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A short guide on
the innovation
effects of regulation
Research and
Innovation
Regulatory
screening
EUROPEAN COMMISSION
Directorate-General for Research and Innovation
Directorate B – Innovation Union and European Research Area
Unit B1 – Innovation Union Policy
Contact: Peter Dröll
E-mail: Peter.Droell@ec.europa.eu
 RTD-PUBLICATIONS@ec.europa.eu
European Commission
B-1049 Brussels
EUROPEAN COMMISSION
Directorate-General for Research and Innovation2014
Regulatory screening
A short guide on
the innovation effects of regulation
Viola Peter
Geert van der Veen
Asel Doranova
Technopolis Group
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This document has been prepared for the European Commission however it reflects the views only
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Cataloguing data can be found at the end of this publication.
Luxembourg: Publications Office of the European Union, 2014
ISBN 978-92-79-34788-7
doi:10.2777/52771
© European Union, 2014
Reproduction is authorised provided the source is acknowledged.
Cover image © peshkova, #55269067, 2014. Source: Fotolia.com.
Authors
Viola Peter, Geert van der Veen, Asel Doranova - Technopolis Group
Acknowledgements
This guide is the condensed form of a methodological screening, developed
and tested in a project for the European Commission, DG-RTD (Contract: MS
(2012) 1055187). It benefited greatly from the learning process within the
project, involving several external thematic experts, colleagues and the
most constructive feedback from the involved EC services. We would like to
acknowledge and thank Leonor Pires and Sivasegaram Manimaaran from DG-
RTD for their support and feedback.
The full report including many case studies can be downloaded from http://
www.europa.eu/research/innovationunion/index_en.cfm?pg=other-studies
4
Innovation and regulation…
what is it about ?
Innovation creates jobs, drives growth and improves the quality of goods and
services. The role of innovation in economic growth has been acknowledged widely
in academia and policy – no wonder it is central in the EU policies for smart,
sustainable and inclusive growth. It plays an important role in tackling major societal
challenges like climate change, ageing, energy and resource scarcities.
Innovation is the outcome of the interplay of various actors such as businesses,
research organisations or financial institutes. Each is embedded in a complex
system framed by ambitions, regulations and a number of other drivers.
Typical barriers to innovation include both cultural norms and market conditions.
In some cases innovation can be hampered by excessive or outdated regulation;
at other times regulation may actually be a driver of innovation. In fact, we have
seen an example of the latter in the case of environmental regulation where some
European countries have a competitive, innovative edge largely due to early and
strict regulation. The negative side, regulation acting
as a barrier, is also possible. Regulation effects on innovation are not uniform.
Industries will also encounter different compliance cost levels along the way, and
may therefore respond differently to regulation over time.
The smart regulation approach of the European Commission aims to address the
innovation effects of new regulatory proposals in its impact assessments, with
active stakeholder involvement and input. But it is also important to check if existing
regulation is still ‘fit for purpose’, including a check on its effects on innovation.
For this purpose the Commission carries out evaluations of its existing regulatory
framework, including cross-cutting REFIT-evaluations in which this ‘fitness for
purpose’ is thoroughly checked. In these exercises guidance will be needed to
address the innovation effects of regulation.
While the effects of regulation show up at micro level, i.e., industries, firms, and
consumers, ‘fit for purpose’ checks have a high relevance at national level where
the often-complex innovation systems absorb EC directives in various ways. Often a
fine-tuning of implementation modes may be necessary to trigger positive effects.
5
However, in order to find out the necessary tools, a screening exercise may be
necessary.
What is meant by regulation?
Regulation comes down to ‘the rules of the game’: some regulations, such as market
entry regulations of price, quality, or conditional entry, are set by governments.
The OECD defines regulation quite usefully as “the diverse set of instruments
by which governments set requirements on enterprises and citizens. Regulations
include laws, formal and informal orders and subordinate rules issued by all levels
of government, and rules issued by non-governmental or self-regulatory bodies to
whom governments have delegated regulatory powers.” (OECD, 1997)
Much of the negative connotations surrounding regulation and its effects on
innovation is likely due to the fact that innovation is rarely a clear objective of a
regulation. Rather, regulation is mostly concerned with quality and safety issues –
or at least that is the perception. Environmental concerns have gained considerable
regulatory traction, but innovation is frequently not put in the same category. The
growing interest and notion of wanted/unwanted effects of regulation on innovation
need a dedicated approach to better identify, analyse, address and plan innovation
regulation effects.
Who is addressed?
Policy makers at EC as well as national level are already well aware of the need
to maximise benefits and reduce costs, including regulatory burdens. In this
respect, procedures and methods are already highly advanced at EC-level, where
impact assessments are common for new regulation, and more fitness checks and
evaluations are being carried out on existing regulation.
This guide aims to complement this and to provide tools to support a specific aspect
in the regulatory screening, i.e. to see if the regulation is stimulating or hindering
innovation.
At country level, systematic analyses of existing regulation are less prevalent, and
especially given the complexity and vast quantity of regulations in each country,
this is understandable. However, national policy makers have a strong interest in
6
shaping key regulations affecting innovation in their countries in a desired way. A
better and complete understanding of regulation effects are therefore necessary
prerequisites.
This short guide aims to provide a step-wise approach for addressing this complex
issue and to provide tools and tips for organising the screening systematically.
Three pillars… and six Steps
Analysing regulatory effects needs to take place in a broad context. So far, regulation
and innovation meet in practice, but they seem to be worlds apart. Therefore, the
analysis starts with a better understanding of the two pillars:
•	 regulation – and what are the effects of regulation on innovation, and
•	 innovation – and what are the functions of a regulation for innovation.
The third pillar is a crucial, linking one. It is important to include the positions and
views of a wide range of
•	 stakeholders,
particularly those who are directly, and possibly indirectly, affected. Stakeholders
have a view when and where regulation hampers or fosters innovation. They may be
useful to help point out a number of underlying explanations, drivers and barriers.
An overview of the system and its components is presented in Figure 1.
Bringing onboard and consulting with stakeholders is a great opportunity to collect
a heterogeneous set of information which otherwise may not be mentioned by the
‘core’ affected companies.
There are six steps helpful steps to help analyse the regulation-innovation complex
and form the basis for policy recommendations or rethinking regulatory set-ups.
The individual steps have a core objective, but it may be more useful to combine
some steps. Steps 2, 3, and 4 are treated separately, yet they are interrelated and
add to the overall ‘explanatory power’ of the screening exercise.
7
Each step may require a considerably longer or shorter amount of time or require
different levels of knowledge. Some suggestions may not need to be followed at all.
The approach is designed to be flexible since each analysis needs a slightly different
approach.
The steps
Step 1 – Identification
Step 2 – Scoping
Step 3 – Drivers and Barriers
Step 4 – Regulatory landscape
Step 5 – Linking regulation and innovation
Step 6 – Recap and action
The next pages guide you through these steps, their role and what can be done.
Figure1.Frameworkforasystemanalysis
Regulatory
framework
➔typologies
(legal,
objective)
InnovationprocessesandoutputsSocio
economic
impacts
➔Economic
➔Social
➔Environmental
➔Technological
Widerframeworkconditions:Innovationdriversandbarriers
Widerregulatoryandpolicyframework;marketconditions;nanceandcapitalmarkets;institutionalandculturalaspectsetc)
Policy
objectives
(levelofambition)
➔screenkeyobjectives
fortheareaunder
scrunityrelevantfor
innovation(=change)
➔assessexternal
coherence(policy
rationalebehind
variousregulations
maybediverse)
➔enquire„hierachy”of
ojectives
➔currentand
expectedregulations
(regulationsinthe
„pipeline”)
INDIRECT
IMPACT!
IMPACT!
DIRECT
INDIRECT
IMPACT!
Source:Technopolis
RI
activities
➔Innovation
activity,
incl.RD
➔Innovation
collaboration
➔Business
activities
relevantfor
innovation
RI
outputs/
results
➔Products
➔Procesess
➔Services
➔New
buisness
models
WIDER
IMPACTS!
RI
comer-
tialisation
➔Implemen-
tation
➔Diffusion
RIoutputs/results
Perspectivesofinnovationsystemactors,
notablycompanies(sectoralperspectives)
9

