COMMISSION OF THE EUROPEAN COMMUNITIES
`
`tr oe
`oes
`
`Ww
`
`Wr yy
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`Brussels, 13.6.2006
`SEC(2006) 737
`
`COMMISSION STAFF WORKING DOCUMENT
`
`Annex to the
`
`Report from the Commission “Better Lawmaking 2005”
`pursuantto Article 9 of the Protocol on the application
`of the principles of subsidiarity and proportionality (13th Report)
`
`{COM(2006) 289 final}
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`TABLE OF CONTENTS
`
`TntrOductiOn.........ceccecccesesseseesceseseesseecsevsesaeceessesevsecaeaesavsessaeseeaeeaeaesaaesecaeeessaeeaeaesaeeaeeaees 4
`
`Better regulation 2.0...ccc cccccssccssceesseceeseceessececsecesssecsseessceecsscecsaecesseceessecssceceseeessseees4
`
`2.1.
`
`Actions taken by the Commission .............0.:.ccccccccccessesessenscceessceesseceseceessecssceceeeeesseees4
`
`2.1.1.
`
`2.1.2.
`
`2.1.3.
`
`2.1.4.
`
`2.1.5.
`
`Consultation of interested parties .........0..cc ccc cccc cece seccseceeceecsseecsuscesseceeseecesseceeseesseees 5
`
`Timpact ASSCSSIMEML..... seeeeeeecccecececeesceeeeccececceesceseceseeceneceseeseeesaeeseesaeseaceesceessenssesseeeees 6
`
`Collection and use Of CxpertiSe ...........ccccceecceecessceceeeeseceeeeeseesseeseeeeeceesceeseecseeseesteetseeesee
`
`Explanatory Memorandum sae sncncnonsimwannwen sais Anne aiAANa nwa
`
`Updating and simplifying the Community acquis ..................:c::cecceeeesceeeceeteeeseeeteeeees 9
`
`2.1.6.
`
`Estimation of administrative costs imposed by EU legislation ..........eee 10
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`2.1.7.
`
`Choice of instruments (self and coregulation)..............cccccccecssessecesecessesscescesesseseeseees 11
`
`2.1.8.
`
`Monitoring the application of EU law .0.......cc cece cece cecssenssceceseeesecesseceesseessseeeseees 12
`
`2.1.9.
`
`Regulatory indicators 000... ccececceccsecessecessecesceesnnececsececssecessecsacessaseeessesesseceeneecsseecneers 14
`
`2.1.10.
`
`Other Actions 2.22... ....ccceccecececeeseeesceseeeceeeeeceaecaceeecesesesseseaecseeeseeeseessaeseaeeeeeeeseeseeseeneeee 14
`
`Dds
`
`2.3.
`
`Actionsat the level of EU institutions, the European Economic and Social
`Committee and the Committee of the Regions ...............ccccccccccessececesceeceeeesstesseescescees 15
`
`Actions taken by the MemberStates ................0.ccccccccscesceseeceesceeseeseesesesesseescessesseeseees 18
`
`Application ofthe principles of subsidiarity and proportionality ............c cece 19
`
`3.1.
`
`The legal andinstitutional framework ..0....0...00..0ccccecccscsesesecessecsteeseceseesceesceessseseeseees 19
`
`3.1.1.
`
`The definition given by the Treaties ..............0ccccccccccceceesceseeessccsersceeceesesesssessseeseeerens 19
`
`3.12.
`
`Modesofapplication, commentand Control.............cccecesseseceseeeseesessesseeeesessecsseneeeene 20
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`3.2.
`
`Application of the principles in 2005 ..........cc cece ccscscseseseeessecsecescesecrscessceesssessseseees21
`
`3.2.1.
`
`3.2.2.
`
`3.2.3.
`
`3.2.4.
`
`3.25.
`
`3.2.6.
