title: 2012/616/EU: Decision of the European Parliament of 10 May 2012 on discharge in respect of the implementation of the budget of the SESAR Joint Undertaking for the financial year 2010#Resolution of the European Parliament of 10 May 2012 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget for the SESAR Joint Undertaking for the financial year 2010

text:
               17.10.2012

               EN

               Official Journal of the European Union

               L 286/349

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2012
   on discharge in respect of the implementation of the budget of the SESAR Joint Undertaking for the financial year 2010
   (2012/616/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the SESAR Joint Undertaking for the financial year 2010,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the SESAR Joint Undertaking for the financial year 2010, together with the replies of the Joint Undertaking (1),

               —

               having regard to the Council’s recommendation of 21 February 2012 (06086/2012 - C7-0050/2012),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Council Regulation (EC) No 1361/2008 of 16 December 2008 amending Regulation (EC) No 219/2007 on the establishment of a joint undertaking to develop the new generation European air traffic management system (SESAR) (3), and in particular Article 4b thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Transport and Tourism (A7-0114/2012),

               1.

               Grants the Executive Director of the SESAR Joint Undertaking discharge in respect of the implementation of the Joint Undertaking’s budget for the financial year 2010;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the SESAR Joint Undertaking, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 368, 16.12.2011, p. 32.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 352, 31.12.2008, p. 12.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2012
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget for the SESAR Joint Undertaking for the financial year 2010
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the SESAR Joint Undertaking for the financial year 2010,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the SESAR Joint Undertaking for the financial year 2010, together with the replies of the Joint Undertaking (1),

                  —

                  having regard to the Council’s recommendation of 21 February 2012 (06086/2012 - C7-0050/2012),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Council Regulation (EC) No 1361/2008 of 16 December 2008 amending Regulation (EC) No 219/2007 on the establishment of a joint undertaking to develop the new generation European air traffic management system (SESAR) (3), and in particular Article 4b thereof,

                  —

                  having regard to the Financial Rules of the SESAR Joint Undertaking adopted by the SESAR Administrative Board on 28 July 2009 (‘SESAR Financial Rules’),

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Transport and Tourism (A7-0114/2012),

                  A.

                  whereas the SESAR Joint Undertaking (‘the Joint Undertaking’) was set up in February 2007 to run the Single European Sky Air Traffic Management Research (SESAR) programme,

                  B.

                  whereas the Joint Undertaking started to work autonomously in August 2007,

                  C.

                  whereas the Joint Undertaking will own all the tangible and intangible assets which it creates or which are transferred to it for the development phase of the SESAR project in accordance with specific agreements with its members,

                  D.

                  whereas the Court of Auditors states that it has obtained reasonable assurances that the annual accounts for the financial year 2010 are reliable and that the underlying transactions are legal and regular,

                  E.

                  whereas in April 2010 the Court of Auditors delivered Opinion No 2/2010 on the SESAR Financial Rules,

                  F.

                  whereas the budget for the 2008-2013 development phase of the SESAR project is EUR 2 100 000 000,

                  G.

                  whereas for the financial year 2010 the final budget of the Joint Undertaking amounted to EUR 143 000 000,

         Budget and financial management

                  1.

                  Takes note that the Joint Undertaking’s final budget for the financial year 2010 included commitment appropriations of EUR 135 000 000 and payment appropriations of EUR 143 000 000; further acknowledges that the utilisation rates for commitment and payment appropriations were 97,3 % and 82,2 % respectively;

                  2.

                  Establishes from the Court of Auditors that, at year-end 2010, the Joint Undertaking had a positive budget outturn of EUR 53 500 000 and that deposits in bank accounts represented EUR 57 200 000; notes that the situation resulted from:

                              —

                              the contributions from members: EUR 55 600 000,

                              —

                              the outturn of the previous year: EUR 86 500 000,

                              —

                              payments to the Joint Undertaking: EUR 84 900 000,

                              —

                              carry-over of appropriations: EUR 3 700 000;

                  3.

                  Reminds the Joint Undertaking that this situation is against the budgetary principle of equilibrium; notes however the Joint Undertaking’s replies to the Court of Auditors that the 2010 cash balance decreased by 34 % compared to 2009 and that out of the EUR 55 600 000 of contributions from members, EUR 43 800 000 were received in the last weeks of 2010 to ensure the funding of operations in 2011; calls on the Joint Undertaking to develop an Action Plan with concrete measures and deadlines to keep its budget balanced and to inform the discharge authority about this matter;

                  4.

                  Underlines that according to Article 6 of the SESAR Financial Rules, no expenditure may be committed or authorised in excess of the appropriations authorised by the budget; is seriously concerned that for two budget headings — administrative expenditure, studies and development — authorised expenditure exceeded budgetary appropriations by 11 % and 9 % respectively; takes note that the Joint Undertaking considers that it can only enter the total payment appropriations once into the overall budget for 2007-2016, in order to avoid exceeding the total budget ceiling by the end of the SESAR development phase in 2016; reminds the Joint Undertaking that it must comply with its own Financial Rules and expects that authorised expenditure exceeding budgetary appropriations shall not occur in future financial years;

         Internal control systems

                  5.

                  Notes that in 2010, the Joint Undertaking began to use the financial reporting systems also used by the Commission (ABAC and SAP); regrets that the Joint Undertaking operational programme management system was not integrated into these financial reporting systems and that at the end of 2010, the underlying business processes had not been validated by the Accounting Officer as required by the SESAR Financial Rules;

                  6.

                  Understands from the Joint Undertaking that it has developed an operational programme management system that complements the financial and budgetary information and considers that it has integrated its systems as far as possible, given the constraints on its use of ABAC and SAP; notes moreover that the Joint Undertaking planned to implement ABAC Assets and ABAC Contract by the end of 2011 and that the report of the Accounting Officer on the validation of the local systems was to be finalised in 2011;

                  7.

                  Calls on the Joint Undertaking to inform the discharge authority about:

                              —

                              the nature of the constraints experienced by the Joint Undertaking on its use of ABAC and SAP,

                              —

                              the state of validation of the underlying business processes and in particular the local systems;

                  8.

                  Urges the Joint Undertaking, nevertheless, to integrate its financial reporting systems (ABAC and SAP) with its operational programme management system allowing costs to be allocated to specific work packages and funding sources of operational costs to be identified;

         Project management

                  9.

                  Acknowledges from the Joint Undertaking 2010 Annual Activity Report (AAR) that the SESAR Programme consisted of 304 projects of which 171 were initiated in 2009 while 114 additional projects were launched in 2010; takes note that 80,9 % of the projects are in execution phase, excluding those projects that have been cancelled (3) or suspended (10); notes that, for each cancelled or suspended project, the Joint Undertaking provided justification and explained the corrective actions undertaken; notes in particular in respect of the currently suspended projects that:

                              —

                              about 60 % are related to activities that require other projects to deliver first mature results before being re-started,

                              —

                              about 20 % is related to projects which have not a reliable coupling with other programme activities,

                        the remaining 20 % has been suspended due to a lack of clear link with the future concept of operations or because of the lack of connection with the Master Plan;

                  10.

