Regulatory Affairs: What you should know about implementing and delegated acts

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Regulatory Affairs: What you
should know about implementing
and delegated acts

Free Webinar - 22 May 2013 -1-2pm
Please turn up your computer speakers or put on your
headset
You can ask questions in writing in the chat panel
WELCOME to the 3rd FREE
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SPEAKER
David O’Leary:
DirectoratBurson-MarstellerBrussels.HespecialisesintheworkingsoftheEUinstitutionsandinpolicyareassuch
asfood,consumergoodsandICT.
and delegated acts

SPEAKER MODERATOR
David O’Leary András BANETH
DirectoratBurson-MarstellerBrussels.Hespecialises Director–EuropeanTrainingAcademy
intheworkingsoftheEUinstitutionsandinpolicyareas
suchasfood,consumergoodsandICT.
and delegated acts

Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
THE NEW COMITOLOGY:
WHAT YOU SHOULD
KNOW ABOUT
IMPLEMENTING AND
DELEGATED ACTS
David O’Leary //Burson-Marsteller Brussels

Evidence-based communications. Inform. Measure. Monitor. Succeed.
TODAY’S PRESENTATION
Part 1
Comitology basics: what, who, why, when?
Part 2
New comitology
a) Delegated acts
b) Implementing acts
Part 3
Conflicts and controversies
Part 4
Tips for working with the new comitology

PART 1
COMITOLOGY BASICS:
WHAT, WHO, WHY, WHEN?

WHAT IS COMITOLOGY?
• ‘Filling in the gaps’or ‘dealing with details’
• ‘An obscure system for taking important decisions’

WHAT IS COMITOLOGY?
• A way of ‘filling in the gaps’or ‘dealing with details’
• An obscure system for taking big decisions

WHAT IS COMITOLOGY?
Affects a wide range of sectors:

Commission
EP Council
CO-DECISION
PROPOSES LEGISLATION
WHAT IS COMITOLOGY?12to48months

Commission
EP Counil
CO-DECISION
PROPOSES LEGISLATION
WHAT IS COMITOLOGY?
NON-LEGISLATIVE ACTS
(VIA COMITOLOGY)
EP Council
Commission
(+ experts)
12to48months2daystoseveralmonths

BASIC ACT
WHO’S INVOLVED?
COMMISSION ADOPTS
NON-LEGISLATIVE ACT
Consults expert
committees
Commission
proposes
Legislator
(EP & Council)
controls
(scrutiny or
veto)

WHO’S INVOLVED
Around 250 committees of national
experts, chaired by the Commission

WHY COMITOLOGY?
• Speed: faster than co-decision
• Efficient: does not block EP/Council
• Reactive: no need to convene ministers, MEPs
• Expertise: technical details need specialist knowledge
But:
• Democracy?
• Accountability?
• Transparency?

A BRIEF HISTORY OF COMITOLOGY
60s
CAPneeds rules
Ad hoc procedures

60s
CAPneeds rules
Ad hoc procedures
70s
Rapid development

60s
CAPneeds rules
Ad hoc procedures
70s
Rapid development
1987
First horizontalrules

60s
CAPneeds rules
Ad hoc procedures
70s
Rapid development
1987
1999
New horizontal
decision+ EP involved

60s
CAPneeds rules
Ad hoc procedures
70s
Rapid development
1987
2006
1999
Amended rules:
RPS + EP veto
New horizontal

60s
CAPneeds rules
Ad hoc procedures
70s
Rapid development
1987
2009 2006
1999
Lisbon: Delegated &
ImplementingActs
(plus RPS ‘hangover’)
Amended rules:
RPS + EP veto
New horizontal

PART 2
NEW COMITOLOGY :
CHANGES AFTER LISBON

THE PRE-LISBON REGIME
• One legal basis:
Article 202 EC
• One legal framework / set of rules:
Comitology Decision (Council Decision 1999/468)

THE POST-LISBON REGIME
• Two legal bases:
Delegated acts (DAs): Articles 290 TFEU
Implementing acts (IAs): Article 291 TFEU
• Two legal frameworks / sets of rules:
DAs: Article 290
IAs: Article 291 + Comitology Regulation (Council
and EP Regulation 182/2011)

