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		52011SC0822

			Recommendation for a COUNCIL RECOMMENDATION on the National Reform Programme 2011 of Latviaand delivering a Council opinionon the updated Convergence Programme of Latvia, 2011-2014 /* SEC/2011/0822 final */

			   	Recommendation for a
COUNCIL RECOMMENDATION
on the National Reform Programme 2011 of
Latvia
and delivering a Council opinion
on the updated Convergence Programme of Latvia, 2011-2014
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 121(2) and 148(4)
thereof,
Having regard to Council Regulation (EC) No
1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary
positions and the surveillance and coordination of economic policies, and in
particular Article 9(3) thereof,
Having regard to the recommendation of the
European Commission,
Having regard to the conclusions of the
European Council,
Having regard to the opinion of the
Employment Committee,
After consulting the Economic and Financial
Committee,
Whereas:
(1)
On 20 January 2009, the Council of the European
Union (EU) adopted a Decision (2009/290) to make available to Latvia medium-term financial assistance for a
period of three years under the provisions of Article 143 of the Treaty. The
accompanying Memorandum of Understanding signed on 28 January 2009 and its
successive supplements lay down the economic policy conditions on the basis of
which the financial assistance is disbursed. The Council decision was amended
on 13 July 2009. The last supplement to the Memorandum of Understanding was
signed in June 2011.
(2)
On 26 March 2010, the European Council agreed to
the European Commission's proposal to launch a new strategy for jobs and
growth, Europe 2020, based on enhanced coordination of economic policies, which
will focus on the key areas where action is needed to boost Europe’s potential
for sustainable growth and competitiveness.
(3)
On 13 July 2010, the Council adopted a
recommendation on the broad guidelines for the economic policies of the Member
States and the Union (2010 to 2014) and, on 21 October 2010, adopted a decision
on Guidelines for the employment policies of the Member States[1],
which together form the “integrated guidelines”. Member States were invited to
take the integrated guidelines into account in their national economic and
employment policies.
(4)
On 12 January 2011, the Commission adopted the
first Annual Growth Survey, marking the start of a new cycle of economic
governance in the EU and the first European semester of ex-ante and integrated
policy coordination, which is anchored in the Europe 2020 strategy.
(5)
On 25 March 2011, the European Council endorsed
the priorities for fiscal consolidation and structural reform (in line with the
Council’s conclusions of 15 February and 7 March 2011 and further to the
Commission’s Annual Growth Survey). It underscored the need to give priority to
restoring sound budgets and fiscal sustainability, reducing unemployment
through labour market reforms and making new efforts to enhance growth. It
requested Member States to translate these priorities into concrete measures to
be included in their Stability or Convergence Programmes and National Reform
Programmes.
(6)
On 25 March 2011, the European Council also
invited the Member States participating in the Euro Plus Pact to present their
commitments to be included in their Stability or Convergence Programmes and
their National Reform Programmes. Specific commitments and actions for 2011 are
not explicitly communicated in the Latvian Convergence Programme and the
National Reform Programme but are expected to be submitted to the European
Council.
(7)
On 29 April 2011, Latvia submitted its 2011
Convergence Programme update covering the period 2011-2014 and its 2011
National Reform Programme. In order to take account of the interlinkages, the
two programmes have been assessed at the same time.
(8)
The Latvian economy grew faster than any other
EU Member State from 2000 to 2007, reflecting convergence prospects, foreign
financial inflows and very strong consumption demand. However, at least partly
as a result of an expansionary macroeconomic policy, the economy overheated.
Sizable imbalances accumulated, illustrated by a current account deficit of
22.3% of GDP in 2007 and 13.1% in 2008; consequently, during 2008-2009, the
economy experienced the steepest contraction in the EU. During this period real
GDP contracted by 25% from peak to trough as a collapse in domestic demand was
amplified by a slump in global trade. The Latvian employment rate, previously
amongst the highest in the EU (75.8% in 2008), fell by over 10 percentage
points and the unemployment rate of over 18% is now one of the highest in the
EU. The general government deficit was 9.7% in 2009 but as a result of fiscal
consolidation measures, decreased to 7.7% in 2010. This outcome includes
sizeable financial sector stabilisation measures that amounted to 1.1% of GDP in 2009 and 2.3% of GDP in 2010.
(9)
Based on the assessment of the updated
Convergence Programme pursuant to Council Regulation (EC) No 1466/97, the
Council is of the opinion that the macroeconomic scenario underpinning the
budgetary projections in the programme is plausible. The medium-term budgetary
strategy of the programme is to bring the headline general government deficit
below the 3% reference value by the deadline foreseen in the Council Recommendation
of 7 July 2009. Taking into account the measures implemented since the issuance
of the recommendation to correct the excessive deficit situation and additional
consolidation implied in the updated Convergence Programme, the planned fiscal
effort for 2011-2012 is in line with the required adjustment. In view of the
starting point, the programme does not foresee the achievement of the
medium-term objective (MTO) by the end of the programme period, while the
planned fiscal effort to reach the MTO after the correction of the excessive
deficit situation could be accelerated in particular in 2013. The fiscal
consolidation path envisaged in the programme is mostly expenditure based. The
budgetary targets are subject to downside risks, as the programme does not
provide full information on measures to underpin the achievement of the set
targets. These measures are expected to be spelled out in the forthcoming
budgets. Reducing the primary deficit over the medium term, as foreseen in the
programme, would help reduce the risks to the
sustainability of public finances.
(10)
The Commission has assessed the Convergence
Programme and National Reform Programme[2]. It has taken into
account not only their relevance for sustainable fiscal and socio-economic
policy in Latvia but also of their conformity with EU rules and guidance, given
the need to strengthen the overall economic governance of the European Union by
providing EU level input into future national decisions. In this context, the
Commission stresses the urgency of implementing the planned measures to comply
with Council Decision (2009/290/EC).
HEREBY RECOMMENDS that Latvia should
:
Implement the measures as laid down in the
Council Decision 2009/290/EC, as amended by Council Decision 2009/592/EC, and further specified in the
Memorandum of Understanding of 20 January 2009 and its subsequent supplements
[in particular the last supplement of June 2011].
Done at Brussels,
                                                                       For
the Council
                                                                       The
President
[1]               Maintained for 2011 by Council Decision 2011/308/EU
of 19 May 2011.
[2]               See SEC(2011) 722.