                  Urges the Joint Undertaking to continue to inform the discharge authority on the stage of implementation of the projects under the SESAR programme and to present the results achieved;

         Performance

                  11.

                  Encourages the Commission and the Member States to increase the effectiveness of how the Single European Sky Regulations are applied, in order to increase the effectiveness of investments in the SESAR project;

                  12.

                  Draws attention to the sound management of financial resources and emphasises the importance of the Joint Undertaking to the Single European Sky;

                  13.

                  Establishes from the AAR that a comprehensive review of the SESAR Programme implementation approach was conducted and that its conclusions highlighted the need to break down the Programme high-level objectives into a more technical and operational level defining in detail what has to be done, by whom and when, and thus to clearly identify the SESAR validated deliverables which will contribute to the SESAR Development Phase objectives as well as to the specific 2012 Strategic Objectives; calls on the Joint Undertaking to develop an Action Plan with concrete measures and deadlines to address the results of the comprehensive review;

                  14.

                  Notes moreover that, at the end of 2009, it was decided to establish a common SESAR execution framework to enable adequate programme/project management through streamlined monitoring and control activities; takes note that at year-end 2010 the execution framework has been completely defined and is about 85 % implemented and deployed; calls on the Joint Undertaking to inform the discharge authority of the current stage of implementation and deployment of the execution framework as well as the progress achieved;

                  15.

                  Acknowledges that the Commission carried out the first intermediate evaluation of the Joint Undertaking in 2010; notes that the evaluation underlines the ability of the Joint Undertaking to provide an optimal response to the needs of the airspace users and service providers; is nevertheless of the opinion that interim evaluations and evaluations should be carried out by external and independent experts;

         Internal audit

                  16.

                  Welcomes the fact that at the end of 2010 the Executive Director of the Joint Undertaking established the Internal Audit Capability (IAC), appointed the former Joint Undertaking’s Internal Auditor to assume the IAC role, and approved the IAC audit work programme for 2011;

                  17.

                  Acknowledges from the final annual accounts that the Joint Undertaking signed a framework contract for audit services in May 2010;

                  18.

                  Welcomes that the Joint Undertaking and the Commission have taken action to ensure a clearer definition of the respective operational roles of the Commission’s Internal Audit Service (IAS) and of the internal auditing function of the Joint Undertaking; albeit notes that the Statutes of the Joint Undertaking have not been amended;

                  19.

                  Notes with satisfaction that the IAS confirmed its responsibilities under the general Financial Regulation as the Internal Auditor of the Joint Undertakings and that the Joint Undertaking’s Administrative Board has modified the charter of its internal auditing function accordingly;

         Late payment of membership contributions

                  20.

                  Is concerned that the deadline for payment of the cash contributions to the Joint Undertaking from its members was not respected; takes note that the payment delays ranged from 12 to 113 days and that at the end of 2010 two members had paid no contribution at all; notes the Joint Undertaking’s reply that those contributions were received at the beginning of 2011;

         Horizontal observations on the Joint Undertakings

                  21.

                  Underlines that seven Joint Undertakings have so far been established by the Commission under Article 187 of the Treaty on the Functioning of the European Union; notes that six Joint Undertakings (IMI, Artemis, ENIAC, Clean Sky, FCH and ITER-F4E) are in the research area under the Commission’s DGs RTD and INFSO and one is charged with developing the new air traffic management system (SESAR) in the transport domain whose activities are supervised by DG MOVE;

                  22.

                  Notes that the total indicative resources deemed necessary for the Joint Undertakings for their period of existence amounts to EUR 21 793 000 000;

                  23.

                  Notes that the total Union contribution deemed necessary for the Joint Undertakings for their period of existence amounts to EUR 11 489 000 000;

                  24.

                  Notes that, for the financial year 2010, the overall Union contribution to the budget of the Joint Undertakings amounted to EUR 505 000 000;

                  25.

                  Calls on the European Commission to provide the discharge authority annually with consolidated information on the total annual funding per Joint Undertaking made from the general budget of the Union in order to ensure transparency and clarity on the use of the Union’s funds and restore trust among the European taxpayers;

                  26.

                  Welcomes the initiative of Artemis to include information in its AAR on the monitoring and review of its ongoing projects; believes this is a practice that should be followed by the other Joint Undertakings;

                  27.

                  Recalls that Joint Undertakings are public-private partnerships and that as a consequence public and private interests are intertwined; is of the opinion that under the circumstances the likelihood of conflicts of interest should not be dismissed but addressed properly; calls therefore on the Joint Undertakings to inform the discharge authority on the verification mechanisms which exist in their respective structures to enable a proper management and prevention of conflicts of interest;

                  28.

                  Notes, with the notable exception of the Joint Undertaking for ITER and the Development of Fusion Energy, that Joint Undertakings are relatively small structures and geographically-concentrated; believes therefore that they should pool their resources where possible;

                  29.

                  Calls on the Court of Auditors to provide the discharge authority with a follow-up on the comments it has made for each of the Joint Undertakings in their respective report on the annual accounts for the financial year 2011;

                  30.

                  Invites the Court of Auditors to provide, within a reasonable deadline, a special report to Parliament, on the added value of the establishment of the Joint Undertakings for the efficient execution of Union research, technological development and demonstration programmes; further notes that the same report should include an assessment of the effectiveness of the Joint Undertakings’ establishment.

         (1)  OJ C 368, 16.12.2011, p. 32.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 352, 31.12.2008, p. 12.

         (4)  OJ L 357, 31.12.2002, p. 72.


title: 2012/472/EU: Council Decision of 26 April 2012 on the conclusion of the Agreement between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security#Agreement between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security

text:
               11.8.2012

               EN

               Official Journal of the European Union

               L 215/4

         COUNCIL DECISION
   of 26 April 2012
   on the conclusion of the Agreement between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security
   (2012/472/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 82(1)(d) and Article 87(2)(a), in conjunction with Article 218(6)(a) thereof,
   Having regard to the proposal from the European Commission,
   Having regard to the consent of the European Parliament (1),
   Whereas:

               (1)

               On 2 December 2010, the Council adopted a decision, together with negotiation directives, authorising the Commission to open negotiations between the Union and the United States of America on the transfer and use of passenger name records (PNR) to prevent and combat terrorism and other serious transnational crime.

               (2)

               In accordance with Council Decision 2012/471/EU (2), the Agreement between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security (‘the Agreement’) was signed on 14 December 2011, subject to its conclusion.

               (3)

               The Agreement respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, notably the right to private and family life, recognised in Article 7 thereof, the right to the protection of personal data, recognised in Article 8 thereof and the right to effective remedy and fair trial recognised in Article 47 thereof. This Agreement should be applied in accordance with those rights and principles.

               (4)

               In accordance with Article 3 of Protocol (No 21) on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, the United Kingdom has notified its wish to take part in the adoption and application of this Decision.

