Faster access of patients to new medicines Revised Transparency Directive
|
|
- Barry Ramsey
- 5 years ago
- Views:
Transcription
1 MEMO/12/148 Brussels, 1 March 2012 Faster access of patients to new medicines Revised Transparency Directive Today the Commission adopted the Directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems. The new Directive shall repeal and replace Directive 89/105/EEC ("so-called Transparency Directive"). Reflecting a reality dating back twenty years ago, the Directive needed to be updated so as to take into consideration the evolution of pricing and reimbursement policies in the Member States. Member States are responsible for healthcare systems Member States are responsible for the organisation of their healthcare system and for the delivery of health services and medical care. Each Member State can take measures to manage the consumption of medicines, regulate their prices or establish the conditions of their public funding. In the EU, medicinal products can be placed on the market only if they have received a marketing authorisation from the European Commission or from the competent national authorities. Marketing authorisations are granted in accordance with harmonised rules intended to ensure the quality, safety and efficacy of medicines. 1 Once the marketing authorisation is granted, it is up to the Member States to decide whether the medicine is eligible to reimbursement. National authorities use sophisticated methodologies, such as health technology assessments*, to evaluate the added-value or the effectiveness of innovative medicines in view of determining their price and reimbursement conditions. 2 1 Directive 2001/83/EC as amended, OJ L311, 28/11/2004, p. 67, and Regulation (EC) N 726/2004, OJ L 136, , p. 1. (1) 2 health technology assessment means an assessment of the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition.
2 Barriers to trade The described national measures are susceptible to create barriers to trade as they affect the capacity of pharmaceutical companies to sell their products in domestic markets. According to the Treaty, Member States are responsible for the organisation of their own health systems and for the allocation of resources devoted to healthcare (Article 168 TFEU). However, Basic procedural obligations must be met to ensure that the pricing and reimbursement measures are compatible with Single Market rules: in particular, pricing and reimbursement measures must be free of discrimination against imported medicinal products. The directive does not affect the definition of national pricing and reimbursement policies, nor does it dictate the decisions that Member States should take in this field. What is the aim of the existing so-called "Transparency Directive"? The "Transparency Directive" lays down a general procedural framework to ensure the transparency of measures regulating the pricing and reimbursement of medicinal products. To prevent that national measures do not create barriers within the internal market, the directive lays down a series of procedural requirements applicable to any national measure regulating the prices of medicines and their inclusion in the scope of health insurance systems. Main obligations of the existing Directive 89/105/EEC (see also figure below): - Strict time limits - Rule = 90 days from receipt of application for decisions on prices and 90 days for decisions on reimbursement schemes (or 180 days for both pricing and reimbursement decisions altogether) - Reasons for such decisions based on transparent criteria - Objective and verifiable criteria must be defined and published; - Individual decisions must be motivated in light of these criteria (statement of reasons to applicant) - Legal remedies - applicants must be informed of the legal remedies available and timeframe to appeal (independent judicial body) Reasons for review Member States have been confronted to a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems. In particular, Member States authorities have implemented a broad range of measures to control the prescription of medicines, to regulate their prices or to establish the conditions of their public funding. Thus the conditions of Directive 89/105/EEC have fundamentally changed since 1989, for instance with the emergence of generic medicines providing cheaper versions of existing products or the development of increasingly innovative (yet often expensive) research-based medicinal products. This situation not only results in legal uncertainties but also in a reduced transparency of national pricing and reimbursement measures, which negatively affects the smooth functioning of the internal market to the detriment of European patients and pharmaceutical companies. 2
3 Secondly, the time limits for pricing and reimbursement decisions are regularly exceeded by Member States. This leads to delays in the marketing of medicinal products, which in turn slows down the availability of valuable treatments for patients. One OECD study shows that the number of days from pricing and reimbursement application to decision, during can reach even 700 days. 3 The same study shows that for the same period, six Member States have delays that exceed the 180 day period stipulated by the Transparency Directive. With regard to generics, the European Generic Medicines Association (EGA) observed that generic companies wait on average 153 days after marketing authorisation to receive pricing and reimbursement status. 4 In the case of generics as well, there are delays that can exceed 250 days in some Member States. Average number of days for pricing and reimbursement decisions 2004 compared to OECD (2008) Health Policy Studies Pharmaceutical Pricing Policies in a Global Market, pg European Generic Medicines Association (2009) How to increase patient access to generic medicines in the European Union. 3
