide
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
See 1.11
User of animals - National
(Name
public sector
confidential Respondent 009)
Such database is not needed; companies know what they have done to comply with regulations in one
Yes, we are
representing all country and should simply be avble to use the same data for the same purpose in the other country.
physiological
researchers in
the
Netherlands; we
have about 300
members
User of animals - Worldwide
(Name
public sector
confidential Respondent 010)
The impact of data bases is grossly overestimated. The EU contributes a decreasing share of
One of several
scientific results globally. More results are being generated in US and increasingly in Asian countries,
global
pharmaceutical eg. Japan and China. Most results would be outdated at time of publication. Results from
pharmaceutical industry would hardly contribute to decrease animal numbers since companies
companies
typically work on patentable compounds. The administrative burden to justify experiments when
similar but nort equal experiments have to be discussed would be tremendous. There is clear need to
replicate results. Reliability and reproducibility are crucial for medical ethics to assure quality.
Research has to deal with species and strain differences. In this respect the public opinion is often
misled.
30
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 011)
Other
organisations in
Austria: KarlFranzensUniversity;
Medical
University
Vienna; Medical
University
Innsbruck
The publication of negative findings is as time-consuming and costly as positive findings, but negative
findings do have very little impact, because they do not prove or disprove a principle: from negative
findings it can usually only be inferred that one has to try in a slightly different way. Important and
conclusive negative findings are published anyway. The second problem is intellectual property.
Publishing negative results would disclose the scope of current work a nd the methods applied. In this
respect, most negative findings are confidential. Therefore, publishing negative findings must remain
optional.
User of animals - Not applicable
(Name
public sector
confidential Respondent 018)
we are a
medical
university.
A centralised EU-wide database will not help to prevent duplication of testing. In addition, the
scientific journals provide timely and comprehensive information about all non-confidential
authorised projects in Europe. An EU database of this kind will waste a huge amount of money. It will
neither increase animal welfare nor the quality of science. The bottomline is that most experiments
do need to be duplicated. Who would send in information about their experiments? The ones that
worked or conversely the ones that didn’t work? Who would send in results of experiments which are
not yet published or are waiting for patents? This does not make sense.
User of animals - Local; National
(Name
public sector
confidential Respondent 023)
see IX.e
There are
several central
laboratory
animal facilities
at Austrian
universities
31
User of animals - National
(Name
public sector
confidential Respondent 028)
yes. There are The value of such a database with regard to its effect on reduction of animal experimentation is
other academic questionable. First of all, true duplication of experiments is hard to find. Each (Pharma) company has
medical centres its own specific compounds, formulations. Almost by definition there is no duplication in academia
due to the virtual absence of GLP/ GMP/ SOPs. The publication of ‘negative results’ through such a
database will only lead to a reduction if results are accompanied by detailed descriptions of the
experimental set up and materials and methods used. There is a scientific need to confirm
experimental data, which is a basic to the scientific validation of data in general, as irreproducible
data are considered invalid. Also, in case a method from literature is to be used, it is essential that
the published method can be reproduced before additional experimental variables are introduced into
the modelsystem. The phrasing, if at all included, should be: “unnecessary duplication”.
User of animals - Local
(Name
public sector
confidential Respondent 032)
yes
No, such a database does neither increase animal welfare nor does quality of science. There are other
mechanisms already established (see top IX.e).
User of animals - Regional;
(Name
public sector
National
confidential Respondent 047)
yes
see 1.11
User of animals - Local
(Name
public sector
confidential Respondent 048)
Not applicable, I it will be impractical
am not an
organisation
User of animals - National
(Name
public sector
confidential Respondent 053)
Some smaller
institutes exist
in the
Netherlands
No opinion. I think this would only be relevant for regulatory testing. For all other experiments the
complications with confidentiality issues would be tremendous, except when dealing with obsolete
results. The gain for basic projects would be small, and be outweighed entirely by the additional
costs.
32
User of animals - Worldwide
(Name
public sector
confidential Respondent 066)
Yes,
representative
This is total nonsense, at least when applied to scientific research. We are aware of what our
colleagues are doing, often well before publication occurs. In addition, it is often necessary and
appropriate to repeat experiments in other labs if their results are difficult to integrate into current
theory.
GlaxoSmithKline User of animals - Worldwide
private sector
Thre are other As above this is an unreasonable solution for a policy failure at European level. The primary problem
of duplication is with regulatory authorities. This where the problem should be addressed
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
User of animals - Worldwide
private sector
No - ABPI and
EFPIA repesent
the
pharmaceutical
industry in
UK/EU
It is being assumed that there is a problem with duplication of testing. Batch release resting should
not really be regarded as duplication, as each test is a specific evaluation of a particular batch, to
ensure efficacy and safety of that batch. ICH and mutual recognition agreements would be more
useful than any database. Management of such a database would be very difficult and labour/cost
intensive. Much data on regulatory studies would be missing because of confidentiality, so it may not
help in avoiding any duplication of testing. In the regulatory field, there should perhaps be an
obligation on regulatory agencies to inform Companies of data in the public domain that could be
used to circumvent repeat testing of products, or to encourage two Sponsors with related/similar
products to share data. This would do more to reduce duplication than a central database.
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is
the largest
pharmaceutical
company in
Europe and
ranks third
worldwide
The proposition is based on the assumption that there is something wrong with duplication of testing.
Good science is based on reproducibility and that previous projects are duplicated as part of
validation prior to moving on to the next step. Duplication could be avoided in product testing and
vaccine quality assurance. A database is not going to influence this. ICH and regulatory authority
agreement will.
Protherics
Medicines
Development
Ltd.
33
User of animals - Worldwide
(Name
private sector
confidential Respondent 074)
Yes
The database very difficult to keep up to date. Mutual recognition much better.
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
Actually yes but Duplication of experiments should be limited to specific objectives. Regulations tend
to harmonize regukatory request to avoid duplication. + problem of confidentiality
User of animals - National;
(Name
private sector
Worldwide
confidential Respondent 079)
yes
Actually, it is not a really a "duplication" issue… at least as a first objective. All efforts should be
concentrated in priority on the real stake i.e. international harmonisation and recognition of
regulatory testing
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
yes but, Duplication of experiments should be limited to specific objectives. Regulations tend to
harmonize regukatory request to avoid duplication. + problem of confidentiality
User of animals - Worldwide
(Name
private sector
confidential Respondent 084)
yes
Quality of science and animal welfare will not depend on this database
34
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many
other such
organisations in
Europe
It is difficult to support the analysis when there is a presumption that avoiding the duplication of
licence approvals will result in avoiding the duplication of data sets. For example, would only one
single establishment gain approval to conduct studies to generate safety data for crop protection
compounds? This is a very important ambiguity about the practical operation of such proposals which
must be resolved and the flawed implementation of this proposal will have many negative
repercussions for both the public and private sectors. For example, the pharmaceutical industry
invests in projects which are at high risk of not eventually delivering medicines for unmet medical
needs and therefore the collective innovation of many players simultaneously working on the same
problems is highly desirable. It is not clear if the proposal outlined about would prevent several
pharma working on key targets for intervention in diseases such as asthma or HIV/AIDS.
User of animals - Worldwide
(Name
private sector
confidential Respondent 087)
No
No need to set up such a large and unwieldy database, with potential for misuse of data if the
Directives which require duplicate testing are revised.
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
Actually yes, but: It is being assumed that there is a problem with duplication of testing. This is not
the case. There is limited retesting (batch release for e.g. polio testing. ICH and mutual recognition
agreements would be more useful than any database. Reference documents: EFPIA impact
assessment on data bases of experiments and our discussion on who should have access to data and
specificity of pharmaceutical research + pilot project on data sharing. Please do not forget
requirement to publish data under REACH.
User of animals - Worldwide
(Name
private sector
confidential Respondent 095)
Yes
A central database is for research companies not practicable as the majority of experiments are
unique due the different nature of compounds. Duplication must be avoided by adapation of the
regulatory requirements of the EU countries and not by the introdcution of a money consuming
datbase.
User of animals - Worldwide
(Name
private sector
confidential Respondent 102)
no
For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to
nearly everybody. Then, all confidentiality and intellectual property protection rights have to be
violated. In addition, too many people will have to work on collecting data and putting them into the
database.
35
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
It is being assumed that there is a problem with duplication of testing. This is not the case. There is
limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would
be more useful than any database. Reference documents: EFPIA impact assessment on data bases of
experiments and our discussion on who should have access to data and specificity of pharmaceutical
research + pilot project on data sharing. Please do not forget requirement to publish data under
REACH.
User of animals - Worldwide
(Name
private sector
confidential Respondent 105)
yes
There is only limited number of duplications of testing. In addition proof for reproducibility of
methods and results is a scientific requirement.
User of animals - Worldwide
(Name
private sector
confidential Respondent 106)
Yes
If at all, duplicate testing may be an animal welfare problem only for basic research. Adequate
management of a useful database would require a high amount of resources.
User of animals - Worldwide
(Name
private sector
confidential Respondent 107)
yes
---
User of animals - National
(Name
private sector
confidential Respondent 110)
representative
For basic research such a data bank would only be accepted if intellectual property issues are
included. Furthermore, a very actual database must be available. If the data are more than 3 month
behind, nobody would use it. For regulatory sensitive data and animal studies a data base could be
helpful.
User of animals - Worldwide
(Name
private sector
confidential Respondent 198)
Mutual recognition agreements would be much more useful than any databases.
Don't
understand this
question
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
A database would not be able to perform the function stated even if heavily resourced.
36
Public authority National;
(Name
European;
confidential Worldwide
Respondent 120)
Yes
The administration, costs and user compliance associated with the database might reduce its efficacy.
Private organisations would be unlikely to contribute to this. However, another method of
encouraging sharing of animal resources an dminimising duplication might be to minimise the
beaurocracy associated with the transport/movement of animals from one authority to another. This
would facilitate researchers sharing eg genetically modified rodents.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
Negative results are rarely published and establishmetn of an accurate relevant database is unlikley
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS It would be beneficiary so it is not neutral but positive in my opinion
is also involved
Public authority National;
(Name
European
confidential Respondent 133)
I bel;ieve this option will have a higher impact as hier above supposed. A EU- central data is an
Yes, together
essential tool to get a real oevrview of infromation available to teke the richt measures ( at EU level)
with the
to avoid duplication of researach when not necessary.
National Food
and Product
safety Authority
Public authority Worldwide
(Name
confidential Respondent 135)
yes
I would consider the benefit/effort ratio as too little
37
1.Animal Aid
Other
National
This is not neutral. It falls far short of what is required – a statutory obligation to avoid duplication.
Other
organisations do
exist
Biosciences
Federation
Other
National;
European
There are other See 1.11 - Justification
relevant
organisations
COST Action B24 Other
“Laboratory
Animal Science
Welfare” http://biomedic
um.ut.ee/costb
24
European
No
Medical
University of
Vienna
Other
Other
(Name
confidential Respondent 138)
No, such a database does neither increase animal welfare nor does quality of science. There are other
mechanisms already established (see top IX.e).
Local; Regional; Research in
Medicine
National;
European;
Worldwide
see 1.11.
National
This idea lacks knowledge on mechanism of science. If there is an ongoing project on – say- the
mechanism of Parkinson disease (basic science) then no need for another? Or a project for
antiparkinson drugs (pharma industry) makes similar projects unnecessary? A basic rule of science is
the replicability of the results. Therefore any new finding must be reproduced before it gains
acceptance. On the other hand, journals do not accept simple replication of well established results,
each experiment must go at least one step further in the exploration of a problem.
I am the chair of
the Hungarian
Scientific
Ethical
Committeeon
Animal
Experimentation
38
Other
(Name
confidential Respondent 141)
Not applicable
other
Other
(Name
confidential Respondent 157)
Worldwide
pharmaceutical see answer above
industry
Austrian Society Nongovernmental
of Toxicoloy
organisation
(ASTOX)
National
Yes
such a database does neither increase animal welfare nor quality of science. There are other
mechanisms already to there see top IX.e).
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
The overall assessment ‘neutral’ assumes balance between the benefits and the costs. Until the
design and mode of operation of the database(s) is decided, maximising the benefit/cost ratio, the
assessment is premature. Costs at all levels would depend on design factors such as level of detail,
and would be counterbalanced by the benefits of reducing the use of animals and avoiding the waste
of resources. Additional effort and costs required at the establishment level should not be high since
all projects require evaluation and reporting as a matter of good scientific practice. Submission to a
database should require little extra effort or cost. Additional costs at the MS and EU levels will be
cost-effective in the long term. We would stress that a precise definitions are needed on what are
considered “non-confidential” authorised projects or “non-confidential information on authorised
projects” to ensure harmonisation between the Member States.
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by
duplicate work
39
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
The benefit of this option has been underscored. The benefits of this approach can be immense but
only if all experiments are covered by this provision. Regulatory testing, with the exception of batch
retesting of vaccines can and should also be included.