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32001H0191

Council Recommendation of 12 February 2001 with a view to ending the inconsistency with the broad guidelines of the economic policies in Ireland

Official Journal L 069 , 10/03/2001 P. 0022 - 0023

Council Recommendationof 12 February 2001with a view to ending the inconsistency with the broad guidelines of the economic policies in Ireland(2001/191/EC)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 99(4) thereof,Having regard to the recommendation of the Commission,Whereas:(1) On 19 June 2000, the Council recommended the Irish authorities, in its recommendation on the broad guidelines of the economic policies of the Member States and the Community(1), to be ready, already in 2000, to use budgetary policy to ensure economic stability given the extent of overheating in the economy and to gear the budget for 2001 to this objective.(2) On 6 December 2000 Ireland submitted the 2000 update of the Stability Programme which contains objectives in the budgetary area for the period up to 2003 and which should be read in conjunction with the budget for 2001 released on the same day.(3) The Council, in its opinion of 12 February 2001 on the 2000 update of the Irish Stability Programme in accordance with Article 5(3) of Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies(2), considers that Irish budgetary plans for 2001 are not consistent with the broad guidelines of the economic policies as regards budgetary policy.(4) Proper functioning of the coordination of economic policies in the euro area requires a timely use of instruments available under Article 99(4).(5) The European Council of Helsinki on 10 and 11 December 1999 emphasised that existing processes and arrangements for economic policy coordination by the Council should be effectively applied and that policy implementation should be closely monitored.In recognition of the following:(a) The Irish economy has shown a bright performance and continued to grow very rapidly in 2000, with real GDP growth just over 10 % expected for 2000. As a result, the budgetary projections in the 1999 update of the Stability Programme have been exceeded by a large margin. The debt ratio is projected to decline to 24 % of GDP by 2003. With a positive output gap, inflationary pressures in Ireland intensified in the course of 2000. HICP inflation was 5,3 % on average in 2000. While the rapid rise in the rate of inflation in the course of 2000 is partly due to external and temporary factors which are expected gradually to fall out of the consumer price index, there has also been an increased contribution from domestically-generated inflation, which remains a cause of concern.(b) On 6 December 2000, the Irish budget for 2001 was presented. The main measures are: a direct tax package (consisting of cuts in tax rates and increases in allowances) with a full-year cost of around 1,5 % of GDP; indirect tax cuts with a full-year cost of 0,4 % of GDP; an 18 % increase in voted current spending over the projected 2000 out-turn (about 40 % of which is for pay expenditure) and a 29 % increase in voted capital expenditure. The 2000 update of Ireland's Stability Programme projects a reduction of the general government surplus in 2001 of 0,4 % of GDP from 4,7 % of GDP, implying a deterioration in the underlying budgetary position.(c) The budget for 2001 will give a further substantial boost to demand in Ireland and its possible supply effects are likely to be small in the short term. It will therefore aggravate overheating and inflationary pressures and widen the positive output gap, which, according to the 2000 update, will peak at 5,4 % of trend GDP in 2001.(d) The strategy of inducing labour force increases through an alleviation of the direct tax burden, which was recommended in the 2000 BEPG with respect to labour market, may have become less effective than in the past because it took place in the context of an expansionary budgetary policy, and the tightness of the labour market could well hamper further attempts at encouraging wage moderation with direct tax cuts. Further, while indirect tax cuts have a once-and-for-all effect on the price level, they probably have no lasting effects on the rate of inflation but clearly further stimulate demand. Given the current stance of the single monetary policy set for the euro area, the planned contribution of fiscal policy to the macroeconomic policy mix is inappropriate.(e) The Irish budget for 2001 is expansionary and pro-cyclical and therefore inconsistent with the Council's 2000 broad guidelines of the economic policies, which state that the Irish authorities should "be ready, already in 2000, to use budgetary policy to ensure economic stability given the extent of overheating in the economy; gear the budget for 2001 to this objective". The Commission estimates that restrictive measures equivalent to at least 0,5 % of GDP would offset the expansionary nature of the budgetary plans for 2001,HEREBY RECOMMENDS:1. To remove the inconsistency with the broad guidelines of the economic policies, engendered by the budget plans for 2001, the Irish Government should take countervailing budgetary measures during the current fiscal year. Under the macroeconomic assumptions of the 2000 update in the Stability Programme, this should ensure that no reduction in the underlying budgetary surplus from 2000 takes place.2. The Commission is invited to report during 2001 on economic and budgetary developments in Ireland. The Council will closely monitor these developments and in particular assess consistency with the broad guidelines of the economic policies.This recommendation is addressed to Ireland.Done at Brussels, 12 February 2001.For the CouncilThe PresidentB. Ringholm(1) OJ L 210, 21.8.2000, p. 1.(2) OJ L 209, 2.8.1997, p. 1.


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31991H0561

91/561/EEC: Commission recommendation of 24 October 1991 on the standardization of notices of public contracts

Official Journal L 305 , 06/11/1991 P. 0019 - 0021

COMMISSION RECOMMENDATION  of 24 October 1991  on the standardization of notices of public contracts  (91/561/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regad to the Treaty establishing the European Economic Community, and in particular Article 155, second indent, thereof,  Whereas Council Directives 71/305/EEC (1), 72/277/EEC (2) and 89/440/EEC (3), and Council Directives 77/62/EEC (4) and 88/295/EEC (5), make it compulsory to publish notices in the Official Journal of the European Communities for the procurement  procedures covered by those Directives, and lay down the items of information to be included in the notices published;  Having regard to the declaration by the Council and the Commission (6) on model notices of invitation to tender and the use of new technology during the adoption of Directive 88/295/EEC,  Having regard to the communication from the Commission to the Council on promoting SME participation in public procurement in the Community (7) and the Council's conclusions regarding the potential contribution of more transparent tendering procedures  to improving SME access to public procurement (8),  Whereas standardizing the information contained under each item, with due regard to Community legislation and each Member State's national legislation on the awarding of public contracts, will contribute to better achievement of the objectives of the  policy of opening up public contracts, and in particular to:  - better understanding by competing bidders of the conditions for participation, thanks to a common language of public contract notices, which is fundamental to transparent procedures,  - a reduction in unintentional errors and incorrect application of the Directives by contracting authorities due to misunderstanding of the Community legislation, thanks to the new approach which serves as a guide to users,  - simplification of the task of preparing notices, which will now consist simply of selecting the words or phrases applicable and adding the further information necessary in each case;  Whereas this standardization will also lead to simplification of internal administrative procedures for preparing notices and to a substantial reduction in the cost of free publication in the Supplement to the Official Journal of the European  Communities;  Whereas in order to be fully effective this system also entails adopting nomenclatures for the description of the works, services or supplies being put out to tender;  Whereas it is desirable that the system be finally adopted only after experience has been gained in a transitional period;  Having regard to the favourable opinion of the Advisory Committee on Public Contracts on the solution proposed,  HEREBY FORMULATES THIS RECOMMENDATION: 1. It is recommended that the Member States take the necessary measures to ensure that:  - contracting authorities within the meaning of Article 1 of the abovementioned Directives make optional use, for advertising public contracts in the Official Journal of the European Communities, of standard forms for notices,  - for public works contracts, contracting authorities within the meaning of Directive 71/305/EEC for the Kingdom of Spain, the Hellenic Republic and the Portuguese Republic and within the meaning of that Directive as amended by Directive 89/440/EEC for  the other Member States make optional use of the 'General Public Works Nomenclature' for the description of the work put out to tender.  2. Member States are invited to implement this recommendation not later than 1 January 1992 and to inform the Commission by the same date of the wording of the measures enacted.  3. Member States are invited to inform the Commission not later than 1 January 1993 of their comments, if any, on the implementation of these provisions. Done at Brussels, 24 October 1991. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 185, 16. 8. 1971, p. 5. (2) OJ No L 176, 3. 8. 1972, p. 12. (3) OJ No L 210, 21. 7. 1989, p. 1. (4) OJ No L 13, 15. 1. 1977, p. 1. (5) OJ No L 127, 20. 5. 1988, p. 1. (6) Minutes (Doc. No 5275/88) of the Council, 22. 3. 1988. (7)  COM(90) 166, 7. 5. 1990. (8) Minutes (Doc. No 6617/90) of the Council, 28. 5. 1990.    ANNEX  The standard forms mentioned in the first indent of point 1 of this recommendation and the instructions for their use and the 'General Public Works Nomenclature' mentioned in the second indent of point 1 will be published as  indicated in the following table:       Member State  Language  Publication      Belgium  German  OJ No S 217 A of 16 November 1991      Belgium  French  OJ No S 217 B of 16 November 1991      Belgium  Dutch  OJ No S 217 C of 16 November 1991      Denmark  Danish  OJ No S 217 D of  16 November 1991      Germany  German  OJ No S 217 E of 16 November 1991      Greece (*)  Greek  OJ No S 217 F of 16 November 1991      Spain (*)  Spanish  OJ No S 217 G of 16 November 1991      France  French  OJ No S 217 H of 16 November 1991       Ireland  English  OJ No S 217 I of 16 November 1991      Italy  Italian  OJ No S 217 J of 16 November 1991      Luxembourg  French  OJ No S 217 K of 16 November 1991      Netherlands  Dutch  OJ No S 217 L of 16 November 1991      Portugal (*)   Portuguese  OJ No S 217 M of 16 November 1991      United Kingdom  English  OJ No S 217 N of 16 November 1991     (*) The standard forms for these three Member States will be adapted to the requirements of Directives 88/295/EEC and 89/440/EEC as  from 1 March 1992.