               (5)

               In accordance with Articles 1 and 2 of Protocol (No 21) on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, and without prejudice to Article 4 of that Protocol, Ireland is not taking part in the adoption of this Decision and is not bound by it or subject to its application.

               (6)

               In accordance with Articles 1 and 2 of Protocol (No 22) on the Position of Denmark annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by the Agreement or subject to its application.

               (7)

               The Agreement should be approved,

         HAS ADOPTED THIS DECISION:
   Article 1
   The Agreement between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security is hereby approved on behalf of the Union.
   The text of the Agreement is attached to this Decision.
   Article 2
   The President of the Council shall designate the person(s) empowered to proceed, on behalf of the Union, to the exchange of the notifications provided for in Article 27 of the Agreement, in order to express the consent of the Union to be bound by the Agreement.
   Article 3
   This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      Done at Luxembourg, 26 April 2012.

            For the Council

            The President

         M. BØDSKOV

      (1)  Consent of 19 April 2012 (not yet published in the Official Journal).

      (2)  See page 1 of this Official Journal.

      AGREEMENT
      between the United States of America and the European Union on the use and transfer of passenger name records to the United States Department of Homeland Security
      THE UNITED STATES OF AMERICA,
      hereinafter referred to also as ‘the United States’, and
      THE EUROPEAN UNION,
      hereinafter referred to also as ‘the EU’,
      together hereinafter referred to as ‘the Parties’,
      DESIRING to prevent and combat terrorism and serious transnational crime effectively as a means of protecting their respective democratic societies and common values;
      SEEKING to enhance and encourage cooperation between the Parties in the spirit of transatlantic partnership;
      RECOGNISING the right and responsibility of States to ensure the security of their citizens and protect their borders and mindful of the responsibility of all nations to protect the life and safety of the public including those using international transportation systems;
      CONVINCED that information sharing is an essential component in the fight against terrorism and serious transnational crime and that in this context, the processing and use of passenger name records (PNR) is a necessary tool that gives information that cannot be obtained by other means;
      DETERMINED to prevent and combat terrorist offences and transnational crime, while respecting fundamental rights and freedoms and recognising the importance of privacy and the protection of personal data and information;
      HAVING REGARD for international instruments, US statutes and regulations requiring each air carrier operating passenger flights in foreign air transportation to or from the United States to make PNR available to the Department of Homeland Security (DHS) to the extent they are collected and contained in the air carrier’s automated reservation/departure control systems, and comparable requirements that are or may be implemented in the EU;
      NOTING that DHS processes and uses PNR for the purpose of preventing, detecting, investigating and prosecuting terrorist offences and transnational crime in compliance with safeguards on privacy and the protection of personal data and information, as set out in this Agreement;
      STRESSING the importance of sharing PNR and relevant and appropriate analytical information obtained from PNR by the United States with competent police and judicial authorities of Member States of the European Union, hereinafter ‘EU Member States’, and Europol or Eurojust as a means to foster international police and judicial cooperation;
      ACKNOWLEDGING both Parties’ longstanding traditions of respect for individual privacy, as reflected in their laws and founding documents;
      MINDFUL of the EU’s commitments pursuant to Article 6 of the Treaty on European Union on respect for fundamental rights, the right to privacy with regard to the processing of personal data as stipulated in Article 16 of the Treaty on the Functioning of the European Union, the principles of proportionality and necessity concerning the right to private and family life, the respect for privacy, and the protection of personal data under Article 8 of the European Convention on the Protection of Human Rights and Fundamental Freedoms, Council of Europe Convention No 108 for the Protection of Individuals with regard to Automatic Processing of Personal Data and its additional Protocol 181, and Articles 7 and 8 of the Charter of Fundamental Rights of the European Union;
      MINDFUL that DHS currently employs robust processes to protect personal privacy and ensure data integrity, including physical security, access controls, data separation and encryption, audit capabilities and effective accountability measures;
      RECOGNISING the importance of ensuring data quality, accuracy, integrity, and security, and instituting appropriate accountability to ensure these principles are observed;
      NOTING in particular the principle of transparency and the various means by which the United States ensures that passengers whose PNR is collected by DHS are made aware of the need for and use of their PNR;
      FURTHER RECOGNISING that the collection and analysis of PNR is necessary for DHS to carry out its border security mission, while ensuring that collection and use of PNR remains relevant and necessary for the purposes for which it is collected;
      RECOGNISING that, in consideration of this Agreement and its implementation, DHS shall be deemed to ensure an adequate level of data protection for the processing and use of PNR transferred to DHS;
      MINDFUL that the United States and the European Union are committed to ensuring a high level of protection of personal information while fighting crime and terrorism, and are determined to reach, without delay, an agreement to protect personal information exchanged in the context of fighting crime and terrorism in a comprehensive manner that will advance our mutual goals;
      ACKNOWLEDGING the successful Joint Reviews in 2005 and 2010 of the 2004 and 2007 Agreements between the Parties on the transfer of PNR;
      NOTING the interest of the Parties, as well as EU Member States, in exchanging information regarding the method of transmission of PNR as well as the onward transfer of PNR as set forth in the relevant articles of this Agreement, and further noting the EU’s interest in having this addressed in the context of the consultation and review mechanism set forth in this Agreement;
      AFFIRMING that this Agreement does not constitute a precedent for any future arrangements between the Parties, or between either of the Parties and any other party, regarding the processing, use, or transfer of PNR or any other form of data, or regarding data protection;
      RECOGNISING the related principles of proportionality as well as relevance and necessity that guide this Agreement and its implementation by the European Union and the United States; and
      HAVING REGARD to the possibility of the Parties to further discuss the transfer of PNR data in the maritime mode;
      HEREBY AGREE:
      CHAPTER I

         GENERAL PROVISIONS

      Article 1
      Purpose
      1.   The purpose of this Agreement is to ensure security and to protect the life and safety of the public.
      2.   For this purpose, this Agreement sets forth the responsibilities of the Parties with respect to the conditions under which PNR may be transferred, processed and used, and protected.
      Article 2
      Scope
      1.   PNR, as set forth in the Guidelines of the International Civil Aviation Organisation, shall mean the record created by air carriers or their authorised agents for each journey booked by or on behalf of any passenger and contained in carriers’ reservation systems, departure control systems, or equivalent systems providing similar functionality (collectively referred to in this Agreement as ‘reservation systems’). Specifically, as used in this Agreement, PNR consists of the data types set forth in the Annex to this Agreement (‘Annex’).
      2.   This Agreement shall apply to carriers operating passenger flights between the European Union and the United States.
      3.   This Agreement shall also apply to carriers incorporated or storing data in the European Union and operating passenger flights to or from the United States.
      Article 3
      Provision of PNR
      The Parties agree that carriers shall provide PNR contained in their reservation systems to DHS as required by and in accordance with DHS standards and consistent with this Agreement. Should PNR transferred by carriers include data beyond those listed in the Annex, DHS shall delete such data upon receipt.
      Article 4
      Use of PNR
      1.   The United States collects, uses and processes PNR for the purposes of preventing, detecting, investigating, and prosecuting:

                  (a)

                  Terrorist offences and related crimes, including:

                              (i)

                              Conduct that —

                                          1.