Nongovernmental
organisation
European
FELASA
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
The cost-benefit analysis does not support the establishment of a centralised database. True
duplication is a very rare event, extremely so in the industrial sector owing to differences in
molecular structure of compounds and in formulations and excipients. This analysis is supported by
the UK Home Office, based on detailed inspections and licensing system in place in that country.
Such a database would therefore have a minimal effect on reduction in animal use. There would also
be considerable concern at possible disclosure of information that could be of benefit to competitors,
and this could lead to a movement of research outside Europe.
Gesellschaft für NonVersuchstierkun governmental
de - Society for organisation
Laboratory
Animal Science
(GV-SOLAS)
National;
European
Yes
No, such a database does neither increase animal welfare nor does quality of science. There are other
mechanisms already established (see top IX.e).
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
40
NonNorwegian
Animal Welfare governmental
organisation
Aliance
National
2 other relevant A database would be very useful and sufficient resources should be set aside for it.
organisations
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
The NAVS supports a centralised EU-wide database, and believes that the overall outcome would be
very positive, since one of the major obstacles for avoiding duplication is the non-publication of
negative results. Our organisation has repeatedly pointed out the vast problem of duplication
associated with (non-regulatory) animal experiments. This problem will not be solved exclusively by
having a thorough ethical review process, since the individuals of an ethical panel cannot be expected
to search the scientific literature for examples of previous similar work, even less so to find the
results of non-published work (1). In addition the EU is, under REACH, already committing to a level
of data sharing. This principle should be expanded as wide as possible. See the ADI/NAVS report "Keep
animals out of REACH". (1) Accountability: Animal Experiments and Freedom of Information (1997)
NAVS report. http://www.navs.org.uk/downloads/accountability.pdf
Nongovernmental
organisation
Worldwide
Many other
Learned
Societies aer
also
representative
Recent UK history of the development of major national databases has shown that they are very
expensive, fraught with technical problems and rarely fit for purpose.
The
Physiological
Society
41
National
Yes. The Royal
Society is the
independent
scientific
academy of the
UK dedicated to
promoting
excellence in
science. The
Society plays an
influential role
in national and
international
science policy
Whilst we support the principle of avoiding duplication by setting up an EU wide database where
negative data could be published, we believe that there is a risk that the costs and resources required
will not be proportional to the benefits to be gained from it. The time and resources need to get all
data into a consistent searchable and useful format would be enormous. There are also issues of
security, confidentiality and IP protection.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
The impact of an EU database is underscored as it would be immense – if it included all experiments,
including regulatory testing - as it would give the chance to actually compare what has already been
done and what hasn't. We have written statements by the regulatory bodies of the Austrian Länder, in
which they state that even in a small country like Austria, avoidance of duplicate testing is not always
possible. (letters can be provided upon request)
Non(Name
governmental
confidential Respondent 164) organisation
National
yes
as IX.e
Breeder of
(Name
animals
confidential Respondent 182)
Worldwide
Representative
see IXe
The Royal
Society
Nongovernmental
organisation
42
The resource implications appear to me to be seriously underestimated. As commented in response
to the overall assessment - it is likely that this would be very difficult to maintain and would require
several (probably many) dedicated and full time staff to input data and ensure that it could be
searched and retrieved.
(Name
confidential Respondent 188)
Regional;
National
Not applicable:
response is
personal opinion
based on
personal
expertise
(Name
confidential Respondent 189)
National;
European
There are other There will be an overall negative impact due to increased administrative burden without welfare
organisations
benefit.
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
see below
43
Question IX.1.2.
Question text:
1.2 Animal welfare – basic research:
An EU database would have moderate positive impacts on animal welfare for animals used in
basic research, due to more information available on negative results of previous projects not
yet published.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
95 respondents stated that they support the preliminary analysis.
35 respondents stated that they have no opinion in relation to this question.
86 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.2a.
ness
the
organisation
44
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
See comment on 1.1 above.
chair of lab.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
User of animals - Local; National
Dezentrale
Biomedizinische public sector
Einrichtungen
der Med.
Universität Wien
yes
Gesellschaft zur User of animals - National
Förderung der public sector
biomedizischen
Forschung
The organisation No welfare effect of central database, sufficient assessable scientific databases exist.
is
representative
for the field at
the respective
activity level.
see above
45
Hannover
Medical School
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Local; Regional; Hannover
public sector
National
Medical School
currently ranks
highest with
respect to
research
activities and
aquired
research grants
Hannu
Komulainen
User of animals - National;
public sector
European
Is relevant
I doubt such a database. Who would maintain it. A lot of bureaurcracy for researchers to send the
information (or for somebody else).
Hans J. Hedrich User of animals - Local; Regional; I am currently No No welfare effect of central database, sufficient assessable scientific databases exist.
President of the
public sector
National;
European
European
College of
Laboratory
Animal Medicine
(ECLAM) and
Vicepresident
Gesellschaft zur
Förderung der
Biomedizinische
n Forschung
46
Prof. Dr. R.
Nobiling,
University of
Heidelberg
User of animals - Regional;
public sector
National;
European;
Worldwide
Timo Nevalainen User of animals - Local
public sector
Biomed research Proof of reproducibility of results and including control groups is imperative in science. However, this
is not a duplication of experiments or projects. This can exluded in a well organized scientific
at Univ.
community
Heidelberg is
Top - ranked
Yes
Basic research has several knowledge bases, which are already used efficiently. Why to double the
effort?
User of animals - Local; Regional; Yes, guess so ... I don´t agree to "moderate impact", but rather to "no impact".
Torgny
National
Jeneskog, Umeå public sector
University,
Sweden
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 001)
yes
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
User of animals - National
(Name
public sector
confidential Respondent 004)
XXX are
representative
of our scientifi
activity (basic
research)
No , the info would not be detailed enough to allow for that analysis. In addition, it is in fact quite
rare that a new experiment has already been performed under the very same conditions. Any
different factor, be it minor, could be invoked to claim that this is a different experiment. No
regulation can solve this issue.
User of animals - Worldwide
(Name
public sector
confidential Respondent 005)
there are others No welfare effect of central database, sufficient assessable scientific databases exist.
47
User of animals - National
(Name
public sector
confidential Respondent 009)
see above
Yes, we are
representing all
physiological
researchers in
the
Netherlands; we
have about 300
members
User of animals - Worldwide
(Name
public sector
confidential Respondent 010)
One of several The EU contributes a decreasing share of scientific results globally. More results are being generated
in US and increasingly in Asian countries, eg Japan and China. Research has often to deal with species
global
pharmaceutical and strain differences. The impact of data bases is grossly overestimated.
companies
User of animals - Not applicable
(Name
public sector
confidential Respondent 018)
we are a
medical
university.
User of animals - Local; National
(Name
public sector
confidential Respondent 023)
Scientific databases already exist. Unnecessary duplication may occur, but in negligible numbers.
There are
several central Scientifically justified retesting must be allowed.
laboratory
animal facilities
at Austrian
universities
With all the gigabytes of scientific literature available to us at the keystroke of a computer key, why
would we waste time reading about experiments that didn’t work. Even if I did read about
experiments that are similar to my own that didn’t work, it doesn’t mean that mine won’t work.
Published works are generally NOT exact replicas. We are not discussing exact replicas because the
likelihood that two labs do the exact same experiment is very low. In addition, there are many
documented experiments in which there were differences in what were thought to be exact replicas
in different and often competing laboratories. It has been demonstrated that two labs doing the
exact experiment that get different results, DID NOT DO THE SAME EXPERIMENT. It is critical that we
don’t accept everything that we see and read, for this would halt our progress. Regrettably, it means
doing more experiments, often with animals and it means scientific and medical progress.
48
User of animals - Local
(Name
public sector
confidential Respondent 025)
representative
A central data base is a bureaucratic monster without welfare effect on animals. Nowadays all
relevant information can be retrieved from scientific databases
User of animals - National
(Name
public sector
confidential Respondent 028)
yes. There are See 1.1
other academic
medical centres
User of animals - Local; Regional; No
(Name
public sector
National;
confidential European;
Respondent 029)
Worldwide
By making negative results available other research groups know that a certain subject/model was
already investigated but that it didn't give good results. So it has no sense to try the same
experiments again and by that prevent unnecessary use of animals.
User of animals - Local
(Name
public sector
confidential Respondent 032)
yes
No, it is a prejudice that there is a considerable amount of duplications of experiments in research.
Scientists usually have an excellent overview of the literature within their respective fields of
specialisation. Especially in basic research also the so-called “negative results” are important results
which are published. Scientific journals will no accept results (regardless whether they are “positive”
or “negative”) which are already published elsewhere. This prevents already duplication of
experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate
that experiments are not doubled. A literature search has to be performed for that reason.
User of animals - National
(Name
public sector
confidential Respondent 041)
no
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - National
(Name
public sector
confidential Respondent 046)
yes
Negative results need to be validated before implementation in the database. This is very similar to
publication. Incitation must be done on publication. In absence of validation false result will be
implemented leading to poor science quality.
49
User of animals - Regional;
(Name
public sector
National
confidential Respondent 047)
yes
see 1.11
User of animals - National
(Name
public sector
confidential Respondent 053)
Some smaller
institutes exist
in the
Netherlands
No. The gain would be very limited due to confidentiality issues.
User of animals - National
(Name
public sector
confidential Respondent 054)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Local; Regional;
(Name
public sector
National;
confidential European;
Respondent 069)
Worldwide
It is a
University, the
question is
meaningless
see 1.1 above
Bayer
HealthCare
organisation is
representative
for the field
1.2 See comment above
Thre are other
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
This analysis implies that such a database becomes a parallel publication process, or even an on-line
‘journal of negative results’. There are several objections to this. Negative results may not be peer
reviewed. They may not be place in a framework to communicate significance, as in published work.
Information may be confidential or a trade secret. Finally work done in third countries is excluded
User of animals - Worldwide
private sector
GlaxoSmithKline User of animals - Worldwide
private sector
50
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
See 1.1
No - ABPI and
EFPIA repesent
the
pharmaceutical
industry in
UK/EU
User of animals - National
(Name
private sector
confidential Respondent 071)
yes
See comments point A
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is See above
the largest
pharmaceutical
company in
Europe and
ranks third
worldwide
User of animals - Worldwide
(Name
private sector
confidential Respondent 074)
Yes
See 1.1
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
see 1.1
User of animals - Worldwide
(Name
private sector
confidential Respondent 076)
Yes
See overall analysis. Since most researchers are interested in publishing their data, the amount of
useful information on negative results is considered small and since there would always be a time
gap, even this information will come too late in most fields, which tend to develop fast in our days.
51
User of animals - European
(Name
private sector
confidential Respondent 080)
Representitive
I think it would have low benefit for animal welfare, as not most research can be filtered at the grant
application stage, and it is not in the private companies interests to supply this information to its
competitors too soon.
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
See 1.1
User of animals - Worldwide
(Name
private sector
confidential Respondent 084)
yes
The exchange of scientific information and the access to appropriate date is very high at present,
negative results of an experiment are not hided and kept under closure
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many
other such
organisations in
Europe
This proposal is entirely counter to the need to have several innovators working in competition on the
same projects or problems. The proposal appears to neglect the fundamental difficulties and risks
inherent in research, public health and unmet medical need. In the pharmaceutical industry
“negative” test results do not carry the same prejudiced connotation as presented in the analysis
above. All results in the pharmaceutical and biomedical sector are “decision-making” and enable
research to take new directions in an informed manner. All decision-making studies potentially have a
role in the protection of intellectual property.
User of animals - Worldwide
(Name
private sector
confidential Respondent 090)
Yes
There are many variations of individual experiments and, consequently, it will be extremely difficult
for a central administrator to determine which are duplications.
User of animals - Worldwide
(Name
private sector
confidential Respondent 092)
No welfare effect of a central database - scientific DBs already available
Global
pharmaceutical
research and
development
52
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
see comment above
User of animals - National
(Name
private sector
confidential Respondent 097)
Yes
Please see 1.11
User of animals - Worldwide
(Name
private sector
confidential Respondent 098)
Representative
See above comments.
User of animals - Worldwide
(Name
private sector
confidential Respondent 099)
yes
It is being assumed that there is a problem with duplication of testing. This is not the case.
Pharmaceutical companies work on their own compounds and patent these at an early stage so that 2
companies would not be working on the same ones. There is limited retesting (batch release for polio
testing). ICH and mutual recognition agreements would be more useful than any database.
User of animals - Worldwide
(Name
private sector
confidential Respondent 102)
no
Why is this only aiming at an EU wide database? Experiments are performed globally!
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
See comment above
User of animals - National
(Name
private sector
confidential Respondent 110)
representative
See comment above
53
User of animals - Worldwide
(Name
private sector
confidential Respondent 198)
See 1.1
Don't
understand this
question
Coenraad
Public authority National
F.M.Hendriksen
at the national
level: yes
There are many variables that might influence the outcome of an animal experiment which makes it
almost impossible to store all this information into a data-base.