title: Recommendation of the European Systemic Risk Board of 22 December 2011 on the macro-prudential mandate of national authorities (ESRB/2011/3)

text:
               14.2.2012

               EN

               Official Journal of the European Union

               C 41/1

         RECOMMENDATION OF THE EUROPEAN SYSTEMIC RISK BOARD
   of 22 December 2011
   on the macro-prudential mandate of national authorities
   (ESRB/2011/3)
   2012/C 41/01
   THE GENERAL BOARD OF THE EUROPEAN SYSTEMIC RISK BOARD,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 2(2) and 4(2)(a) and Protocol (No 25) on the exercise of shared competence thereof,
   Having regard to Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (1), and in particular Article 3(2)(b), (d) and (f) and Articles 16 to 18 thereof,
   Having regard to Decision ESRB/2011/1 of the European Systemic Risk Board of 20 January 2011 adopting the Rules of Procedure of the European Systemic Risk Board (2), and in particular Article 15(3)(e) and Articles 18 to 20 thereof,
   Whereas:

               (1)

               A well-defined policy framework is a necessary condition for effective macro-prudential policy. With the establishment of the European Systemic Risk Board (ESRB) within the European System of Financial Supervision, a policy framework was put in place for macro-prudential policy at the European Union level, to be exercised through warnings and recommendations, which need to be implemented.

               (2)

               The effectiveness of macro-prudential policy in the Union also depends on the national macro-prudential policy frameworks of the Member States, since the responsibility for the adoption of the measures necessary to maintain financial stability lies first within national frameworks.

               (3)

               Legislative initiatives are currently being discussed in some Member States regarding macro-prudential frameworks.

               (4)

               It is necessary to provide guiding principles on core elements of national macro-prudential mandates, balancing the need for consistency among national approaches with the flexibility to accommodate national specificities.

               (5)

               Setting out explicitly a clear objective would help the national macro-prudential authorities to overcome the bias towards inaction. Macro-prudential policies can be pursued at national level upon the initiative of the national macro-prudential authorities, or as a follow-up to recommendations or warnings from the ESRB.

               (6)

               Generally, macro-prudential policy can be pursued by either a single institution or a board composed of several institutions, depending on the national institutional frameworks. In any case, the entrusted authority should be identified in a clear and transparent way.

               (7)

               Recital 24 of Regulation (EU) No 1092/2010 provides that: ‘the national central banks should have a leading role in macro-prudential oversight because of their expertise and their existing responsibilities in the area of financial stability.’ This conclusion is further strengthened when central banks are also in charge of micro-prudential supervision.

               (8)

               Depending on the national institutional framework, co-operation among authorities with competences influencing financial stability may take different forms, ranging from coordination to exchange of data and information.

               (9)

               The ESRB will discuss potential cross-border policy spill-overs of macro-prudential measures planned by the competent national authorities so as to ensure a minimum degree of coordination and limit possible negative spill-over effects. To this end, the ESRB Secretariat should be informed in advance of significant macro-prudential actions proposed by national authorities, for discussion by the Steering Committee of the ESRB. If deemed appropriate by the Steering Committee, the proposed macro-prudential actions may be drawn to the attention of the General Board.

               (10)

               The tasks and powers of the macro-prudential authority should be clearly defined. Taking into account the impact that the ongoing EU reform of the capital requirements framework for credit institutions (3) might have, the procedures to assign instruments to the macro-prudential authority should allow — within the principles of the relevant legislative framework — for timely adjustments of the policy toolkit in response to innovation and change within the financial system and to the changing nature of risks to financial stability. The macro-prudential authority should justify ex-ante why it needs certain instruments, and have the right of initiative to request the assignment of those instruments. Instruments should include both those that can affect cyclical risks, such as unsustainable levels of leverage, maturity mismatch and credit growth, and those that can affect market structures. An institutional separation between non-binding and binding instruments could be provided for.

               (11)

               Transparency improves the understanding of macro-prudential policies by the financial sector and the public at large, and is a necessary requirement for accountability vis-à-vis the legislature, as the representative of the wider population. Given that the ultimate objective of macro-prudential policy is difficult to quantify, accountability may be phrased in terms of achieving intermediate objectives, or explaining publicly the rationale of the use of macro-prudential instruments.

               (12)

               Pressures can be put on macro-prudential policy makers not to tighten policies in a boom or to loosen them in a bust. In order to safeguard policy credibility, macro-prudential authorities should be shielded against outside pressures through independence. Central banks entrusted with macro-prudential mandates should be independent in the sense of Article 130 of the Treaty.

               (13)

               This Recommendation is without prejudice to the monetary policy mandates of the central banks in the Union, and to the tasks entrusted to the ESRB.

               (14)

               ESRB recommendations are published after informing the Council of the European Union of the General Board’s intention to do so and providing the Council with an opportunity to react,

         HAS ADOPTED THIS RECOMMENDATION:
   SECTION 1

      RECOMMENDATIONS

      Recommendation A —   Objective

   Member States are recommended to:

               1.

               specify that the ultimate objective of macro-prudential policy is to contribute to the safeguard of the stability of the financial system as a whole, including by strengthening the resilience of the financial system and decreasing the build up of systemic risks, thereby ensuring a sustainable contribution of the financial sector to economic growth;

               2.

               ensure that macro-prudential policies can be pursued at national level upon the initiative of the national macro-prudential authority, or as a follow-up to recommendations or warnings from the ESRB.

