This booklet clearly and visually explains the Better Regulation Package of 2015 (and its Inter-institutional Agreement on Better Law-making signed in April 2016), its impact on the EU decision-making process and what it means for European Public Affairs.

1. 1© Copyright PACT European Affairs
OCTOBER2016
PACT European Affairs - 21, square de Meeûs - B–1050 Brussels - Tel +32 (0)2 230 38 68 - info@pacteurope.eu - www.pacteurope.eu
WHAT DOES IT MEAN
FOR EU PUBLIC AFFAIRS?
The ‘Better Regulation’ package
10 GRAPHS TO HELP YOU UNDERSTAND
and Inter-institutional Agreement

2. 2 © Copyright PACT European Affairs
THE FIVE MAJOR INITIATIVES OF THE‘BETTER REGULATION’PACKAGE
President Jean-Claude Juncker has made ‘Better Regulation’ a flagship initiative of his Commission, emphasising this priority by
granting the portfolio to his First Vice-President Frans Timmermans. The objective: guarantee that EU action is effective, transparent
and inclusive across all stages of the policy cycle – from early conception to implementation and review – and ensure that EU law
does not impose unnecessary administrative burden and red tape on stakeholders.
On 19 May 2015, Frans Timmermans unveiled a package of concrete measures aiming to make ‘Better Regulation’ a reality. The
package consisted of five major initiatives, including a proposal for an Inter-institutional Agreement which, following negotiations
between the Commission, European Parliament and Council, was signed in April 2016.
Inter-institutional Agreement
on Better Law-making
Commission Communication and Decision
setting up a Regulatory Scrutiny Board
BETTER REGULATION PACKAGE
Communication on Better Regulation
Commission Communication and Decision
setting up a REFIT Platform
Better Regulation Guidelines
(incl. on impact assessments) and Toolbox
(over 400 pages!)
SIGNED AND ENTERED INTO
FORCE ON 13 APRIL 2016
ADOPTED BY THE
COMMISSION

3. 3© Copyright PACT European Affairs
CHANGES AT FOUR STAGES IN THE EU DECISION–MAKING PROCESS
The impact of the package on each of these four phases is illustrated in the following pages.
1. Drafting
Impact assessment by
Commission of proposals,
with an extended role for
the Regulatory Scrutiny
Board
Ordinary legislative
procedure:
An appropriate degree of
transparency in trilogues
Delegated and
implementing acts:
Possible impact
assessment, expert groups
confirmed and public
consultation Overall assessment of
effectiveness of legislation:
REFIT actions, the REFIT
Platform and the possible
involvement of the
Regulatory Scrutiny Board
2. Adoption
3. Implementation
4. Ex post
evaluation

4. 4 © Copyright PACT European Affairs
COMMISSION REGULATORY SCRUTINY BOARD–ENHANCED ROLE FOR CIVIL SOCIETY
In operation since 1 July 2015, the RSB’s role is to scrutinise the
quality of and issue opinions on all impact assessments, major
evaluations and fitness-checks carried out by the Commission.
In principle, the Commission services are obliged to re-submit
their impact assessments if the RSB delivers a negative opinion.
However, the Commission can, as a political institution, decide to
move ahead without making changes, although it must publicly
explain its decision.
In 2016, the RSB has so far issued opinions on 34 initiatives.
COMMENTS
The involvement of external experts
Commission can disregard RSB opinion in certain
circumstances
Until now, they have been under-estimated and
under-used. Impact assessments should genuinely
be part of a Public Affairs toolbox.
TIP :
• Map out members of inter-service steering groups
• Closely monitor the impact assessment process
and intervene where necessary
7 MEMBERS
COMMISSION SECRETARIAT GENERAL:
ADMINISTRATIVE SUPPORT
• Chair: Anne Bucher
• Didier Herbert (COM)
• Vassili Lelakis (COM)
• Bernard Naudts (COM)
• Nils Bjoerksten (External)
• Isabelle Schömann (External)
• Third external member TBD
INTER-SERVICE STEERING GROUP
A group comprising officials from the lead Commission DG
and other DGs, allowing the latter to give input into Commission
initiatives such as impact assessments
Ò Quorum: 4 members
(incl. Chair)
Ò Simple majority vote if
no consensus, Chair has
casting vote in case of a tie
Ò Fixed term of 3 years