Public authority National
Coordination
group for
laboratory
animal activities
Yes
Basic research has several knowledge bases, which are already used efficiently. Why to double the
effort?
Prof. Dr. Bernd
Hoffmann,
Justus-LiebigUniversität
Giessen
Public authority National;
European
similar to other see statements made above
universities
Public authority Local
(Name
confidential Respondent 115)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
Public authority Local
(Name
confidential Respondent 116)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
It is extremely unlikely that animal welfare will be impacted in any way by such a database. Negative
results are a specific issue which are a concern, but the lklehood that such a database can prevent
these is VERY slim.
54
Public authority Local; Regional no
(Name
confidential Respondent 119)
the database will not be read by most of the people. Many researchers know what their nearby
colleagues investigate. And in the private sectors, secrets remain secrets
Public authority National;
(Name
European;
confidential Worldwide
Respondent 120)
Yes
It is unlikely that researchers would take the time to publish negative results on a public database.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
see 1.11
Public authority National;
(Name
European;
confidential Worldwide
Respondent 128)
Although we are Doubt of welfare effect due to a central database. Sufficient scientific databases already exist.
a smaller
University,
about half of
the research
groups involving
animal
experiments
belong to
leading
institutions in
their field.
55
Public authority National
(Name
confidential Respondent 129)
representative
1.Animal Aid
National
This is unlikely to have any impact on animal welfare, since many research projects involving basic
Other
organisations do research are justified on the grounds that they are not repetitious of previous experiments – based on
minor modifications in the experimental protocol. A good example of this can be found at
exist
www.animalaid.org.uk/viv/curiosity.htm which illustrates the characteristic use of one study to
justify the next. In many cases, unanswered (usually unforeseen) questions arising from one study
produced the rationale for a later study. In several instances, the team invokes conflicting or
erroneous results from previous studies (sometimes their own) to justify another study.
COST Action B24 Other
“Laboratory
Animal Science
Welfare” http://biomedic
um.ut.ee/costb
24
European
No
No, it is a prejudice that there is a considerable amount of duplications of experiments in research.
Scientists usually have an excellent overview of the literature within their respective fields of
specialisation. Especially in basic research also the so-called “negative results” are important results
which are published. Scientific journals will not accept results (regardless whether they are
“positive” or “negative”) which are already published elsewhere. This prevents already duplication of
experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate
that experiments are not doubled. A literature search has to be performed for that reason.
Cris Iles-Wright Other
Not applicable
Not applicable
Such a database would have to link regulators to current events and the availablity of technology
available since the 1960s which has eliminated the need for tests such as those they are approving.
Involvement of NGOs would enable this.
Medical
University of
Vienna
Other
Other
Local; Regional; Research in
Medicine
National;
European;
Worldwide
No welfare effect of central database, sufficient assessable scientific databases exist.
see 1.11.
56
Other
(Name
confidential Respondent 141)
Not applicable
other
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by
duplicate work
Other
(Name
confidential Respondent 144)
National
Yes
It is not the case that there is a problem with duplication of testing.
Other
(Name
confidential Respondent 155)
Worldwide
These comments The scientific world eliminates the use of duplicates itself by reviewing articles and refusing funding
originate from a to non-original work. Moreover, filling out a database will be an extra burden, but will also only be
large academic done once the work is published to avoid revealing interesting information to other research groups,
making the database completely superseded.
institution in
Belgium with a
large tradition
in biomedical
research and
were formulated
by mutual
agreement
Other
(Name
confidential Respondent 157)
Worldwide
pharmaceutical see answer at the top
industry
57
Other
(Name
confidential Respondent 199)
European
yes
These findings assume that there is a problem with duplication of testing. This is not the case.
Austrian Society Nongovernmental
of Toxicoloy
organisation
(ASTOX)
National
Yes
it is a prejudice that there is a considerable amount of duplications of experiments in research.
Scientists usually have an excellent overview of the literature within their respective fields of
specialisation. Especially in basic research also the so-called “negative results” are important results
which are published. Scientific journals will not accept results (regardless whether they are
“positive” or “negative”) which are already published elsewhere. This prevents already duplication of
experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate
that experiments are not doubled. A literature search has to be performed for that reason.
British Heart
Foundation
National
No further comment
We are a
medical
research
charity, of
which there are
many in the UK
Nongovernmental
organisation
58
Nongovernmental
organisation
European
See comment on 1.1 above.
FELASA
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
Gesellschaft für NonVersuchstierkun governmental
de - Society for organisation
Laboratory
Animal Science
(GV-SOLAS)
National;
European
Yes
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
No, it is a prejudice that there is a considerable amount of duplications of experiments in research.
Scientists usually have an excellent overview of the literature within their respective fields of
specialisation. Especially in basic research also the so-called “negative results” are important results
which are published. Scientific journals will no accept results (regardless whether they are “positive”
or “negative”) which are already published elsewhere. This prevents already duplication of
experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate
that experiments are not doubled. A literature search has to be performed for that reason.
59
National;
European;
Worldwide
The NAVS is the We believe that an EU-wide database would have high positive (+++) impact on animal welfare in
basic research, since our investigations have shown that duplication is frequently occurring within this
leading and
area (1). (1) Access denied 1996. NAVS report http://www.navs.org.uk/publications/reports/c=1
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Nongovernmental
organisation
National
LASA represents See above comment
animal user
community in
academic,
government &
industry sectors.
Non(Name
governmental
confidential Respondent 164) organisation
National
yes
NonThe National
Anti-Vivisection governmental
organisation
Society
UK Laboratory
Animal Science
Association
(LASA)
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
60
Non(Name
governmental
confidential Respondent 166) organisation
National
NO OTHER
RELEVANT
ORGANISATION
The info would not be detailed enough to allow for that analysis
Non(Name
governmental
confidential Respondent 174) organisation
Worldwide
-
-
Non(Name
governmental
confidential Respondent 175) organisation
National
yes
This will not work.
Non(Name
governmental
confidential Respondent 176) organisation
Worldwide
yes
No welfare effect by central database, sufficient accessible scientific databases exist.
Breeder of
(Name
animals
confidential Respondent 182)
Worldwide
Representative
It is unrealistic that negative results will be published in such a database
(Name
confidential Respondent 188)
Regional;
National
Not applicable: It is extremely unlikely that animal welfare will be impacted in any way by such a database. Negative
results are a specific issue which are a concern, but the likelihood that such a database can prevent
response is
personal opinion these is VERY slim.
based on
personal
expertise
61
(Name
confidential Respondent 189)
National;
European
There are other First, it will not be possible to assimilate and publish on the database all research data in a timely
organisations
manner to be useful. Second, the premature dissemination of data will be a threat to intellectual
property. Third, duplication of basic research is reduced in the peer review process prior to research
being funded or conducted. Duplication that occurs due to regulatory requirements will need to be
addressed by regulators rather than a database. Fourth, the proposal also seems to focus on project
authorisation rather than experimental authorisation – and will not be able to achieve its objectives
of avoiding experimental duplication.
(Name
confidential Respondent 190)
Regional;
Worldwide
also others
see 1.11
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
see below
62
Question IX.1.3.
Question text:
Animal welfare – regulatory testing:
0
An EU database would have no positive impacts on animal welfare regarding the approx.
160.000 animals used in retesting of e.g. pharmaceutical products for regulatory purposes per
year.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
156 respondents stated that they support the preliminary analysis.
38 respondents stated that they have no opinion in relation to this question.
19 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.3a.
ness
the
organisation
63
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
See comment on 1.1 above.
chair of lab.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
User of animals - Local; Regional; No
(Name
public sector
National;
confidential European;
Respondent 029)
Worldwide
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
I agree with your statement that a significant reduction of duplication in regulatory testing would
require changes in numerous legislative requirements at Member State level and that the EU wide
database dissolves only a small part of the problem. Nevertheless if we can save 20% of the 160.000
animals you mentioned that would be still worthwhile to consider! Moreover I think that we must
investigate together with the pharmaceutical industry and the government if retesting of e.g.
pharmaceutical products on animals can be considerably decreased
See 1.1
No - ABPI and
EFPIA repesent
the
pharmaceutical
industry in
UK/EU
64
User of animals - European
(Name
private sector
confidential Respondent 072)
Yes
There is little difference in research logic in pharmaceutical products and basic research. Such a
database very positively impact both pharmaceutical products and basic research.
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many This finding is not supported by the arguments presented above as licence and authorisation
duplication will not solve the issues of portability of results between regulatory agencies in the EU
other such
organisations in and third countries.
Europe
User of animals - Worldwide
(Name
private sector
confidential Respondent 087)
No
This issue should be addressed rather than ignored.
User of animals - Worldwide
(Name
private sector
confidential Respondent 091)
YES (Safety
Assessment)
It is being assumed that there is a problem with duplication of testing. This is not the case.
Pharmaceutical companies work on their own compounds and patent these at an early stage so that 2
companies would not be working on the same ones. There is limited retesting (batch release for polio
testing). ICH and mutual recognition agreements would be more useful than any database.
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
See comment above
User of animals - Worldwide
(Name
private sector
confidential Respondent 106)
Yes
There is a strong interest for pharmaceutical companies to avoid duplicate regulatory testing for
economic reasons.
65
Public authority National
(Name
confidential Respondent 114)
EU databasa is very necessary. mainly collection of date chemical elemnts, articles( rodenticides,
SVFA SR is
hernicides, .....)
central
conpetent
authority for
approvel for the
experiments and
inspections
animal
protection
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS it should not only include retesting but also exchanging 3R information and Turned down projects
is also involved
1.Animal Aid
There should be a regime to ensure that data obtained from authorised testing centres are recognized
Other
organisations do across the EU.
exist
Other
National
The case has not been made that there is a significant amount of unnecessary duplication. Proprietary
and intellectual property considerations essentially prevent unnecessary duplication within this
sector. Whist the UK strongly encourages and promotes data sharing, the proposed database would be
prohibitively expensive and difficult to establish and maintain if it was ever to be seriously considered
as a means of finding sufficient high-quality, comprehensive, accurate and up to date information to
be of practical use. It is also important to appreciate that data is often owned by those who
commission testing – and not the test labs themselves
66
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
This assessment is based only on data for retesting of pharmaceutical products, which is only one
specialised part of regulatory testing on animals where repeat testing is done intentionally. In other
areas, such as chemicals testing, a database would be more effective in preventing duplication and is
necessary to ensure that read across and grouping of substances can take place, to minimise testing.
The need for data sharing, by means of databases, was a recommendation of a 2005 study ‘Regulatory
Animal Testing: A Survey of the Factors Influencing the Use of Animal Testing to Meet Regulatory
Requirements’ by Marie-Jeanne Schiffelers et al. of Utrecht University (See website:
www.bio.uu.nl/scienceshop). Such a database or databases would certainly have a positive impact on
animal welfare.
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
It is unclear where this figure has come from. We do not agree with the statement that ‘retesting is a
legal requirement for general medical products for human and veterinary use’. Harmonisation of
testing requirements under ICH and OECD mean that this should not happen. We do not accept that
there is a general requirement for retesting of medical products. Duplication of animal tests is a
problem at both the basic, applied and regulatory research level (see 2001 White paper on REACH,
APC Review of the cost: benefit assessment of the use of animals in research 2003, Bridges, J. 2000
Chemistry and Industry 20 Nov). All forms and sources of duplication should be tackled. To fail to
tackle regulatory testing goes against the ethos of the existing legislation and the 3Rs.
67
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
Nongovernmental
organisation
European
See comment on 1.1 above.
FELASA
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
PETA Europe
Ltd.
Nongovernmental
organisation
Worldwide
both
1.3 No – Any requirements to carry out repeat testing due to lack of harmonization of information
requirements must be tackled through Mutual Recognition Agreements, and the revised directive
should identify this as a priority for action. Duplication of studies carried out within the EU should be
prevented in part through a central authorization system for regulatory tests, where regulators are
made aware of which substances are being tested or have already been tested before granting an
authorization. Systems similar to this are in place in Germany, and will be introduced through
REACH. Application of the 3Rs requires that duplicate testing is eliminated, so the cost of
establishing the system should be embraced as an expression of the commitment made by the EU to
animal welfare.
68
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the As we have outlined in our report “Keep animals out of REACH”, we would expect some positive
impact following the introduction of a EU database. Reference: Keep animals out of REACH (2005) ADI
leading and
report http://www.navs.org.uk/downloads/reachbriefing.pdf
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
Please refer to statements by ECEAE and PETA
69
Question IX.1.4.
Question text:
Ethical concerns – basic research:
An EU database would assist in the ethical evaluation of projects (outside regulatory testing),
because during ethical review competent persons could more easily double check the project
information on an EU-wide basis, taking into account results of previous experiments.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
100 respondents stated that they support the preliminary analysis.
29 respondents stated that they have no opinion in relation to this question.