      Recommendation B —   Institutional arrangements

   Member States are recommended to:

               1.

               designate in the national legislation an authority entrusted with the conduct of macro-prudential policy, generally either as a single institution or as a board composed of the authorities whose actions have a material impact on financial stability. The national legislation should specify the decision-making process of the governing body of the macro-prudential authority;

               2.

               where a single institution is designated as the macro-prudential authority, establish mechanisms for cooperation among all authorities whose actions have a material impact on financial stability, without prejudice to their respective mandates;

               3.

               ensure that the central bank plays a leading role in the macro-prudential policy and that macro-prudential policy does not undermine its independence in accordance with Article 130 of the Treaty;

               4.

               mandate the macro-prudential authority to cooperate and to exchange information also cross-border, in particular by informing the ESRB of the actions taken to address systemic risks at national level.

      Recommendation C —   Tasks, powers, instruments

   Member States are recommended to:

               1.

               entrust the macro-prudential authority as a minimum with the tasks of identifying, monitoring and assessing risks to financial stability and of implementing policies to achieve its objective by preventing and mitigating those risks;

               2.

               ensure that the macro-prudential authority has the power to require and obtain in a timely fashion all national data and information relevant for the exercise of its tasks, including information from micro-prudential and securities market supervisors and information from outside the regulatory perimeter, as well as institution-specific information upon reasoned request and with adequate arrangements to ensure confidentiality. Under the same principles the macro-prudential authority should share with micro-prudential supervisory authorities the data and information relevant for the exercise of the tasks of those authorities;

               3.

               entrust the macro-prudential authority with the power to designate and/or develop the surveillance approaches for identifying, in coordination or together with the micro-prudential and securities market supervisors, the financial institutions and structures that are systemically relevant for the respective Member State, and to determine or recommend on the perimeter of national regulation;

               4.

               ensure that the macro-prudential authority has control over appropriate instruments for achieving its objectives. Where necessary, clear and expeditious procedures should be established for assigning instruments to the macro-prudential authority.

      Recommendation D —   Transparency and accountability

   Member States are recommended to:

               1.

               ensure that macro-prudential policy decisions and their motivations are made public in a timely manner, unless there are risks to financial stability in doing so, and that the macro-prudential policy strategies are set out and published by the macro-prudential authority;

               2.

               entrust the macro-prudential authority with the power to make public and private statements on systemic risk;

               3.

               make the macro-prudential authority ultimately accountable to the national parliament;

               4.

               ensure legal protection for the macro-prudential authority and its staff when they act in good faith.

      Recommendation E —   Independence

   Member States are recommended to ensure that:

               1.

               in the pursuit of its objective, the macro-prudential authority is as a minimum operationally independent, in particular from political bodies and from the financial industry;

               2.

               organisational and financial arrangements do not jeopardise the conduct of macro-prudential policy.

         SECTION 2

      IMPLEMENTATION

   1.   Interpretation

   Terms used in this Recommendation have the following meanings:

               ‘financial institutions’ means financial institutions as defined in Regulation (EU) No 1092/2010;

               ‘financial system’ means financial system as defined in Regulation (EU) No 1092/2010.

         2.   Criteria for implementation

               1.

               The following criteria apply to the implementation of this Recommendation:

                           (a)

                           the recommended measures should be enacted in the national legislation;

                           (b)

                           regulatory arbitrage should be avoided;

                           (c)

                           due regard should be paid to the principle of proportionality in the implementation, with reference to the different systemic significance of the financial institutions, to the different institutional systems, and taking into account the objective and the content of each recommendation;

                           (d)

                           For the purpose of recommendation A:

                                       (i)

                                       intermediate policy objectives may be identified as operational specifications of the ultimate objective;

                                       (ii)

                                       macro-prudential policy should allow action also on measures that have macro-prudential relevance.

               2.

               Addressees are requested to communicate to the ESRB and to the Council the actions taken in response to this Recommendation, or adequately justify inaction. The reports should as a minimum contain:

                           (a)

                           information on the substance and timeline of the actions taken;

                           (b)

                           an assessment of the functioning of the actions taken, from the perspective of the objectives of this Recommendation;

                           (c)

                           detailed justification of any inaction or departure from this Recommendation, including any delays.

         3.   Timeline for the follow-up

               1.

               Addressees are requested to communicate to the ESRB and the Council the actions taken in response to this Recommendation, or adequately justify inaction, as specified in the following paragraphs.

               2.

               By 30 June 2012, addressees communicate to the ESRB an interim report covering at the minimum the following aspects: (a) a statement concerning whether a macro-prudential mandate has been implemented or is planned to be implemented; (b) an examination of the legal basis for the implementation of this Recommendation; (c) the foreseen institutional shaping of the macro-prudential authority and the devised institutional changes; (d) an assessment for each recommendation hereby provided of whether it is or will be covered by the national measures on the macro-prudential mandate and, if not, adequate explanations. The ESRB may inform the addressees of its views on the interim report.

               3.

               By 30 June 2013, addressees communicate the final report to the ESRB and the Council. Recommended measures should be in force not later than the 1 July 2013.

               4.

               The General Board may extend the deadlines in paragraphs 2 and 3 where legislative initiatives are necessary to comply with one or more recommendations.

         4.   Monitoring and assessment

               1.

               The ESRB Secretariat:

                           (a)

                           assists the addressees, including by facilitating coordinated reporting, providing relevant templates and detailing where necessary the modalities and the timeline for the follow-up;

                           (b)

                           verifies the follow-up by the addressees, including by assisting them upon their request, and reports on the follow-up to the General Board via the Steering Committee within two months from the expiry of the deadlines for the follow-up.

               2.

               The General Board assesses the actions and the justifications reported by the addressees and, where appropriate, decides whether this Recommendation has not been followed and the addressees have failed to adequately justify their inaction.

      Done at Frankfurt am Main, 22 December 2011.

            The Chair of the ESRB

         Mario DRAGHI

      (1)  OJ L 331, 15.12.2010, p. 1.

      (2)  OJ C 58, 24.2.2011, p. 4.

      (3)  Commission proposals for a directive of the European Parliament and of the Council on the access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms and amending Directive 2002/87/EC of the European Parliament and of the Council on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (COM(2011) 453 final) and for a regulation of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms (COM(2011) 452 final).