5. 5© Copyright PACT European Affairs
A PUSH TOWARDS MORE IMPACT ASSESSMENTS(IA)
COMMENTS
• Imbalance between EP and Council
• The ‘onion effect’: layer after layer
after layer will not necessarily make the
decision-making process smoother and
more balanced
• What about timing? A surely lengthier
adoption process.
COMMISSION
REGULATORY
SCRUTINY BOARD
DRAFT
IA
PUBLICATION
OF LEGISLATIVE
PROPOSAL
ADOPTION OF
LEGISLATIVE ACT
IMPLEMENTATION
OF LEGISLATIVE ACT
COUNCIL IMPACT
ASSESSMENT
No IA unit in place yet
Inter-institutional Agreement (IIA) on
Better Law-making gives EP and Council the right to
carry out IAs on substantial amendments…
…but this is not an obligation!
OR
EP IMPACT
ASSESSMENT
“Directorate for
Impact Assessment and
European Added Value”
POSSIBLE IA ON
“SUBSTANTIAL
AMENDMENTS”
IIA on Better
Law-making calls
on COM to do IA on delegated
and implementing acts
with “significant economic,
environmental or social
impacts”

6. 6 © Copyright PACT European Affairs
IMPACT ASSESSMENT STRUCTURE WITHIN THE EUROPEAN PARLIAMENT–SLOWING DOWN THE PROCESS
CURRENT TASKS OF THE
EP IMPACT ASSESSMENT
DIRECTORATE INCLUDE:
• In-house appraisals of Com-
mission Impact Assessments;
• Substitute or complementary
Impact Assessments (where
there is no Commission IA or
the IA is not comprehensive);
• Outsourcing IAs on substantive
amendmentsbeingconsidered
by an EP Committee;
• Routine screening of the road-
maps under Commission’s
Annual Work Programme, to
identify proposals including
IAs.
COMMENTS
• Many MEPs insist that given their
democratically elected role as EU
legislator, they cannot agree to a
reduction of their legislative role
and be forced into doing IAs.
• Joe Dunne, Head of the
EP’s Directorate for Impact
Assessment, believes IAs do not
slow down the legislative process
too much, and time can usually
be found during committee
deliberations. Regarding cost,
outsourcing an IA can range from
€20,000-€40,000.
• Thereiscurrentlygreatuncertainty
about how and when IA will be
performed by the European
Parliament.
WHAT WILL THE COUNCIL DO?
At this point, there is no unit in the Council devoted to impact assessment. A third
of Member States are reportedly in favour of setting up such a unit but so far the
initiative has been resisted.
Ex Ante
Impact
Assessment
Unit
Policy
Performance
Appraisal
Unit
Ex Post
Impact
Assessment
Unit
Directorate for Impact Assessment
and European Added Value
European Parliament
Directorate-General for Parliamentary
Research Services

7. 7© Copyright PACT European Affairs
INFORMAL TRILOGUES–TOWARDS MORE TRANSPARENCY?
It is now a systematic practice for the European Parliament, Council of Ministers and
European Commission to hold informal three-way negotiations (known as “trilogues”),
with the aim of reaching agreements on legislative acts at the first reading stage.
These informal trilogues are always held behind closed doors, the role of stakeholders is
limited and information about the meetings is very rarely made public.
The IIA on Better Law-making addresses this issue as follows: “The three Institutions will
ensure the transparency of legislative procedures, on the basis of the relevant legislation
and case law, including an appropriate handling of trilateral negotiations.”
COMMENTS
• Thephrase“appropriatehandling”
is vague and gives little indication
of what it actually means.
• Will four-column documents be
made public systematically? The
answer is probably ‘no’.
• The Commission is promoting
an even earlier coordination
of activity between the three
Institutions. While certainly
efficient this is again far from
transparent and democratic.
• The EU decision-making system
has the potential to become
transparent, but so far the trend
has been towards a more closed,
opaque system with a now well-
known slide towards ‘‘legislation
lite’’, which in turn leads to more
and more secondary legislation.
European Parliament Council of Ministers
European Commission

8. 8 © Copyright PACT European Affairs
PREPARATION OF DELEGATED ACTS(DA)–MORE TRANSPARENCY DOES NOT MEAN LESS COMPLEXITY
COMMENTS
• Roadmap impact assessment
only when DA has a ‘significant
impact’ = rare
• Increased transparency in Expert
Groups: drafts shared with
members, EP Council can attend
as observers
• 4-week public consultation: late
in the process and illogically takes
placeafterexpertgroupdiscussion
• Exceptions to consultation are
open to interpretation
• Slowing down of the process
• Consultation = ticks the box but
insufficient; direct lobbying will
still be required
Roadmap Agenda
Planning 12 months
before adoption
(if ‘significant impact’)
The new IIA on Better Law-making
calls on the Institutions to negotiate
objective criteria to help delineate
delegated acts from implementing
acts. However, the talks may not
bear much fruit as each Institution
will likely maintain its own legal
interpretation.
Impact
assessment
(if ‘significant
impact’)
4-week
stakeholder
consultation
Expert group given
chance to react
if changes made by
stakeholders
NEW
NEW
Drafted by
Commission
Unit
Expert group
(Member State
experts) consulted
on draft
Delegated act
sent to EP
and Council
for scrutiny
Legislative
act
adopted
Delegated act adopted
via Commission internal
process
No consultation carried out when:
→ No discretion over content
→ Already drafted and submitted for
consultation by another body
→ Urgency procedure