85 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.4a.
ness
the
organisation
70
User of animals - Local; National
Dezentrale
Biomedizinische public sector
Einrichtungen
der Med.
Universität Wien
yes
No, too much dependent on informatio submitted
Gesellschaft zur User of animals - National
Förderung der public sector
biomedizischen
Forschung
The organisation at 1.4
is
representative
for the field at
the respective
activity level.
No No welfare effect of central database, sufficient assessable scientific databases exist.
Hannover
Medical School
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Local; Regional; Hannover
public sector
National
Medical School
currently ranks
highest with
respect to
research
activities and
aquired
research grants
Hannu
Komulainen
User of animals - National;
public sector
European
Is relevant
The whole concept about avoiding replication is wrong. The results should be replicated by another
study to be true. If there is only one result, it is not posiible to know , how "right" it is. This will be
the main problem for example in toxicity testing in REACH.
71
Hans J. Hedrich User of animals - Local; Regional; I am currently No No welfare effect of central database, sufficient assessable scientific databases exist.
President of the
public sector
National;
European
European
College of
Laboratory
Animal Medicine
(ECLAM) and
Vicepresident
Gesellschaft zur
Förderung der
Biomedizinische
n Forschung
Prof. Dr. R.
Nobiling,
University of
Heidelberg
User of animals - Regional;
public sector
National;
European;
Worldwide
Biomed research Proof of reproducibility of results and including control groups is imperative in science. However, this
is not a duplication of experiments or projects. This can exluded in a well organized scientific
at Univ.
community
Heidelberg is
Top - ranked
User of animals - Local; Regional; Yes, guess so ... I just don´t think this is a reality, and not even a "good thought".
Torgny
National
Jeneskog, Umeå public sector
University,
Sweden
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 001)
yes
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
72
User of animals - Local; Regional; XXX
(Name
public sector
National;
confidential European;
Respondent 002)
Worldwide
See 1.11
User of animals - Worldwide
(Name
public sector
confidential Respondent 005)
there are others No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Worldwide
(Name
public sector
confidential Respondent 010)
One of several
global
pharmaceutical
companies
The EU contributes a decreasing share of scientific results globally. More results are being generated
in US and increasingly in Asian countries, eg Japan and China. I cannot see how such a data base
would be able to compete with existing tools. It is doubtful that during ethical review competent
persons could more easily double check the project information. The researcher him/herself has
usually the deepest insight in competing results. The potential impact of such a separate data base is
grossly overestimated.
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 011)
Other
organisations in
Austria: KarlFranzensUniversity;
Medical
University
Vienna; Medical
University
Innsbruck
This would increase the administrative load considerably to the applicants but would not have any
positive impact, since negative results from other groups, unless performed adequately, described in
detail, and published in peer-reviewed journals, can not be the basis for planning further
experiments.
73
User of animals - National
(Name
public sector
confidential Respondent 012)
yes, competitive
in the field of
small animal
research
In case in science a duplicate experiment is performed it has often also benefits since it provides
evidence concerning other environmental and local factors that we are unaware of.In our experience
some interventions in cardiovascular research that were performed in mice in the USA, could not be
repeated here in Europe (NL and Germany), for reasons that are still not understood. Many factors
were excluded and retested and small deviations in genetic background may lead to very different
phenotypes. If it is not allowed anymore to duplicate another study, as an additional control, science
is not going to benefit from this, in contrast.
User of animals - Not applicable
(Name
public sector
confidential Respondent 018)
we are a
medical
university.
this is totally unreasonable. I would be horrified to hear that I was unable to do an experiment
because someone in an unknown laboratory somewhere/anywhere in Europe has done a similar
experiment and was unable to get a positive result. This is not good scientific practice. I would
certainly restrain from doing experiments that have been done in good labs that appear to be similar
to my own, or answer the questions that I would have liked to address. In addition to publishing
manuscripts, we apply for grant money to fund our work. If we propose experiments that have been
done or those that have been addressed well and have been published, then we are not funded for
these projects. This is yet another level in which our experimental work is evaluated, criticized and,
so to speak, authorized.
User of animals - Local; National
(Name
public sector
confidential Respondent 023)
The establishment and updating of such a database would be an enormous task and we doubt
There are
several central whether it can be more up to date as the searchable scientific literature is or just a doubling of
information.
laboratory
animal facilities
at Austrian
universities
User of animals - Local
(Name
public sector
confidential Respondent 025)
representative
A central data base is a bureaucratic monster without welfare effect on animals. Nowadays all
relevant information can be retrieved from scientific databases
74
User of animals - Local
(Name
public sector
confidential Respondent 032)
yes
No, because such a database can only work if it really contains all information from all institutions /
companies of all Member States and if it is always immediately updated. The experience with the
statistical reporting (it takes years until all Member States can submit the data and even France is one
year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete
data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on
an international level into account.
User of animals - National
(Name
public sector
confidential Respondent 041)
no
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Regional;
(Name
public sector
National
confidential Respondent 047)
yes
see 1.11
User of animals - Local
(Name
public sector
confidential Respondent 048)
Not applicable, I This is impractical and if the experiements are not undertaken identically the information may be
meaningless
am not an
organisation
User of animals - National
(Name
public sector
confidential Respondent 054)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
User of animals - Local; Regional;
(Name
public sector
National;
confidential European;
Respondent 069)
Worldwide
It is a
University, the
question is
meaningless
see 1.1 above
Bayer
HealthCare
organisation is
representative
for the field
1.4 Such a database can only be useful if contains all information in real time. Feasibility of actual
data is doubtful.
User of animals - Worldwide
private sector
75
GlaxoSmithKline User of animals - Worldwide
private sector
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
Thre are other No as above in 1.2
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
Such a database can only be useful if contains all information in real time. Feasibility is extremely
No - ABPI and
EFPIA repesent doubtful.
the
pharmaceutical
industry in
UK/EU
User of animals - National
(Name
private sector
confidential Respondent 071)
yes
See comments point A, keeping the database up-to-date will be very time-consuming, it is
questionably if this aim could be achieved.
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is See introductory comment. The time taken to get the data into a database and the work load needed
would lead to data being redundant long before it is available in the base.
the largest
pharmaceutical
company in
Europe and
ranks third
worldwide
User of animals - Worldwide
(Name
private sector
confidential Respondent 074)
Yes
The feasibility of getting comprehensive and up to date information into a database to make it truly
useful is extremely doubtful
76
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
It should be not possible to complete the database in real time
User of animals - Worldwide
(Name
private sector
confidential Respondent 076)
Yes
Duplication of experiments is not considered a major problem, since most researchers work in
specialized fields. For ethical review, harm-benefit assessment is more critical and in this respect,
the database will be of little value for a different experiment with a different test compound
User of animals - National;
(Name
private sector
Worldwide
confidential Respondent 079)
yes
The practical management of such a database would be very complex, resource consuming… if
manageable!
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
It should be not possible to complete the database in real time
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many
other such
organisations in
Europe
This preliminary finding is not supported by the arguments cited above as scientists would be
conducting individual studies within the context of programmes of work already authorised. The
proposal would bring no new information to scientists than that presented a scientific conferences
and through the publication of peer-reviewed manuscripts. The proposal would only work by
constricting the number of authorised facilities and this will suffocate innovation. Various EU
sponsored programmes already aim to bring scientists across the EU into dialogue and collaboration.
User of animals - Worldwide
(Name
private sector
confidential Respondent 088)
pharmaceutical To be really efficient, such a database need to be frequently updated. Feasibility is absolutely
doubtful.
User of animals - Worldwide
(Name
private sector
confidential Respondent 090)
Yes
There are many variations of individual experiments and, consequently, it will be extremely difficult
for a central administrator to determine which are duplications.
77
User of animals - Worldwide
(Name
private sector
confidential Respondent 091)
YES (Safety
Assessment)
This would not be practical at all due to the impossibility of having a real time database.
User of animals - Worldwide
(Name
private sector
confidential Respondent 092)
real time access ?
Global
pharmaceutical
research and
development
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
Such a database can only be useful if contains all information in real time. Feasibility is extremely
doubtful.
User of animals - National
(Name
private sector
confidential Respondent 097)
Yes
This would require that all information was available and continuously updated. This is extremely
doubtful.
User of animals - Worldwide
(Name
private sector
confidential Respondent 098)
Representative
See above comments.
User of animals - Worldwide
(Name
private sector
confidential Respondent 099)
yes
This would not be practical at all due the impossibility of having a real time database.
User of animals - Worldwide
(Name
private sector
confidential Respondent 101)
yes
Such a database can only be useful if contains all information in real time. Feasibility is extremely
doubtful.
78
User of animals - Worldwide
(Name
private sector
confidential Respondent 102)
no
For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to
nearly everybody. Then, intellectual property protection rights will be violated. In addition, lots of
people will have to collect data and put them into the database. Why is this only aiming at an EU
wide database? Experiments are performed globally! The prerequisite is, that duplication of animal
experiments is really an issue. For our sectors and the entire industry this is not true! In the
agrochemical sector as well as in the pharmaceutical sector every company is working on their own
active compounds without overlaps. For chemicals, avoiding duplication of experiments is already a
prominent part of REACH (information exchange fora must be formed and testing proposals must be
submitted to the agency). Overall, this will have a high negative impact on European research and
industry and this cannot be the goal. Setting up such a database is neither feasible nor reasonable.
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
Such a database can only be useful if contains all information in real time. Feasibility is extremely
doubtful.
User of animals - National
(Name
private sector
confidential Respondent 110)
representative
Such a database can only be useful if contains all information in real time. Feasibility of actual data is
doubtful.
User of animals - Worldwide
(Name
private sector
confidential Respondent 198)
The feasibility of getting comprehensive and up to date information into a database to make it truly
Don't
understand this useful is extremely doubtful.
question
Coenraad
Public authority National
F.M.Hendriksen
at the national
level: yes
see 1.2.
79
Public authority National
Coordination
group for
laboratory
animal activities
Francois
Lachapelle
INSERM
Public authority National
Yes
Knowledge bases are already used for the purpose. And they are not restricted to Europe only.
BEA du CNRS, de this would require a high level of scientific competence of the members of Ethical comitee
l'INRA, du CEA
Public authority Local
(Name
confidential Respondent 115)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
Public authority Local
(Name
confidential Respondent 116)
yes
No welfare effect of central database, sufficient assessable scientific databases exist.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
Such information is largely available in published papers. The probablility of a databse being able to
deliver sufficient information to assist in this evaluation is very slim. It seem likely that to extract
relevant information form the database would be difficult. Many apparently duplicated experiments
in fact are not. Duplication can occur outside EU and this database will not assit in preventing this.
Public authority National
(Name
confidential Respondent 118)
Yes
Absolutely wrong. You leave the present project.
Public authority Local; Regional no
(Name
confidential Respondent 119)
see comment on 1.2
80
Public authority National;
(Name
European;
confidential Worldwide
Respondent 120)
Yes
Sounds really cumbersome.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
Unlikley that database could give sufficient inforamtion for scientisits to judge if work is relevant etc.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 128)
Although we are Doubt of welfare effect due to a central database. Sufficient scientific databases exist.
a smaller
University,
about half of
the research
groups involving
animal
experiments
belong to
leading
institutions in
their field.
Public authority National
(Name
confidential Respondent 129)
representative
No welfare effect of central database, sufficient assessable scientific databases exist.
81
Other
National;
European
There are other See 1.11 - Justification
relevant
organisations
COST Action B24 Other
“Laboratory
Animal Science
Welfare” http://biomedic
um.ut.ee/costb
24
European
No
No, because such a database can only work if it really contains all information from all institutions /
companies of all Member States and if it is always immediately updated. The experience with the
statistical reporting (it takes years until all Member States can submit the data and even France is one
year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete
data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on
an international level into account.
Cris Iles-Wright Other
Not applicable
Not applicable
Animal experiments of this type are done for purely legal reasons and are routinely approved.
Biosciences
Federation
Medical
University of
Vienna
Other
Other
(Name
confidential Respondent 138)
Local; Regional; Research in
Medicine
National;
European;
Worldwide
National
see 1.11.
I am the chair of Highly negative impact (--)! Each project has to be evaluated on its own merit. Considering the
the Hungarian presence of a similar project in the ethical evaluation as “duplication” bears the risk of misjudgement
and refusal of the given project.
Scientific
Ethical
Committeeon
Animal
Experimentation
82
Other
(Name
confidential Respondent 141)
Not applicable
other
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by
duplicate work
Other
(Name
confidential Respondent 144)
National
Yes
A database would only be useful if it contained all the information in real time. It is highly unlikely
that this would be feasible.
Other
(Name
confidential Respondent 147)
Not applicable
not applicable
I doubt that such a database is always up to date and current at all times.