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31996H0280

96/280/EC: Commission Recommendation of 3 April 1996 concerning the definition of small and medium-sized enterprises (Text with EEA relevance)

Official Journal L 107 , 30/04/1996 P. 0004 - 0009

COMMISSION RECOMMENDATION of 3 April 1996 concerning the definition of small and medium-sized enterprises (Text with EEA relevance) (96/280/EC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 155, second indent, thereof,Whereas the implementation of the Integrated Programme in Favour of Small and Medium-Sized Enterprises (SMEs) and the Craft Sector (hereinafter referred to as 'the Integrated Programme`) (1), in accordance with the White Paper on Growth, Competitiveness and Employment, requires the establishment of a coherent, visible and effective framework within which the enterprise policy in favour of SMEs can take its place;Whereas, well before the implementation of the Integrated Programme, various Community policies were targeted at SMEs, each policy using different criteria to define them; whereas a number of Community policies have developed gradually with no joint approach or overall consideration of what, objectively, constitutes an SME; the result being a diversity of criteria used to define an SME and thus, a multiplicity of definitions currently in use at Community level in addition to the definitions used by the European Investment Bank (EIB) and the European Investment Fund (EIF) together with a rather wide range of definitions in the Member States;Whereas many Member States have no general definition and operate ad hoc with rules based on local practice or which apply to particular sectors; whereas others adhere rigidly to the definition contained in the Community guidelines on State aid to SMEs (2);Whereas the existence of different definitions at Community level and at national level can create inconsistencies and can also distort competition between enterprises; whereas the Integrated Programme aims at a more forceful coordination between, on the one hand, the different Community initiatives in favour of SMEs and, on the other hand, between these and the initiatives which exist at national level; whereas these objectives cannot be realized successfully unless the question of the definition of SMEs is clarified;Whereas the Commission's Report to the European Council meeting in Madrid on 15 and 16 December 1995 has underlined that a refocused effort in favour of SMEs is required in order to create more jobs across all sectors of the economy;Whereas the 'Research` Council of 29 September 1994 agreed that preferential treatment for SMEs should be accompanied by a clearer definition of what was meant by a small or medium-sized enterprise; therefore it has requested the Commission to re-examine the criteria to be selected for defining SMEs;Whereas, in a first Report presented in 1992 at the request of the 'Industry` Council held on 28 May 1990, the Commission had already proposed limiting the proliferation of definitions in use at Community level; specifically, it favoured the adoption of the following four criteria: number of persons employed, turnover, balance-sheet total and independence, while proposing thresholds of 50 and 250 employees for small and for medium-sized enterprises respectively;Whereas this definition has been adopted in the Community guidelines on State aid for SMEs and in all the other guidelines or communications concerning State aid which have been adopted or revised since 1992 (it applies in particular to the Commission Communication to the Member States on the accelerated clearance of aid schemes for SMEs and of amendments of existing schemes (3), the guidelines on State aid for environmental protection (4) and the guidelines on State aids for rescuing and restructuring firms in difficulty (5);Whereas other measures adopt this definition wholly or in part, notably the Fourth Council Directive (78/660/EEC) of 25 July 1978 based on Article 54 (3) (g) of the Treaty on the annual accounts of certain types of companies (6), as last amended by Directive 94/8/EC (7), Council Decision 94/217/EEC of 19 April 1994 on the provision of Community interest subsidies on loans for small and medium-sized enterprises extended by the European Investment Bank under its temporary lending facility (8), and the Commission's Communication (9) on the Community SME Initiative under the Structural Funds;Whereas, however, full convergence has not yet been achieved; some programmes still fix very varied thresholds or disregard certain criteria, such as independence;Whereas it is appropriate that this convergence continues and is completed on the basis of the rules set out in the Community guidelines on State aids for SMEs, and that the Commission should apply, in all the policies it administers, the same criteria and the same thresholds which it requires Member States to observe;Whereas in a single market without internal frontiers, the treatment of enterprises must be based on a set of common rules, particularly as regards State support - national or Community;Whereas this approach is all the more necessary in view of the extensive interaction between national and Community measures assisting SMEs, for example as regards Structural Funds and research; it means that situations in which the Community targets its action on a certain category of SMEs and the Member States on another must be avoided;Whereas application of the same definition by the Commission, the Member States, the EIB and the EIF would reinforce the consistency and effectiveness of policies targeting SMEs and would, therefore, limit the risk of distortion of competition; whereas, moreover, many programmes intended for SMEs are co-financed by the Member States and the European Community and, in some cases, by the EIB and the EIF;Whereas before proposing thresholds for defining SMEs, it should be pointed out that this attempt to rationalize and lay down a reference standard does not mean that enterprises which exceed these thresholds do not deserve State or Community attention; however it would be more appropriate to solve this problem through specific measures in the framework of the relevant programmes, in particular international cooperation programmes, rather than by adopting or maintaining a different SME definition;Whereas the criterion of number of persons employed is undoubtedly one of the most important and must be regarded as imperative but that introducing a financial criterion is a necessary complement in order to grasp the real importance and performance of an enterprise and its position compared to its competitors;Whereas, however, it would not be desirable to adopt turnover as the sole financial criterion because enterprise in the trade and distribution sector have by their nature higher turnover figures than those in the manufacturing sector, thus the turnover criterion should be combined with that of the balance sheet total, a criterion which represents the overall wealth of a business, with the possibility of one of these two financial criteria being exceeded;Whereas independence is also a basic criterion in that an SME belonging to a large group has access to funds and assistance not available to competitors of equal size; whereas there is also a need to rule out legal entities composed of SMEs which form a grouping whose actual economic power is greater than that of an SME;Whereas, in respect of the independence criterion, the Member States, the EIB and the EIF should ensure that the definition is not circumvented by those enterprises which, whilst formally meeting this criterion, are in fact controlled by one large enterprise or jointly by several large enterprises;Whereas stakes held by public investment corporations or venture capital companies do not normally change the character of a firm from that of an SME, and may therefore be disregarded; the same applies to stakes held by institutional investors, who usually maintain an 'arm's-length` relationship with the company in which they have invested;Whereas a solution must be found to the problem of joint stock enterprises which, although they are SMEs, cannot state with any accuracy the composition of their share ownership due to the way in which their capital is dispersed and the anonymity of their shareholders and cannot therefore know whether they meet the condition of independence;Whereas, therefore, fairly strict criteria must be laid down for defining SMEs if the measures aimed at them are genuinely to benefit the enterprises for which size represents a handicap;Whereas the threshold of 500 employees is not truly selective, since it encompasses almost all enterprises (99,9 % of the 14 million enterprises) and almost three-quarters of the European economy in terms of employment and turnover; furthermore, an enterprise with 500 employees has access to human, financial and technical resources which fall well outside the framework of the medium-sized enterprise, namely ownership and management in the same hands, often family-owned, and lack of a dominant position on the market;Whereas, not only do enterprises between 250 and 500 employees often have very strong market positions but they also possess very solid management structures in the fields of production, sales, marketing, research and personnel management, which clearly distinguish them from medium-sized enterprises with up to 250 employees; whereas in the latter group, such structures are far more fragile; whereas the threshold of 250 persons employed is therefore a more meaningful reflection of the reality of an SME;Whereas this threshold of 250 employees is already the most prevalent among the definitions used at Community level and whereas it has been taken up in the legislation of many Member States as a result of the Community guidelines on State aid for SMEs; whereas the EIB had also decided to use this definition for a substantial part of the loans granted in the framework of the 'SME facility` provided for in Decision 94/217/EEC;Whereas, according to Eurostat figures, the turnover of an