                                          involves a violent act or an act dangerous to human life, property, or infrastructure; and

                                          2.

                                          appears to be intended to —

                                                      a.

                                                      intimidate or coerce a civilian population;

                                                      b.

                                                      influence the policy of a government by intimidation or coercion; or

                                                      c.

                                                      affect the conduct of a government by mass destruction, assassination, kidnapping, or hostage-taking;

                              (ii)

                              Activities constituting an offence within the scope of and as defined in applicable international conventions and protocols relating to terrorism;

                              (iii)

                              Providing or collecting funds, by any means, directly or indirectly, with the intention that they should be used or in the knowledge that they are to be used, in full or in part, in order to carry out any of the acts described in subparagraphs (i) or (ii);

                              (iv)

                              Attempting to commit any of the acts described in subparagraphs (i), (ii), or (iii);

                              (v)

                              Participating as an accomplice in the commission of any of the acts described in subparagraphs (i), (ii), or (iii);

                              (vi)

                              Organising or directing others to commit any of the acts described in subparagraphs (i), (ii), or (iii);

                              (vii)

                              Contributing in any other way to the commission of any of the acts described in subparagraphs (i), (ii), or (iii);

                              (viii)

                              Threatening to commit an act described in subparagraph (i) under circumstances which indicate that the threat is credible;

                  (b)

                  Other crimes that are punishable by a sentence of imprisonment of three years or more and that are transnational in nature.
                  A crime is considered as transnational in nature in particular if:

                              (i)

                              it is committed in more than one country;

                              (ii)

                              it is committed in one country but a substantial part of its preparation, planning, direction or control takes place in another country;

                              (iii)

                              it is committed in one country but involves an organised criminal group that engages in criminal activities in more than one country;

                              (iv)

                              it is committed in one country but has substantial effects in another country; or

                              (v)

                              it is committed in one country and the offender is in or intends to travel to another country.

            2.   PNR may be used and processed on a case-by-case basis where necessary in view of a serious threat and for the protection of vital interests of any individual or if ordered by a court.
      3.   PNR may be used and processed by DHS to identify persons who would be subject to closer questioning or examination upon arrival to or departure from the United States or who may require further examination.
      4.   Paragraphs 1, 2, and 3 shall be without prejudice to domestic law enforcement, judicial powers, or proceedings, where other violations of law or indications thereof are detected in the course of the use and processing of PNR.
      CHAPTER II

         SAFEGUARDS APPLICABLE TO THE USE OF PNR

      Article 5
      Data security
      1.   DHS shall ensure that appropriate technical measures and organisational arrangements are implemented to protect personal data and personal information contained in PNR against accidental, unlawful or unauthorised destruction, loss, disclosure, alteration, access, processing or use.
      2.   DHS shall make appropriate use of technology to ensure data protection, security, confidentiality and integrity. In particular, DHS shall ensure that:

                  (a)

                  encryption, authorisation and documentation procedures recognised by competent authorities are applied. In particular, access to PNR shall be secured and limited to specifically authorised officials;

                  (b)

                  PNR shall be held in a secure physical environment and protected with physical intrusion controls; and

                  (c)

                  a mechanism exists to ensure that PNR queries are conducted consistent with Article 4.

            3.   In the event of a privacy incident (including unauthorised access or disclosure), DHS shall take reasonable measures to notify affected individuals as appropriate, to mitigate the risk of harm of unauthorised disclosures of personal data and information, and to institute remedial measures as may be technically practicable.
      4.   Within the scope of this Agreement, DHS shall inform without undue delay the relevant European authorities about cases of significant privacy incidents involving PNR of EU citizens or residents resulting from accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, or any unlawful forms of processing or use.
      5.   The United States confirms that effective administrative, civil, and criminal enforcement measures are available under US law for privacy incidents. DHS may take disciplinary action against persons responsible for any such privacy incident, as appropriate, to include denial of system access, formal reprimands, suspension, demotion, or removal from duty.
      6.   All access to PNR, as well as its processing and use, shall be logged or documented by DHS. Logs or documentation shall be used only for oversight, auditing, and system maintenance purposes or as otherwise required by law.
      Article 6
      Sensitive data
      1.   To the extent that PNR of a passenger as collected includes sensitive data (i.e. personal data and information revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, or data concerning the health or sex life of the individual), DHS shall employ automated systems to filter and mask out sensitive data from PNR. In addition, DHS shall not further process or use such data, except in accordance with paragraphs 3 and 4.
      2.   DHS shall provide to the European Commission within 90 days of the entry into force of this Agreement a list of codes and terms identifying sensitive data that shall be filtered out.
      3.   Access to, as well as processing and use of, sensitive data shall be permitted in exceptional circumstances where the life of an individual could be imperilled or seriously impaired. Such data may be exclusively accessed using restrictive processes on a case-by-case basis with the approval of a DHS senior manager.
      4.   Sensitive data shall be permanently deleted not later than 30 days from the last receipt of PNR containing such data by DHS. However, sensitive data may be retained for the time specified in US law for the purpose of a specific investigation, prosecution or enforcement action.
      Article 7
      Automated individual decisions
      The United States shall not make decisions that produce significant adverse actions affecting the legal interests of individuals based solely on automated processing and use of PNR.
      Article 8
      Retention of data
      1.   DHS retains PNR in an active database for up to five years. After the initial six months of this period, PNR shall be depersonalised and masked in accordance with paragraph 2 of this Article. Access to this active database shall, unless otherwise permitted by this Agreement, be restricted to a limited number of specifically authorised officials.
      2.   To achieve depersonalisation, personally identifiable information contained in the following PNR data types shall be masked out:

                  (a)

                  name(s);

                  (b)

                  other names on PNR;

                  (c)

                  all available contact information (including originator information);

                  (d)

                  general remarks, including other supplementary information (OSI), special service information (SSI), and special service request (SSR); and

                  (e)

                  any collected Advance Passenger Information System (APIS) information.