9. 9© Copyright PACT European Affairs
PREPARATION OF IMPLEMENTING ACTS(IA)–UNDERMINING THE FAST-TRACK PROCEDURE?
COMMENTS
• Numerous exceptions to
the need for consultation.
• Slowing down what is
supposed to be a fast-track
process.
• More consultations = more
transparency, but this does
not mean less complexity.
• Consultation = ticks the box
but insufficient as such;
direct lobbying will still be
required.
Roadmap Agenda
Planning 12 months
before adoption
(if significant)
Impact
assessment
(if significant)
4-week stakeholder
consultation for “important”
implementing acts
NEW
Drafted by
Commission
Unit
Possible initial discussion
of draft by comitology
committee
Comitology committee
votes on draft
implementing act
Legislative
act
adopted
Implementing act
adopted
by Commission
No consultation carried out when:
→ Concerns financial management
→ No discretion over content
→ Already drafted and submitted
for consultation by another body
→ Urgency procedure
→ Individual measures
The 4-week consultation tool
demonstrated its value in September
2016 when the Commission was
pressured into withdrawing a draft
implementing act on roaming. After
just 4 days of consultation, 140 negative
comments from the public were
received.

10. 10 © Copyright PACT European Affairs
REGULATORY FITNESS AND PERFORMANCE(REFIT)FOR EX-POST EVALUATION
The Regulatory Fitness and Performance Programme (REFIT) is nothing new and has already been an objective of the Commission
for some years. The goal of the ‘Better Regulation’ package is to strengthen REFIT and make it, in the Commission’s words, “more
targeted, quantitative, inclusive and politically prioritised.” The aim of REFIT is to make sure existing EU legislation is “fit for purpose”,
guaranteeing its effectiveness and efficiency while removing red tape and administrative costs where possible. Concretely, REFIT
manifests itself via a number of possible ex post actions:
e.g. Directive on retrofitting of
mirrors in heavy goods vehicles
e.g. Directive on
misleading advertising
Incorporating
successive
amendments into one
single act,
e.g. trade legislationAssessing relevance,
coherence,
effectiveness and
EU added value of
legislation. Identify
opportunities for
simplification and
reduction burden
e.g. General Food Law
Regulation
Assessing effects of
all EU legislation on
profit margins and
competitiveness in the
internal market
e.g. chemicals and
construction sectors.
Part of normal process
of review after EU
legislation enters into
force e.g. Renewable
Energy Directive
COMMENTS
• REFIT covers a lot of actions
which are – even for
Commission officials – not
always easy to understand
and distinguish.
• The goal is honorable but
the concrete execution
may be overly complicated.
Will it succeed?
REPEALS
SIMPLIFICATIONS
CODIFICATIONS
AND RECASTS
FITNESS
CHECKS
CUMULATIVE
COST
ASSESSMENTS
EVALUATIONS
REFIT
ACTIONS

11. 11© Copyright PACT European Affairs
REFIT PLATFORM:A PERMANENT DIALOGUE FORUM,BUT WILL IT DELIVER RESULTS?
The REFIT Platform was set up in 2015 to provide a permanent forum for dialogue between the Commission, Member States and
stakeholders on how to improve EU legislation in the context of REFIT.
The Platform collects concerns or suggestions from stakeholders (e.g. on cutting red tape) and forwards them to the Commission or
Member State concerned, who will reply explaining what action (if any) they will take to address the concern. The Commission can
also request the REFIT Platform to give information and comments on any planned or current REFIT initiative.
Ad hoc experts may be invited
PLATFORM CHAIR
First Vice-President of the Commission Frans Timmermans
Deputy: Anne Bucher, Chair of the Regulatory Scrutiny Board (RSB)
GOVERNMENT GROUP
Chair: Anne Bucher
28 experts from national
authorities appointed by
Member States (rank: deputy
Director-General from national
ministry).
Full list of members
available here
WORKING
PARTIES
STAKEHOLDER GROUP
Chair: Anne Bucher
Up to 20 experts from
business/SMEs, social
partners, civil society, 1 EESC
expert, 1 CoR expert.
Full list of members
available here
WORKING
PARTIES
COMMENTS
Provides stakeholders
with an additional means
of involvement
Heavy structure which
needs to demonstrate
whether it can deliver
tangible results
Track record so far: the full
REFIT Platform has met twice,
while the Government group
and Stakeholder group have
each met three times.
Overall, it has considered over
100 contributions submitted
to it, producing 17 opinions
with concrete suggestions on
various policy issues.
Ad hoc
experts
may be
invited
Ad hoc
experts
may be
invited
1 annual
joint
meeting
COMMISSION SECRETARIAT-GENERAL:
ADMINISTRATIVE SUPPORT