4 Time delays by country for pricing and reimbursement approval Source: EGA Time delay (in days) for P&R approval for a generic medicine after granting of market authorisation (2005) Source: EGA 4
5 Proposed changes Shorter time limits for originator medicinal products The proposal provides for shorter time limits for the adoption of pricing and reimbursement decisions for medicinal products in general: 120 days instead of 180 days, except for more complex procedures which remain subject to the 180 days rule. The time-limits laid down in the current directive have been set to reflect a balance between three equally important factors: - the need for Member States to assess the (added) value of medicines that may eventually be financed from public funds; - the objective of market access for pharmaceutical companies in order to recoup their costs: R&D costs are particularly high for the research-based pharmaceutical industry and any delay in launching a product reduces the period of protection during which investments can be recouped and profits can be earned; - the necessity for patients to have access to the medicinal products authorised by the competent EU or national authorities as quickly as possible. The reduction of time limits for originators is meant to ensure: - Earlier patient access to medicines and associated welfare gains. - Earlier return on investment for pharmaceutical companies, with potentially positive effects on research and innovation. Delayed pricing and reimbursement decisions postpone market access or, at least, defer the availability of medicines under the national health system. Such delays affect patients and research-based companies (see figure below). Impact of pricing and reimbursement delays Originator products 5
6 Shorter time limits for generic medicines The proposal provides for shorter time-limits for generic medicinal products: 30 days instead of 180 days. For new medicines, national authorities use sophisticated methodologies, such as health technology assessments, to evaluate the added-value or the effectiveness of innovative medicines in view of determining their price and reimbursement conditions. However, pricing and reimbursement procedures for generic medicines should logically not require any new or detailed assessment since the characteristics of the product are already well known. Therefore, a dramatic reduction of the time-limits is justified and necessary. The conclusions of the Pharmaceutical Sector Inquiry pointed to delays regarding the entry of generic medicines into EU markets after the loss of exclusivity of the originator products. The Pharmaceutical Sector Inquiry demonstrated, based on a sample of medicines analysed during the period , that it took more than seven months (on a weighed average basis) for generic entry to occur once originator medicines lost exclusivity. 5 It concluded that savings due to generic entry could have been 20% higher than they actually were, if entry had taken place immediately following loss of exclusivity. According to the in-depth analysis of this sample, the aggregate expenditure amounting to about 50 billion for the period after loss of exclusivity would have been about 15 billion higher without generic entry (evaluated at constant volumes). However, additional savings of some 3 billion could have been attained, had entry taken place immediately. 6 Delays in time to market generic medicinal products affect patients and generic companies, but also national healthcare systems (see figure below). 5 6 Commission Communication on the Pharmaceutical Sector Inquiry, Section 2.1.2; Staff Working Document, 191 et seq. Commission Communication on the Pharmaceutical Sector Inquiry, Section 2.1.2; Staff Working Document,
7 Impact of pricing and reimbursement delays Generic products The reduction of the time-limit for generics is meant to: - Ensure earlier market access for generic products, earlier price competition in off-patent market. - Achieve significant savings for public health budgets Other changes: - Measures meant to increase the effectiveness of the directive by proposing strong enforcement measures, i.e. in case of non-compliance with the time limits, a Member State has to designate a body entrusted with the powers to take rapid measures such as: - adopting interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned; - awarding damages to the applicant; - imposing a penalty payment, calculated by day of delay. - Obligation for MS to regularly report on the actual timing for pricing and reimbursement decisions. - Obligation for MS to notify national pricing and reimbursement measures at a draft stage in order to allow the Commission to check compliance with transparency requirements and to prevent problems. - Measures meant to ensure legal clarity and consistency with the Court of Justice case-law and clarifying the scope of transparency obligations. - Measures meant to address the uncertainties relating to innovative pricing and reimbursement procedures: e.g. exclusion of tendering (covered by public procurement law) and of managed entry agreements (covered by contractual/administrative law) from the scope of application of the Directive. - Prohibition of "patent linkage" - The Directive stipulates that the protection of intellectual property rights shall not be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system. 7