`
`When subsidiarity calls for EU action even if the problem does not concern
`all MemberStates .0............ccccccccccccecescceeeeccceeceeeeceseeeeseseeseseeeseecseecsaeseeeeeeeeesceeeeeeesseees 21
`
`Whensubsidiarity calls for the scope of a (proposed) measure to be extended
`to cross-border and domestic Cases............ccccccccsceescecseeeseceseeeeeesseesseeeeeeeeeesceeseeeeeseess 22
`
`Wheninternational obligations frame the application of the principles of
`subsidiarity and proportionality ...............cccccccccesceeceeeseeesceseeeseecececsceeceeeecesseseeeneeeeeeees23
`
`Whenproportionality demands moreprescriptive action. .............:::::cccccceeseeeteeeteee 23
`
`Whenproportionality calls for regulatory alternatives such as co-regulation............ 23
`
`Whenproportionality calls for strict administrative obligations.................::::0:000024
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`3.2.7. When proportionality calls for the suppression of most administrative
`ODL GAtONS rss evre since nyse eases IT eeE NEE ah LR NOUBU
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`24
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`3.3.
`
`Opinions, contributions and ex post control of the application of the
`Principles in 2005... eee cceccessccesceesosseessecesseceesseessseseeeceseeecsseeesseeessseeeseeenssecees25
`
`3.3.1. Opinions and contributions in 2005 002.2... cce cece eeeeee eens ceeeececeseceeeceeeceeeeesseeeeeeteeee25
`
`33.22
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`Ex post-control 12005 sec seen eeesuscoancn ees ee aren enone re ieee
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`26
`
`Annex |: Legislative activity 1m 2005 ooo... ...cccccccccccessccesssesesseessccesseceesseeesseseessessasecsaeeeseeeesasess
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`29
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`Annex 2: Public consultation and information in 2005 ....00.0.cccecccccececccceceesecccccesececeetseeeeeeeeeee
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`32
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`Annex 3: Better Regulation actions in MemberStates in 2005 ...............cccceeceeeeeceeeeeeeteteeeeees
`
`34
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`Annex 4: Scoreboard 2002-5 —of the European Commission Action Plan for Better
`RGOUIAGON sissssssayassseassa sus csscazeeysiseee asia esa ck cee GG SaAU Soe SUAS oa GoaGUN
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`1.
`
`INTRODUCTION
`
`The first part of this working document is mainly concerned with the progress made in 2005
`in implementing the Commission action plan on better regulation as revised in March 2005!
`and the Inter-institutional Agreement (IIA) on “Better Lawmaking” of December 2003”.
`Progressin the individual MemberStates is covered in a succinct manner.
`
`The second part of the documentrelates to the application of the principles of subsidiarity and
`proportionality. Describingfirstly the legal and institutional framework in place 2005, it goes
`on to review the way in which the principles have been interpreted and applied by the
`Commission, Parliament and Council during the past year. Finally, it examines action taken
`by the Committee of the Regions and national parliaments and also looks at the case law of
`the Court of Justice of the European Communities.
`
`2;
`
`BETTER REGULATION
`
`Owing to the division of responsibilities within the Union, improvementof the regulatory
`environment requires joint efforts on the part of the European Parliament, the Council, the
`Commission and the MemberStates. The following sections analyse the main developments
`in 2005, with reference to the various players (Commission, other EU institutions, Member
`States).
`
`2.1.
`
`Actions taken by the Commission
`
`In its 2005 Communication to the spring European Council entitled “Working together for
`growth and jobs - A newstart for the Lisbon Strategy”, the Commission proposed to give
`fresh impetus to the Lisbon Strategy by channelling its efforts into two main goals: achieving
`stronger and lasting growth and creating more andbetter jobs. Improving European regulation
`(i.e. in particular create the right incentives for business, cut unnecessary costs and remove
`obstacles to adaptability and innovation) was identified as one of the key priorities in that
`perspective. The Communication of March 2005, “Better regulation for growth and jobs in the
`European Union”further stressed that point.
`
`Since then, the Commissionin line with its Action Plan:
`.
`.
`.
`.
`4
`— endorsed revised impact assessmentguidelines’;
`
`“Better regulation for growth and jobs in the European Union” COM(2005)97, March 2005, referred to
`subsequently as the “action plan”. This Communication updates and completes the Action Plan set in
`2002 (“Simplifying and improving the regulatory environment”, COM(2002) 278, 5 June 2002). The
`action plan follows up the White Paper on European Governance (COM(2001) 727, 25 June 2001).It
`takes into account
`the recommendations made by the Group on Regulatory Quality chaired by
`D. Mandelkern, presented to the Laeken European Council in December 2001. For more information on
`the eight specific communications detailing its objectives, see the annual report “Better Lawmaking
`2003”, COM(2003)770, 12 December 2003. For the previous annual report, see COM (2005)98 and
`SEC (2005)364.