            3.   After this active period, PNR shall be transferred to a dormant database for a period of up to ten years. This dormant database shall be subject to additional controls, including a more restricted number of authorised personnel, as well as a higher level of supervisory approval required before access. In this dormant database, PNR shall not be repersonalised except in connection with law enforcement operations and then only in connection with an identifiable case, threat or risk. As regards the purposes as set out in Article 4(1)(b), PNR in this dormant database may only be repersonalised for a period of up to five years.
      4.   Following the dormant period, data retained must be rendered fully anonymised by deleting all data types which could serve to identify the passenger to whom PNR relate without the possibility of repersonalisation.
      5.   Data that are related to a specific case or investigation may be retained in an active PNR database until the case or investigation is archived. This paragraph is without prejudice to data retention requirements for individual investigation or prosecution files.
      6.   The Parties agree that, within the framework of the evaluation as provided for in Article 23(1), the necessity of a 10-year dormant period of retention will be considered.
      Article 9
      Non-discrimination
      The United States shall ensure that the safeguards applicable to processing and use of PNR under this Agreement apply to all passengers on an equal basis without unlawful discrimination.
      Article 10
      Transparency
      1.   DHS shall provide information to the travelling public regarding its use and processing of PNR through:

                  (a)

                  publications in the Federal Register;

                  (b)

                  publications on its website;

                  (c)

                  notices that may be incorporated by the carriers into contracts of carriage;

                  (d)

                  statutorily required reporting to Congress; and

                  (e)

                  other appropriate measures as may be developed.

            2.   DHS shall publish and provide to the EU for possible publication its procedures and modalities regarding access, correction or rectification, and redress procedures.
      3.   The Parties shall work with the aviation industry to encourage greater visibility to passengers at the time of booking on the purpose of the collection, processing and use of PNR by DHS, and on how to request access, correction and redress.
      Article 11
      Access for individuals
      1.   In accordance with the provisions of the Freedom of Information Act, any individual, regardless of nationality, country of origin, or place of residence is entitled to request his or her PNR from DHS. DHS shall timely provide such PNR subject to the provisions of paragraphs 2 and 3 of this Article.
      2.   Disclosure of information contained in PNR may be subject to reasonable legal limitations, applicable under US law, including any such limitations as may be necessary to safeguard privacy-protected, national security, and law enforcement sensitive information.
      3.   Any refusal or restriction of access shall be set forth in writing and provided to the requesting individual on a timely basis. Such notification shall include the legal basis on which information was withheld and shall inform the individual of the options available under US law for seeking redress.
      4.   DHS shall not disclose PNR to the public, except to the individual whose PNR has been processed and used or his or her representative, or as required by US law.
      Article 12
      Correction or rectification for individuals
      1.   Any individual regardless of nationality, country of origin, or place of residence may seek the correction or rectification, including the possibility of erasure or blocking, of his or her PNR by DHS pursuant to the processes described in this Agreement.
      2.   DHS shall inform, without undue delay, the requesting individual in writing of its decision whether to correct or rectify the PNR at issue.
      3.   Any refusal or restriction of correction or rectification shall be set forth in writing and provided to the requesting individual on a timely basis. Such notification shall include the legal basis of such refusal or restriction and shall inform the individual of the options available under US law for seeking redress.
      Article 13
      Redress for individuals
      1.   Any individual regardless of nationality, country of origin, or place of residence whose personal data and personal information has been processed and used in a manner inconsistent with this Agreement may seek effective administrative and judicial redress in accordance with US law.
      2.   Any individual is entitled to seek to administratively challenge DHS decisions related to the use and processing of PNR.
      3.   Under the provisions of the Administrative Procedure Act and other applicable law, any individual is entitled to petition for judicial review in US federal court of any final agency action by DHS. Further, any individual is entitled to petition for judicial review in accordance with applicable law and relevant provisions of:

                  (a)

                  the Freedom of Information Act;

                  (b)

                  the Computer Fraud and Abuse Act;

                  (c)

                  the Electronic Communications Privacy Act; and

                  (d)

                  other applicable provisions of US law.

            4.   In particular, DHS provides all individuals an administrative means (currently the DHS Traveller Redress Inquiry Program (DHS TRIP)) to resolve travel-related inquiries including those related to the use of PNR. DHS TRIP provides a redress process for individuals who believe they have been delayed or prohibited from boarding a commercial aircraft because they were wrongly identified as a threat. Pursuant to the Administrative Procedure Act and Title 49, United States Code, Section 46110, any such aggrieved individual is entitled to petition for judicial review in US federal court from any final agency action by DHS relating to such concerns.
      Article 14
      Oversight
      1.   Compliance with the privacy safeguards in this Agreement shall be subject to independent review and oversight by Department Privacy Officers, such as the DHS Chief Privacy Officer, who:

                  (a)

                  have a proven record of autonomy;

                  (b)

                  exercise effective powers of oversight, investigation, intervention, and review; and

                  (c)

                  have the power to refer violations of law related to this Agreement for prosecution or disciplinary action, when appropriate.

            They shall, in particular, ensure that complaints relating to non-compliance with this Agreement are received, investigated, responded to, and appropriately redressed. These complaints may be brought by any individual, regardless of nationality, country of origin, or place of residence.
      2.   In addition, application of this Agreement by the United States shall be subject to independent review and oversight by one or more of the following entities:

                  (a)

                  the DHS Office of Inspector General;

                  (b)

                  the Government Accountability Office as established by Congress; and

                  (c)

                  the US Congress.

            Such oversight may be manifested in the findings and recommendations of public reports, public hearings, and analyses.
      CHAPTER III

         MODALITIES OF TRANSFERS

      Article 15
      Method of PNR transmission
      1.   For the purposes of this Agreement, carriers shall be required to transfer PNR to DHS using the ‘push’ method, in furtherance of the need for accuracy, timeliness and completeness of PNR.
      2.   Carriers shall be required to transfer PNR to DHS by secure electronic means in compliance with the technical requirements of DHS.
      3.   Carriers shall be required to transfer PNR to DHS in accordance with paragraphs 1 and 2, initially at 96 hours before the scheduled flight departure and additionally either in real time or for a fixed number of routine and scheduled transfers as specified by DHS.
      4.   In any case, the Parties agree that all carriers shall be required to acquire the technical ability to use the ‘push’ method not later than 24 months following entry into force of this Agreement.
      5.   DHS may, where necessary, on a case-by-case basis, require a carrier to provide PNR between or after the regular transfers described in paragraph 3. Wherever carriers are unable, for technical reasons, to respond timely to requests under this Article in accordance with DHS standards, or, in exceptional circumstances in order to respond to a specific, urgent, and serious threat, DHS may require carriers to otherwise provide access.
      Article 16
      Domestic sharing
      1.   DHS may share PNR only pursuant to a careful assessment of the following safeguards:

                  (a)

                  Exclusively as consistent with Article 4;

                  (b)

                  Only with domestic government authorities when acting in furtherance of the uses outlined in Article 4;

                  (c)

                  Receiving authorities shall afford to PNR equivalent or comparable safeguards as set out in this Agreement; and

                  (d)

                  PNR shall be shared only in support of those cases under examination or investigation and pursuant to written understandings and US law on the exchange of information between domestic government authorities.