Step one – identify your area
You may already have a concrete example in mind where innovation is hampered
or fostered by regulation. Maybe an industry association has complained about how
badly a certain excessive tax affects RD spending and warned that the “introduction
of plant-specific targets for carbon reductions” will impact their employment levels.
Is this a sound complaint? Before a new piece of legislation is drafted or an existing
one revised it might be worth analysing in greater detail business communities’
perceived injustices.
In other cases, policy-makers or regulators may want to learn from other examples:
What makes Germany a leader in selling environmental goods – in spite of or
because of high regulation levels? Why does Italy has a waste problem? Could it be
solved with regulation and innovation?
To do’s
Initiate a discussion…
•	 within your organisation. This may be a regional agency or government, or
a ministry. The idea is to brainstorm on the topic: can you identify a single
regulation that impacts innovation in a specific industry or across multiple
industries?
Set up a small team…
•	 possibly of experts who know about the regulations in place, the business
communities’ views and the views of consumers.
•	 Decide on the point of departure, such as:
̪̪ boundaries; e.g., do you want to analyse effects on a specific or several
industries?
̪̪ type of regulation: do you aim to analyse the implementation of an EC directive,
a national law, or a standard?
̪̪ regulatory agent or level: e.g., by looking at regional, national or supra-national
level.
10

Enlarge your team…
You may soon meet the limits of an internal team. Try to identify colleagues in other
departments or ministries that may equally have a say concerning the regulation, or
who are concerned with other sectors or areas such as procurement, employment,
or other seemingly remote areas.
Plan ahead…
You may have the internal resources and capacities to organise the screening, or
you may want to involve external experts. Whatever you chose, make sure you
designate colleagues to follow, provide feedback and report back. These colleagues
will be the interface between the analysis and subsequent actions.
11

Step two – Start scoping
your area
What is scoping?
Scoping is a systematic exercise that aims to identify and collect information that is
then used for further analysis. It addresses questions such as:
•	 What are the main innovation needs?
•	 Who are the main actors involved?
•	 Is there available data supporting the analysis?
The level of detail in the information that can be collected will vary highly. For an
analysis that starts with a specific regulation, a more narrow focus may be sufficient
in order to identify the range of affected actors. The more complex the subject
matter is, the broader the scoping exercise may become and the more difficult it
may be to isolate regulatory effects.
To do’s
Indentify the relevant actors
•	 You may know best about the industries that are vocal in their disapproval,
but there may be other groups: other businesses, end-users, public bodies or
NGOs. Identifying a broader set of actors enhances not only their chances of
being heard in your workshops or via interviews, but you may identify thus
broader, indirect and unintended effects on other stakeholders.
Check the social importance of the chosen area
•	 Is the sector/industry relevant for a small group or does it have it a wider role
within society? Try to obtain qualitative information from external people.
Check the economic importance of the area
The scoping area may already be important or it may be a political goal to gain
12

leadership. Common knowledge may indicate the area’s importance, but it’s
necessary to check data such as productivity, employment, final consumption
expenditure or RD data such as expenditure or the number of human resources.
Important innovation indicators can be built around patent and trade data, for
example.
Use time series and comparative, international data. Isolated data of a given year
is not very revealing. Through a descriptive analysis over time (around 5-10 years)
and/or a comparison to international competitors, patterns can be observed and
possible outliers identified. In some instances, outliers are the starting year(s) for a
new trend that may tentatively be linked to important structural changes.
Discuss and analyse the first findings
•	 Once you have accumulated the information, include it in a document (‘a
scoping paper’) which can serve as basis for discussion and further analysis.
This paper may grow during the course of the process and it may be revised
to reflect the information collected, analysed and validated.
•	 Analyse the findings and identified some names within your internal group;
you may also want to discuss it with external experts.
How to do
➔ Data can be found at national statistical offices as well as Eurostat or the OECD.
Patent searches can be done from espacenet, a service of the European Patent
Office.
•	 interviews with external experts are useful in the first phase of the screening,
particularly if you have been relying only on internal knowledge.
•	 a small workshop with experts and your team is useful to compliment and
validate your findings. It is also an opportunity to obtain new ideas and
views you may not have had before.
•	 Make sure you are not only discussing with the ‘usual suspects’ but try to
bring in diversity of thoughts and opinions.
13

Step three – Identification of
drivers and barriers
Regulation has intended and unintended, direct and indirect effects on innovation.
This step provides two analytical tools which can help structure the full analysis
and identify framework conditions that influence innovation either directly or
indirectly via regulation.
When you have already identified your area, the main actors and gathered
quantitative and qualitative information, you may characterise the innovation
impacted by the regulation more clearly. It will help to classify the innovation
effects – namely, when and to whom they occur in the innovation process.
Policy-makers may want to rectify the regulatory situation. This requires a holistic
approach which can be done by identifying drivers and barriers. Innovation is not
only affected by regulation such as a direct law; there are other areas, possibly
equally influences by regulation, and perhaps equally important.
This step provides another piece of analysis useful in the assessment of the
regulation and its effects on innovation.
To do’s
Check: what type(s) of innovation are you dealing
with?
•	 Regulation may impact products, processes, marketing or organisational
innovations. They may be incremental or disruptive. You can differentiate
by looking at the functions of innovation, such as knowledge creation,
knowledge diffusion, or market formation etc.
Which type(s) do apply in your case?
Identify drivers and barriers
A given regulation may seem to be the focus of attention, but given that the
regulation does not function in isolation, it is useful to analyse the broader
context and how that one may influence the regulation in its innovation impacts.
14

•	 Use a broad →check-list of possible drivers and barriers. You may not have
envisaged remote factors that may be influential and having explanatory
power.
•	 Experts may at that point be even more valuable. You may envisage to
discuss drivers and barriers with the external experts in a workshop.
how to do
A checklist of drivers and barriers can be very broad. We suggest looking at four
fields:
•	 Policy, regulation, governance;
•	 Economic and market;
•	 RD capabilities;
•	 Socio-cultural.
Within each of the fields, many factors can be identified that work either as a
driver or barrier – or are neutral. The following provides a shortened example
from a larger exercise, followed by a longer checklist you may use for inspiration.
Always identify and add factors to help explain your particular focus.
The added value of the broad checklist is that it includes items not necessarily
at the primary focus for each individual. However, when experts are asked to
think more broadly – guiding them for example with a written list – it may
provide a rich and inspiring discussion with useful but counter-intuitive findings.
15
Table 1. Regulation, drivers and barriers in the UK
FActor Driver BArrier
Economic and market factors
Current industry structure + competition stimulates
innovation and cost
reduction.
--- most product design
is globally oriented,
while recycling (WEEE)
regulation is national
Pricing + markets for most of
the recovered materials
--- prices are often too
low and volatile, do
not provide incentive
to collect other
material than ferrous
metals
Market demand + market demand for
most raw materials
+ increasing attention/
value given to rare
earth metals/minerals
--- most of the supply
chains are not
oriented towards
recovered materials
such as plastics
Consumer market
demand
+ growing awareness
for energy use of
appliances
-- no real consumer ‘pull’
for resource efficient
products or ‘product-
as-a-service’ concepts’
International
competiveness
--- Recovery market is
competing with low-
labour disassembly in
non-EU countries
Example
Analysis of the drivers and barriers of the WEEE regulation and its revision in
the UK in 2013 on its role for recovery of raw materials, revealed economic and
market factors are the dominant barriers. These would need to change in order
to turn them into drivers.