`OJ C 321, 31 December 2003, p.1.
`COM(2005)24.
`SEC(2005)791. See http://www.europa.eu.int/comm/secretariat_general/impact/docs_en.htm.
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`— adopted a Communication on an EU common methodology for assessing administrative
`costs imposedbylegislation’;
`
`— adopted a Communication on the outcome of the screening of pending legislative
`proposals°;
`
`— adopted a Communication on a strategy for
`environment.
`
`the simplification of the regulatory
`
`— launchedthe groupofhigh-levelnational regulatory experts’.
`
`The Commission has special responsibility at three levels: legislative preparation and proposal
`(with exclusive rightofinitiative for EC policies); participation in legislative deliberation; and
`implementation of the legislation. Progress made within the ‘better lawmaking’ framework is
`presentedin that order.
`
`2.1.1.
`
`Consultation of interested parties
`
`The Commission has consulted extensively in 2005, as the figures in the box below show.
`
`the Commission produced 14 Green Papers (+8 compared to 2004), 2 White
`In 2005,
`Papers (+1) and 187 non-legislative Communications (+28). It also published 92 reports(-
`18) and organised 106 internet-based consultations (+11) via the web portal “Your Voice in
`
`Europe””— the Commission’s single access point for consultation’”.
`
`The consultation process normally spreads over a long period of time and is based on a
`combination oftools (e.g. open as well as targeted internet consultations, workshops, hearings
`and advisory groups). For instance,
`the preparation of the “thematic strategies” in the
`environmental
`field (e.g. air pollution, marine environment)
`involved a variety of
`consultations techniques.
`
`Compliance with most minimum standards for public consultation has been good.'' Services
`reported very few problems. The preparation of major policy initiatives (those requiring an
`impact assessment) has been specifically reviewed by central services. That review did not
`reveal either major or numerous infringements. There was a particularly high level of
`compliance with obligations regarding the use of “Your Voice in Europe’, on time limits for
`responses and on consultation feedback and on reporting on the consultation process.
`
`One area where further progress is needed is feedback on how comments were taken into
`account
`in a proposal or why they were discarded.
`In some targeted consultations (for
`instance, via conferences and hearings), information provided on the parties consulted was
`
`osm
`
`i
`
`COM(2005)5 18.
`COM(2005)462.
`COM(2005)535.
`The two meetings (November and December) were essentially devoted to better regulation in the
`Lisbon national programmes. The mandate of the group is to advise the Commission on better
`regulation issues in general, but also to provide an efficient interface between the Commission and key
`governmental authorities for the developmentofbetter regulation at EU andnationallevels.
`
`http://europa.eu.int/yourvoice/index_en.htm.
`For a detailed assessment on public consultation in 2005, see Annex 2.
`These standards have been introduced in 2003 (COM(2002)704, 11 December 2002).
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`relatively vague. While the “Your Voice in Europe’ web portal was widely used to publicise
`new consultations,
`there were some cases where the Commission did not publish the
`comments received.
`In other cases, a period of less than eight weeks was allowed for
`consultation. This was generally due to the urgency of the matter or because consultations had
`already been carried out on the sameissues.
`
`In a few consultations, the range of responses was not sufficiently representative because of
`the small number of contributions received or high mobilisation in a specific country. The
`availability of the questionnaire and/or background documents in a limited number of
`linguistic versions had also an impact on participation in the consultation.
`
`The Commission services widely recognised that the consultation of stakeholders improves
`the quality of the end product(i.e. the policy proposal).
`
`All in all, the Commissionstill needs to make additional efforts in providing general feedback
`and further improving transparency.
`
`2.1.2.
`
`Impact assessment
`
`In 2005, the Commission further improved its methodological framework for assessing the
`potential impacts of its proposals and boosted the number and quality of Impact Assessments
`(IA) accompanying its most importantinitiatives.
`
`The Commission’s internal Impact Assessment guidelines were revised, building on the
`preparatory work done in the previous year'’ and were endorsed by the Commission on 15
`June 2005'°. These second generation guidelines have been widely welcomed for their
`improved readability, “user-friendliness’ and sharper focus on the types of impacts that ought
`to be addressed.