CHOOSING THE RIGHT PROCEDURE
Delegated acts
Non-legislative act
Amend/supplement legislation
Non-essential

CHOOSING THE RIGHT PROCEDURE
Delegated acts
Non-legislative act
Amend/supplement legislation
Non-essential
Implementing acts
Non-legislative act
Implement legislation
Often essential

In detail:
Delegated acts

DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:
Commission formally acts alone
(but… informal consultation with national experts)

• No horizontal procedure, only treaty rules:
Legislator decides case-by-case on how to delegate
(but… „common understanding‟to avoid confusion)

• Strong powers for legislator
Either EP or Council can veto measure or revoke power

• Strong powers for legislator
• Inter-institutional parity
EP and Council have equal powers, right to information

• Strong powers for legislator:
• Inter-institutional parity:
EP and Council have equal powers, right to information

‘COMMON UNDERSTANDING’
Legislator decides case-by-case on how to delegate – in
terms of objectives, content, duration and scope
Common understanding gives basic models:

VETOING OR REVOKING POWERS
• EP and Council cannot amend draft measures
• ‘Nuclear options’: veto or revoke power
• Big majorities needed to veto or revoke:
– EP: absolute majority of all MEPs
– Council: qualified majority

VETOING OR REVOKING POWERS
• EP and Council cannot amend draft measures
• ‘Nuclear options’: veto or revoke power
• Big majorities needed to veto or revoke:
– EP: absolute majority of all MEPs
– Council: qualified majority
• EP/Council have 2+2 months to object to an act
• Any reason allowed for veto or revocation
• Under ‘common understanding’, EP and Council must
give each other one month’s notice of intention to revoke

Delegated acts:
An example

AN EXAMPLE: ENERGY LABELLING

AN EXAMPLE: ENERGY LABELLING
New labels from 1 July 2013:
A +++
A ++
A +
A
B
C
D
A++

In detail:
Implementing acts

IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:
Commission cannot act as it wishes

• Horizontal procedures set by EP and Council:
‘Advisory’and ‘examination’procedures

• Weaker powers for legislator:
Only right of scrutiny – oblige Commission to review act

• Horizontal procedures laid down by EP and Council:
• Inter-institutional disparity
Member states in control in committees

• Inter-institutional disparity
Member states in control in committees

IMPLEMENTING ACTS: TWO PROCEDURES
Advisory procedure:
• ‘Default’procedure
• Used for funding decisions; less controversial measures
• Commission takes ‘utmost account’of committee’s views

Advisory procedure:
Examination procedure:
• Applies to issues of ‘general scope’or ‘sensitive topics’ –
e.g. trade, taxation, human health, animal
health, plant health, the
environment, agriculture, fisheries…
• Committee votes on measures
• Appeal committee (deputy perm reps) may intervene
• Member states keep significant control

Advisory procedure:
Examination procedure:
• Applies to issues of ‘general scope’or ‘sensitive topics’ –
e.g. trade, taxation, human health, animal
health, plant health, the
environment, agriculture, fisheries…
• Committee votes on measures
• Appeal committee (deputy perm reps) may intervene
• Member states retain significant control

EXAMINATION PROCEDURE
Commission proposes
QM +
COM may adopt unless:
Simple majority against
Basic act forbids
‘Sensitive topic’
EXAMINATION COMMITTEE
No QMQM - ACT ADOPTED
COM acts:
(Within two months) Submits new draft act
(Within one month) Send to appeal cttee

EXAMINATION PROCEDURE
QM +
COM may adopt unless:
Multilateral trade safeguard
On sensitive issues, decision
must reflect predominant view
APPEAL COMMITTEE
No QMQM - ACT ADOPTEDACT NOT ADOPTED

ACTING URGENTLY
• Commission can adopt urgent measures if needed
• Committees have ex-post control – a negative opinion
means the act is repealed
• Example: post-Fukushima measures

Implementing acts:
An example

AN EXAMPLE: ORPHACOL
• Positive EMA opinion on Orphacol - but Commission
proposed not to give a market authorisation
• Examination committee: QMV opposed Commission
• Appeal committee: QMV opposed Commission
• New draft tabled: no QMV either way
• Commission had discretion – and stuck by its
original decision