16
Pricing
Current market demand
Current industry structure
Market power of competing products
/ substitution potential of these
products
Lack of transparency
Industrialisation
Deindustrialisation
Facility of transportation
Technological challenges
(use and integration of spillover)
Enabling infrastructures
Table 2. List of drivers and barriers (non-exhaustive)
Governance structures
(e.g., monopolies, ownership
structures…)
Multi-stakeholders approach
in governance
Coherence with other existing
regulation
Risk assessment approach for
harmonized EU regulation
National/international (demand-side)
policies:
• Innovation procurement
• Regulation
• Standardisation
• Demonstration projects
• Prototyping
• Tax incentives
• Labeling
• Information campaigns
Competition law (incl. State Aid rules)
Trade agreements
Dedicated sectoral (supply-side)
policies
Policy, regulation,
governance factors
Economic and
market factors

17
Own financial resources (High/Low)
Access to finance (Good/poor)
Current industry structure
Innovation costs (High/low)
Qualified internal technological skills
(good availability/shortage)
Skills related to innovation
management
(good availability/shortage)
Abilities to spot market opportunities –
lack of information on markets
(EU and global) (good /lack of ability)
Risk perception
Abilities to test market readiness
(limited/good)
Population (growth/decline)
Ageing of the population
Environmental concerns
Geopolitics and world conflicts
Quality of life
Personalisation
Table 3. List of drivers and barriers (non-exhaustive)
RD capabilities Socio-cultural

18

19

Step Four – Screening
the regulatory landscape
Regulations can come from drivers fields and they differ by type and effect.
While they impact innovations, they are rarely designed for inducing innovation.
Regulations are broadly categorised under economic, social, and institutional
objectives. Environmental protection, for example, is classified under social
objectives. This type of regulation can stimulate new products and processes by
requiring high technical standards not met by currently existing products. They
can however limit RD budgets since compliance costs with the regulation may
be very high.
You may want to use a coherent scheme that may equally broaden the
perspective and may help characterise the regulation in terms of negative or
positive effects you address in the screening.
Finally, most regulation comes in packages. It is rarely a single law that shapes
the issue but sub-laws, standards, tax regimes, etc. can equally be mentioned.
Similar to the drivers and barriers identification exercise in Step 3, the screening
of the regulation will help you identifying the relevant set of regulations and
other types of policy measures that may be under scrutiny for change.
To do’s
Check: into what type of regulation
yours is falling?
•	 Use the type of regulation effects list as guidance for classifying your
regulation.
Can you identify other relevant regulation?
•	 For identifying other relevant regulation, your group and external experts
may be of help. Also, the drivers and barriers exercise (step 3) may have
already identified other relevant regulation.
20

how to do
Types of regulations and their effects can be manifold. The classification
following Blind (2010) is one possibility to identify positive or negative effects.
Since you may have come across related regulation during the scoping process
already, you can classify those as well – and see if there is potential conflict
between the types and their effects.
21
Table 4. Classification by type of regulations
and their effects
Economic
Competition Increases incentive to
invest in innovation
Reduces rents for
innovators
Reduces RD co-operation
Antitrust Competitive pressure by
market entrants
Merger  Acquisitions Restrictions protect
management from short
term market pressure
MA restrictions limit
takeover pressure and
innovation incentives
Market entry Can protect infant
industries
Restricts market entry of
(innovative) newcomers
Price regulation Minimum prices decrease
risk
Price caps reduce
innovation incentive
Natural monopolies/
public enterprises
Stability allows for long
time-horizons
Monopoly results in low
incentives
Social
Environmental
protection
Creates incentive
for new eco-friendly
products and processes
by creating temporary
market barriers (Porter
Hypothesis)
Compliance costs limit
RD budget
Workers health and
safety protection
Creates incentive to
develop new processes
with higher work safety
Compliance costs limit
RD budget
Product and
consumer safety
Increases acceptance/
demand for new products
among consumers
Compliance costs limit
RD budget
Type of
regulation
positive
effects
Negative
effects

22
Institutional
Liability Increases acceptance
and diffusion among
consumers
Too high liability reduces
incentives to develop new
products
Employment protection
legislation
Job security Higher adjustment costs
Immigration More competitive/flexible
job market
Integration costs
Bankruptcy Increased confidence
of creditors to invest in
innovation
Restriction to acquire
external funds for risky
investments
Intellectual property
rights
Additional incentives
to invest in RD due to
monopoly rights
Restricts development
and diffusion of new
technologies
Source: Blind (2010)
Type of
regulation
positive
effects
Negative
effects

23

Step Five – Analysing
the linkages
A clear taxonomy determining the direct and indirect innovation effects of a
given regulation does not exist. Similarly, we have no clear or complete view on
how regulations affect innovation processes. An analysis of the links between
regulation and innovation should therefore be approached in a pragmatic way.
While the screening methodology so far has relied on collecting information and
by using different schemes to structure points of the analysis, it is time to bring
the pieces together.
Coming back to the starting point to screen regulation for its innovation impacts,
we want to link the information obtained from using data as well as experts’
opinions.
Depending on your ultimate goal, you may want not only to know if a specific
regulation is impacting innovation but also how and in which context. There is
scant evidence that regulation has only negative impacts. More often, some
will feel negatively impacted while others may benefit. This can be the case
between industry sectors but a trade-off may equally happen between different
stakeholders. A regulation that may hamper the economic short-term benefit of
firms may yield high social benefits and possibly in the longer run also positive
ones for firms.
To do’s
Summarise the insights gained…
•	 and the data you collected. You may have already identified hampering or
fostering effects of regulation during the screening process;
•	 synthesise the results stemming from the discussions with various internal
and external experts. They may have broadened the scope of the screening
exercise but also helped focus on the key components.
24

Analyse and compare the effects
•	 Once you have brought together the findings, some hampering or fostering
effects of regulation may have become clearer while others may have been
identified at the outset.
Try to link the information over time
•	 Can you identify patterns our strong changes in the data you collected, for
example by comparing countries or indicators?
•	 Does/did the regulation promote large-scale implementation of current
technologies or new innovations? For new innovations, effects may come
with a larger lag than for current technologies.
•	 Have you identified single events that seem probable for explaining changes
in innovation behaviour and innovation outcomes?
Validate with stakeholders
•	 Much of the interpretation of the data and findings benefit from expert
knowledge. It is helpful to check the findings and discuss them with internal
and external experts.
Ideally, you may be able to detect innovation impacts when analysing patent or
trade data and link it to actual events.
Figure 2 links the effects of a safety regulation (REACH) to the innovation
developments for less harmful substances. As a ‘quality regulation’ with
environmental and social impacts, the regulation pushed the search for a safer
material to replace a banned one. The output may be a new, safer product
offering wider societal benefits. The regulation also has a signalling function:
a new market for a safer product will be created. This provides some certainty
about a future demand – and thus a push to invest RD resources into this
direction.
While regulation can directly impact innovation in the sense of new products
and processes, regulation can equally boost existing technologies.
25
Figure 2. Development of phthalates and
non-phthalates patent innovations
following EU regulation
Source: CIEL 2013
numberofpatentedinventions(aspatentfamilies)
1999: Temporary EU
phthalate directive
1972
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
0
5
10
15
20
25
Non-phthalate inventions
Inventions that can uses
phthalates or non-phthalate
2008: 4 phthaltes
added to REACH
Candidate List
2006:
EU REACH
Reg. Adopted
1999: European
Commission
SCTEE opinion and
Recomendation
This may not immediately lead to an increase in innovations, as can be seen
with the developments around the Water Framework Directive (WFD) from the
year 2000. Looking at patent applications at the European Patent Office (EPO)
we see from Figure 3 a rise of EU applications from the early 1990s to 1999.
On average annually the number of patent applications rose by 7.3% (Japan:
13.6%, USA: 3%). While the trend was continuously growing for the EU and
Japan, the USA had its peak in 1995 and declined from then onwards. From
1997-2000 when the WFD was discussed at EU-level, the number of EU patent
applications had a first peak. During the period between the Directive’s adoption
and its transposition into national law by 2003, applications declined. Only after
the transposition, applications rose again until a second peak in 2008.