`
`The Commission also prepared the launch of an independent evaluation of the impact
`assessment system, as foreseen in the March 2005 Communication on Better Regulation. It
`will review experience with regard to the implementation and results of the Commission’s
`approach to impact assessment and draw lessons on any need for further development or
`refinement of the approach. The results of the evaluation, expected in early 2007, will be
`madepublic.
`
`Besides work on the procedural and methodological framework, the Commission substantially
`increased the number of IAs completed in a year (see box below). The fact that all items on
`the Commission’s annual Legislative and Work Programme normally have to be based on an
`impact assessment was a major challenge in terms of time and resources. A limited number of
`IAs were also carried out on non-Work Programme items, even though not formally
`required ©.
`
`:
`
`SEC(2004)1377.
`
`SEC(2005)791. See http://www.europa.eu.int/comm/secretariat_general/impact/docs_en.htm.
`See,
`for
`instance,
`the
`JA
`on White
`Paper
`on
`Financial
`Services
`
`http://europa.eu.int/comm/secretariat_general/regexp/index.cfm?lang=EN.
`
`Policy
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`Of 91 items adopted in 2005, 10 were initially exempted from IA because oftheir nature (9
`Green Papers and | proposal for consultation with Social Partners)'*. This left 81 items
`requiring an IA. Out of these, 77 were presented'® (~ 95%), which represents a significant
`step forward compared to 29 IAs delivered in 2004 and 21 in 2003. The 4 remaining items
`were eventually adopted without formal IA due to their broad nature and/or the fact that a
`separate study had been prepared.
`
`Progress was also made in terms of JA quality. In particular, the definition of the problem
`calling for action was generally judged to be of a high standard. Special efforts were made to
`quantify the problem andthe likely impacts of different policy options. Upstream inter-service
`co-operation and consultation with stakeholders were also confirmed as key elements to
`ensure high quality assessments. IAs clearly helped to improve the quality of a significant
`numberof proposals'” and in some cases affected the choice of instruments'*. In some cases,
`preliminary analysis even led the Commission to conclude that
`intervention would be
`premature or unnecessary'’. The independentevaluation to be launchedin 2006will provide
`more specific data on the evolution in the overall quality of Commission’s IAs.
`
`However, there is no room for complacency and the Commission recognises that more needs
`to be doneto ensure that impact assessments are as comprehensive andrigorousaspossible”’.
`The identification and assessmentof alternative policy options is one area in need of greater
`attention. Greater efforts are also necessary to ensure that the impact assessment workstarts
`early enough in the policy developmentprocess.
`
`2.1.3.
`
`Collection and use ofexpertise
`
`2005 saw the operational launch of SINAPSE (Scientific INformAtion for Policy Support in
`Europe), a new interface between experts and (EU) policy makers”’. Once the registration
`phase completed, this web application will offer: (1) a library of scientific advice and opinion;
`(2) an EC consultation module complementing existing scientific consultation mechanisms
`
`
`The 2005 Legislative and Work Programme had more than 91 items, but the adoption of some has been
`postponed to 2006 or removed from the Programme in the mid-term review,
`to allow further
`preparatory work.
`This figure includes some cases where the Roadmaps were consideredto be sufficient as ‘proportionate’
`impact assessments. N.B. each item of the Work Programmeis accompanied by a ‘Roadmap’ providing
`a numberof key data, including a statement on the likely impacts of each policy option and on whois
`likely to be affected.
`The IA preparing the Thematic Strategy on Air Pollution is a clear example of ‘best practice’. Based on
`a thorough options analysis,
`it was fully used in the policy debate and helped identify the most
`appropriate ambition level in terms of pollution cuts, ensuring a fair balance between costs and benefits.
`For instance, as a result of the IA on cross-border management of copyright and related rights in the
`online music sector, it was decided to opt for a recommendation instead ofa draft directive. A number
`of prescriptive and detailed measures to double bio-energy use were eventually not included in the
`Biomass action plan presented in December 2005 (COM(2005)628). Similarly the preparatory
`Communication for
`the Thematic Strategy on Urban Environment was envisaging framework
`directives. On the basis of the A, the Commission opted for a voluntary approach (COM(2005)718).