8 Which are the characteristics of the pharmaceutical sector in the EU? The pharmaceutical sector plays a strategic role in Europe by contributing to public health, scientific innovation and economic wealth. Medicines improve the level of welfare of European citizens. They are also vital to our economy as the pharmaceutical sector relies upon a highly skilled, research-driven industry which generates employment and fuels economic growth. There are approximately 4,000 pharmaceutical companies in the EU, representing 630,000 employees and generating a global turnover close to 200bn. Roughly three fourth of these companies develop originator medicinal products, while the remaining fourth manufactures generic medicinal products. The structure of the pharmaceutical sector is specific and unique. It is characterised by a wide variety of market players and a high degree of regulation across the supply chain. Public intervention in the pharmaceutical market is crucial to achieve multiple objectives, which range from ensuring a high level of public health to supporting innovation and keeping public expenditure under control. In all EU countries, healthcare expenditure is to a large extent subsidised by public budgets and governments seek to ensure the sustainable provision of medicines to their citizens in the framework of public health insurance systems. This is another major characteristic of the EU pharmaceutical market: a large share of pharmaceutical expenditure is publicly financed, with 50 to 80% of the pharmaceutical bill paid from public budgets in the Member States. The share of pharmaceutical expenditure which is not financed by the State is either supported by patients or covered by private health insurance schemes. 8
9 Public share of pharmaceutical expenditure in OECD countries Note: data for Belgium and Greece not available Source: OECD Health Data 2007 in Pharmaceutical Pricing Policies in a Global Market (OECD Health Policy Studies, 2008). Since the 1980s, EU countries have been confronted to a constant increase in health and pharmaceutical expenditure. Nevertheless, public spending on medicines has been increasing more than total health expenditure and at a quicker rate than economic growth measured in terms of GDP. 9
Directive 2011/7/EU. of the European Parliament and of the Council of 16 February 2011 on combating late payment in commercial transactions
Directive 2011/7/EU of the European Parliament and of the Council of 16 February 2011 on combating late payment in commercial transactions THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
More informationEUROPEAN UNION. Brussels, 13 January 2011 (OR. en) 2009/0054 (COD) PE-CONS 57/10 MI 395 COMPET 304 IND 128 ECO 87 FIN 498 CODEC 1104
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Brussels, 13 January 2011 (OR. en) 2009/0054 (COD) PE-CONS 57/10 MI 395 COMPET 304 IND 128 ECO 87 FIN 498 CODEC 1104 LEGISLATIVE ACTS AND OTHER INSTRUMTS
More informationL 145/30 Official Journal of the European Union
L 145/30 Official Journal of the European Union 31.5.2011 REGULATION (EU) No 513/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2011 amending Regulation (EC) No 1060/2009 on credit rating
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2009R0987 EN 01.01.2014 004.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EC) No 987/2009 OF THE EUROPEAN PARLIAMENT
More information(recast) (Text with EEA relevance)
29.3.2014 Official Journal of the European Union L 96/107 DIRECTIVE 2014/31/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating
More informationOfficial Journal of the European Union L 78/41
20.3.2013 Official Journal of the European Union L 78/41 REGULATION (EU) No 229/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 March 2013 laying down specific measures for agriculture in favour
More informationEBA FINAL draft Regulatory Technical Standards
EBA/RTS/2016/05 27 July 2016 EBA FINAL draft Regulatory Technical Standards on separation of payment card schemes and processing entities under Article 7 (6) of Regulation (EU) 2015/751 Contents Abbreviations
More informationEUROPEA U IO. Brussels, 12 June 2009 (OR. en) 2007/0198 (COD) PE-CO S 3651/09 E ER 173 CODEC 704
EUROPEA U IO THE EUROPEA PARLIAMT THE COU CIL Brussels, 12 June 2009 (OR. en) 2007/0198 (COD) PE-CO S 3651/09 ER 173 CODEC 704 LEGISLATIVE ACTS A D OTHER I STRUMTS Subject: REGULATION OF THE EUROPEAN PARLIAMENT
More information(Legislative acts) REGULATIONS
10.11.2017 Official Journal of the European Union L 293/1 I (Legislative acts) REGULATIONS REGULATION (EU) 2017/1991 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2017 amending Regulation
More informationAssess record for 'Public Consultation on a possible revision of Council Directive 89/105/EEC ("Transparency Directive")'
Assess record for 'Public Consultation on a possible revision of Council Directive 89/105/EEC ("Transparency Directive")' Respondent profile Please indicate the type of organisation on behalf of which
More informationPE-CONS 37/17 DGG 1B EUROPEAN UNION. Brussels, 20 September 2017 (OR. en) 2016/0221 (COD) PE-CONS 37/17 EF 144 ECOFIN 595 CODEC 1159