Figure3.Patentapplicationsofwatergoods,EPO1990-2009
Data:EPO,Calculations:Technopolis
1996199719981997200020012002200320042005200620072008200920102011
ECproposal
WaterFramework
Directive
Transposition
innat.legislation
Financial
crisis
Introduction
pricingpolicies
250000
200000
150000
100000
50000
0
EU27JAPANUSA
27
Effects of the regulation can also be seen in terms of traded goods. The trade
balance increases in water goods in Figure 4 following the WFD seemed largely
to be a diffusion of existing technologies since the two indicators show at first
sight opposite developments with a decrease of patent applications after 2000
– while trade of water goods increased during the same period. The growth
rates immediately after 2000 were nearly the highest during the decade. We
can then assume that the large share of traded goods diffused were mostly
previous innovations.
Regulation effects may not always be measurable with data. In many cases,
stakeholders will only be able to report positive or negative effects from their
experiences.
One example is too strict regulation: the use of high quality water (drinking
water quality) may be the only option for households and industry alike.
However, several water using processes in industry (e.g. chemical industries), do
not require drinking water quality but could reuse water (so-called greywater).
Some examples were identified where industry was not allowed to use greywater,
even if it would have made economic sense and the industry was able to install
a greywater system. Here, it seems that caution from governments prevents
a wider use of greywater. Since water supply conditions and water related
regulation tend to be implemented at local level, existing quality standards may
need revision. In this respect, the ‘fit for purpose’ check is an appropriate tool
even at the lowest, often local, implementation level.

Figure4.Tradebalanceofwatergoods,1996-2011
Data:Comtrade,Calculations:Technopolis
WFD-preandpost
Implementationphase
EU27JAPANUSA
19901991199219931994199519961997199819992000200120022003200320052006200720082009
1200,00
1000,00
800,00
600,00
400,00
200,00
0,00
29

Step Six – Recommendations
Based on the analysis of the innovation system and the interplay of regulation
and innovation obtained via the collection of data and the qualitative
involvement of experts and stakeholders, recommendations may be derived
from the complex analysis phase. Given that in the previous steps the regulation
was tackled in a broader context, it is likely that several ‘construction sites’. i.e.
fields that influence regulation, were identified. These need to be addressed in
order to improve regulation effects on innovation.
Policy-makers should be aware of the various effects. Political decisions,
including those on regulation, need to be increasingly based on evidence. This
holds true for new regulation as well as for those under scrutiny, which may
face an amendment, replacement or abolishment. Each decision will almost
inevitably bring about different incentives and thus also have different innovation
consequences for different stakeholders.
In providing recommendations, it is also necessary to take into consideration
that the possible impact - while being positive for innovation - might have
negative effects in other fields. When it comes to environmental pressures, it
could create rebound effects (e.g., encouraging water or material efficiency can
lead to an increase of company rents, which in turn can be used in a non-
sustainable way). Not only a comprehensive analysis of the expected, direct
and indirect innovation effects should already be included in an ex-ante impact
assessment for new regulation, but their complex analysis is also necessary
when revising regulation.
To do’s
Compare the insights gained
•	 On innovation effects of the regulation, possibly on more than just one
industry.
•	 Given the data collected, discuss how changes in regulation will likely shift
incentives and induce different behaviours.
30

Decide…
•	 Do the necessary amendments of the regulation take into account the
expected innovation effects when changing a particular instrument?
The following Figure 5 provides a recap of the steps, the questions addressed
and the necessary actions.
Figure5.Adecisiontree
Doyouhaveaspecific
sectororindustryin
mindwhereregulation
mayimpact?
Dowehaveanoverview
ontheinnovationsystem,
theregulationissupposed
tohamper?
Identifythrough
collectingdata,
involvingexperts
Doweknowthe
innovationeffects?
Isaninnovation
influencingregulation
identified?
Doweknowif
regulationeffectsare
differentforvarious
actors/stakeholders?
Canweidentifyand
quantifytheeconomic
relevance?
Hastheregulationhad
significantnegativeeffects
ononeormorestakeholder?
Review
legislation
Collectrelevantdata
(revenues,trade,..)
Collectrelevant
data(RD,
patents,…)
Identify;
involvevarious
stakeholders
Canweidentifytheinnova-
tionperformanceofthe
sectors/industries?
IdentifyDoweidentifyall
relevantactorsand
stakeholders?
Identify;
engagewith
experts
Doweknowdirect/
indirectdrivers
andbarriers?
Canweidentifythe
linksbetweenregulation
andinnovation?
Exit
Exit
Colorcoding:
NO
YES
input
action
exit
32
Further reading
Blind, K. (2012): The impact of regulation on innovation. Manchester Institute of
Innovation Research.
CIEL (2013): Driving innovation. How stronger laws help bring safer chemicals
to market. Report by B. Tuncak. http://www.ciel.org/Publications/Innovation_
Chemical_Feb2013.pdf
Eco-innovation Observatory (2011): Water innovation. http://www.eco-
innovation.eu/index.php?option=com_contentview=articleid=284%3Awater-
innovationcatid=79%3Athematic-reportsItemid=212
Hekkert, M.; Suurs, R.; Negro, S.; Kuhlmann, S.; Smits R. (2007). Functions of
innovation systems: A new approach for analysing technological change,
Technological Forecasting and Social Change 74(4): 413-432.
Horbach J.; Rammer, C., Rennings, K. (2012) Determinants of eco-innovations
by type of environmental impact — The role of regulatory push/pull, technology
push and market pull, Ecological Economics, Volume 78, June 2012, Pages 112-
122.
Massarutto, A., and Ermano P. (2013): “Drowned in an Inch of Water: How Poor
Regulation Has Weakened the Italian Water Reform.” Water Utility Regulation in
Developed Countries 24 (0) (March), pp 20–31.
UBA (2008): Instrumente zur Förderung von Umweltinnovationen,
Bestandsaufnahme, Bewertung und Defizitanalyse. Studie durchgeführt von
ZEW und FU Berlin, Forschungsstelle für Umweltpolitik. UBA Schriftenreihe
Umwelt, Innovation, Beschäftigung 02/08
This guide is based on the full study report, ‘Screening of
regulatory framework’, commissioned by DG-RTD and provided
by Technopolis Consulting Group. The report can be downloaded
from http://www.europa.eu/research/innovationunion/index_
en.cfm?pg=other-studies
HOW TO OBTAIN EU PUBLICATIONS
Free publications:
•	 one copy:
via EU Bookshop (http://bookshop.europa.eu);
•	 more than one copy or posters/maps:
from the European Union’s representations (http://ec.europa.eu/represent_en.htm);
from the delegations in non-EU countries (http://eeas.europa.eu/delegations/index_en.htm);
by contacting the Europe Direct service (http://europa.eu/europedirect/index_en.htm) or
calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) (*).
(*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you).
Priced publications:
•	 via EU Bookshop (http://bookshop.europa.eu).
Priced subscriptions
•	 via one of the sales agents of the Publications Office of the European Union
(http://publications.europa.eu/others/agents/index_en.htm).
The regulatory environment is an important
factor influencing the innovation activities of
companies and the wider economic system
within which they operate. A methodology for
assessing the impact of regulation on innovation
was developed and applied to two sectors:
Water and Raw Materials. Implementing one
of the commitments of the Innovation Union,
this methodology can now be used to screen
the innovation impacts of existing regulatory
frameworks in different areas with a view
to identifying their effectiveness as catalysts
of innovative behaviours. This short guide
provides a practical step-by-step approach
on how to go about in implementing
the methodology in any area.
KI-01-13-849-EN-N
doi:10.2777/52771