            2.   When transferring analytical information obtained from PNR under this Agreement, the safeguards set forth in paragraph 1 of this Article shall be respected.
      Article 17
      Onward transfer
      1.   The United States may transfer PNR to competent government authorities of third countries only under terms consistent with this Agreement and only upon ascertaining that the recipient’s intended use is consistent with those terms.
      2.   Apart from emergency circumstances, any such transfer of data shall occur pursuant to express understandings that incorporate data privacy protections comparable to those applied to PNR by DHS as set out in this Agreement.
      3.   PNR shall be shared only in support of those cases under examination or investigation.
      4.   Where DHS is aware that PNR of a citizen or a resident of an EU Member State is transferred, the competent authorities of the concerned Member State shall be informed of the matter at the earliest appropriate opportunity.
      5.   When transferring analytical information obtained from PNR under this Agreement, the safeguards set forth in paragraphs 1 to 4 shall be respected.
      Article 18
      Police, law enforcement and judicial cooperation
      1.   Consistent with existing law enforcement or other information-sharing agreements or arrangements between the United States and any EU Member State or Europol and Eurojust, DHS shall provide to competent police, other specialised law enforcement or judicial authorities of the EU Member States and Europol and Eurojust within the remit of their respective mandates, as soon as practicable, relevant, and appropriate, analytical information obtained from PNR in those cases under examination or investigation to prevent, detect, investigate, or prosecute within the European Union terrorist offences and related crimes or transnational crime as described in Article 4(1)(b).
      2.   A police or judicial authority of an EU Member State, or Europol or Eurojust, may request, within its mandate, access to PNR or relevant analytical information obtained from PNR that are necessary in a specific case to prevent, detect, investigate, or prosecute within the European Union terrorist offences and related crimes or transnational crime as described in Article 4(1)(b). DHS shall, subject to the agreements and arrangements noted in paragraph 1 of this Article, provide such information.
      3.   Pursuant to paragraphs 1 and 2 of this Article, DHS shall share PNR only following a careful assessment of the following safeguards:

                  (a)

                  Exclusively as consistent with Article 4;

                  (b)

                  Only when acting in furtherance of the uses outlined in Article 4; and

                  (c)

                  Receiving authorities shall afford to PNR equivalent or comparable safeguards as set out in this Agreement.

            4.   When transferring analytical information obtained from PNR under this Agreement, the safeguards set forth in paragraphs 1 to 3 of this Article shall be respected.
      CHAPTER IV

         IMPLEMENTING AND FINAL PROVISIONS

      Article 19
      Adequacy
      In consideration of this Agreement and its implementation, DHS shall be deemed to provide, within the meaning of relevant EU data protection law, an adequate level of protection for PNR processing and use. In this respect, carriers which have provided PNR to DHS in compliance with this Agreement shall be deemed to have complied with applicable legal requirements in the EU related to the transfer of such data from the EU to the United States.
      Article 20
      Reciprocity
      1.   The Parties shall actively promote the cooperation of carriers within their respective jurisdictions with any PNR system operating or as may be adopted in the other’s jurisdiction, consistent with this Agreement.
      2.   Given that the establishment of an EU PNR system could have a material effect on the Parties’ obligations under this Agreement, if and when an EU PNR system is adopted, the Parties shall consult to determine whether this Agreement would need to be adjusted accordingly to ensure full reciprocity. Such consultations shall in particular examine whether any future EU PNR system would apply less stringent data protection standards than those provided for in this Agreement, and whether, therefore, this Agreement should be amended.
      Article 21
      Implementation and non-derogation
      1.   This Agreement shall not create or confer, under US law, any right or benefit on any person or entity, private or public. Each Party shall ensure that the provisions of this Agreement are properly implemented.
      2.   Nothing in this Agreement shall derogate from existing obligations of the United States and EU Member States, including under the Agreement on Mutual Legal Assistance between the European Union and the United States of 25 June 2003 and the related bilateral mutual legal assistance instruments between the United States and EU Member States.
      Article 22
      Notification of changes in domestic law
      The Parties shall advise each other regarding the enactment of any legislation that materially affects the implementation of this Agreement.
      Article 23
      Review and evaluation
      1.   The Parties shall jointly review the implementation of this Agreement one year after its entry into force and regularly thereafter as jointly agreed. Further, the Parties shall jointly evaluate this Agreement four years after its entry into force.
      2.   The Parties shall jointly determine in advance the modalities and terms of the joint review and shall communicate to each other the composition of their respective teams. For the purpose of the joint review, the European Union shall be represented by the European Commission, and the United States shall be represented by DHS. The teams may include appropriate experts on data protection and law enforcement. Subject to applicable laws, participants in the joint review shall be required to have appropriate security clearances and to respect the confidentiality of the discussions. For the purpose of the joint review, DHS shall ensure appropriate access to relevant documentation, systems, and personnel.
      3.   Following the joint review, the European Commission shall present a report to the European Parliament and the Council of the European Union. The United States shall be given an opportunity to provide written comments which shall be attached to the report.
      Article 24
      Resolution of disputes and suspension of agreement
      1.   Any dispute arising from the implementation of this Agreement, and any matters related thereto, shall give rise to consultations between the Parties, with a view to reaching a mutually agreeable resolution, including providing an opportunity for either Party to cure within a reasonable time.
      2.   In the event that consultations do not result in a resolution of the dispute, either Party may suspend the application of this Agreement by written notification through diplomatic channels, with any such suspension to take effect 90 days from the date of such notification, unless the Parties otherwise agree to a different effective date.
      3.   Notwithstanding any suspension of this Agreement, all PNR obtained by DHS pursuant to this Agreement prior to its suspension shall continue to be processed and used in accordance with the safeguards of this Agreement.
      Article 25
      Termination
      1.   Either Party may terminate this Agreement at any time by written notification through diplomatic channels.
      2.   Termination shall take effect 120 days from the date of such notification, unless the Parties otherwise agree to a different effective date.
      3.   Prior to any termination of this Agreement, the Parties shall consult each other in a manner which allows sufficient time for reaching a mutually agreeable resolution.
      4.   Notwithstanding any termination of this Agreement, all PNR obtained by DHS pursuant to this Agreement prior to its termination shall continue to be processed and used in accordance with the safeguards of this Agreement.
      Article 26
      Duration
      1.   Subject to Article 25, this Agreement shall remain in force for a period of seven years from the date of its entry into force.
      2.   Upon the expiry of the period set forth in paragraph 1 of this Article, as well as any subsequent period of renewal under this paragraph, the Agreement shall be renewed for a subsequent period of seven years unless one of the Parties notifies the other in writing through diplomatic channels, at least twelve months in advance, of its intention not to renew the Agreement.
      3.   Notwithstanding the expiration of this Agreement, all PNR obtained by DHS under the terms of this Agreement shall continue to be processed and used in accordance with the safeguards of this Agreement. Similarly, all PNR obtained by DHS under the terms of the Agreement between the United States of America and the European Union on the processing and transfer of passenger name record (PNR) data by air carriers to the United States Department of Homeland Security (DHS), signed at Brussels and Washington, 23 and 26 July 2007, shall continue to be processed and used in accordance with the safeguards of that Agreement.
      Article 27
      Final provisions
      1.   This Agreement shall enter into force on the first day of the month after the date on which the Parties have exchanged notifications indicating that they have completed their internal procedures for this purpose.
      2.   This Agreement, as of the date of its entry into force, shall supersede the 23 and 26 July 2007 Agreement.
      3.   This Agreement will only apply to the territory of Denmark, the United Kingdom or Ireland, if the European Commission notifies the United States in writing that Denmark, the United Kingdom or Ireland has chosen to be bound by this Agreement.
      4.   If the European Commission notifies the United States before the entry into force of this Agreement that it will apply to the territory of Denmark, the United Kingdom or Ireland, this Agreement shall apply to the territory of the relevant State on the same day as for the other EU Member States bound by this Agreement.
      5.   If the European Commission notifies the United States before the entry into force of this Agreement that it will apply to the territory of Denmark, the United Kingdom or Ireland, this Agreement shall apply to the territory of the relevant State on the first day following receipt of the notification by the United States.