Other
(Name
confidential Respondent 157)
Worldwide
pharmaceutical see answer at the top
industry
Other
(Name
confidential Respondent 199)
European
yes
British Heart
Foundation
National
No further comment
We are a
medical
research
charity, of
which there are
many in the UK
Nongovernmental
organisation
Such a database would only be useful if it contained all the information in real time; this is highly
unfeasible.
83
Gesellschaft für NonVersuchstierkun governmental
de - Society for organisation
Laboratory
Animal Science
(GV-SOLAS)
National;
European
Yes
No, because such a database can only work if it really contains all information from all institutions /
companies of all Member States and if it is always immediately updated. The experience with the
statistical reporting (it takes years until all Member States can submit the data and even France is one
year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete
data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on
an international level into account.
Recent UK history of the development of major national databases has shown that they are very
expensive, fraught with technical problems and rarely fit for purpose.
The
Physiological
Society
Nongovernmental
organisation
Worldwide
Many other
Learned
Societies aer
also
representative
UK Laboratory
Animal Science
Association
(LASA)
Nongovernmental
organisation
National
LASA represents There are significant logistical problems with providing a current database.
animal user
community in
academic,
government &
industry sectors.
Non(Name
governmental
confidential Respondent 164) organisation
National
yes
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
Non(Name
governmental
confidential Respondent 174) organisation
Worldwide
-
-
84
Non(Name
governmental
confidential Respondent 175) organisation
National
yes
It is not in the scope of the ethical evaluation.
Non(Name
governmental
confidential Respondent 176) organisation
Worldwide
yes
No welfare effect by central database, sufficient accessible scientific databases exist.
Breeder of
(Name
animals
confidential Respondent 182)
Worldwide
Representative
Because there exists no general regulation to evaluate scientific results regarding the ethical aspects.
(Name
confidential Respondent 188)
Regional;
National
Not applicable:
response is
personal opinion
based on
personal
expertise
Such information is largely available in published papers. The probability of a databse being able to
deliver sufficient information to assist in this evaluation is very slim. It seem likely that to extract
relevant information form the database would be difficult. Many apparently duplicated experiments
in fact are not. Duplication can occur outside EU and this database will not assist in preventing this
(Name
confidential Respondent 189)
National;
European
There are other First, it will not be possible to assimilate and publish on the database all research data in a timely
organisations
manner to be useful. Second, the premature dissemination of data will be a threat to intellectual
property. Third, previous results are considered in the peer review process prior to research being
funded or conducted. Fourth, the proposal also seems to focus on project authorisation rather than
experimental authorisation.
(Name
confidential Respondent 190)
Regional;
Worldwide
also others
see 1.11
85
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
see below
(Name
confidential Respondent 194)
Local
representative
It is not in the scope of the ethical evaluation.
(Name
confidential Respondent 195)
National;
European;
Worldwide
Yes, we are
representarive
for the field
It is not in the scope of the ethical evaluation.
86
Question IX.1.5.
Question text:
Ethical concerns – regulatory testing:
0
An EU database will have no positive impact on the improvement of ethical evaluation of
projects in regulatory retesting, because these tests are required by national legislation.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
154 respondents stated that they support the preliminary analysis.
44 respondents stated that they have no opinion in relation to this question.
15 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.5a.
ness
the
organisation
Timo Nevalainen User of animals - Local
public sector
Yes
Knowledge bases are already used for the purpose. And they are not restricted to Europe only.
87
User of animals - Local; National; representative
(Name
of a research
public sector
European;
confidential university
Worldwide
Respondent 008)
Nevertheless they may still be capable of refinement and standard tests should be challenged
User of animals - National
(Name
public sector
confidential Respondent 028)
yes. There are This underlines the importance of authorities to also make full use of such a database and
other academic acknowledge testing results performed in other countries.
medical centres
User of animals - National;
(Name
public sector
Worldwide
confidential Respondent 055)
there are other An EU database certanley will improve the nationla level of ethical evaluation of projects
relevant
organisation in
the region
User of animals - European
(Name
private sector
confidential Respondent 072)
Yes
As mentioned in 1.4, regulatory retesting will immensly recheck the necessity of the set project nad
save the scientist to waste time, material and animal life.
User of animals - Worldwide
(Name
private sector
confidential Respondent 087)
No
This should be addressed. If we are talking about harmonising all these areas with regard to animal
use, similar effort should be made where legislation forces duplicate testing.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS implementing of 3Rs within prescribed methods is beneficiary and possible
is also involved
88
National
There should be a regime to ensure that data obtained from authorised testing centres are recognized
Other
organisations do across the EU.
exist
National
Yes
because such a database can only work if it really contains all information from all institutions /
companies of all Member States and if it is always immediately updated. The experience with the
statistical reporting (it takes years until all Member States can submit the data and even France is one
year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete
data makes situation worse!
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
It is crucial to the ethical evaluation of projects, even in regulatory testing, to ensure that the
proposed testing is not duplicating tests already carried out and that the testing requirement cannot
be waived on the basis of making use of existing data from other sources. A database or databases,
preferably associated with the appropriate regulatory authorities, would be necessary for obtaining
information to allow such assessments during ethical evaluation. The need for data sharing, by means
of databases, was a recommendation of a 2005 study ‘Regulatory Animal Testing: A Survey of the
Factors Influencing the Use of Animal Testing to Meet Regulatory Requirements’ by Marie-Jeanne
Schiffelers et al. of Utrecht University (See website: www.bio.uu.nl/scienceshop).
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
To state that the impacts will be neutral because you are excluding one aspect (which should not be
excluded) of duplication is incorrect and suggests that the full implications of this proposal have not
been properly assessed. An EU database would avoid duplication and enable read-across and grouping
of substances.
PETA Europe
Ltd.
Worldwide
both
Regulatory testing, even where tests are required by national legislation, should be subject to ethical
evaluation based on the proposed purpose of the substance being tested and the existence of similar
substances or data already held on that substance.
1.Animal Aid
Other
Austrian Society Nongovernmental
of Toxicoloy
organisation
(ASTOX)
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
Nongovernmental
organisation
89
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the As we have outlined in our report “Keep animals out of REACH”, we would expect some positive
impact following the introduction of a EU database. Reference: Keep animals out of REACH (2005) ADI
leading and
report http://www.navs.org.uk/downloads/reachbriefing.pdf
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
This EU database could have a positive impact as it would make read-across and grouping of
substances possible, and possibly lead to more data sharing between countries.
90
Question IX.1.6.
Question text:
Regulatory compliance:
An EU database would have low positive impacts on national inspections, due to better
availability of comparative information, especially regarding control on group authorisation of
projects in regulatory testing.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
101 respondents stated that they support the preliminary analysis.
64 respondents stated that they have no opinion in relation to this question.
47 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.6a.
ness
the
organisation
91
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
See comment on 1.1 above.
chair of lab.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
User of animals - Local; National
Dezentrale
Biomedizinische public sector
Einrichtungen
der Med.
Universität Wien
yes
User of animals - Local; National; representative
(Name
of a research
public sector
European;
confidential university
Worldwide
Respondent 008)
see above
might have a high impact in some MSs
92
User of animals - Local; National
(Name
public sector
confidential Respondent 023)
see 1.4
There are
several central
laboratory
animal facilities
at Austrian
universities
User of animals - Local
(Name
public sector
confidential Respondent 032)
yes
see top 1.4
User of animals - Local
(Name
public sector
confidential Respondent 056)
organisation is
representative
this question was not in the questionnaire when I printed it out
Bayer
HealthCare
organisation is
representative
for the field
1.6 This information would be confidential anyway. Also, it is very rare for two companies to work on
the same molecule.
User of animals - Worldwide
private sector
GlaxoSmithKline User of animals - Worldwide
private sector
Thre are other This is unlikely unless this database provided extremely rich context.
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
93
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
This information would be confidential anyway. Also, it is very rare for two companies to work on the
No - ABPI and
EFPIA repesent same molecule
the
pharmaceutical
industry in
UK/EU
User of animals - National
(Name
private sector
confidential Respondent 071)
yes
There are made too great demands on authority, they cannot check the differences between all
experiments to distinguish between duplication of experiments or not, especially some information is
confidential.
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is Much of the information would be confidential and there wouldbe constant challenged to intellectual
property. It is also highly unlikely that any two companies would be working on the same molecule
the largest
pharmaceutical and thus there would be inherent differences in the data.
company in
Europe and
ranks third
worldwide
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
Problem of confidentiality and time required to do this comparison
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
Problem of confidentiality and time required to do this comparison
User of animals - Worldwide
(Name
private sector
confidential Respondent 088)
pharmaceutical Much better than a database would be mutual recognition of sets of studies that were already done.
94
User of animals - Worldwide
(Name
private sector
confidential Respondent 091)
YES (Safety
Assessment)
This information would be confidential.
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
This information would be confidential anyway. Also, it is very rare for two companies to work on the
same molecule.
User of animals - National
(Name
private sector
confidential Respondent 097)
Yes
It is very rare for two companies to work on the same compound.
User of animals - Worldwide
(Name
private sector
confidential Respondent 098)
Representative
It is almost unrealistic that different Companies work on exactly the same molecule.
User of animals - Worldwide
(Name
private sector
confidential Respondent 099)
yes
This information would be confidential.
95
User of animals - Worldwide
(Name
private sector
confidential Respondent 102)
no
For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to
nearly everybody. Then, intellectual property protection rights will be violated. In addition, lots of
people will have to collect data and put them into the database. Why is this only aiming at an EU
wide database? Experiments are performed globally! The prerequisite is, that duplication of animal
experiments is really an issue. For our sectors and the entire industry this is not true! In the
agrochemical sector as well as in the pharmaceutical sector every company is working on their own
active compounds without overlaps. For chemicals, avoiding duplication of experiments is already a
prominent part of REACH (information exchange fora must be formed and testing proposals must be
submitted to the agency). Overall, this will have a high negative impact on European research and
industry and this cannot be the goal. Setting up such a database is neither feasible nor reasonable.
User of animals - Worldwide
(Name
private sector
confidential Respondent 103)
As companies are very much specialized nowadays, double testing on the same molecule is very
The
unlikely, we would even say can not happen.
bquestionaire
will be
completed for
the German
sites. Other site
head in other
countries will
reply
individually
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
This information would be confidential anyway. Also, it is very rare for two companies to work on the
same molecule.
User of animals - Worldwide
(Name
private sector
confidential Respondent 107)
yes
----
96
User of animals - National
(Name
private sector
confidential Respondent 110)
representative
This information would be confidential anyway. Also, it is very rare for two companies to work on the
same molecule.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
It is VERY unlikely that the level of detail available on a database will be sufficient to inform the
inspection process. It could show where similar work is going on in order that similar standards could
be applied to similar projects and inspectors could find colleagues with whom to discuss complex
matters, but good communication systems between inspectors could serve this purpose at much lower
resource implication.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
see 1.11
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS its effect is underrated
is also involved
1.Animal Aid
We need the database and more inspections.
Other
organisations do
exist
Other
National
97
COST Action B24 Other
“Laboratory
Animal Science
Welfare” http://biomedic
um.ut.ee/costb
24
European
No
see top 1.4
Other
(Name
confidential Respondent 138)
National
I am the chair of Probably no impact. This is mere speculation on the outcome of non existent, hardly realizable
the Hungarian mechanisms.
Scientific
Ethical
Committeeon
Animal
Experimentation
Other
(Name
confidential Respondent 141)
Not applicable
other
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by
duplicate work
Other
(Name
confidential Respondent 144)
National
Yes
This information would be confidential. It is also very unlikely that two companies would be working
on the same molecule.
98
Other
(Name
confidential Respondent 147)
Not applicable
not applicable
Other
(Name
confidential Respondent 157)
Worldwide
pharmaceutical see answer at the top
industry
Other
(Name
confidential Respondent 199)
European
yes
This information would be confidential. Furthermore, it would be extremely unlikely that two
companies would be working on the same molecule.
Austrian Society Nongovernmental
of Toxicoloy
organisation
(ASTOX)
National
Yes
see top 1.4
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
We believe that a database would only have a positive effect on national inspections if consultation of
the database were mandatory as part of the authorisation and ethical evaluation process. If group
authorisations are allowed, provision of the results obtained from consultation of the database for
each substance tested should be made a condition of the authorisation, and audited by the
authorities.
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
Confidential information. Also, it is very rare that two companies work on the same target molecule.
99
Nongovernmental
organisation
European
See comment on 1.1 above.
FELASA
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
Gesellschaft für NonVersuchstierkun governmental
de - Society for organisation
Laboratory
Animal Science
(GV-SOLAS)
National;
European
Yes
No, because such a database can only work if it really contains all information from all institutions /
companies of all Member States and if it is always immediately updated. The experience with the
statistical reporting (it takes years until all Member States can submit the data and even France is one
year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete
data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on
an international level into account.