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RegulatoryScreening_short_guide

  • 1. A short guide on the innovation effects of regulation Research and Innovation Regulatory screening
  • 2. EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B – Innovation Union and European Research Area Unit B1 – Innovation Union Policy Contact: Peter Dröll E-mail: Peter.Droell@ec.europa.eu  RTD-PUBLICATIONS@ec.europa.eu European Commission B-1049 Brussels
  • 3. EUROPEAN COMMISSION Directorate-General for Research and Innovation2014 Regulatory screening A short guide on the innovation effects of regulation Viola Peter Geert van der Veen Asel Doranova Technopolis Group
  • 4. EUROPE DIRECT is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed LEGAL NOTICE This document has been prepared for the European Commission however it reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found at the end of this publication. Luxembourg: Publications Office of the European Union, 2014 ISBN 978-92-79-34788-7 doi:10.2777/52771 © European Union, 2014 Reproduction is authorised provided the source is acknowledged. Cover image © peshkova, #55269067, 2014. Source: Fotolia.com.
  • 5. Authors Viola Peter, Geert van der Veen, Asel Doranova - Technopolis Group Acknowledgements This guide is the condensed form of a methodological screening, developed and tested in a project for the European Commission, DG-RTD (Contract: MS (2012) 1055187). It benefited greatly from the learning process within the project, involving several external thematic experts, colleagues and the most constructive feedback from the involved EC services. We would like to acknowledge and thank Leonor Pires and Sivasegaram Manimaaran from DG- RTD for their support and feedback. The full report including many case studies can be downloaded from http:// www.europa.eu/research/innovationunion/index_en.cfm?pg=other-studies
  • 6. 4 Innovation and regulation… what is it about ? Innovation creates jobs, drives growth and improves the quality of goods and services. The role of innovation in economic growth has been acknowledged widely in academia and policy – no wonder it is central in the EU policies for smart, sustainable and inclusive growth. It plays an important role in tackling major societal challenges like climate change, ageing, energy and resource scarcities. Innovation is the outcome of the interplay of various actors such as businesses, research organisations or financial institutes. Each is embedded in a complex system framed by ambitions, regulations and a number of other drivers. Typical barriers to innovation include both cultural norms and market conditions. In some cases innovation can be hampered by excessive or outdated regulation; at other times regulation may actually be a driver of innovation. In fact, we have seen an example of the latter in the case of environmental regulation where some European countries have a competitive, innovative edge largely due to early and strict regulation. The negative side, regulation acting as a barrier, is also possible. Regulation effects on innovation are not uniform. Industries will also encounter different compliance cost levels along the way, and may therefore respond differently to regulation over time. The smart regulation approach of the European Commission aims to address the innovation effects of new regulatory proposals in its impact assessments, with active stakeholder involvement and input. But it is also important to check if existing regulation is still ‘fit for purpose’, including a check on its effects on innovation. For this purpose the Commission carries out evaluations of its existing regulatory framework, including cross-cutting REFIT-evaluations in which this ‘fitness for purpose’ is thoroughly checked. In these exercises guidance will be needed to address the innovation effects of regulation. While the effects of regulation show up at micro level, i.e., industries, firms, and consumers, ‘fit for purpose’ checks have a high relevance at national level where the often-complex innovation systems absorb EC directives in various ways. Often a fine-tuning of implementation modes may be necessary to trigger positive effects.
  • 7. 5 However, in order to find out the necessary tools, a screening exercise may be necessary. What is meant by regulation? Regulation comes down to ‘the rules of the game’: some regulations, such as market entry regulations of price, quality, or conditional entry, are set by governments. The OECD defines regulation quite usefully as “the diverse set of instruments by which governments set requirements on enterprises and citizens. Regulations include laws, formal and informal orders and subordinate rules issued by all levels of government, and rules issued by non-governmental or self-regulatory bodies to whom governments have delegated regulatory powers.” (OECD, 1997) Much of the negative connotations surrounding regulation and its effects on innovation is likely due to the fact that innovation is rarely a clear objective of a regulation. Rather, regulation is mostly concerned with quality and safety issues – or at least that is the perception. Environmental concerns have gained considerable regulatory traction, but innovation is frequently not put in the same category. The growing interest and notion of wanted/unwanted effects of regulation on innovation need a dedicated approach to better identify, analyse, address and plan innovation regulation effects. Who is addressed? Policy makers at EC as well as national level are already well aware of the need to maximise benefits and reduce costs, including regulatory burdens. In this respect, procedures and methods are already highly advanced at EC-level, where impact assessments are common for new regulation, and more fitness checks and evaluations are being carried out on existing regulation. This guide aims to complement this and to provide tools to support a specific aspect in the regulatory screening, i.e. to see if the regulation is stimulating or hindering innovation. At country level, systematic analyses of existing regulation are less prevalent, and especially given the complexity and vast quantity of regulations in each country, this is understandable. However, national policy makers have a strong interest in
  • 8. 6 shaping key regulations affecting innovation in their countries in a desired way. A better and complete understanding of regulation effects are therefore necessary prerequisites. This short guide aims to provide a step-wise approach for addressing this complex issue and to provide tools and tips for organising the screening systematically. Three pillars… and six Steps Analysing regulatory effects needs to take place in a broad context. So far, regulation and innovation meet in practice, but they seem to be worlds apart. Therefore, the analysis starts with a better understanding of the two pillars: • regulation – and what are the effects of regulation on innovation, and • innovation – and what are the functions of a regulation for innovation. The third pillar is a crucial, linking one. It is important to include the positions and views of a wide range of • stakeholders, particularly those who are directly, and possibly indirectly, affected. Stakeholders have a view when and where regulation hampers or fosters innovation. They may be useful to help point out a number of underlying explanations, drivers and barriers. An overview of the system and its components is presented in Figure 1. Bringing onboard and consulting with stakeholders is a great opportunity to collect a heterogeneous set of information which otherwise may not be mentioned by the ‘core’ affected companies. There are six steps helpful steps to help analyse the regulation-innovation complex and form the basis for policy recommendations or rethinking regulatory set-ups. The individual steps have a core objective, but it may be more useful to combine some steps. Steps 2, 3, and 4 are treated separately, yet they are interrelated and add to the overall ‘explanatory power’ of the screening exercise.
  • 9. 7 Each step may require a considerably longer or shorter amount of time or require different levels of knowledge. Some suggestions may not need to be followed at all. The approach is designed to be flexible since each analysis needs a slightly different approach. The steps Step 1 – Identification Step 2 – Scoping Step 3 – Drivers and Barriers Step 4 – Regulatory landscape Step 5 – Linking regulation and innovation Step 6 – Recap and action The next pages guide you through these steps, their role and what can be done.
  • 10. Figure1.Frameworkforasystemanalysis Regulatory framework ➔typologies (legal, objective) InnovationprocessesandoutputsSocio economic impacts ➔Economic ➔Social ➔Environmental ➔Technological Widerframeworkconditions:Innovationdriversandbarriers Widerregulatoryandpolicyframework;marketconditions;nanceandcapitalmarkets;institutionalandculturalaspectsetc) Policy objectives (levelofambition) ➔screenkeyobjectives fortheareaunder scrunityrelevantfor innovation(=change) ➔assessexternal coherence(policy rationalebehind variousregulations maybediverse) ➔enquire„hierachy”of ojectives ➔currentand expectedregulations (regulationsinthe „pipeline”) INDIRECT IMPACT! IMPACT! DIRECT INDIRECT IMPACT! Source:Technopolis RI activities ➔Innovation activity, incl.RD ➔Innovation collaboration ➔Business activities relevantfor innovation RI outputs/ results ➔Products ➔Procesess ➔Services ➔New buisness models WIDER IMPACTS! RI comer- tialisation ➔Implemen- tation ➔Diffusion RIoutputs/results Perspectivesofinnovationsystemactors, notablycompanies(sectoralperspectives)