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Brussels, 20 September 2017 (OR. en) 2016/0221 (COD) PE-CONS 37/17 EF 144 ECOFIN 595 CODEC 1159 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: REGULATION
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a COUNCIL REGULATION
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 2.6.2006 COM(2006) 264 final 2006/0093 (CNS) Proposal for a COUNCIL REGULATION laying down specific measures for agriculture in favour of the smaller Aegean
More informationConsultation paper Introduction of a mechanism for eliminating double imposition of VAT in individual cases
EUROPEAN COMMISSION DIRECTORATE-GENERAL TAXATION AND CUSTOMS UNION INDIRECT TAXATION AND TAX ADMINISTRATION VAT and other turnover taxes TAXUD/D1/. 5 January 2007 Consultation paper Introduction of a mechanism
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 13.10.2008 COM(2008) 640 final 2008/0194 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cross-border payments
More informationEU Commission Publishes New Regulations and Guidelines on the Application of EU Competition Law to Certain Categories of Commercial Contracts
September 22, 2010 EU Commission Publishes New Regulations and Guidelines on the Application of EU Competition Law to Certain Categories of Commercial Contracts Barry D. Glazer Partner Co-head of London
More informationQuestionnaire. On the patent system in Europe
EN PATSTRAT EN EN EUROPEAN COMMISSION Internal Market and Services DG Knowledge-based Economy Industrial property Brussels, 09/01/06 Questionnaire On the patent system in Europe EN EN INTRODUCTION The
More informationCOMMUNICATION FROM THE COMMISSION
EUROPEAN COMMISSION Brussels, XXX [ ](2012) XXX draft COMMUNICATION FROM THE COMMISSION Communication from the Commission to the Member States on the application of Articles 107 and 108 TFEU to short-term
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 10.12.2008 COM(2008) 665 final 2008/0260 (COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards pharmacovigilance,
More informationCONTRIBUTION OF THE EUROPEAN GAMING AND BETTING ASSOCIATION TO THE PUBLIC CONSULTATION ON SPAIN'S DRAFT PRELIMINARY GAMBLING LAW
CONTRIBUTION OF THE EUROPEAN GAMING AND BETTING ASSOCIATION TO THE PUBLIC CONSULTATION ON SPAIN'S DRAFT PRELIMINARY GAMBLING LAW The European Gaming and Betting Association (EGBA) welcomes the Spanish
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a COUNCIL DIRECTIVE
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 7.11.2007 COM(2007) 677 final 2007/0238 (CNS) Proposal for a COUNCIL DIRECTIVE amending VAT Directive 2006/112/EC of 28 November 2006 on the common system
More informationCOMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
EN EN EN EUROPEAN COMMISSION Brussels, 23.3.2011 COM(2011) 146 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE
More informationCommittee on Petitions NOTICE TO MEMBERS
EUROPEAN PARLIAMT 2009-2014 Committee on Petitions 16.12.2011 NOTICE TO MEMBERS Subject: Petition 156/2005 by Szilvia Deminger (Hungarian) concerning the registration fee payable in Hungary on the import
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 30.10.2015 C(2015) 7554 final COMMISSION DELEGATED REGULATION (EU) /... of 30.10.2015 amending Delegated Regulation (EU) No 110/2014 on the model financial regulation for
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a COUNCIL DIRECTIVE
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 17.10.2003 COM(2003) 613 final 2003/0239 (CNS) Proposal for a COUNCIL DIRECTIVE amending Directive 90/434/EEC of 23 July 1990 on the common system of taxation
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 11.7.2018 C(2018) 4364 final COMMISSION DELEGATED REGULATION (EU) /... of 11.7.2018 amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards
More informationIntroduction. Regulation Number and Paragraph. Citation, commencement, interpretation and application
The National Health Service (Procurement, Patient Choice and Competition) Regulations 2013: made under sections 75 to 77 of the Health and Social Care Act 2012 - Notes on each regulation Introduction These
More informationFunding and functioning of the European Globalisation Adjustment Fund
C 308 E/30 Official Journal of the European Union 20.10.2011 Self supply, public catering, food waste 57. Calls on the Commission to pay due attention, when reviewing EU standards, also to locally based
More informationDelegations will find attached the text of the above-mentioned Regulation, as provisionally agreed with the European Parliament.
Council of the European Union Brussels, 27 June 2017 (OR. en) Interinstitutional File: 2016/0221 (COD) 10573/17 ADD 1 EF 137 ECOFIN 566 CODEC 1119 'I' ITEM NOTE From: To: No. Cion doc.: Subject: General
More informationPATSTRAT. Error! Unknown document property name. EN
PATSTRAT Error! Unknown document property name. EUROPEAN COMMISSION Internal Market and Services DG Knowledge-based Economy Industrial property Brussels, 09/01/06 REPLY FROM CHIESI FARMACEUTICI SPS (30/03/2006)
More informationOfficial Journal of the European Union
7.6.2014 L 168/39 COUNCIL REGULATION (EU, Euratom) No 609/2014 of 26 May 2014 on the methods and procedure for making available the traditional, VAT and GNI-based own resources and on the measures to meet
More informationThe new EC Financial Penalties Regime - a bridge too far?