         Done at Brussels this fourteenth day of December in the year two thousand and eleven, in two originals.
         Pursuant to EU law, this Agreement shall also be drawn up by the EU in the Bulgarian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages.

            For the European Union

            For the United States of America

         ANNEX

            PNR DATA TYPES

                     1.

                     PNR record locator code

                     2.

                     Date of reservation/issue of ticket

                     3.

                     Date(s) of intended travel

                     4.

                     Name(s)

                     5.

                     Available frequent flier and benefit information (i.e. free tickets, upgrades, etc.)

                     6.

                     Other names on PNR, including number of travellers on PNR

                     7.

                     All available contact information (including originator information)

                     8.

                     All available payment/billing information (not including other transaction details linked to a credit card or account and not connected to the travel transaction)

                     9.

                     Travel itinerary for specific PNR

                     10.

                     Travel agency/travel agent

                     11.

                     Code share information

                     12.

                     Split/divided information

                     13.

                     Travel status of passenger (including confirmations and check-in status)

                     14.

                     Ticketing information, including ticket number, one-way tickets and automated ticket fare quote

                     15.

                     All baggage information

                     16.

                     Seat information, including seat number

                     17.

                     General remarks including OSI, SSI and SSR information

                     18.

                     Any collected APIS information

                     19.

                     All historical changes to the PNR listed under points 1 to 18


title: 2013/584/EU: Decision of the European Parliament of 17 April 2013 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011#Resolution of the European Parliament of 17 April 2013 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011

text:
               16.11.2013

               EN

               Official Journal of the European Union

               L 308/254

         DECISION OF THE EUROPEAN PARLIAMENT
   of 17 April 2013
   on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011
   (2013/584/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Medicines Agency for the financial year 2011,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2011, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7-0041/2013),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), and in particular Article 208 thereof,

               —

               having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0098/2013),

               1.

               Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2011;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 388, 15.12.2012, p. 116.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 298, 26.10.2012, p. 1.

      (4)  OJ L 136, 30.4.2004, p. 1.

      (5)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 17 April 2013
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Medicines Agency for the financial year 2011,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2011, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7-0041/2013),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), and in particular Article 208 thereof,

                  —

                  having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0098/2013),

                  A.

                  whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the European Medicines Agency (‘the Agency’) for the financial year 2011 are reliable and that the underlying transactions are legal and regular,

                  B.

                  whereas on 23 October 2012, Parliament granted the Executive Director of the Agency discharge for the implementation of its budget for the financial year 2010 (6), and in its resolution accompanying the discharge, inter alia:

                              —

                              called on the Agency to inform the discharge authority about the timeframe and outcomes for the remaining 46 % of the screening process concerning declarations of interest of its experts and committee members who have been actively involved in the Agency’s activities between 1 January and 31 May 2012 against their curriculum vitae by the start of the next discharge procedure,

                              —

                              asked the Agency to provide the discharge authority with a precise timetable for the implementation of a new ex ante and ex post system for declarations of interest, notably by means of random comparison with curriculum vitae and information furnished by experts at national level,

                              —

                              called on the Agency to introduce a special section describing the actions taken to prevent and manage conflict of interest in each of its future annual activity reports (AARs), which should include, inter alia:

                                          —

                                          the number of alleged conflict of interest cases verified,

                                          —

                                          the number of revolving door cases,

                                          —

                                          the measures taken in each category of cases,

                                          —

                                          the number of breach of trust procedures launched and their outcomes,

                                          —

                                          the sanctions applied,

                              —

                              requested the Agency to inform the discharge authority of the detailed measures taken,

                  C.

                  whereas the Agency’s budget for 2011 was EUR 208 863 000, which represents a nominal increase of 0,22 % over the financial year 2010,

                  D.

                  whereas the overall contribution of the Union to the Agency’s budget for 2011 was EUR 39 765 191,39, compared to EUR 36 755 652,07 in 2010,

         Follow-up of 2010 discharge

                  1.

                  Acknowledges from the Agency that as regards an ex post check of the declarations of interest of its experts and committee members, a representative sample of the remaining 46 % of the experts will be included in the ex post check currently being performed; notes that a new, more thorough check is being developed as a result of lessons learned from the ex post control check performed in the context of the 2010 discharge; takes note of the timetable as communicated by the Agency and awaits to be duly informed on the outcome of the check;

                  2.

                  Notes with satisfaction that a special section describing the actions taken to prevent and manage conflicts of interest is to be introduced in each of the Agency’s AARs, starting with the 2012 AAR;

         Budgetary and financial management

                  3.

                  Recalls that the total Union contributions amounted to EUR 39 765 191,39 for 2011, which represents an 8,65 % increase compared to the previous year;

                  4.

                  Acknowledges that the Agency’s budget is financed by both the Union budget and fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations; finds from the annual accounts that in 2011, 77,7 % of the Agency’s revenue is estimated to have derived from the fee revenue, which continues to increase year on year, the relative percentage income from the Union contribution 18,3 % in 2011 (18,8 % in 2010, or 14 % if the recovery of surplus was deduced from the total Union contribution);

                  5.

                  Observes that in terms of committed and paid appropriations, the Agency’s execution rate stands at 95,21 % and 81,97 % respectively, compared with 95,65 % and 79,10 % in 2010; calls on the Agency to continue its efforts to improve its execution rate of payment;

                  6.

                  Notes with concern that as in its previous reports, the Court of Auditors has noted the need to introduce a system of remuneration for services provided by Member States authorities, based on their real costs; regrets that no progress has been made on this issue since 2009, when a proposal for a new payment system was presented to the Management Board but no agreement was reached; notes that the Agency will present a new proposal for a new payment system to the Management Board in March 2013; acknowledges the efforts made by the Agency’s executives to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs; is fully aware of the fact that the little progress made is due to the lack of decision taken by the Management Board; welcomes, therefore, the approach by the Agency’s administration to call upon the Commission for further assistance in this matter; urges the Agency to inform the discharge authority about the developments on this issue, inter alia, on the state of play as regards the new action plan and the Management Board’s position on it;

         Carry-over appropriations

                  7.