  • 11. 9  Step one – identify your area You may already have a concrete example in mind where innovation is hampered or fostered by regulation. Maybe an industry association has complained about how badly a certain excessive tax affects RD spending and warned that the “introduction of plant-specific targets for carbon reductions” will impact their employment levels. Is this a sound complaint? Before a new piece of legislation is drafted or an existing one revised it might be worth analysing in greater detail business communities’ perceived injustices. In other cases, policy-makers or regulators may want to learn from other examples: What makes Germany a leader in selling environmental goods – in spite of or because of high regulation levels? Why does Italy has a waste problem? Could it be solved with regulation and innovation? To do’s Initiate a discussion… • within your organisation. This may be a regional agency or government, or a ministry. The idea is to brainstorm on the topic: can you identify a single regulation that impacts innovation in a specific industry or across multiple industries? Set up a small team… • possibly of experts who know about the regulations in place, the business communities’ views and the views of consumers. • Decide on the point of departure, such as: ̪̪ boundaries; e.g., do you want to analyse effects on a specific or several industries? ̪̪ type of regulation: do you aim to analyse the implementation of an EC directive, a national law, or a standard? ̪̪ regulatory agent or level: e.g., by looking at regional, national or supra-national level.
  • 12. 10  Enlarge your team… You may soon meet the limits of an internal team. Try to identify colleagues in other departments or ministries that may equally have a say concerning the regulation, or who are concerned with other sectors or areas such as procurement, employment, or other seemingly remote areas. Plan ahead… You may have the internal resources and capacities to organise the screening, or you may want to involve external experts. Whatever you chose, make sure you designate colleagues to follow, provide feedback and report back. These colleagues will be the interface between the analysis and subsequent actions.
  • 13. 11  Step two – Start scoping your area What is scoping? Scoping is a systematic exercise that aims to identify and collect information that is then used for further analysis. It addresses questions such as: • What are the main innovation needs? • Who are the main actors involved? • Is there available data supporting the analysis? The level of detail in the information that can be collected will vary highly. For an analysis that starts with a specific regulation, a more narrow focus may be sufficient in order to identify the range of affected actors. The more complex the subject matter is, the broader the scoping exercise may become and the more difficult it may be to isolate regulatory effects. To do’s Indentify the relevant actors • You may know best about the industries that are vocal in their disapproval, but there may be other groups: other businesses, end-users, public bodies or NGOs. Identifying a broader set of actors enhances not only their chances of being heard in your workshops or via interviews, but you may identify thus broader, indirect and unintended effects on other stakeholders. Check the social importance of the chosen area • Is the sector/industry relevant for a small group or does it have it a wider role within society? Try to obtain qualitative information from external people. Check the economic importance of the area The scoping area may already be important or it may be a political goal to gain
  • 14. 12  leadership. Common knowledge may indicate the area’s importance, but it’s necessary to check data such as productivity, employment, final consumption expenditure or RD data such as expenditure or the number of human resources. Important innovation indicators can be built around patent and trade data, for example. Use time series and comparative, international data. Isolated data of a given year is not very revealing. Through a descriptive analysis over time (around 5-10 years) and/or a comparison to international competitors, patterns can be observed and possible outliers identified. In some instances, outliers are the starting year(s) for a new trend that may tentatively be linked to important structural changes. Discuss and analyse the first findings • Once you have accumulated the information, include it in a document (‘a scoping paper’) which can serve as basis for discussion and further analysis. This paper may grow during the course of the process and it may be revised to reflect the information collected, analysed and validated. • Analyse the findings and identified some names within your internal group; you may also want to discuss it with external experts. How to do ➔ Data can be found at national statistical offices as well as Eurostat or the OECD. Patent searches can be done from espacenet, a service of the European Patent Office. • interviews with external experts are useful in the first phase of the screening, particularly if you have been relying only on internal knowledge. • a small workshop with experts and your team is useful to compliment and validate your findings. It is also an opportunity to obtain new ideas and views you may not have had before. • Make sure you are not only discussing with the ‘usual suspects’ but try to bring in diversity of thoughts and opinions.
  • 15. 13  Step three – Identification of drivers and barriers Regulation has intended and unintended, direct and indirect effects on innovation. This step provides two analytical tools which can help structure the full analysis and identify framework conditions that influence innovation either directly or indirectly via regulation. When you have already identified your area, the main actors and gathered quantitative and qualitative information, you may characterise the innovation impacted by the regulation more clearly. It will help to classify the innovation effects – namely, when and to whom they occur in the innovation process. Policy-makers may want to rectify the regulatory situation. This requires a holistic approach which can be done by identifying drivers and barriers. Innovation is not only affected by regulation such as a direct law; there are other areas, possibly equally influences by regulation, and perhaps equally important. This step provides another piece of analysis useful in the assessment of the regulation and its effects on innovation. To do’s Check: what type(s) of innovation are you dealing with? • Regulation may impact products, processes, marketing or organisational innovations. They may be incremental or disruptive. You can differentiate by looking at the functions of innovation, such as knowledge creation, knowledge diffusion, or market formation etc. Which type(s) do apply in your case? Identify drivers and barriers A given regulation may seem to be the focus of attention, but given that the regulation does not function in isolation, it is useful to analyse the broader context and how that one may influence the regulation in its innovation impacts.
  • 16. 14  • Use a broad →check-list of possible drivers and barriers. You may not have envisaged remote factors that may be influential and having explanatory power. • Experts may at that point be even more valuable. You may envisage to discuss drivers and barriers with the external experts in a workshop. how to do A checklist of drivers and barriers can be very broad. We suggest looking at four fields: • Policy, regulation, governance; • Economic and market; • RD capabilities; • Socio-cultural. Within each of the fields, many factors can be identified that work either as a driver or barrier – or are neutral. The following provides a shortened example from a larger exercise, followed by a longer checklist you may use for inspiration. Always identify and add factors to help explain your particular focus. The added value of the broad checklist is that it includes items not necessarily at the primary focus for each individual. However, when experts are asked to think more broadly – guiding them for example with a written list – it may provide a rich and inspiring discussion with useful but counter-intuitive findings.