Life Sciences 2007/08 The new EC Financial Penalties Regime - a bridge too far? Peter Bogaert, Covington & Burling LLP, Brussels www.practicallaw.com/5-378-8635 On 14 June 2007, the European Commission
More informationEuropean Economic and Social Committee OPINION. European Economic and Social Committee
European Economic and Social Committee ECO/442 VAT reform package (I) OPINION European Economic and Social Committee Communication from the Commission to the European Parliament, the Council and the European
More informationDraft decisions for designating undertakings with significant market power and imposing specific obligations in the markets for voice call
Draft decisions for designating undertakings with significant market power and imposing specific obligations in the markets for voice call termination on individual mobile networks (market 7) 25. August
More informationANNEX II. SHORT FORM CO FOR THE NOTIFICATION OF A CONCENTRATION PURSUANT TO REGULATION (EC) No 139/2004
ANNEX II SHORT FORM CO FOR THE NOTIFICATION OF A CONCENTRATION PURSUANT TO REGULATION (EC) No 139/2004 1. INTRODUCTION 1.1. The purpose of the Short Form CO The Short Form CO specifies the information
More information1. Summary. 2. Facts. Page 1 of 10. By Rosanna Cooper
Determination of the taxable amount for VAT where a pharmaceutical company grants discount to a private health insurance company, for the purposes of Article 90(1) of Council Directive 2006/112/EC By Rosanna
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 28.8.2017 C(2017) 5812 final COMMISSION DELEGATED REGULATION (EU) /... of 28.8.2017 amending Delegated Regulation (EU) 2017/565 as regards the specification of the definition
More informationChasing Opportunity at the County Level: The New Growth Area for China s Pharmaceutical Market
www.pwccn.com Chasing Opportunity at the County Level: The New Growth Area for China s Pharmaceutical Market December 2015 The promising county level pharmaceutical market As the world s fastest-growing
More informationHaving regard to the opinion of the European Economic and Social Committee ( 1 ),
27.6.2014 Official Journal of the European Union L 189/143 REGULATION (EU) No 661/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 amending Council Regulation (EC) No 2012/2002 establishing
More informationDECISIONS Official Journal of the European Union L 7/3
11.1.2012 Official Journal of the European Union L 7/3 DECISIONS COMMISSION DECISION of 20 December 2011 on the application of Article 106(2) of the Treaty on the Functioning of the European Union to State
More information7148/16 HG/NT/kp,vm DGG 2B
Council of the European Union Brussels, 11 May 2016 (OR. en) Interinstitutional File: 2016/0010 (CNS) 7148/16 FISC 39 ECOFIN 231 LEGISLATIVE ACTS AND OTHER INSTRUMENTS Subject: COUNCIL DIRECTIVE amending
More informationRecommendations for improving the medicinal product pricing process
Recommendations for improving the medicinal product pricing process Zagreb, June 2018 Contents Introduction... 3 The Current Situation in the Republic of Croatia... 4 Time Frames for Issuing Decisions...
More informationMarkets in Financial Instruments Directive (MiFID): Frequently Asked Questions (see IP/07/1625)
MEMO/07/439 Brussels, 29 October 2007 Markets in Financial Instruments Directive (MiFID): Frequently Asked Questions (see IP/07/1625) 1. What is the "MiFID"? The MiFID is the Markets in Financial Instruments
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2006R1828 EN 01.12.2011 003.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B C1 COMMISSION REGULATION (EC) No 1828/2006 of
More informationINTERNAL MARKET SCOREBOARD. No. 35
I NTERNALMARKET SCOREBOARD No.35 EEAEFTASTATES oft heeuropeaneconomi CAREA Apr i l2015 Event No: 374279 INTERNAL MARKET SCOREBOARD No. 35 EFTA STATES of the EUROPEAN ECONOMIC AREA April 2015 EFTA SURVEILLANCE
More informationTEXTS ADOPTED. Long-term shareholder engagement and corporate governance statement ***I
European Parliament 2014-2019 TEXTS ADOPTED P8_TA(2015)0257 Long-term shareholder engagement and corporate governance statement ***I Amendments adopted by the European Parliament on 8 July 2015 on the
More informationEUROPEAN UNION REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON INTERCHANGE FEES FOR CARD-BASED PAYMENT TRANSACTIONS
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Strasbourg, 29 April 2015 (OR. en) 2013/0265 (COD) LEX 1599 PE-CONS 3/1/15 REV 1 EF 14 ECOFIN 38 CONSOM 14 CODEC 76 REGULATION OF THE EUROPEAN PARLIAMT
More informationFinancial Regulation European Insurance and Occupational Pensions Authority (EIOPA) December 2013
EIOPA/13/474 31 December 2013/TL Financial Regulation European Insurance and Occupational Pensions Authority (EIOPA) December 2013 EIOPA Westhafen Tower, Westhafenplatz 1 60327 Frankfurt Germany Tel. +