`Having analysed the 1500 reactions to the Green Paper on equality and non-discrimination in the EU
`(COM(2004)379), the Commission made knownthat no new legislative proposals based on article 13
`TEC were envisagedat this stage.
`For example, the European Consensus for Developmentadopted by the Parliament, the Council and the
`Commission on 20 December 2005 (COM(2005)311) reaffirms the need for taking better account of
`developmental concerns in the context of impact assessment.
`
`http://europa.eu.int/comm/secretariat_general/regexp/index.cfm?lang=EN.
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`(expert groups); (3) an early warning system that communities of experts can use to raise
`awareness of policy makers on incoming (scientific) challenges and dangers; (4) “Yellow
`Pages”of expertise for quickly identifying and contacting scientists or scientific organisations
`with specific expertise. More than 300 European and international scientific organisations
`such as the European Science Foundation or European Mathematical Society registered in
`2005. This tool will contribute to the quality, openness and effectiveness of collection of
`expertise,
`in line with the principles and standards set by the Commission in its 2002
`Communication on the collection and use of advice from external experts”.
`
`In addition, initiatives aimed at widening and systematising the collection of expertise in
`specific domains have beentaken”’.
`
`Following the commitments made in July 2004 by President Barroso to the European
`Parliament, the Commission has taken major steps for improving transparency on its expert
`groups. This has in particular resulted in the launching,
`in October 2005, of a register
`providing the Parliament and the public at large with standard information on approximately
`1200 expert groups advising the Commission”. The register covers formal bodies established
`by Commission decisions and informal advisory bodies set up by the Commissionservices.It
`provides key information on those groups, such as the lead service in the Commission, the
`group's tasks as well as the category of participants. The register also contains direct links to
`Commission departments’ websites where more detailed information is available.
`
`2.1.4.
`
`Explanatory memorandum
`
`In 2005 the Commission worked further on improving the content and presentation of the
`explanatory memorandum accompanying each ofits legislative proposals. The explanatory
`memorandum is particularly important becauseit allows the legislator and the citizen to see at
`a glance whyan initiative has been taken. It contributes directly to greater transparency and
`accountability in the Union.
`
`In order to improve compliance with the standard explanatory memorandum adopted in
`December 2003 for its legislative proposals, the Commission has put an informatics tool in
`place whichstructures the required information and reminds services of key obligations. As a
`result, the consistency and coverage of explanatory memoranda accompanyinglegislative
`proposals transmitted to the legislator in the second part of 2005 have markedly improved.
`This was in particular true for sections demonstrating how the proposal complies with the
`principles of subsidiarity and proportionality.
`
`22
`23
`
`COM(2002) 713, 11 December 2002.
`For example, in order to prevent the repetition of catastrophes similar to those provoked by the Erika in
`Brittany or the “Prestige” in Galicia and apply most properly the principle of precaution, special efforts
`have been made to collect the expertise from MemberStates, the European Maritime Safety Agency,
`the International Maritime Organisation and other international organisations (OECD, HELCOM,
`CBSS,etc.). Collected expertise was used to draft the third package oflegislative measures on maritime
`safety in the European Union (COM(2005)585). Special efforts were also made for the future revision
`ofDirective 2001/23 on the cross-border dimension oftransfers of undertakings; as well as for the three
`framework programmes for the period 2007-2013 on “Fundamental Rights and Justice”, on “Solidarity
`and Managementof Migration Flows” and on “Security and Safeguarding Liberties” (COM(2005)122,
`123 and 124).
`
`Register access http://europa.eu.int/comm/secretariat_general/regexp/index.cfm?lang=EN.
`
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`2.1.5.|Updating and simplifying the Community acquis
`
`The Commission adopted in October 2005 a strategy for simplification of existing rules”,
`which builds on the first comprehensive simplification programme launched in February
`20037°. Based on input from the Member States’’ and stakeholders’’,
`the new strategy
`proposed a 3-year rolling programme which will be regularly updated. The number of
`simplification proposals presented by the Commission will significantly increase: the rolling
`.
`wee 9
`30
`;
`programme indeed foresees the repeal, codification” , recasting”
`or modification of over 220
`pieces of legislation (with knock on effects on more than 1.400related legal acts).