  • 17. 15 Table 1. Regulation, drivers and barriers in the UK FActor Driver BArrier Economic and market factors Current industry structure + competition stimulates innovation and cost reduction. --- most product design is globally oriented, while recycling (WEEE) regulation is national Pricing + markets for most of the recovered materials --- prices are often too low and volatile, do not provide incentive to collect other material than ferrous metals Market demand + market demand for most raw materials + increasing attention/ value given to rare earth metals/minerals --- most of the supply chains are not oriented towards recovered materials such as plastics Consumer market demand + growing awareness for energy use of appliances -- no real consumer ‘pull’ for resource efficient products or ‘product- as-a-service’ concepts’ International competiveness --- Recovery market is competing with low- labour disassembly in non-EU countries Example Analysis of the drivers and barriers of the WEEE regulation and its revision in the UK in 2013 on its role for recovery of raw materials, revealed economic and market factors are the dominant barriers. These would need to change in order to turn them into drivers. 
  • 18. 16 Pricing Current market demand Current industry structure Market power of competing products / substitution potential of these products Lack of transparency Industrialisation Deindustrialisation Facility of transportation Technological challenges (use and integration of spillover) Enabling infrastructures Table 2. List of drivers and barriers (non-exhaustive) Governance structures (e.g., monopolies, ownership structures…) Multi-stakeholders approach in governance Coherence with other existing regulation Risk assessment approach for harmonized EU regulation National/international (demand-side) policies: • Innovation procurement • Regulation • Standardisation • Demonstration projects • Prototyping • Tax incentives • Labeling • Information campaigns Competition law (incl. State Aid rules) Trade agreements Dedicated sectoral (supply-side) policies Policy, regulation, governance factors Economic and market factors 
  • 19. 17 Own financial resources (High/Low) Access to finance (Good/poor) Current industry structure Innovation costs (High/low) Qualified internal technological skills (good availability/shortage) Skills related to innovation management (good availability/shortage) Abilities to spot market opportunities – lack of information on markets (EU and global) (good /lack of ability) Risk perception Abilities to test market readiness (limited/good) Population (growth/decline) Ageing of the population Environmental concerns Geopolitics and world conflicts Quality of life Personalisation Table 3. List of drivers and barriers (non-exhaustive) RD capabilities Socio-cultural 
  • 21. 19  Step Four – Screening the regulatory landscape Regulations can come from drivers fields and they differ by type and effect. While they impact innovations, they are rarely designed for inducing innovation. Regulations are broadly categorised under economic, social, and institutional objectives. Environmental protection, for example, is classified under social objectives. This type of regulation can stimulate new products and processes by requiring high technical standards not met by currently existing products. They can however limit RD budgets since compliance costs with the regulation may be very high. You may want to use a coherent scheme that may equally broaden the perspective and may help characterise the regulation in terms of negative or positive effects you address in the screening. Finally, most regulation comes in packages. It is rarely a single law that shapes the issue but sub-laws, standards, tax regimes, etc. can equally be mentioned. Similar to the drivers and barriers identification exercise in Step 3, the screening of the regulation will help you identifying the relevant set of regulations and other types of policy measures that may be under scrutiny for change. To do’s Check: into what type of regulation yours is falling? • Use the type of regulation effects list as guidance for classifying your regulation. Can you identify other relevant regulation? • For identifying other relevant regulation, your group and external experts may be of help. Also, the drivers and barriers exercise (step 3) may have already identified other relevant regulation.
  • 22. 20  how to do Types of regulations and their effects can be manifold. The classification following Blind (2010) is one possibility to identify positive or negative effects. Since you may have come across related regulation during the scoping process already, you can classify those as well – and see if there is potential conflict between the types and their effects.
  • 23. 21 Table 4. Classification by type of regulations and their effects Economic Competition Increases incentive to invest in innovation Reduces rents for innovators Reduces RD co-operation Antitrust Competitive pressure by market entrants Merger Acquisitions Restrictions protect management from short term market pressure MA restrictions limit takeover pressure and innovation incentives Market entry Can protect infant industries Restricts market entry of (innovative) newcomers Price regulation Minimum prices decrease risk Price caps reduce innovation incentive Natural monopolies/ public enterprises Stability allows for long time-horizons Monopoly results in low incentives Social Environmental protection Creates incentive for new eco-friendly products and processes by creating temporary market barriers (Porter Hypothesis) Compliance costs limit RD budget Workers health and safety protection Creates incentive to develop new processes with higher work safety Compliance costs limit RD budget Product and consumer safety Increases acceptance/ demand for new products among consumers Compliance costs limit RD budget Type of regulation positive effects Negative effects 
  • 24. 22 Institutional Liability Increases acceptance and diffusion among consumers Too high liability reduces incentives to develop new products Employment protection legislation Job security Higher adjustment costs Immigration More competitive/flexible job market Integration costs Bankruptcy Increased confidence of creditors to invest in innovation Restriction to acquire external funds for risky investments Intellectual property rights Additional incentives to invest in RD due to monopoly rights Restricts development and diffusion of new technologies Source: Blind (2010) Type of regulation positive effects Negative effects 
  • 25. 23  Step Five – Analysing the linkages A clear taxonomy determining the direct and indirect innovation effects of a given regulation does not exist. Similarly, we have no clear or complete view on how regulations affect innovation processes. An analysis of the links between regulation and innovation should therefore be approached in a pragmatic way. While the screening methodology so far has relied on collecting information and by using different schemes to structure points of the analysis, it is time to bring the pieces together. Coming back to the starting point to screen regulation for its innovation impacts, we want to link the information obtained from using data as well as experts’ opinions. Depending on your ultimate goal, you may want not only to know if a specific regulation is impacting innovation but also how and in which context. There is scant evidence that regulation has only negative impacts. More often, some will feel negatively impacted while others may benefit. This can be the case between industry sectors but a trade-off may equally happen between different stakeholders. A regulation that may hamper the economic short-term benefit of firms may yield high social benefits and possibly in the longer run also positive ones for firms. To do’s Summarise the insights gained… • and the data you collected. You may have already identified hampering or fostering effects of regulation during the screening process; • synthesise the results stemming from the discussions with various internal and external experts. They may have broadened the scope of the screening exercise but also helped focus on the key components.
  • 26. 24  Analyse and compare the effects • Once you have brought together the findings, some hampering or fostering effects of regulation may have become clearer while others may have been identified at the outset. Try to link the information over time • Can you identify patterns our strong changes in the data you collected, for example by comparing countries or indicators? • Does/did the regulation promote large-scale implementation of current technologies or new innovations? For new innovations, effects may come with a larger lag than for current technologies. • Have you identified single events that seem probable for explaining changes in innovation behaviour and innovation outcomes? Validate with stakeholders • Much of the interpretation of the data and findings benefit from expert knowledge. It is helpful to check the findings and discuss them with internal and external experts. Ideally, you may be able to detect innovation impacts when analysing patent or trade data and link it to actual events. Figure 2 links the effects of a safety regulation (REACH) to the innovation developments for less harmful substances. As a ‘quality regulation’ with environmental and social impacts, the regulation pushed the search for a safer material to replace a banned one. The output may be a new, safer product offering wider societal benefits. The regulation also has a signalling function: a new market for a safer product will be created. This provides some certainty about a future demand – and thus a push to invest RD resources into this direction. While regulation can directly impact innovation in the sense of new products and processes, regulation can equally boost existing technologies.