Overview:
Delegated acts vs
implementing acts

OVERVIEW
Delegated acts Implementing acts
Supplement and amend
‘non essential elements’
Role Provide uniform conditions
for implementing EU acts
General application Scope General or individual
application
No (not formally) Expert committees Yes
In individual legislation +
‘common understanding’
Legal basis Horizontal EP/Council
Regulation
EP/Council can veto or
revoke delegation
Scrutiny Member states can block;
EP/Council scrutiny
Ongoing replacement of
‘RPS’ until 2014 – and
some disputes…
Alignment Automatically replaced old
comitology on 1 March
2011

PART 3
CONFLICTS AND
CONTROVERSIES

ISSUE 1: POST-LISBON ALIGNMENT
OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)
ADVISORY ADVISORY
MANAGEMENT
EXAMINATION
REGULATORY

ISSUE 1: POST-LISBON ALIGNMENT
OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)
ADVISORY ADVISORY
MANAGEMENT
EXAMINATION
REGULATORY
DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)
REGULATORY PROCEDURE WITH
SCRUTINY
DELEGATED ACTS

ISSUE 2: CHOICE OF PROCEDURE
WEEE – EP vs Council
• EP concedes to Council – IAs chosen over DAs
• Notes than “shall not be used as a precedent”

Cross-border healthcare – EP/Council vs Commission
• Commission notes that legality of IAs may be questioned
– says they should be DAs

Cross-border healthcare – EP/Council vs Commission
• Commission notes that legality of IAs may be questioned
– says they should be DAs
Biocides – EP/Council vs Commission, the ECJ rules
• Commission takes EP/Council to Court to challenge use
of IAs

‘Procedure’becoming part of the negotiation between
EP and Council
• EP seems willing to trade ‘substance’for ‘procedure’
• Biocides case should give clearer indication of line
between DAs and IAs

ISSUE 3: THE ‘NUCLEAR OPTION’
‘Take it or leave it’ choice can be tricky…
Food additives:
• Commission included a ‘meat glue’ in a list of 20 food
additives
• EP vetoed, blocking all 20 additives
• Did Commission think EP would not veto all additives
because it disliked one additive?

ISSUE 4: PUTTING POLICY IN ‘SILOS’
Some issues encompass wider interests that can be
missed in policy-specific comitology procedures
Airport body scanners:
• Commission draft act adopted by transport experts
• EP Transport Committee signalled its approval
• MEPs on Civil Liberties Committee heard about plan and
objected to lack of privacy safeguards
• EP President wrote to Commission, which withdrew
measure
NB: a formal veto is not the only way to block a proposal…

PART 4
TIPS FOR WORKING WITH
THE NEW COMITOLOGY

‘NEW COMITOLOGY’ TIPS
Impact:
• Don’t forget the impact of comitology:
– 60-70 legislative acts per year
– > 2,000 delegated or implementing acts per year
• It can affect key business issues –
labelling, marketing, authorisations…
Procedure:
• Ensure you know which one applies to your issue
• In the legislative phase, think about whether you can
affect the choice in your favour (including for texts that
need to be aligned)

Timing:
• Think about comitology impact from legislative phase so
that ‘objective, scope, duration, content’ suit your needs
• Focus on comitology measures as soon as the law is
passed – the Commission will be thinking about them!
• Get in early – influence the content while the Commission
is drafting to avoid calling for a ‘nuclear option’
• Remember, the nuclear option is difficult to achieve:
– Lack of expertise/understanding in EP/Council
– Too many measures
– Too little time (2+2 months)
– Thresholds are very high (absolute majority / QMV)

Network:
• For DAs and IAs, know the Commission desk officer
responsible
• For IAs in particular, find out the committee involved and
who sits on it – often officials in national capitals
• For DAs in particular, consider which MEPs are
interested and wish to be kept informed… you may need
them in the scrutiny phase (Baby milk health claim case)
• Consultations may include experts from Parliament or
non-institutional actors - another chance to influence

Stay informed:
• Commission desk officer
• EP committee secretariats
• Perm Reps
• Comitology register

ANY QUESTIONS?

Thank you for
your attention
…and see you on 12 June!

Regulatory Affairs: What you should know about implementing and delegated acts

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