More informationQuestions and answers
Questions and answers Transparency Directive (2004/109/EC) 31 January 2019 ESMA31-67-127 Date: 31 January 2019 ESMA31-67-127 Content I. Background... 4 II. Purpose... 4 III. Status... 5 IV. Questions and
More informationProposal for a COUNCIL DIRECTIVE. laying down the general arrangements for excise duty (recast)
EUROPEAN COMMISSION Brussels, 25.5.2018 COM(2018) 346 final 2018/0176 (CNS) Proposal for a COUNCIL DIRECTIVE laying down the general arrangements for excise duty (recast) {SEC(2018) 255 final} - {SWD(2018)
More informationOfficial Journal of the European Union. (Legislative acts) DIRECTIVES
25.4.2014 L 124/1 I (Legislative acts) DIRECTIVES DIRECTIVE 2014/52/EU OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 16 April 2014 amending Directive 2011/92/EU on the assessment of the effects of certain
More informationProposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. on Short Selling and certain aspects of Credit Default Swaps
EN EN EN EUROPEAN COMMISSION Brussels, 15.9.2010 COM(2010) 482 final 2010/0251 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Short Selling and certain aspects of Credit
More informationMethodology for analysing State aid linked to stranded costs 1
Page 1 PART IV: SECTOR SPECIFIC RULES Methodology for analysing State aid linked to stranded costs 1 1 Introduction (1) European Parliament and Council Directive 96/92/EC of 19 December 1996 concerning
More informationDischarge 2012: Innovative Medicines Initiative Joint Undertaking
P7_TA-PROV(2014)0335 Discharge 2012: Innovative Medicines Initiative Joint Undertaking 1. European Parliament decision of 3 April 2014 on discharge in respect of the implementation of the budget of the
More informationTekes preliminary comments on the first draft of the General Block Exemption Regulation (published 8th of May 2013)
1 Tekes preliminary comments on the first draft of the General Block Exemption Regulation (published 8th of May 2013) This document contains Tekes comments on the first draft of the General Block Exemption
More informationOfficial Journal of the European Union L 318/17
17.11.2006 Official Journal of the European Union L 318/17 COMMISSION DIRECTIVE 2006/111/EC of 16 November 2006 on the transparency of financial relations between Member States and public undertakings
More informationOfficial Journal of the European Union. (Non-legislative acts) REGULATIONS
10.1.2017 L 5/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMTING REGULATION (EU) 2017/39 of 3 November 2016 on rules for the application of Regulation (EU) No 1308/2013 of the European Parliament
More informationDECISIONS. COUNCIL DECISION of 26 May 2014 on the system of own resources of the European Union. (2014/335/EU, Euratom)
7.6.2014 L 168/105 DECISIONS COUNCIL DECISION of 26 May 2014 on the system of own resources of the European Union (2014/335/EU, Euratom) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on
More informationSecretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director
COUNCIL OF THE EUROPEAN UNION Brussels, 10 April 2014 (OR. en) 8847/14 Interinstitutional File: 2014/0121 (COD) DRS 53 CODEC 1090 COVER NOTE From: date of receipt: 10 April 2014 To: No. Cion doc.: Subject:
More informationPUBLIC. Brussels, 28 October 2002 COUNCIL OF THE EUROPEAN UNION 13545/02 LIMITE FISC 271
Conseil UE COUNCIL OF THE EUROPEAN UNION Brussels, 28 October 2002 13545/02 PUBLIC LIMITE FISC 271 COVER NOTE from : the Secretary-General of the European Commission signed by Mr Sylvain BISARRE, Director
More informationLawyer Chief Expert at the Ministry of Health
by Jakub Adamski Vienna, 30/09/2011 Lawyer Chief Expert at the Ministry of Health participation in European Commission and Council working groups member of the EUCERD coordination of works of the Rare
More informationOPINION OF THE EUROPEAN CENTRAL BANK. of 4 January 2002
EN OPINION OF THE EUROPEAN CENTRAL BANK of 4 January 2002 at the request of the Finnish Ministry of Finance on a draft proposal concerning the revision of the Credit Institution Act (CON/2002/1) 1. On
More informationEUROPEAN UNION. Brussels, 16 March 2004 (OR. en) 2002/0240 (COD) PE-CONS 3607/04 DRS 1 CODEC 73 OC 34
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Brussels, 16 March 2004 (OR. en) 2002/0240 (COD) PE-CONS 3607/04 DRS 1 CODEC 73 OC 34 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject : Directive of the European
More informationANNEX. to the Comission Decision. amending Decision C(2013) 1573
EUROPEAN COMMISSION Brussels, 30.4.2015 C(2015) 2771 final ANNEX 1 ANNEX to the Comission Decision amending Decision C(2013) 1573 on the approval of the guidelines on the closure of operational programmes
More informationThe EU's Financial Services Action Plan