  • 27. 25 Figure 2. Development of phthalates and non-phthalates patent innovations following EU regulation Source: CIEL 2013 numberofpatentedinventions(aspatentfamilies) 1999: Temporary EU phthalate directive 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 0 5 10 15 20 25 Non-phthalate inventions Inventions that can uses phthalates or non-phthalate 2008: 4 phthaltes added to REACH Candidate List 2006: EU REACH Reg. Adopted 1999: European Commission SCTEE opinion and Recomendation This may not immediately lead to an increase in innovations, as can be seen with the developments around the Water Framework Directive (WFD) from the year 2000. Looking at patent applications at the European Patent Office (EPO) we see from Figure 3 a rise of EU applications from the early 1990s to 1999. On average annually the number of patent applications rose by 7.3% (Japan: 13.6%, USA: 3%). While the trend was continuously growing for the EU and Japan, the USA had its peak in 1995 and declined from then onwards. From 1997-2000 when the WFD was discussed at EU-level, the number of EU patent applications had a first peak. During the period between the Directive’s adoption and its transposition into national law by 2003, applications declined. Only after the transposition, applications rose again until a second peak in 2008. 
  • 29. 27 Effects of the regulation can also be seen in terms of traded goods. The trade balance increases in water goods in Figure 4 following the WFD seemed largely to be a diffusion of existing technologies since the two indicators show at first sight opposite developments with a decrease of patent applications after 2000 – while trade of water goods increased during the same period. The growth rates immediately after 2000 were nearly the highest during the decade. We can then assume that the large share of traded goods diffused were mostly previous innovations. Regulation effects may not always be measurable with data. In many cases, stakeholders will only be able to report positive or negative effects from their experiences. One example is too strict regulation: the use of high quality water (drinking water quality) may be the only option for households and industry alike. However, several water using processes in industry (e.g. chemical industries), do not require drinking water quality but could reuse water (so-called greywater). Some examples were identified where industry was not allowed to use greywater, even if it would have made economic sense and the industry was able to install a greywater system. Here, it seems that caution from governments prevents a wider use of greywater. Since water supply conditions and water related regulation tend to be implemented at local level, existing quality standards may need revision. In this respect, the ‘fit for purpose’ check is an appropriate tool even at the lowest, often local, implementation level. 
  • 31. 29  Step Six – Recommendations Based on the analysis of the innovation system and the interplay of regulation and innovation obtained via the collection of data and the qualitative involvement of experts and stakeholders, recommendations may be derived from the complex analysis phase. Given that in the previous steps the regulation was tackled in a broader context, it is likely that several ‘construction sites’. i.e. fields that influence regulation, were identified. These need to be addressed in order to improve regulation effects on innovation. Policy-makers should be aware of the various effects. Political decisions, including those on regulation, need to be increasingly based on evidence. This holds true for new regulation as well as for those under scrutiny, which may face an amendment, replacement or abolishment. Each decision will almost inevitably bring about different incentives and thus also have different innovation consequences for different stakeholders. In providing recommendations, it is also necessary to take into consideration that the possible impact - while being positive for innovation - might have negative effects in other fields. When it comes to environmental pressures, it could create rebound effects (e.g., encouraging water or material efficiency can lead to an increase of company rents, which in turn can be used in a non- sustainable way). Not only a comprehensive analysis of the expected, direct and indirect innovation effects should already be included in an ex-ante impact assessment for new regulation, but their complex analysis is also necessary when revising regulation. To do’s Compare the insights gained • On innovation effects of the regulation, possibly on more than just one industry. • Given the data collected, discuss how changes in regulation will likely shift incentives and induce different behaviours.
  • 32. 30  Decide… • Do the necessary amendments of the regulation take into account the expected innovation effects when changing a particular instrument? The following Figure 5 provides a recap of the steps, the questions addressed and the necessary actions.
  • 33. Figure5.Adecisiontree Doyouhaveaspecific sectororindustryin mindwhereregulation mayimpact? Dowehaveanoverview ontheinnovationsystem, theregulationissupposed tohamper? Identifythrough collectingdata, involvingexperts Doweknowthe innovationeffects? Isaninnovation influencingregulation identified? Doweknowif regulationeffectsare differentforvarious actors/stakeholders? Canweidentifyand quantifytheeconomic relevance? Hastheregulationhad significantnegativeeffects ononeormorestakeholder? Review legislation Collectrelevantdata (revenues,trade,..) Collectrelevant data(RD, patents,…) Identify; involvevarious stakeholders Canweidentifytheinnova- tionperformanceofthe sectors/industries? IdentifyDoweidentifyall relevantactorsand stakeholders? Identify; engagewith experts Doweknowdirect/ indirectdrivers andbarriers? Canweidentifythe linksbetweenregulation andinnovation? Exit Exit Colorcoding: NO YES input action exit
  • 34. 32 Further reading Blind, K. (2012): The impact of regulation on innovation. Manchester Institute of Innovation Research. CIEL (2013): Driving innovation. How stronger laws help bring safer chemicals to market. Report by B. Tuncak. http://www.ciel.org/Publications/Innovation_ Chemical_Feb2013.pdf Eco-innovation Observatory (2011): Water innovation. http://www.eco- innovation.eu/index.php?option=com_contentview=articleid=284%3Awater- innovationcatid=79%3Athematic-reportsItemid=212 Hekkert, M.; Suurs, R.; Negro, S.; Kuhlmann, S.; Smits R. (2007). Functions of innovation systems: A new approach for analysing technological change, Technological Forecasting and Social Change 74(4): 413-432. Horbach J.; Rammer, C., Rennings, K. (2012) Determinants of eco-innovations by type of environmental impact — The role of regulatory push/pull, technology push and market pull, Ecological Economics, Volume 78, June 2012, Pages 112- 122. Massarutto, A., and Ermano P. (2013): “Drowned in an Inch of Water: How Poor Regulation Has Weakened the Italian Water Reform.” Water Utility Regulation in Developed Countries 24 (0) (March), pp 20–31. UBA (2008): Instrumente zur Förderung von Umweltinnovationen, Bestandsaufnahme, Bewertung und Defizitanalyse. Studie durchgeführt von ZEW und FU Berlin, Forschungsstelle für Umweltpolitik. UBA Schriftenreihe Umwelt, Innovation, Beschäftigung 02/08 This guide is based on the full study report, ‘Screening of regulatory framework’, commissioned by DG-RTD and provided by Technopolis Consulting Group. The report can be downloaded from http://www.europa.eu/research/innovationunion/index_ en.cfm?pg=other-studies
  • 35. HOW TO OBTAIN EU PUBLICATIONS Free publications: • one copy: via EU Bookshop (http://bookshop.europa.eu); • more than one copy or posters/maps: from the European Union’s representations (http://ec.europa.eu/represent_en.htm); from the delegations in non-EU countries (http://eeas.europa.eu/delegations/index_en.htm); by contacting the Europe Direct service (http://europa.eu/europedirect/index_en.htm) or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) (*). (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). Priced publications: • via EU Bookshop (http://bookshop.europa.eu). Priced subscriptions • via one of the sales agents of the Publications Office of the European Union (http://publications.europa.eu/others/agents/index_en.htm).
  • 36. The regulatory environment is an important factor influencing the innovation activities of companies and the wider economic system within which they operate. A methodology for assessing the impact of regulation on innovation was developed and applied to two sectors: Water and Raw Materials. Implementing one of the commitments of the Innovation Union, this methodology can now be used to screen the innovation impacts of existing regulatory frameworks in different areas with a view to identifying their effectiveness as catalysts of innovative behaviours. This short guide provides a practical step-by-step approach on how to go about in implementing the methodology in any area. KI-01-13-849-EN-N doi:10.2777/52771