`
`This programmewill be regularly updated. The Commission will develop its simplification
`priorities by meansof:
`
`— acomprehensive analysis of impact of legislation on selected sectors, including economic,
`environmental and social aspects;
`
`such as
`— techniques
`implementation;
`
`repeal,
`
`codification,
`
`recasting and a different approach to
`
`— legislative methods entailing a clear preference for essential requirements rather than
`technical specifications,
`the increased use of co-regulation, review/sunset clauses and
`increased use of information technologies;
`
`— increased use, as appropriate and on a case-by-case basis, of regulations instead of
`directives.
`
`The codification and recasting efforts predating the new strategy have also been pursued. In
`November 2001 the Commission launched a major programme for the codification ofall
`Community legislation, which was scheduled tobe completed by the end of 2005. This
`timetable has not been achieved because delays occurred in the translation®' and publication
`processes. These delays were compoundedbytechnical difficulties experienced by the Office
`for Official Publications in the production of consolidated texts in the new official languages.
`
`
`
`3s
`
`*6
`7
`28
`
`31
`
`complementary
`issue
`to
`intention
`its
`also announced
`COM(2005)535. The Commission
`communications indicating in more detail how simplification work will be brought forward or
`integrated in various sectors. This was the case in particular for agriculture (“Simplification and Better
`Regulation for
`the Common Agricultural Policy” COM(2005)509)
`and environment
`(“Better
`Regulation and the Thematic Strategies for the Environment” COM(2005)466).
`COM(2003)71.
`Including simplification priorities identified by the Council in November 2004.
`The Commission launched on | June of 2005 a public consultation on internet “10 Minutes to improve
`
`the business environment”(http://europa.eu.int/comm/secretariat_general/regexp/index.cfm? lang=EN).
`Codification is a textual exercise implying no change in policy. It consists of the adoption of a new
`instrument which incorporates and repeals the previous instruments (i.e.
`the basic act and all
`intervening amending instruments).
`Recasting refers to a mix of substantial amendment and codification. The legislator uses the opportunity
`provided by a substantial amendment
`to the basic instrument
`to codify that
`instrument and all
`subsequent amendments.
`New MemberStates haveto translate the acquis in their official language(s).
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`Delivery of consolidated texts” in the new languages began in July 2005 and by the end of
`the year some 500 texts — of which 400 were on the priority list for codification — had been
`delivered. With the resolution of technical problems and consolidated texts in the 9 new
`languages becomingavailable, it should be possible in 2006 to move forward with a great
`numberof codification proposals**. A concerted effort has been made to finalise 250acts in
`the new languages (having already been finalised in 11 languages, and of which 120 are
`pending before the legislative authority in 11 languages) and to have them adopted by the
`legislative authority in 2006. 415 acts already exist in a finalised French or English version
`(mastercopy) and these are in the course of being published by OPOCEinorderto facilitate
`public accessto the provisional results of the codification project. The Commission will make
`every effort to ensure that a maximum ofcodifiable acts is adopted prior to the enlargement of
`the Union to Bulgaria and Romania.
`
`As for recasting, the Commission has submitted 12 proposals to the legislative authority, of
`which two have been adopted as of end 2005**.
`
`2.1.6.
`
`Estimation ofadministrative costs imposed by EUlegislation
`
`the
`In its Communication of March 2005 on Better Regulation for Growth and Jobs**,
`Commission announcedits intention to look into the possibility of developing a common
`approach for assessing administrative costs associated with existing and proposed Community
`legislation. A prototype approach called “EU net administrative cost model” was outlined in
`the Staff Working Documentannexed to the Communication®® and put to the test from April
`to September. At the end of that pilot phase,
`the Commission concluded that a common
`approach at EU level was feasible and would have clear added value. The prototype was
`revised onthe basis of the pilot phase findings and the best practices at MemberState level.
`
`The methodology validated by the pilot phase (common definition, common core equation
`and commonreporting sheet) was presented in a Communication adopted on 21 October
`2005°’. The Commission also announced the inclusion of that methodology in its impact
`assessment guidelines and evaluation guidelines*®. Furthermore,
`it
`invited the Council
`to
`
`32
`
`4
`
`8
`%6
`
`Consolidation consists of editorial assembling, outside any legislative procedure, ofthe scattered parts
`of legislation on a specific issue (in other words, bringing into a single text
`the original act and
`subsequent amendments). This clarification exercise does not entail the adoption of a new instrument
`and the resulting text therefore has no formal
`legal effect. Consolidated texts, converted into the
`informatics tool, Legiswrite Codification/Refonte, constitute the raw material
`required for
`the
`preparation of a codified version to begin.