Non(Name
governmental
confidential Respondent 174) organisation
Worldwide
-
-
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
100
Breeder of
(Name
animals
confidential Respondent 182)
Worldwide
Representative
see 1.4
(Name
confidential Respondent 188)
Regional;
National
Not applicable:
response is
personal opinion
based on
personal
expertise
It is VERY unlikely that the level of detail available on a database will be sufficient to inform the
inspection process. It could show where similar work is going on in order that similar standards could
be applied to similar projects and inspectors could find colleagues with whom to discuss complex
matters, but good communication systems between inspectors could serve this purpose at much lower
resource implication
(Name
confidential Respondent 189)
National;
European
There are other Data will likely be confidential.
organisations
(Name
confidential Respondent 190)
Regional;
Worldwide
also others
see 1.11
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
see below
101
Question IX.1.7.
Question text:
Administrative burden:
The establishment of an EU database would create a high administrative burden at
establishment level due to the need for timely reporting of up-to-date information.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
178 respondents stated that they support the preliminary analysis.
23 respondents stated that they have no opinion in relation to this question.
12 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.7a.
ness
the
organisation
User of animals - National
(Name
public sector
confidential Respondent 007)
jes
-
102
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 045)
Our organisation We would not welcome additional administrative burdens on top of what we already have to achieve
in terms of administration and documentation load.
is
representative
within the field
of cancer
research but we
have many
collaborations
with other like
organisations.
User of animals - Worldwide
(Name
private sector
confidential Respondent 092)
This would be confidential information
Global
pharmaceutical
research and
development
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS administrative burden might be overrated one doesn't have to include every single detail but with a
is also involved kind of bulletin board system
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
Clearly there would be some administration necessary at an establishment level but this should not be
high. All projects require evaluation and reporting of results, and provided the nature of the
information and the way it is presented is well defined, then submission to a database should require
little extra effort. A good evaluation and reporting system will be of benefit in the long term.
103
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
The negative impacts on this have been overestimated and should be reduced to – Establishments
already have to complete a license application and will have to submit figures and severity levels
retrospectively (see Ethical Review). Reporting of results is a minor burden on establishments since it
is already required for reports to funding bodies and/or publication submissions, regardless of
outcome. There will be limited administrative burden on establishments to collate this information in
the correct form for submission to the EU database.
PETA Europe
Ltd.
Nongovernmental
organisation
Worldwide
both
Regulatory testing, even where tests are required by national legislation, should be subject to ethical
evaluation based on the proposed purpose of the substance being tested and the existence of similar
substances or data already held on that substance.
PROFESSOR RD NonCOMBES - FRAME governmental
organisation
Worldwide
THERE ARE
OTHERS
No evidence is provided for this assertion and I do not believe there would be a high burden.
Stichting EDEV - Nongovernmental
Een DIER Een
organisation
VRIEND
National;
European
We cooperate
with animal
organisations
within the
ECEAE
Thats part of the work not a burden.
104
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Due to the large potential of an EU database to significantly reduce duplication of animal
experiments, the administrative burden seems to have been widely overestimated, since avoiding
duplication would lead to a notable decrease in administrative burden. Such a database should
improve effectiveness and efficiency at establishment level which would offset any additional
administrative burden.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
The negative aspects have been overstated.
(Name
confidential Respondent 197)
National
Not sure
Administration could be cut if the database was like a non-peer reviewed journal, where experiments
could be fully cited and could contribute to author’s publications. It is frustrating for (academic)
researchers to carry out unpublishable experiments, so they would probably be quite motivated to
contribute in timely fashion to the database. The requirements could be for a brief summary of the
procedure, sample size, control groups, etc – something the authors could almost cut and paste from
their grant proposals, with the addition of the negative result. Google scholar might make it
wonderfully searchable. Even an incomplete database would be a great help.
105
Question IX.1.8.
Question text:
Cost to establishments:
Although 60% of establishments already have internal statistical registration that goes beyond
the legal requirements, the additional cost to feed information into such a database would be
high, because establishments would be forced to collate it, write it up in an orderly fashion, and
provide on-time information.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
172 respondents stated that they support the preliminary analysis.
30 respondents stated that they have no opinion in relation to this question.
11 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.8a.
ness
the
organisation
106
User of animals - National
(Name
public sector
confidential Respondent 007)
jes
-
User of animals - Worldwide
(Name
public sector
confidential Respondent 024)
Representative
Additional costs to feed information into such a database could be low, is personal is motivated and
determined. Importance of training and education of personal.
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 045)
Our organisation We would not welcome additional administrative burdens on top of what we already have to achieve
in terms of administration and documentation load.
is
representative
within the field
of cancer
research but we
have many
collaborations
with other like
organisations.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS might be overrated
is also involved
Yes the information collected at present is not useful to prevent duplication. This would entail a
whole new set of information which it seems difficult to see what format much of the useful data
could be presented in other than free text. This would not be amenable to database entry.
107
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
Clearly there would be some additional costs at an establishment level but these should not be high.
All projects require evaluation and reporting of results, and provided the nature of the information
and the way it is presented is well defined, then submission to a database should require little extra
resources. A good evaluation and reporting system will be cost-effective in the long term.
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
This cost has been overestimated and also duplicates the cost described in 1.7. See response to 1.7.
PETA Europe
Ltd.
Worldwide
both
the information is already available and systems introduced at EU level will support facilities by
providing uniform requirements thereby reducing the burden on individual facilities. This will also
assist in ensuring market harmonisation.
National;
European
We cooperate
with animal
organisations
within the
ECEAE
So the 40% has to organise things better
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
Nongovernmental
organisation
Stichting EDEV - Nongovernmental
Een DIER Een
organisation
VRIEND
108
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Due to the large potential of an EU database to significantly reduce duplication of animal
experiments, the cost to establishments seems to have been widely overestimated, since avoiding
duplication would lead to a notable decrease in costs. Access to results published in the database by
other establishments would add to the saving, since fewer experiments would need to be carried out.
The data requirements are unlikely to exceed existing reporting requirements within the institution.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
please refer to statements by ECEAE and PETA
109
Question IX.1.9.
Question text:
Administrative costs for Member States:
The establishment and maintenance of an EU database would create high, partly temporary,
administrative costs for most Member States, as only 25% of all Member states currently have
an automated system of data collection.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
170 respondents stated that they support the preliminary analysis.
36 respondents stated that they have no opinion in relation to this question.
7 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.9a.
ness
the
organisation
110
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 045)
Our organisation We would not welcome additional administrative burdens on top of what we already have to achieve
in terms of administration and documentation load.
is
representative
within the field
of cancer
research but we
have many
collaborations
with other like
organisations.
GlaxoSmithKline User of animals - Worldwide
private sector
Thre are other The primary cost of an EU database would be to the EU government institutions, commission etc,
itself: see 1.10
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
111
Animal
Procedures
Committee
(APC)
Public authority National
The APC provide The costs will be ongoing due to maintenance of the automated system.
independent
advice to UK
Government on
the use of
animals in
scientific
procedures. The
APC consider
science,
industry and
animal welfare.
Members are
from a variety
of backgrounds.
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use. The above proposition is wrong to assume that anyone currently has either the
infrastructure or information required to make this happen.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
Public authority National
(Name
confidential Respondent 127)
Ministry of VWS it should be like traces: an EU based system with EU as guardian
is also involved
112
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
NonThe National
Anti-Vivisection governmental
organisation
Society
European
Eurogroup/EWL Level of costs depends on how efficiently the system is set up. All Member States should set up a
A is made up of system for data collection for the efficient administration of project licencing. There is no reason why
animal welfare compatibility with the needs of a central database should entail high additional costs.
Member
Organisations
and Observers in
all Member
States
National;
European;
Worldwide
The NAVS is the The costs of such a system should not be prohibitive.
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
113
Question IX.1.10.
Question text:
Resource requirements at an EU-level:
An EU wide database would create high additional administrative burden at EU-level due to
the costs involved in establishing, managing and coordinating the system internationally and
the need to organise effective data collection (right information in right format) on a regular
basis to meet deadlines.
Do you support the preliminary findings? Yes/No/ No opinion
Statistics:
178 respondents stated that they support the preliminary analysis.
26 respondents stated that they have no opinion in relation to this question.
10 respondents stated that they do not support the preliminary analysis or components of it. To justify
disagreement, they were asked to provide arguments, facts and figures and if possible indicate the
source of information. However, a number of respondents opted for the "No" reply only to supply
additional arguments in support of the preliminary analysis.
Comments received:
Name of the
expert or
organisation
Type of
organisation
Activity level of Representative- IX.1.10a.
ness
the
organisation
114
User of animals - Worldwide
(Name
public sector
confidential Respondent 024)
Representative
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 045)
Our organisation We would not welcome additional administrative burdens on top of what we already have to achieve
in terms of administration and documentation load.
is
representative
within the field
of cancer
research but we
have many
collaborations
with other like
organisations.
GlaxoSmithKline User of animals - Worldwide
private sector
Thre are other The costs of an EU database would, it could be expected, have to be borne primarily by EU
institutions, e.g Commission. It would be unreasonable for the EU to impose a central EU database
international
pharamceutical and then also the cost.
companies. We
produce 25% of
the worlds
vaccines
User of animals - European
(Name
private sector
confidential Respondent 072)
Yes
1.Animal Aid
The welfare benefits and the rationalisation of data would outweigh the administrative burden.
Other
organisations do
exist
Other
National
Advantages are too much.
Defiend argument s true but again, if this would be the main mentality and the right one for the
development of scientific society, very sure we would not have any of our crucial online databases,
like Pubmed or ScienceDirect whose benefit is out of discussion.
115
European
Eurogroup/EWL A system to collect data and avoid duplication will be cost-effective in the long term. Level of costs
A is made up of also depends on how efficiently the system is set up.
animal welfare
Member
Organisations
and Observers in
all Member
States
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
The cost at this level has been overestimated. It would only be a low to moderate administrative
burden, since for example, substance related databases already exist. Establishments already have to
complete a license application and will have to submit figures and severity levels retrospectively (see
Ethical Review). Incorporating this information and results into a database is the only additional
burden. Electronic reporting and formatting of information with keywords, etc., further can reduce
administrative burden. Harmonisation of this collation of information in the form a of a database will
satisfy improvements to statistical reporting, ethical review, public transparency in addition to
duplication of animal tests. Positive impacts can therefore be added but negative aspects should not.
It is suggested that the authorisation fee for licenses incorporates these costs.
PETA Europe
Ltd.
Worldwide
both
The administrative burden is over estimated and there is no account taken of the fact that the
majority of the cost is in setting up the new system but the benefits over time include economic
benefits due to standardized reporting and administrative procedures being introduced. The animal
welfare benefits are high, and so the additional cost should be embraced as an expression of the
commitment to animal welfare made by the EU.
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
Nongovernmental
organisation
116
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the The additional administrative burden should be low.
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
please refer to statements by ECEAE and PETA
117
Question IX.1.11.
Question text:
Justification (open text box)
Statistics:
(no numbers registered as this was not a closed question)
Comments received:
Activity level of Representative- IX.1.11. Justification
ness
the
organisation
Name of the
expert or
organisation
Type of
organisation
C. Norman
Scholfield
User of animals - Regional;
public sector
National;
European;
Worldwide
yes
High cost Cannot be sure that the current experiments are well conducted Good research ideas can
be stolen by other workers, particularly those outside the EU
118
User of animals - Worldwide
Dept.
public sector
Laboratory
Animal Science,
Utrecht
University, The
Netherlands
chair of lab.
animal sci.
recognized by
national
authorities/resp
onsable for
national
coordination
education and
training in lab.
animal sci./
leading role in
international
laboratory
animal science
The statements on potential benefits cannot be supported as they are based on an assumption that a
significant amount of duplication, outside of that required by national/international regulations,
takes place. There is no evidence to support this; to the contrary, the experience of the UK Home
Office is that there is minimal duplication of animal studies.
Hannu
Komulainen
User of animals - National;
public sector
European
Is relevant
The database very likely would not be any solution and would be very expensive vs. the benefits.
Prof Alan
Palmer
User of animals - Worldwide
public sector
Yes
Clearly to be of use, the database will need to contain sufficient detail to assess whether any
proposed study is indeed a duplication. However, too much information would make the whole thing
unwieldy and therefore reduce its utility. The obvious data that would be of most use would be
outcome measures. However, these are sometimes rather protracted in becoming available and any
delay in entry into the database would provide ample opportunity for duplication. The only real way
of avoiding duplication is rapid entry into the database in which case it would have to rather
promissory without guarantees that the research would be successful or the results definitive.
Prof. Dr. R.
Nobiling,
University of
Heidelberg
User of animals - Regional;
public sector
National;
European;
Worldwide
Biomed research Duplication, however, can and should be avoided in primary safety testing (e.G. REACH).
at Univ.