enterprise with 250 employees does not exceed ECU 40 million (1994 figures); whereas it would therefore appear reasonable to apply a threshold for turnover of ECU 40 million; whereas recent calculations show that the average ratio between turnover and balance sheet total is 1:5 or SMEs and small enterprises (10), whereas, as a result, the threshold for the balance-sheet total should be fixed at ECU 27 million;Whereas, however, a distinction must be drawn, within SMEs, between medium-sized enterprises, small enterprises and micro-enterprises; whereas the latter should not be confused with craft enterprises, which will continue to be defined at national level due to their specific characteristics;Whereas thresholds for small enterprises must be fixed in the same way, meaning thresholds of ECU 7 million for turnover, and ECU 5 million for balance-sheet total;Whereas the thresholds chosen do not necessarily reflect the average SME or small enterprise but represent ceilings designed to allow all enterprises having the characteristics of an SME or a small enterprise to be included within one or other of the categories;Whereas the turnover and balance-sheet total thresholds laid down for defining SMEs should be revised as the need arises to take account of changing economic circumstances such as price levels and increases in the productivity of enterprises;Whereas the Community guidelines on State aids for SMEs will be aligned by replacing the currently used definitions with a reference to those set out in this Recommendation;Whereas it is necessary to provide that when the Fourth Council Directive 78/660/EEC, which affords Member States the right to exempt SMEs from certain obligations relating to the publication of their accounts, is next amended, the Commission will propose that the existing definition be replaced by a reference to this Recommendation;Whereas it would also be desirable for evaluations made of measures in favour of SMEs that the Commission, the Member States, the EIB and the EIF state exactly which enterprises benefit from them, distinguishing various categories of SME according to size, as greater knowledge of the recipients makes it possible to adjust and better target the measures proposed for SMEs, and consequently renders them more effective;Whereas, given that a certain degree of flexibility must be permitted to the Member States, the EIB and the EIF to fix thresholds lower than the Community thresholds if they wish to direct their measures towards a specific category of SME, these thresholds represent only maximum limits;Whereas it is also possible for the Member States, the EIB and the EIF, for reasons of administrative simplification, to retain only one criterion, notably that of the number of employees, for the implementation of some of their policies. However, this flexibility does not apply to the various State aid frameworks where the financial criteria must also be respected;Whereas this Recommendation concerns only the definition of SMEs used in Community policies applied within the Community and the European Economic Area,MAKES THIS RECOMMENDATION:Article 1 Member States, the European Investment Bank and the European Investment Fund are invited:- to comply with the provisions set out in Article 1 of the Annex for their programmes directed towards 'SMEs`, 'medium-sized enterprises`, 'small enterprises` or 'micro-enterprises`,- to comply with the ceilings chosen for the turnover and balance-sheet total where they are amended by the Commission in accordance with Article 2 of the Annex,- to take the necessary steps with a view to using the size classes set out in Article 3 (2) of the Annex, especially where the monitoring of Community financial instruments is concerned.Article 2 The thresholds specified in Article 1 of the Annex are to be regarded as ceilings. Member States, the European Investment Bank and the European Investment Fund may, in certain cases, choose to fix lower thresholds. In implementing certain of their policies, they may also choose to apply only the criterion of number of employees, except in fields to which the various rules on State aid apply.Article 3 To enable the Commission to evaluate what progress has been made, Member States, the European Investment Bank and the European Investment Fund are invited to inform the Commission, before 31 December 1977, of the measures they have taken to comply with this Recommendation.Article 4 This Recommendation concerns the definition of SMEs in Community policies applied within the Community and the European Economic Area and is addressed to the Member States, the European Investment Bank and the European Investment Fund.Done at Brussels, 3 April 1996.For the CommissionChristos PAPOUTSISMember of the Commission(1) COM(94) 207 final.(2) OJ No C 213, 19. 8. 1992, p. 2.(3) OJ No C 213, 19. 8. 1992, p. 10.(4) OJ No C 72, 10. 3. 1994, p. 3, footnote 16.(5) OJ No C 368, 23.12. 1994, p. 12.(6) OJ No L 222, 14. 8. 1978, p. 11.(7) OJ No L 82, 25. 3. 1994, p. 33.(8) OJ No L 107, 28. 4. 1994 p. 57; see Commission Report on this matter (COM(94) 434 final of 19 October 1994).(9) OJ No C 180, 1. 7. 1994, p. 10.(10) Source: 'BACH` (harmonized accounts) database.ANNEX DEFINITION OF SMALL AND MEDIUM-SIZED ENTERPRISES ADOPTED BY THE COMMISSION Article 1 1. Small and medium-sized enterprises, hereinafter referred to as 'SMEs`, are defined as enterprises which:- have fewer than 250 employees, and- have either,an annual turnover not exceeding ECU 40 million, oran annual balance-sheet total not exceeding ECU 27 million,- conform to the criterion of independence as defined in paragraph 3.2. Where it is necessary to distinguish between small and medium-sized enterprises, the 'small enterprise` is defined as an enterprise which:- has fewer than 50 employees and- has either,an annual turnover not exceeding ECU 7 million, oran annual balance-sheet total not exceeding ECU 5 million,- conforms to the criterion of independence as defined in paragraph 3.3. Independent enterprises are those which are not owned as to 25 % or more of the capital or the voting rights by one enterprise, or jointly by several enterprises, falling outside the definition of an SME or a small enterprise, whichever may apply. This threshold may be exceeded in the following two cases:- if the enterprise is held by public investment corporations, venture capital companies or institutional investors, provided no control is exercised either individually or jointly,- if the capital is spread in such a way that it is not possible to determine by whom it is held and if the enterprise declares that it can legitimately presume that it is not owned as to 25 % or more by one enterprise, or jointly by several enterprises, falling outside the definitions of an SME or a small enterprise, whichever may apply.4. In calculating the thresholds referred to in paragraphs 1 and 2, it is therefore necessary to cumulate the relevant figures for the beneficiary enterprise and for all the enterprises which it directly or indirectly controls through possession of 25 % or more of the capital or of the voting rights.5. Where it is necessary to distinguish micro-enterprises from other SMEs, these are defined as enterprises having fewer than 10 employees.6. Where, at the final balance sheet date, an enterprise exceeds or falls below the employee thresholds or financial ceilings, this is to result in its acquiring or losing the status of 'SME`, 'medium-sized enterprise`, 'small enterprise` or 'micro-enterprise` only if the phenomenon is repeated over two consecutive financial years.7. The number of persons employed corresponds to the number of annual working units (AWU), that is to say, the number of full-time workers employed during one year with part-time and seasonal workers being fractions of AWU. The reference year to be considered is that of the last approved accounting period.8. The turnover and balance sheet total thresholds are those of the last approved 12-month accounting period. In the case of newly-established enterprises whose accounts have not yet been approved, the thresholds to apply shall be derived from a reliable estimate made in the course of the financial year.Article 2 The Commission will amend the ceilings chosen for the turnover and balance-sheet total as the need arises and normally every four years from the adoption of this Recommendation, to take account of changing economic circumstances in the Community.Article 3 1. The Commission undertakes to adopt the appropriate measures to ensure that the definition of SMEs, as set out in Article 1, applies to all programmes managed by it in which the terms 'SME`, 'medium-sized enterprise`, 'small enterprise` or 'micro-enterprise` are mentioned.2. The Commission undertakes to adopt the appropriate measures to adapt the statistics that it produces in line with the following size-classes:- 0 employees,- 1 to 9 employees,- 10 to 49 employees,- 50 to 249 employees,- 250 to 499 employees,- 500 employees plus.3. Current Community programmes defining SMEs with criteria other than those mentioned in Article 1 will continue, during a transitional period, to be implemented to the benefit of the enterprises which were considered SMEs when these programmes were adopted. Any modification of the SME definition within these programmes can be made only by adopting the definition contained herein and by replacing the divergent definition with a reference to this Recommendation. This transitional period should in principle end at the latest on 31 December 1997. However, legally binding commitments entered into by the Commission on the basis of these programmes will remain unaffected.4. When the Fourth Council Directive 78/660/EEC is amended, the Commission will propose that the existing criteria for defining SMEs be replaced by a reference to the definition contained in this Recommendation.5. Any provisions adopted by the Commission which mention the terms 'SME`, 'medium-sized enterprise`, 'small enterprise` or 'micro-enterprise`, or any other such term, will refer to the definition contained in this Recommendation.