`The main limitations to the rate of progress in 2006 will be (i) the capacity of the subcontractor to
`prepare linguistic versions in the languages other than the mastercopy and (11) the capacity of the
`legislative authority to process the Commission's proposals.
`Council Regulation (EC) 139/2004 on merger controls and Directive 2005/55/EC ofthe European
`Parliament and of the Council on measures to be taken against the emission of gazeous pollutants from
`vehicle engines. As of 1 March 2006, the numberof pending simplification proposals rose to 20.
`COM(2005)97.
`SEC(2005)1329.
`Communication on an EU common methodology for assessing administrative costs imposed by
`legislation (COM(2005)518, accompanied by Commission Staff Working Document SEC(2005)1329
`Outline of the proposed EU common methodology and Report on the Pilot Phase (April—- September
`2005).
`The Communication specifies that actual implementation and use of the methodology will be “subject
`to (a) the principle of proportionate analysis (the Commission retaining responsibility for judging the
`costs ofits proposals); (b) the availability of sufficient, reliable and representative data, compatible with
`
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`UNITED THERAPEUTICS, EX. 2143
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`in line with the
`reach an agreement with the Commission on a common methodology,
`European Council conclusions of March 2005 requesting the Commission and the Council to
`do so before the end of 2005.
`
`For the longer term, the same Communication declared the Commission’s intention to explore
`whether the proposed EU common methodology could be used to assess cumulative
`administrative burden at sectoral
`level*’.
`It also referred to the optimisation of the
`methodology with the help of the high level group of national experts on better regulation.
`This workis due to start in early 2006.
`
`2.1.7.
`
`Choice ofinstruments (selfand coregulation)
`
`In its 2005 Action Plan, the Commissionstressed the need to pay moreattention to the choice
`of instruments for pursuing Treaty objectives and implementing Community policies,
`including the use of alternative regulatory instruments (self-regulation and co-regulation), the
`decentralisation of tasks to agencies and the conclusion of tripartite contracts between the
`Community, the States and regional or local authorities. The two last items are covered by the
`3" Report on European Governance”.
`
`In order to map where and howregulatory alternatives are used, the Commission started an
`inventory of existing cases of EU self-regulation and coregulation*'. Schemesset up after the
`entry into force of the IIA on “Better Lawmaking” were listed and reviewed to assess
`compliance with the general principles and conditions laid down by the Agreement. The
`Commission listed 20 schemes set up between | January 2004 and 30 November 2005
`(coregulation: 14; self-regulation: 6). A detailed analysis concluded that conditionslaid in the
`IIA were complied with’*. In a limited number ofcases, the choice of coregulation should
`have been justified more explicitly or in greater detail. This inventory will be updated on an
`ongoingbasis.
`
`In 2005 the European Economic and Social Committee (EESC) and the Commission
`examined how to develop synergy to gather operational knowledge on EU self- and co-
`regulation, facilitate exchange of information and identify best practices. The main objective
`is to encourage and support private parties willing to set up or improve self-regulatory
`schemes, as well as to help regulators responsible for designing co-regulatory schemes. Joint
`analysis led to conclude that the redesign of the EESC database, PRISM II, was the best
`approach for maximising synergy. A memorandum of understanding should be signed in 2006
`
`
`the EU common methodology; and (c) the availability of an adequate level ofstaffing and financial
`resources”.
`In the Annual Progress Report on the Lisbon strategy adopted in January 2006, the Commission
`announced that
`it will
`launch “a major exercise to measure the administrative cost arising from
`Community rules (or the way in which they have been implemented) in specific policy areas as part of
`the ongoing workonlegislative simplification, with a special emphasis on SMEs” (COM(2006)30, 25
`January 2006).
`These topics are covered in detail by the 3rd Report on European governance (2004-2005), to be
`
`adopted in March 2006. See http://www.europa.eu.int/comm/governance/index_fr.htm.
`Co-regulation is often