Heidelberg is
Top - ranked
119
Timo Nevalainen User of animals - Local
public sector
Yes
1.6. They can use the very same world-wide knowledge bases already existing.
User of animals - Local; Regional; XXX
(Name
public sector
National;
confidential European;
Respondent 002)
Worldwide
We cannot see how these suggestions could be workable. First, the work to get all data into a
consistent searchable format would be enormous. Second, to be useful, the results would need to
identify the research group, which, as indicated elsewhere, is not feasible on security grounds. [It is
not realistic to imagine that a database available to all scientists across the EU would not soon
become publicly available]. Third, issues of IP protection would obstruct the objective. Fourth, the
central support needed would be considerable and ongoing to maintain the database.
User of animals - Local; National; representative
(Name
of a research
public sector
European;
confidential university
Worldwide
Respondent 008)
But it would still be worth the gain. One might have to make some allowance for experiments of
replication to confirm an existing result, from duplication that simply carries out the same
experiment unwittingly through e.g. not doing a thorough review of the literature. In the field of
regulatory toxicity testing it seems more clear cut, but in those instances efforts should be made to
ensure that the first time it is carried out it is done correctly so that retesting is not needed. That
means coordination of regulatory bodies to avoid different protocols between countries for the same
objectives. 1.4 I agree but It might also provide some practical guidance on the incorporation of
ethical criteria and approaches to animal based research and good practices (NB This should link in
with current proposals in DG ENV RES for FP7).
User of animals - National
(Name
public sector
confidential Respondent 009)
Database for basic research does not make sense; good planning of basic research experiments is done
at the level of the scientist through checking the literature, this can not be exercised by a database
due to the large diversity of topics and the individual interpretation of results required for these
purposes.
Yes, we are
representing all
physiological
researchers in
the
Netherlands; we
have about 300
members
120
Results need to be replicated. Reliability and reproducibility are crucial for medical ethics and
quality. Research has to deal with species and strain differences. In this respect public opinion is
often misled. Legislation should not contribute to such misunderstanding. The EU contributes a
decreasing share of scientific results globally. More results are generated in US and increasingly in
Asian countries. Results from pharmaceutical industry would hardly contribute to decrease animal
numbers since companies typically work on patentable compounds. Other mechanism to limit
replication of experiments are by far more efficient in academia and in industry: eg, simple
replicatiom causes costs and reproduction of existing data is hardly publishable. An EU data bank
covering only a minor share of relevant information in a problematic way would hardly contribute to
animal welfare but rather enhance the bureaucratic burden and decrease in scientific
competitiveness of the EU.
User of animals - Worldwide
(Name
public sector
confidential Respondent 010)
One of several
global
pharmaceutical
companies
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 011)
Overall, the value of an EU wide database would be low, or even adversely impeding research
Other
organisations in progress and costs would be inappropriately high
Austria: KarlFranzensUniversity;
Medical
University
Vienna; Medical
University
Innsbruck
User of animals - National
(Name
public sector
confidential Respondent 012)
yes, competitive
in the field of
small animal
research
This database will only cost money and is a waste of time. Many things can now be found at internet
and scientists have discussion platforms to exchange also things that do not work. Writing negative
publications is not going to work because details at each lab make sometimes the outcome of studies
very different
121
User of animals - Local; Regional; Yes
(Name
public sector
National;
confidential European;
Respondent 014)
Worldwide
While unnecessary duplication should be avoided by all means, the new directive must not harm the
principle of replication which is essential to science and calls for an independent confirmation of a
novel finding. Information on experiments is already widely available through databases such as
Pubmed. However, some facility for publication of negative findings would be useful so that these can
be accessible through the peer-reviewed literature.
User of animals - European
(Name
public sector
confidential Respondent 016)
Yes
Overall the establishment of database of project authorisations and scientific results, available to
inspectors and scientists for exchange of information about problems and for promoting best-practice
is a sensible and helpful proposal. The administrative burden will not be high but the potential
benefits should be worthwhile.
User of animals - Not applicable
(Name
public sector
confidential Respondent 018)
we are a
medical
university.
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 026)
Yes
Very difficult to co-ordinate especially with funding bodies and different techniques. It’s more
important to standardise data/tests so data is comparable.
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 037)
Yes
Careful thought will need to be given to how scientific results are captured. The right balance should
be struck between sufficient details to make the scientific record useful, while avoiding the provision
of excessive information.
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 038)
Yes
The key to capturing scientific results is to appreciate the limited public knowledge of science and
also the extended period before the outcome of work is appreciated.
ridiculous amount of wasted time and money without any impact at any level.
122
We agree with the principle but the detailed implementation relies upon too many factors to
anticipate the outcome. In particular, the database must have quality assurance on all data entered
and will be useful only when the vast majority of studies are entered. It could become a "badge of
identity", so that results from any study not in the database would not be accepted for publication,
because the study "did not exist". In the longer term, the database would create leverage to amend
national laws as suggested, so there may be an argument for starting the database to highlight
duplication before trying to eliminate it. Nevertheless, such a project must be seen as a substantial
and permanent function, and funded on that basis, not as a pilot.
User of animals - National;
(Name
public sector
Worldwide
confidential Respondent 044)
yes, major UK
research
organisation for
aquatic
organisms and
environment
User of animals - National;
(Name
public sector
European;
confidential Worldwide
Respondent 045)
Our organisation We would not welcome additional administrative burdens on top of what we already have to achieve
in terms of administration and documentation load.
is
representative
within the field
of cancer
research but we
have many
collaborations
with other like
organisations.
User of animals - Regional;
(Name
public sector
National
confidential Respondent 047)
yes
I work with genetically modified mice in basic research. Studies with such mice are hardly ever
duplicated, because there are so many variables (genetic background, targeting strategy, transgenic
line etc), that no 2 studies are the same. In addition, certain overlaps between similar studies is
often desirable to ascertain and reproduce findings. Such studies take several years. Nobody will
abandon the study half way into the project, when they find out in the database that others have
done a similar study. Rather, before even applying for a grant including such a study, researchers will
try to get all information possible through the channels of the scientific community, whether such a
study is on the way or not in another laboratory. These channels will be much more up to date than a
database which no researcher will submit to in any detail before their study is published.
123
User of animals - Local
(Name
public sector
confidential Respondent 048)
Not applicable, I This will not work because not all experiments are the same, one may get some benefits in
harmonisation of industrial testing, but they won't want to share data.
am not an
organisation
User of animals - Local
(Name
public sector
confidential Respondent 052)
Yes
The bureaucracy required for the establishment of such a database in my country or even the
communication of data required from my country to EU headquarters would be extremely high. Lack
of specialised personnel in the public sector is a major handicap.
Bayer
HealthCare
organisation is
representative
for the field
See reference: http://www.efpia.org/5_conf/qualitybioresearch300904.pdf.
Thre are other
international
pharamceutical
companies. We
produce 25% of
the worlds
vaccines
There appear to be two assumptions here: 1. Duplicate regulatory testing is a ‘lost cause’; it should
not be and the Commission can be influential 2.That it will be possible and beneficial to create a
useful repository of all results of animal experiments. At present posters and publications synthesise
available significant knowledge; this proposal appear to say the all primary data needs posting in a
database, whatever the significance, if animals were used. This discussion may be useful:
http://www.nuffieldbioethics.org/go/browseablepublications/ethicsofresearchanimals/report_432.ht
ml
User of animals - Worldwide
private sector
GlaxoSmithKline User of animals - Worldwide
private sector
Protherics
Medicines
Development
Ltd.
User of animals - Worldwide
private sector
Reference document: EFPIA public preliminary impact assessment, July 2003
No - ABPI and
EFPIA repesent
the
pharmaceutical
industry in
UK/EU
124
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 073)
Sanofi aventis is This would be a major undertaking requiring significant administrative input and support. Industry
would come up against intellectual property issues. Data input would create significant work loads
the largest
pharmaceutical and the data could be redundant long before it is accessible.
company in
Europe and
ranks third
worldwide
User of animals - Worldwide
(Name
private sector
confidential Respondent 074)
Yes
The competiveness of EU Pharma industry will go down markedly due to increased cycle times. In
addition, such a database will be very difficult to update due to the need for confidentiality and for
IP reasons. You cannot get a patent on data, which are in public domain!
User of animals - Worldwide
(Name
private sector
confidential Respondent 075)
Research and
development
Lots of difficulties to answer in real time. Confidentiality and accuracy of data may be compromised
in this kind of data base and leading to important risks of serious consequences on public health and
patient safety.
User of animals - Worldwide
(Name
private sector
confidential Respondent 076)
Yes
A EU wide database would create high additional administrative burden, the impact of this database
is highly questionable – especially as most of the data from animal experiments will be published in
scientific journals and available via databases anyway
User of animals - National;
(Name
private sector
Worldwide
confidential Respondent 079)
yes
See the EFPIA document on public preliminary impact assessment (July 2003)
User of animals - Worldwide
(Name
private sector
confidential Respondent 081)
other relevant
organisations
no comment
User of animals - Worldwide
(Name
private sector
confidential Respondent 084)
yes
1.4 Heavy doubts about the quality of the database
125
User of animals - Worldwide
(Name
private sector
confidential Respondent 086)
There are many Overall this proposal is of great concern as it is entirely inconsistent with the innovation that comes
through a variety of competitors working on similar high risk projects. Also many aspects appear to
other such
organisations in neglect the essential nature of intellectual property being inherent in paradigms of drug discovery.
Europe
User of animals - Worldwide
(Name
private sector
confidential Respondent 087)
No
User of animals - Worldwide
(Name
private sector
confidential Respondent 088)
pharmaceutical see reference document: EFPIA public preliminary impact assessment, July 2003
User of animals - Worldwide
(Name
private sector
confidential Respondent 091)
YES (Safety
Assessment)
User of animals - Worldwide
(Name
private sector
confidential Respondent 092)
see EFPIA public preliminary impact assessment - July 2003
Global
pharmaceutical
research and
development
User of animals - Worldwide
(Name
private sector
confidential Respondent 093)
yes
Duplicate testing for regulatory purposes is not a large issue in overall animal use, and should be
addressed from the angle of the regulations requiring conduct of the tests. Publication of information
to assist others in design and conduct of studies should be encouraged, even whe the results are
negative in relation to the original purpose. Journals should be encouraged to do so.
A central database would result in an enormous amount of work to input information and it would be
difficult if not impossible to keep the information current in real time. . The massive resource impact
would be out of proportion with any benefit gained. More benefit can be gained from ICH and mutual
recognition agreements.
Reference document: EFPIA public preliminary impact assessment, July 2003
126
User of animals - National;
(Name
private sector
European;
confidential Worldwide
Respondent 096)
No comments
there are
multiple
independent
Contract
Research
Organisations in
UK and EU
User of animals - National
(Name
private sector
confidential Respondent 097)
Yes
It is being assumed that there is a problem with duplication of testing. This is not the case. There is
limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would
be more useful than any data base.
User of animals - Worldwide
(Name
private sector
confidential Respondent 099)
yes
A central database would result in an enormous amount of work to input information. The massive
resource impact would be out of proportion with any benefit gained. More benefit can be gained
from ICH and mutual recognition agreements.
User of animals - Worldwide
(Name
private sector
confidential Respondent 103)
A database can only be as good as the data input. The feasibility that this leads to a current, at any
The
time updated information status of the content is very low taking the complex EU world into account.
bquestionaire
will be
completed for
the German
sites. Other site
head in other
countries will
reply
individually
User of animals - Worldwide
(Name
private sector
confidential Respondent 104)
Many
organisations
Reference document: EFPIA public preliminary impact assessment, July 2003
127
User of animals - National
(Name
private sector
confidential Respondent 110)
Animal
Procedures
Committee
(APC)
Public authority National
Coenraad
Public authority National
F.M.Hendriksen
representative
http://www.efpia.org/5_conf/qualitybioresearch300904.pdf
The APC provide
independent
advice to UK
Government on
the use of
animals in
scientific
procedures. The
APC consider
science,
industry and
animal welfare.
Members are
from a variety
of backgrounds.
Such a database would be onerous and possibly too simplistic to be cost-effective on any large scale.
Would an EU database be an optimally reliable source of information when so much research is
conducted outside the EU? Care must also be taken to avoid the cost of intellectual property theft,
and commercial confidentiality must also be catered for as such factors may lead to research going
outside the EU.
at the national
level: yes
I have strong doubts about the feasability of such a data-base: • Keeping the data-base up-to-date.
This will require substantial administrative support and expenses • Almost unlimited number of
variables in an animal experiment which will make it very difficult to decide whether the proposed
study indeed is a duplication • Who will decide about possible duplication? Only (expensive) experts
will be able to decide about that
128
Federal Public Public authority National
Service - Public
Health (div.
animal welfare
& CITES)
Yes,
EU regulatory legislation (medication, biocides, pesticides) all with their respective review processes
representative. must provide in setting up necessary databases with results of animal tests per molecule (active
substance). Letters of access and/or coordination by EU inspectors between applicants (sharing
registration costs) must interfere in the process of duplication of animal tests.