83 The EU's Financial Services Action Plan Dorte Kurek, Financial Markets INTRODUCTION The work to establish a single market for financial services in the EU was initiated in the 970s but only really gathered
More information(Non-legislative acts) REGULATIONS
12.7.2012 Official Journal of the European Union L 181/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) No 600/2012 of 21 June 2012 on the verification of greenhouse gas emission reports
More informationIII COURT OF AUDITORS
17.8.2018 Official Journal of the European Union C 291/1 III (Preparatory acts) COURT OF AUDITORS OPINION No 1/2018 (pursuant to Article 322(1)(a) TFEU) concerning the proposal of 2 May 2018 for a regulation
More informationProposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, 26.6.2013 COM(2013) 472 final 2013/0222 (COD) C7-0196/13 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 31.1.2003 COM(2003) 44 final 2003/0020 (COD) Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a general Framework for
More information(Information) EUROPEAN COMMISSION
19.12.2012 Official Journal of the European Union C 392/1 II (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Communication from the Commission
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2009R0924 EN 31.03.2012 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EC) No 924/2009 OF THE EUROPEAN PARLIAMENT
More informationJESSICA JOINT EUROPEAN SUPPORT FOR SUSTAINABLE INVESTMENT IN CITY AREAS JESSICA INSTRUMENTS FOR ENERGY EFFICIENCY IN LITHUANIA FINAL REPORT
JESSICA JOINT EUROPEAN SUPPORT FOR SUSTAINABLE INVESTMENT IN CITY AREAS JESSICA INSTRUMENTS FOR ENERGY EFFICIENCY IN LITHUANIA FINAL REPORT 17 April 2009 This document has been produced with the financial
More informationOfficial Journal of the European Union L 111/13
28.4.2007 Official Journal of the European Union L 111/13 COMMISSION REGULATION (EC, EURATOM) No 478/2007 of 23 April 2007 amending Regulation (EC, Euratom) No 2342/2002 laying down detailed rules for
More informationCouncil of the European Union Brussels, 23 April 2018 (OR. en) Eugen Orlando Teodorovici, Minister of Public Finance, Ministry of Public Finance
Council of the European Union Brussels, 23 April 2018 (OR. en) 8257/18 ECOFIN 354 UEM 125 COVER NOTE From: date of receipt: 23 April 2018 To: Subject: Eugen Orlando Teodorovici, Minister of Public Finance,
More informationEBA final draft Implementing Technical Standards
EBA/ITS/2015/07 9 July 2015 EBA final draft Implementing Technical Standards on the form and content of disclosure of financial support agreements under Article 26 of Directive 2014/59/EU 1 Contents Contents
More informationOfficial Journal of the European Union
18.8.2016 C 299/7 COUNCIL RECOMMDATION of 12 July 2016 on the 2016 National Reform Programme of Spain and delivering a Council opinion on the 2016 Stability Programme of Spain (2016/C 299/02) THE COUNCIL
More informationOXFORD CENTRE FOR BUSINESS TAXATION
OXFORD CENTRE FOR BUSINESS TAXATION Oxford, 23 March 2006 "The European Commission's business taxation agenda" SPEAKING NOTES Ladies and gentlemen, It is a great pleasure to be here tonight. I am grateful
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 1.8.2005 COM(2005)354 final COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE
More informationOfficial Journal of the European Union L 347/1. (Acts whose publication is obligatory)
30.12.2005 Official Journal of the European Union L 347/1 I (Acts whose publication is obligatory) COUNCIL REGULATION (EC) No 2173/2005 of 20 December 2005 on the establishment of a FLEGT licensing scheme
More information9194/16 ADB/SBC/mz 1 DG B 3A - DG G 1A
Council of the European Union Brussels, 13 June 2016 (OR. en) 9194/16 NOTE From: To: No. Cion doc.: General Secretariat of the Council ECOFIN 446 UEM 193 SOC 310 EMPL 206 COMPET 280 V 325 EDUC 180 RECH
More informationEUROPEAN UNION. Brussels, 23 July 2014 (OR. en) 2012/0168 (COD) LEX 1569 PE-CONS 75/1/14 REV 1 EF 84 ECOFIN 270 CODEC 808
EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Brussels, 23 July 2014 (OR. en) 2012/0168 (COD) LEX 1569 PE-CONS 75/1/14 REV 1 EF 84 ECOFIN 270 CODEC 808 DIRECTIVE OF THE EUROPEAN PARLIAMT AND OF THE
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES COMMISSION STAFF WORKING DOCUMENT. Initiatives In The Area Of Retail Financial Services
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, SEC(2007) 1520 PROVISIONAL VERSION COMMISSION STAFF WORKING DOCUMT Initiatives In The Area Of Retail Financial Services Accompanying document to the COMMUNICATION
More informationERIC. Practical guidelines. Legal framework for a European Research Infrastructure Consortium. Research and Innovation