12. 12 © Copyright PACT European Affairs
• The ‘Better Regulation’ package is an ‘oeuvre’ of more than 700 pages. The motivation for delivering on this objective
is unquestionably noble. However, we must ask whether this package is merely a symbol of simplification and better
regulation: very large, lacking precision, and creating additional bodies in an already complex decision-making process.
• The goal of more stakeholder involvement and transparency seems to be at least partially achieved (e.g. consultation on
delegated acts). However, from a public affairs point of view, this will by no means generate a simpler system. As always,
public affairs practitioners wishing to remain effective will need to integrate these changes into their day-to-day work
and use the opportunities presented.
• One year on, we may say that the package has made improvements to the EU decision-making process, but more needs
to be done.
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Successive delays in the publication of the draft inter-institutional
agreement (IIA) have inevitably led to leaks. With inter-service
consultation underway, the text is being commented on and
validated before its expected submission to the Commission
College on 19 May. Thus, over recent weeks, we have gotten
a flavour of the draft that will be submitted to the European
Parliament (EP) and Council, with final adoption predicted by
Christmas 2015.
Visually speaking, the text is complicated by the fact that there
is not one, but several documents: a number of Commission
communications on Better Regulation, the proposal for a future
IIA with many sections (stakeholder consultations, criteria for
distinguishing delegated and implementing acts, transparency,
etc.) as well as annexes on a ‘Regulatory Scrutiny Board’ and a new
‘REFIT Platform’.
Good intentions, but avoiding the real issues
This package does have some good intentions. Clarifying the
distinction between delegated acts and implementing acts
is positive, as is the goal of making the role of Expert Groups
systematic in consultations on draft delegated acts, as well as
involving the EP more. Also interesting are the proposals to consult
stakeholders and draw up indicative lists of delegated acts planned
to be adopted in the future.
It is better than nothing, but at the end of the day the system
will remain the same, with its complexity, opacity and case-by-
case management. The Regulatory Scrutiny Board (replacing the
Commission’s internal Impact Assessment Board) and the creation
of a REFIT Platform (a forum of Member States and stakeholders
that will assess the regulatory fitness of EU legislation) equally
represent good intentions.
But ultimately they will make the process even more burdensome
and less operational. The Commission is constantly adding extra
layers to a cake that is already very thick. The proposed changes to
impact assessments are notable: every Institution would have its
own framework of impact assessment, overseen by a co-ordinating
inter-institutional body!
Could we have hoped for better?
The Commission is playing things safe, not taking any risks and
avoiding provoking a full-on confrontation with the EP and/or the
Council. But it is also conscious of protecting as much as possible
the prerogatives it obtained under the Treaty of Lisbon. Given how
urgent and acute the problems are, this is a low-risk approach,
lacking in ambition and vision.
Could it be otherwise? In all honesty, no. The Commission is
not capable of remedying defects that are undermining the EU
from within. In particular, successive Treaty reforms have never
addressed the key questions: defining the goal of the EU (federal
system or free trade area?), its boundary (expanding how far?)
and how to simplify it. On these three crucial issues, the result has
been fiasco.
Another on-going source of blockage is the excessive number of
Commissioners, diluting the Commission’s political power and
strengthening its bureaucratic character. With such a College,
regardless of the ability of its members, can we expect anything
more than a lumbering beast, based on the lowest common
denominator and ineffective governance?
The EU legislative agenda is empty
On 22 April, the news agency Euractiv reported that a number of
important health files (e.g. alcohol labelling, endocrine disruptors,
fatty acids) have been delayed due to the multiplication of decision-
makers at the highest level of the Commission, leading to de facto
paralysis. This has been going on for six months now.
Some interest groups might be delighted the Commission has
forgotten about them, but this legislative void, mixed with growing
delays and inefficiency, gives me a deep feeling of anxiety.
DG
EDITORIAL
Draft inter-institutional agreement:
disappointing, but could it be better?
Contents
EP hearing: secondary legislation linked to accountability
and risk of corruption 2
Court of Justice clarifies power of withdrawal 3
Publication date of draft IIA pushed back again 4
New Anti-Money Laundering rules 5
Academic article on information flows in comitology 6
Ecodesign Directive: state of play 7
Report on pharma delegations / Events 8
#15, April 2015www.comitology.eu
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BETTER REGULATION:MORE POWER FOR BUREAUCRATS THAN POLITICIANS?