title: Council Recommendation of 8 June 2009 on an action in the field of rare diseases

text:
               3.7.2009

               EN

               Official Journal of the European Union

               C 151/7

      COUNCIL RECOMMENDATION

   of 8 June 2009
   on an action in the field of rare diseases
   2009/C 151/02
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular the second subparagraph of Article 152(4) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Parliament (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Whereas:

               (1)

               Rare diseases are a threat to the health of EU citizens insofar as they are life-threatening or chronically debilitating diseases with a low prevalence and a high level of complexity. Despite their rarity, there are so many different types of rare diseases that millions of people are affected.

               (2)

               The principles and overarching values of universality, access to good quality care, equity and solidarity, as endorsed in the Council conclusions on common values and principles in EU health systems of 2 June 2006, are of paramount importance for patients with rare diseases.

               (3)

               The Community action programme on rare diseases, including genetic diseases, was adopted for the period 1 January 1999 to 31 December 2003 (3). This programme defined the prevalence for a rare disease as affecting no more than 5 per 10 000 persons in the EU. A more refined definition based on updated scientific review, taking into account both prevalence and incidence, will be developed using the Second Community Health Programme (4) resources.

               (4)

               Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (5) provides that a medicinal product shall be designated as an ‘orphan medicinal product’ when intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10 000 persons in the Community when the application is made.

               (5)

               It is estimated that between 5 000 and 8 000 distinct rare diseases exist today, affecting between 6 % and 8 % of the population in the course of their lives. In other words, although rare diseases are characterised by low prevalence for each of them, the total number of people affected by rare diseases in the EU is between 27 and 36 million. Most of them suffer from less frequently occurring diseases affecting one in 100 000 people or less. These patients are particularly isolated and vulnerable.

               (6)

               Because of their low prevalence, their specificity and the high total number of people affected, rare diseases call for a global approach based on special and combined efforts to prevent significant morbidity or avoidable premature mortality, and to improve the quality of life and socioeconomic potential of affected persons.

               (7)

               Rare diseases were one of the priorities of the Community's sixth framework programme for research and development (6) and continue to be a priority for action in its seventh framework programme for research and development (7), as developing new diagnostics and treatments for rare disorders, as well as performing epidemiological research on those disorders, require multi-country approaches in order to increase the number of patients for each study.

               (8)

               The Commission, in its White Paper ‘Together for Health: A Strategic Approach for the EU 2008-2013’ of 23 October 2007, which develops the EU Health Strategy, identified rare diseases as a priority for action.

               (9)

               In order to improve the coordination and coherence of national, regional and local initiatives addressing rare diseases and cooperation between research centres, relevant national actions in the field of rare diseases could be integrated into plans or strategies for rare diseases.

               (10)

               According to the Orphanet database, of the thousands of known rare diseases for which a clinical identification is possible, only 250 of them have a code in the existing International Classification of Diseases (ICD) (10th version). An appropriate classification and codification of all rare diseases is necessary in order to give them the necessary visibility and recognition in national health systems.

               (11)

               In 2007 the World Health Organisation (WHO) launched the process of revision of the 10th version of the ICD in order to adopt the new, 11th version of this classification at the World Health Assembly in 2014. The WHO has appointed the Chair of the EU Rare Diseases Task Force as the Chair of the Topic Advisory Group on Rare Diseases in order to contribute to this process of revision, providing proposals for codification and classification of rare diseases.

               (12)

               The implementation of a common identification of rare diseases by all the Member States would strongly reinforce the contribution of the EU in this topic advisory group and would facilitate cooperation at Community level in the field of rare diseases.

               (13)

               In July 2004, a Commission High-Level Group on Health Services and Medical Care was established to bring together experts from all Member States to work on practical aspects of collaboration between national health systems in the EU. One of this High-Level Group's working groups is focusing on European Reference Networks (ERNs) for rare diseases. Some criteria and principles for ERNs have been developed, including their role in tackling rare diseases. ERNs could also serve as research and knowledge centres, treating patients from other Member States and ensuring the availability of subsequent treatment facilities where necessary.

               (14)

               The Community added value of ERNs is particularly high for rare diseases by reason of the rarity of these conditions, which implies both a limited number of patients and a scarcity of expertise within a single country. Gathering expertise at European level is therefore paramount in order to ensure equal access to accurate information, appropriate and timely diagnosis and high quality care for rare disease patients.

               (15)

               In December 2006 an expert group of the European Union Rare Diseases Task Force issued a report ‘Contribution to policy shaping: for a European collaboration on health services and medical care in the field of rare diseases’ to the High-Level Group on Health Services and Medical Care. The expert group report outlines, inter alia, the importance of identifying centres of expertise and the roles that such centres should fulfil. It is also agreed that, in principle and where possible, expertise should travel rather than patients themselves. Some measures called for in the report are included in this recommendation.

               (16)

               Cooperation and knowledge sharing between centres of expertise has proven to be a very efficient approach to dealing with rare diseases in Europe.

               (17)

               The centres of expertise could follow a multidisciplinary approach to care, in order to address the complex and diverse conditions implied by rare diseases.

               (18)

               The specificities of rare diseases — a limited number of patients and a scarcity of relevant knowledge and expertise — single them out as a unique domain of very high added value of action at Community level. This added value can especially be achieved through gathering national expertise on rare diseases which is scattered throughout the Member States.

               (19)

               It is of utmost importance to ensure an active contribution of the Member States to the elaboration of some of the common instruments foreseen in the Commission communication on rare diseases: Europe's challenges of 11 November 2008, especially on diagnostics and medical care and European guidelines on population screening. This could be also the case for the assessment reports on the therapeutic added value of orphan medicinal products, which could contribute to accelerating the price negotiation at national level, thereby reducing delays for access to orphan drugs for rare diseases patients.

               (20)

               The WHO defined empowerment of patients as a ‘pre-requisite for health’ and encouraged a ‘proactive partnership and patient self-care strategy to improve health outcomes and quality of life among the chronically ill’ (8). In this sense, the role of independent patient groups is crucial both in terms of direct support to individuals living with the disease and in terms of the collective work they carry out to improve conditions for the community of rare disease patients as a whole and for the next generations.