                  Is concerned that once again, the Court of Auditors reported that payment appropriations for Title II (‘Administrative expenditure’) amounting to EUR 9 600 000 have been carried over to 2012, representing 29 % of the Title II budget, as well as payment appropriations amounting to EUR 10 300 000 for Title III (‘Operational expenditure’), representing 34 % of the Title III budget; believes the level of carry-over to be excessive and at odds with the principle of annuality;

                  8.

                  Notes with concern the difference between the Court of Auditors’ conclusion and the Agency’s reply as regards the framework contract for Information Technology (IT) services concluded in 2009, for which the Court had qualified its opinion on the legality and regularity of the transactions underlying the Agency’s 2009 accounts; notes that the Court of Auditors considers the increase of the original contract ceiling to be irregular, while the Agency considers that the IT framework contract was not irregular, and therefore does not consider its extension as irregular either; urges the Agency to provide further information on the matter and to take steps in order to resolve the contradiction;

         Procurement procedures

                  9.

                  Acknowledges from the Court of Auditors that there is scope for improving the transparency of procurement procedures as regards the justification of the estimated contract volumes and the definition, publication and application of selection criteria; notes with satisfaction that the Agency has taken note of the Court of Auditors’ comments and updated its procedures with a view to transparency and documentation;

         Recruitment procedures

                  10.

                  Notes that in 2011, the Agency advertised 15 vacancies for temporary agent positions and that at year-end, the total number of staff at the Agency increased from 656 to 689;

                  11.

                  Acknowledges from the Court of Auditors the need to improve the transparency of staff selection procedures; notes with concern that Selection Board members did not always complete their conflict of interest declarations or did not do so in a timely manner and there was no evidence of any action taken to address the issues raised by those declarations; regrets that the documentation of the Selection Board’s proceedings was not always adequate and that there is no evidence as to how the method for the short-listing of candidates was established and that the questions for the written tests or interviews were set before the examinations;

                  12.

                  Notes from the Agency that it has taken note of the Court of Auditors’ comments and updated its procedures with a view to transparency and timely documentation; considers that some of the provisions of the Staff Regulations may present a considerable administrative burden; therefore encourages the Commission to allow for a certain degree of simplification under Article 110 of the Staff Regulations in regard to the agencies;

         Conflict of interest

                  13.

                  Welcomes the fact that the Court of Auditors carried out an audit to evaluate the policies and procedures for the management of conflict of interest situations for four European agencies, including the European Medicines Agency, and presented its results in its Special Report 15/2012;

                  14.

                  Notes that according to the findings of the Court of Auditors, at the time of completion of the field work (October 2011), the Agency did not adequately manage conflict of interest situations but has developed one of the most advanced policies and procedure for declaring, assessing and managing conflicts of interest;

                  15.

                  Welcomes the fact that the Agency has taken a number of steps following the discharge authority’s recommendations for 2010, the Court of Auditors’ audit and the publication of Special Report 15/2012, in particular:

                              —

                              the policy on the handling of conflicts of interests of members and experts of scientific committees, an already revised system which came into effect on 29 September 2011, was further revised in 2012 (mainly to give clearer guidance) and became effective on 3 April 2012,

                              —

                              compulsory screening of the declared conflicts of interests of scientific committees’ members was introduced on 29 September 2011; the possibility, moreover, of pre-screening any expert prior to the formal Agency’s evaluation for involvement in its activities is offered to all nominating authorities,

                              —

                              a revised policy on the handling of conflicts of interests of the Management Board (in line with the policy for scientific committees’ members/experts) came into effect on 3 April 2012,

                              —

                              breach of trust procedures were developed for both scientific committees’ members/experts (which came into effect on 3 April 2012) and Management Board members (which came into effect on 7 June 2012),

                              —

                              as regards transparency, the recording of declared interests has been further fine-tuned in so far as all restricted involvements put in place vis-à-vis the agenda points of the meeting are now recorded (undertaken before December 2012);

                  16.

                  Urges the Agency to continue implementing the Court of Auditors’ recommendations in order to avoid any conflict of interest in its various structures of governance and operation, and to report to the discharge authority on a six months basis on the implementation of the abovementioned policies and procedures, as well as on any further developments regarding management of conflict of interest;

                  17.

                  Calls on the agency to start a structured dialogue with civil society on matters relating to conflicts of interest, to invite the organisations concerned at least twice a year to discuss matters of common interest based on an agreed agenda and to inform the discharge authority on the outcome of those deliberations;

                  18.

                  Welcomes the Agency’s commitment to undertake in the first half of 2013 a review of the implementation of its revised policy on the handling of conflicts of interests and that an ex ante and ex post check on the handling of conflicts of interests is currently being developed for implementation in the second quarter of 2013; calls on the Agency to keep the discharge authority informed on their respective outcomes;

                  19.

                  Welcomes the fact that after the former Head of the Legal Service left the Agency in June 2012 to join a US-based law firm having a number of pharmaceutical industry companies as clients as senior counsel, the Executive Director of the Agency launched a review of his work as Head of the Legal Service, Chair of the Joint Committee, Chair of the Disciplinary Committee and as a member of the Advisory Committee on Procurement and Contracts; acknowledges that no evidence of conflicts of interest nor breach of obligations provided in Articles 11 and 11a of the Staff Regulations could be identified; welcomes the fact that in accordance with Article 16 of the Staff Regulations, the Executive Director imposed some restrictions to the activities of the former Head of Legal Service for a period of two years following his leaving the Agency; calls on the Agency to provide the discharge authority with detailed information on those restrictions;

         Internal audit

                  20.

                  Takes note that an in-depth risk assessment was conducted to determine the audit priorities and as a result, the audit topic agreed for 2012 was ‘Planning and Budgeting’, and the Internal Audit Service (IAS) carried out an audit entitled ‘Operational Business Continuity in the European Medicines Agency’;

                  21.

                  Notes that, based on the results of that audit, the IAS raised 13 recommendations, seven of which were rated as ‘very important’, five as ‘important’ and one as ‘desirable’; notes with satisfaction that all the recommendations were accepted by the Management Board and that the action plan prepared by the Agency to rectify those recommendations was considered to be adequate by the IAS;

                  22.

                  Notes that the IAS also carried out an IT risk assessment exercise in a form of a risk self-assessment, providing an overview of IT risk exposures;

                  23.

                  Acknowledges that as regards earlier recommendations issued by the IAS and their implementation by the Agency by 31 December 2011, there are nine ‘very important’ recommendations open from previous audits, eight of which have been implemented by the Agency and are under review by IAS, and that no critical recommendations remained open on 31 December 2011;

                  24.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its Resolution of 17 April 2013 (7) on the performance, financial management and control of the agencies.

         (1)  OJ C 388, 15.12.2012, p. 116.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 298, 26.10.2012, p. 1.

         (4)  OJ L 136, 30.4.2004, p. 1.

         (5)  OJ L 357, 31.12.2002, p. 72.

         (6)  OJ L 350, 20.12.2012, p. 82.

         (7)  Texts adopted, P7_TA(2013)0134 (see page 374 of this Official Journal).