The MRC is the
UK's leading
publicly funded
biomedical
research
organisation
We have supported the proposal in principle. However, careful thought needs to be given to the
balance between costs and benefits of such a development, and to the risk e.g. of inadvertent public
disclosure of sensitive personal information. Benefits will only be realised if the database is
sufficiently complete and up-to-date. This may be a challenge to achieve and may then require
unrealistic resourcing. Furthermore, the right balance will need to be struck between providing
enough detail to make the scientific record useful, while avoiding excessive information. If the
‘results’ to be collected are the scientific outcomes, there will be a significant delay before reporting
during which time research could be inadvertently duplicated. If the ‘results’ summarise the
intentions of the project, this can be done immediately after authorisation (and funding) of a project
facilitating the objective of avoiding duplication.
Public authority National;
(Name
European;
confidential Worldwide
Respondent 117)
yes
The information collected at present is not useful to prevent duplication. This would entail a whole
new set of information which it seems difficult to see what format much of the useful data could be
presented in other than free text. This would not be amenable to database entry. this would be an
administrative cost to all member states at currently collected statistical information will NOT assist
in this matter. It would be almost impossible to keep this up to date. Duplication may occur between
granting authorisation and publication of results.
Public authority National
(Name
confidential Respondent 122)
We are the
National
Competent
Authority
The case has not been made that there is a significant amount of unnecessary duplication. Whist the
UK strongly encourages and promotes data sharing, the proposed database would be prohibitively
expensive and difficult to establish and maintain if it was ever to be seriously considered as a means
of finding sufficient high-quality, comprehensive, accurate and up to date information to be of
practical use.
UK Medical
Research
Council
Public authority Local; Regional;
National;
European;
Worldwide
129
Public authority National
(Name
confidential Respondent 126)
Regulatory
authority in UK
Negative results are not generally published in peer reviewed publications and could not be identified
for listing on a database. This would make the database incomplete. Also details in the database
would probably be insufficient to make a judgement on the exact studies conducted to determine if
work is being repeated. Science operates globally and establishment of a EU database would miss a
substantial quantity of information. Overall the principle is good but it would not be possible to
achieve stated results and would have huge resource implications.
Public authority Local; Regional This is the only An EU wide database would have a high positive impact on animal welfare. We need to have
(Name
representative information on negative results.
confidential organisation for
Respondent 130)
the Federal
Government of
Styria.
1.Animal Aid
Other
National
There should be a statutory obligation to avoid any duplication. To suggest that it would be too
Other
organisations do complex to introduce such legislation represents a lack of compassion and a disregard for the
suffering of fellow sentient beings. A regime that permits duplication is an affront to the Universal
exist
Declaration of Animal Rights (proclaimed in Paris on 15 October 1978 at the UNESCO headquarters,
and made public in 1990).
Biosciences
Federation
Other
National;
European
There are other We cannot see how these suggestions could be workable. First, recent UK history of the development
of major national databases has shown that they are very expensive, fraught with technical problems
relevant
and rarely fit for purpose. Second, the results would need to identify the research group, which is
organisations
not acceptable for security reasons. Third, issues of IP protection would obstruct the objective, as if
competitors in a particular research field are doing similar research they are not going to release
information to the other side An objective and evidence-based cost-benefit analysis would need to be
undertaken before these proposal should be taken forward.
130
Local; Regional; Research in
Medicine
National;
European;
Worldwide
The mentioned database open to all scientists of Europe will in fact be a public database which will
cause severe problems with a minority of potentially violent animal rights activists. Avoidance of
duplication may be possible in regulatory testing. However, in basic research proof of reproducibility
provided by other groups is a necessity to ensure a critical approach! Databases introduced for
scientific reasons already exist and are used in the evaluation of projects by authorities too (see
Chapter XII).
The Association Other
for the Study of
Animal
Behaviour
Worldwide
yes
There is a danger that in striving to be seen to be reducing duplication, undue confidence will be
placed in existing experimental results. Replication and subtle variation in experimental
methodology to retest outcomes is an essential part of fundamental research and must not be
jeopardized
Other
(Name
confidential Respondent 144)
National
Yes
It is our view that an EU wide database would create significant economic costs for the European
Commission.
Other
(Name
confidential Respondent 151)
Not applicable
Yes
The majority of results in research institutions is published in regular journals and can be assessed in
databases such as Pubmed. Forcing the research institutions to provide these data in another manner
also in a central EU database will lead to a severe burden. However, reporting of negative findings,
that will not be published, within eg one year of finishing the project, to a central database might be
useful.
Austrian Society Nongovernmental
of Toxicoloy
organisation
(ASTOX)
National
Yes
General: Proof of reproducibility is imperative in natural science
Medical
University of
Vienna
Other
131
Eurogroup for
Animal
Welfare/EWLA
Nongovernmental
organisation
NonEuropean
Coalition to End governmental
organisation
Animal
Experiments
(ECEAE)
European
Eurogroup/EWL
A is made up of
animal welfare
Member
Organisations
and Observers in
all Member
States
The assessment is severely hampered by lack of a clear definition of the scope and nature of the
proposed database. For this reason, all assessments of potential costs are highly suspect. Re 1.2,
benefits would also accrue from improving completeness of literature reviews and warning of ongoing
projects before the results are published. Duplication does not just occur because of lack of
publication of negative results. Researchers may not search the literature properly and/or
information may be poorly accessible or in different languages.
Worldwide
Representative
(the only EU
coalition
focusing on
animal
experiments)
In order to be fully useful the database should be mandatory and include all project applications.
Since these are required for authorisation anyway, the burden to put them onto a searchable
database is relatively low. Only truly ‘commercially sensitive’ information should be omitted. In
addition, there is considerable merit in requiring companies (subject to commercial confidentiality
considerations) to publish proposed test plans for a limited period, as happens under the US High
Production Volume Program. This enables other companies (and NGOs) to alert the testing company
and regulator where the data has already been generated, as well as giving them the opportunity of
contending that there may be a better way of generating any required data applying the 3Rs. Such a
database has also the potential to provide a mechanism for data sharing and compensation to the test
result provider, as is occurring with REACH.
132
The statements on potential benefits cannot be supported as they are based on an assumption that a
significant amount of duplication, outside of that required by national/international regulations,
takes place. There is no evidence to support this; to the contrary, the experience of the UK Home
Office is that there is minimal duplication of animal studies.
European
FELASA
represents 13
European lab
animal sci
associations and
therefore some
3-4000 members
of those
associations
(scientists,
veterinary
surgeons,
technicians
etc.). See
www.felasa.org
Nuffield Council Nonon Bioethics
governmental
organisation
National;
Worldwide
There any other The Council questions the assessment of the overall preliminary impacts as neutral. It is possible that
the potential long-term benefits gained from establishing a centralised EU-wide database, in terms of
relevant
reducing the number of animals used in experiments in the EU, would outweigh the costs in terms of
organisations
resource requirements. Paras 15.16, 15.17, 15.68-15.70 and 15.84-87 describe the Council’s views on
duplication, data sharing and the harmonisation of international guidelines, in Nuffield Council on
Bioethics (2005) The ethics of research involving animals (London: Nuffield Council on Bioethics)
Available at: http://www.nuffieldbioethics.org/go/ourwork/animalresearch/publication_178.html
PETA Europe
Ltd.
Worldwide
both
FELASA
(Federation of
European
Laboratory
Animal Science
Associations)
Nongovernmental
organisation
Nongovernmental
organisation
The administrative burden is over estimated and there is no account taken of the fact that the
majority of the cost is in setting up the new system but the benefits over time include economic
benefits due to standardized reporting and administrative procedures being introduced. The animal
welfare benefits are high, and so the additional cost should be embraced as an expression of the
commitment to animal welfare made by the EU.
133
PROFESSOR RD NonCOMBES - FRAME governmental
organisation
Worldwide
THERE ARE
OTHERS
The main problem with databases is finding ways to establish and maintain them and how to
encourage their use. Several ongoing initiatives at EU level to develop databases of animal
experiments should be encouraged. Databases on alternative methods exist e.g. FRAME, ALTEX,
INVITTOX (ECVAM), and the need for strategic planning before conducting research work, to ascertain
whether all or some of the planned research objectives could be achieved without using animals,
should be emphasised.
NonThe National
Anti-Vivisection governmental
organisation
Society
National;
European;
Worldwide
The NAVS is the
leading and
oldest antivivisection
organisation in
the world.
There are a
number of other
relevant antivivisection
organisations
around the
world with
expertise in this
field.
Duplication has been found to occur frequently, and a recent study supported by the UK National
Health Service concluded that animal studies are often carried out even after clinical trials on humans
have been conducted. The study concluded that publication bias was a frequent problem (i.e. not
equal publication rate for positive and negative results). The authors of the study suggest several
steps to improve the validity and usefulness of results from animal models, among them “Prospective
registration of animal experiments would enable researchers conducting reviews of animal studies to
confront the problem of publication bias” (Roberts et al. 2006). References: Roberts, I et al. 2006.
Testing treatments on animals: relevance to humans. NHS report for project RM04/JH18/IR.
Nongovernmental
organisation
Worldwide
Many other
Learned
Societies aer
also
representative
The ability to verify results by repeating experiments lies at the heart of the scientific method. It
should be accepted that non-regulatory duplication is most likely to occur in rapidly-moving, highprofile and high-value fields of research, where the rapid pace motivates against up-to-date central
information and where some duplication is scientifically desirable as a check on over-enthusiastic
claims of major advances.
Non(Name
governmental
confidential Respondent 163) organisation
National;
European;
Worldwide
both
please refer to statements by ECEAE and PETA
The
Physiological
Society
134
Non(Name
governmental
confidential Respondent 169) organisation
National
Represents all Difficult to imagine how this database could be constructed to be useful and not unwieldy. It could
well be a useful resource if it were designed properly.
Finnish
pharmacologists
Non(Name
governmental
confidential Respondent 170) organisation
National
Replication of experiments is an essential part of the scientfic process. Substantial information about
The Danish
previous experiments is already available in databases such as PubMed. However, due to publication
Society of
bias some negative data may not be accessible.
Pharmacology
and Toxicology
represents
Danish
pharmacologists
and
toxicologists.
Non(Name
governmental
confidential Respondent 174) organisation
Worldwide
-
-
Non(Name
governmental
confidential Respondent 177) organisation
Worldwide
Representative
Information on experiments is already widely available through databases such as Pubmed. However,
some facility for publication of negative findings would be useful so that ese can be accessible
through the peer-reviewed literature.
Non(Name
governmental
confidential Respondent 178) organisation
Worldwide
yes
But restrictions are absolutely necessary due to Activist issues, legal property rights and
confidentiality reasons. This tool would be very helpful, but will increase costs and working time as
well.
135
Breeder of
(Name
animals
confidential Respondent 183)
Worldwide
No justification required.
We are
representative
for the field and
constitute about
50 percent of
the activity
Biotechnology
and Biological
Sciences
Research
Council
National
Representative
BBSRC supports the principle but the following issues should be considered by the Commission: i)
security (although access would be restricted to the inspectorate and scientists public access may be
possible under freedom of information legislation); ii) compliance (low compliance would render the
database useless); iii) detail of information captured and iv) when during a project the information is
captured. In the analysis, the Commission has recognised the high cost that might be associated with
this proposal.
(Name
confidential Respondent 188)
Regional;
National
Not applicable:
response is
personal opinion
based on
personal
expertise
supplementary information for 1.8: the information collected at present is not useful to prevent
duplication. This would entail a whole new set of information which it seems difficult to see what
format much of the useful data could be presented in other than free text. This would not be
amenable to database entry. Supplementary information for 1.9: this would be an administrative
cost to all member states at currently collected statistical information will NOT assist in this matter.
Supplementary information for 1.10: It would be almost impossible to keep this up to date.
Duplication may occur between granting authorisation and publication of results.
(Name
confidential Respondent 190)
Regional;
Worldwide
also others
While unnecessary duplication should be avoided by all means, the new directive must not harm the
principle of replication which is essential to science and calls for an independent confirmation of a
novel finding. However, some means to publish negative findings should be supported, but at an
international, not just EU-wide level. With regard to reducing the number of animals, efforts to avoid
duplication of tests for regulatory purposes would certainly be more effective.
136
(Name
confidential Respondent 192)
National;
European;
Worldwide
Yes
An EU database is unlikely to prevent duplicate testing, especially these duplicate testings due to the
fact that negative results are not published. One should also consider that different research groups
will perform seemingly similar experiments with slight differences, or may have different creative
thoughts about the meaning of their negative data. Thus, denial of approval of seemingly similar
experiments may impede progress in basic science.
(Name
confidential Respondent 193)
National
There are other The capture of scientific results should be carefully thought out and the right balance struck between
sufficient detail to make scientific record useful, while avoiding the provision of excessive
relevant
information. If the “results” to be collected are the scientific outcomes, there will be a significant
organisations
delay before reporting during which time research could be inadvertently duplicated. If the “results”
summarise the intentions of the project, this can be done immediately after authorisation (and
funding) of a project facilitating the objective of avoiding duplication.