               (21)

               Member States should aim to involve patients and patients′ representatives in the policy process and seek to promote the activities of patient groups.

               (22)

               The development of research and healthcare infrastructures in the field of rare diseases requires long-lasting projects and therefore an appropriate financial effort to ensure their sustainability in the long term. This effort would notably maximise the synergy with the projects developed under the second community health programme, the seventh framework programme for research and development and the successors of these programmes,

         HEREBY RECOMMENDS THAT MEMBER STATES:
   I.   PLANS AND STRATEGIES IN THE FIELD OF RARE DISEASES

               1.

               Establish and implement plans or strategies for rare diseases at the appropriate level or explore appropriate measures for rare diseases in other public health strategies, in order to aim to ensure that patients with rare diseases have access to high-quality care, including diagnostics, treatments, habilitation for those living with the disease and, if possible, effective orphan drugs, and in particular:

                           (a)

                           elaborate and adopt a plan or strategy as soon as possible, preferably by the end of 2013 at the latest, aimed at guiding and structuring relevant actions in the field of rare diseases within the framework of their health and social systems;

                           (b)

                           take action to integrate current and future initiatives at local, regional and national levels into their plans or strategies for a comprehensive approach;

                           (c)

                           define a limited number of priority actions within their plans or strategies, with objectives and follow-up mechanisms;

                           (d)

                           take note of the development of guidelines and recommendations for the elaboration of national action for rare diseases by relevant authorities at national level in the framework of the ongoing european project for rare diseases national plans development (EUROPLAN) selected for funding over the period 2008-2011 in the first programme of Community action in the field of public health (9).

         II.   ADEQUATE DEFINITION, CODIFICATION AND INVENTORYING OF RARE DISEASES

               2.

               Use for the purposes of Community-level policy work a common definition of rare disease as a disease affecting no more than 5 per 10 000 persons.

               3.

               Aim to ensure that rare diseases are adequately coded and traceable in all health information systems, encouraging an adequate recognition of the disease in the national healthcare and reimbursement systems based on the ICD while respecting national procedures.

               4.

               Contribute actively to the development of the EU easily accessible and dynamic inventory of rare diseases based on the Orphanet network and other existing networks as referred to in the Commission Communication on rare diseases.

               5.

               Consider supporting at all appropriate levels, including the Community level, on the one hand, specific disease information networks and, on the other hand, for epidemiological purposes, registries and databases, whilst being aware of an independent governance.

         III.   RESEARCH ON RARE DISEASES

               6.

               Identify ongoing research and research resources in the national and Community frameworks in order to establish the state of the art, assess the research landscape in the area of rare diseases, and improve the coordination of Community, national and regional programmes for rare diseases research.

               7.

               Identify needs and priorities for basic, clinical, translational and social research in the field of rare diseases and modes of fostering them, and promote interdisciplinary cooperative approaches to be complementarily addressed through national and Community programmes.

               8.

               Foster the participation of national researchers in research projects on rare diseases funded at all appropriate levels, including the Community level.

               9.

               Include in their plans or strategies provisions aimed at fostering research in the field of rare diseases.

               10.

               Facilitate, together with the Commission, the development of research cooperation with third countries active in research on rare diseases and more generally with regard to the exchange of information and the sharing of expertise.

         IV.   CENTRES OF EXPERTISE AND EUROPEAN REFERENCE NETWORKS FOR RARE DISEASES

               11.

               Identify appropriate centres of expertise throughout their national territory by the end of 2013, and consider supporting their creation.

               12.

               Foster the participation of centres of expertise in European reference networks respecting the national competences and rules with regard to their authorisation or recognition.

               13.

               Organise healthcare pathways for patients suffering from rare diseases through the establishment of cooperation with relevant experts and exchange of professionals and expertise within the country or from abroad when necessary.

               14.

               Support the use of information and communication technologies such as telemedicine where it is necessary to ensure distant access to the specific healthcare needed.

               15.

               Include, in their plans or strategies, the necessary conditions for the diffusion and mobility of expertise and knowledge in order to facilitate the treatment of patients in their proximity.

               16.

               Encourage centres of expertise to be based on a multidisciplinary approach to care when addressing rare diseases.

         V.   GATHERING THE EXPERTISE ON RARE DISEASES AT EUROPEAN LEVEL

               17.

               Gather national expertise on rare diseases and support the pooling of that expertise with European counterparts in order to support:

                           (a)

                           the sharing of best practices on diagnostic tools and medical care as well as education and social care in the field of rare diseases;

                           (b)

                           adequate education and training for all health professionals to make them aware of the existence of these diseases and of resources available for their care;

                           (c)

                           the development of medical training in fields relevant to the diagnosis and management of rare diseases, such as genetics, immunology, neurology, oncology or paediatrics;

                           (d)

                           the development of European guidelines on diagnostic tests or population screening, while respecting national decisions and competences;

                           (e)

                           the sharing Member States′ assessment reports on the therapeutic or clinical added value of orphan drugs at Community level where the relevant knowledge and expertise is gathered, in order to minimise delays in access to orphan drugs for rare disease patients.

         VI.   EMPOWERMENT OF PATIENT ORGANISATIONS

               18.

               Consult patients and patients′ representatives on the policies in the field of rare diseases and facilitate patient access to updated information on rare diseases.

               19.

               Promote the activities performed by patient organisations, such as awareness-raising, capacity-building and training, exchange of information and best practices, networking and outreach to very isolated patients.

         VII.   SUSTAINABILITY

               20.

               Together with the Commission, aim to ensure, through appropriate funding and cooperation mechanisms, the long-term sustainability of infrastructures developed in the field of information, research and healthcare for rare diseases.

         HEREBY INVITES THE COMMISSION:

               1.

               To produce, by the end of 2013 and in order to allow proposals in any possible future programme of Community action in the field of health, an implementation report on this recommendation addressed to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions and based on the information provided by the Member States, which should consider the extent to which the proposed measures are working effectively and the need for further action to improve the lives of patients affected by rare diseases and those of their families.

               2.

               To inform the Council of the follow-up to the Commission Communication on rare diseases on a regular basis.

      Done at Luxembourg, 8 June 2009.

            For the Council

            The President

         Petr ŠIMERKA

      (1)  Legislative resolution of 23 April 2009 (not yet published in the Official Journal).

      (2)  Opinion of 25 February 2009 (not yet published in the Official Journal).

      (3)  Decision No 1295/1999/EC of the European Parliament and of the Council of 29 April 1999 adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003) (OJ L 155, 22.6.1999, p. 1). Decision repealed by Decision No 1786/2002/EC (OJ L 271, 9.10.2002, p. 1).

      (4)  Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-2013) (OJ L 301, 20.11.2007, p. 3).

      (5)  OJ L 18, 22.1.2000, p. 1.

      (6)  Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning the sixth framework programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002 to 2006) (OJ L 232, 29.8.2002, p. 1).

      (7)  Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1).

      (8)  http://www.euro.who.int/Document/E88086.pdf

      (9)  Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (OJ L 271, 9.10.2002, p. 1).