ERIC Practical guidelines Legal framework for a European Research Infrastructure Consortium Research and Innovation EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B Innovation
More informationCOMMISSION DELEGATED REGULATION (EU) No /.. of
EUROPEAN COMMISSION Brussels, 11.3.2014 C(2014) 1565 final COMMISSION DELEGATED REGULATION (EU) No /.. of 11.3.2014 supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council
More informationGuide to Financial Issues relating to ICT PSP Grant Agreements
DG COMMUNICATIONS NETWORKS, CONTENT AND TECHNOLOGY ICT Policy Support Programme Competitiveness and Innovation Framework Programme Guide to Financial Issues relating to ICT PSP Grant Agreements Version
More informationL 94/38 Official Journal of the European Union
L 94/38 Official Journal of the European Union 30.3.2012 REGULATION (EU) No 261/2012 OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 14 March 2012 amending Council Regulation (EC) No 1234/2007 as regards
More informationEuropean Union Pension Directive
Cornell University ILR School DigitalCommons@ILR Law Firms Key Workplace Documents June 2003 European Union Pension Directive The European Parliament and the Council of the European Union Follow this and
More informationCOMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT. Accompanying the document. Proposal for a Council Directive
EUROPEAN COMMISSION Brussels, 23.10.2013 SWD(2013) 426 final COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Council Directive amending
More informationCommittee on Budgetary Control
European Parliament 2014-2019 Committee on Budgetary Control 2017/2154(DEC) 30.1.2018 DRAFT REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial
More informationWORKING PAPER. Brussels, 15 February 2019 WK 2235/2019 INIT LIMITE ECOFIN FISC
Brussels, 15 February 2019 WK 2235/2019 INIT LIMITE ECOFIN FISC WORKING PAPER This is a paper intended for a specific community of recipients. Handling and further distribution are under the sole responsibility
More informationCOMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT. Accompanying the document. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, 1.3.2012 SWD(2012) 30 final PART 2 COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF
More informationCOMMISSION DELEGATED REGULATION (EU) /... of
EUROPEAN COMMISSION Brussels, 14.7.2016 C(2016) 4369 final COMMISSION DELEGATED REGULATION (EU) /... of 14.7.2016 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council
More informationOfficial Journal of the European Union. (Acts whose publication is not obligatory) COMMISSION
L 67/18 II (Acts whose publication is not obligatory) COMMISSION COMMISSION DECISION of 3 February 2004 on the implementation of the Preparatory Action on the Enhancement of the European industrial potential
More informationEUJOINTTRANSFERPRICINGFORUM PROCEDURAL IMPROVEMENTS TO THE ARBITRATION CONVENTION AND RELATED MUTUALAGREEMENT PROCEDURES
EUROPEAN COMMISSION DIRECTORATE-GENERAL TAXATION AND CUSTOMS UNION TAX POLICY CoordinationofTaxMatters Brussels, 8November2002 C1/WB/LDH DOC:JTPF/007/2002/REV1/EN EUJOINTTRANSFERPRICINGFORUM PROCEDURAL
More informationExchange of views on TRQs
EUROPEAN COMMISSION Brussels, XXX [ ](2016) XXX draft COMMISSION DELEGATED REGULATION (EU) /... of XXX supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard
More informationa central counterparty, the registration and supervision of trade repositories and the requirements for trade repositories
C 385/10 EN Official Journal of the European Union 15.11.2017 OPINION OF THE EUROPEAN CENTRAL BANK of 11 October 2017 on a proposal for a regulation of the European Parliament and of the Council amending
More informationEN Official Journal of the European Union L 77/77
15.3.2014 EN Official Journal of the European Union L 77/77 REGULATION (EU) No 234/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2014 establishing a Partnership Instrument for cooperation
More information1 di 6 05/11/ :55
1 di 6 05/11/2012 10:55 JUDGMENT OF THE COURT (Second Chamber) 27 January 2011 (*) (Failure of a Member State to fulfil obligations Article 49 EC Freedom to provide services Non reimbursement of costs
More informationCOMMISSION IMPLEMENTING REGULATION (EU) /... of XXX
EUROPEAN COMMISSION Brussels, XXX [ ](2015) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down implementing technical standards with regard to the procedures, formats and templates
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 26.2.2009 COM(2009) 83 final 2009/0035 (COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive
More information(Legislative acts) DIRECTIVES
20.5.2017 Official Journal of the European Union L 132/1 I (Legislative acts) DIRECTIVES DIRECTIVE (EU) 2017/828 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2017 amending Directive 2007/36/EC
More information