{"change_dates":[],"dossier":{"amendments":[{"authors":"Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-1","location":[["Proposal for a decision 1","Paragraph 1"]],"meps":[4751],"meta":{"created":"2019-07-03T06:09:32"},"new":["1. Grants the Executive Director of","the European Medicines Agency discharge","in respect of the implementation of the","Agency\u2019s budget for the financial year","2016;"],"old":["1. Grants the Executive Director of","the European Medicines Agency discharge","in respect of the implementation of the","Agency\u2019s budget for the financial year","2016 / Postpones its decision on granting","the Executive Director of the European","Medicines Agency discharge in respect of","the implementation of the Agency\u2019s","budget for the financial year 2016;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"1","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Monica Macovei","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-2","location":[["Proposal for a decision 1","Paragraph 1"]],"meta":{"created":"2019-07-03T06:09:32"},"new":["1. Grants the Executive Director of","the European Medicines Agency discharge","in respect of the implementation of the","Agency\u2019s budget for the financial year","2016;"],"old":["1. Grants the Executive Director of","the European Medicines Agency discharge","in respect of the implementation of the","Agency\u2019s budget for the financial year","2016 / Postpones its decision on granting","the Executive Director of the European","Medicines Agency discharge in respect of","the implementation of the Agency\u2019s","budget for the financial year 2016;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"2","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Ryszard Czarnecki, Notis Marias, Raffaele Fitto, Beata Gosiewska, Richard Sul\u00edk","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-3","location":[["Proposal for a decision 1","Paragraph 1"]],"meps":[28372,125069,4465,124900,124928],"meta":{"created":"2019-07-03T06:09:32"},"new":["1. Postpones its decision on granting","the Executive Director of the European","Medicines Agency discharge in respect of","the implementation of the Agency\u2019s budget","for the financial year 2016;"],"old":["1. Grants the Executive Director of","the European Medicines Agency","discharge in respect of the","implementation of the Agency\u2019s budget","for the financial year 2016 / Postpones its","decision on granting the Executive Director","of the European Medicines Agency","discharge in respect of the implementation","of the Agency\u2019s budget for the financial","year 2016;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"3","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-4","location":[[" Proposal for a decision 2","Paragraph 1"]],"meps":[4751],"meta":{"created":"2019-07-03T06:09:33"},"new":["1. Approves the closure of the","accounts of the European Medicines","Agency for the financial year 2016;"],"old":["1. Approves the closure of the","accounts of the European Medicines","Agency for the financial year 2016 /","Postpones the closure of the accounts of","the European Medicines Agency for the","financial year 2016;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"4","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-5","location":[[" Motion for a resolution","Paragraph 2"]],"meps":[4751],"meta":{"created":"2019-07-03T06:09:33"},"new":["2. Notes that, according to the Court\u2019s","report, since the introduction of a new IT","accounting system in 2011, reporting on","commitment workflow and consumption","has not been sufficiently transparent;","regrets that, although the matter was","repeatedly raised with the Agency, no","corrective action has been taken; take note","of the Agency's explanation that \"[the","Agency] is currently working to increase","the reporting functionality of its financial","system, in line with the recommendations","by the Court\"; calls on the Agency to","implement corrective actions as soon as","possible in 2018 and to report to the","discharge authority on their","implementation;"],"old":["2. Notes that, according to the Court\u2019s","report, since the introduction of a new IT","accounting system in 2011, reporting on","commitment workflow and consumption","has not been sufficiently transparent;","regrets that, although the matter was","repeatedly raised with the Agency, no","corrective action has been taken; calls on","the Agency to implement corrective actions","as soon as possible in 2018 and to report to","the discharge authority on their","implementation;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"5","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-6","location":[["Motion for a resolution","Paragraph 3"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:33"},"new":["3. Notes with concern that, according","to the Court\u2019s report, the Agency","concluded corporate rate agreements for","the provision of accommodation for","experts with 25 hotels in London without","using a competitive procurement","procedure; notes that for six hotels,","payments made in 2016 were above the","Financial Regulation\u2019s threshold for which","an open or restricted competitive","procurement procedure is required; regrets","that the six corporate rate agreements and","the related 2016 payments, amounting to","some EUR 2 100 000 are therefore","irregular; notes that, according to the","Agency\u2019s reply, it will identify and","implement a solution for hotel bookings","during 2017-2018; calls on the Agency to","report to the discharge authority on the","implementation of that solution;"],"old":["3. Notes that, according to the Court\u2019s","report, the Agency concluded corporate","rate agreements for the provision of","accommodation for experts with 25 hotels","in London without using a competitive","procurement procedure; notes that for six","hotels, payments made in 2016 were above","the Financial Regulation\u2019s threshold for","which an open or restricted competitive","procurement procedure is required; notes","with concern that the six corporate rate","agreements and the related 2016 payments,","amounting to some EUR 2 100 000 are","therefore irregular; notes that, according to","the Agency\u2019s reply, it will identify and","implement a solution for hotel bookings","during 2017-2018; calls on the Agency to","report to the discharge authority on the","implementation of that solution;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"6","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-7","location":[[" Motion for a resolution","Paragraph 9"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:33"},"new":["9. Regrets that, as regards the number","of posts occupied on 31 December 2016","for all staff (including contract agents),","gender balance ratio was 69 % female to","31 % male; notes however that 14 out of 29","(48%) of the Agency\u2019s senior management","staff are female; calls on the Agency to","take the gender balance issue into account","when recruiting new staff and inform the","discharge authority in the next discharge","procedure of the progress made at the end","of the calendar year 2017;"],"old":["9. Regrets that, as regards the number","of posts occupied on 31 December 2016","for all staff (including contract agents),","gender balance has not been met, since the","ratio is 69 % female to 31 % male; notes","however that 14 out of 29 (48%) of the","Agency\u2019s senior management staff are","female; calls on the Agency to take the","gender balance issue into account when","recruiting new staff and inform the","discharge authority in the next discharge","procedure of the progress made at the end","of the calendar years of 2017 and 2018;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"7","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-8","location":[[" Motion for a resolution","Paragraph 14"]],"meps":[4751],"meta":{"created":"2019-07-03T06:09:33"},"new":["14. Notes that, according to the Court\u2019s","report, since 2014 the Agency has","undergone two major re-organisations","including the internal re-allocation of top","and middle management positions; notes","moreover that the re-allocation of key staff","in the area of IT and administration was","not successful, causing material risk of","instability to the Agency and its operations;","notes however that the Agency considers","that no instability was suffered by the","Agency due to organisational changes","which aimed at increasing operational","efficiencies and improving delivery of","strategic objectives and which were","supported by the Agency\u2019s Management","Board; notes moreover that there is no","system in place to analyse skills","availability, identify gaps and to recruit and","allocate appropriate staff; calls on the","Agency to pay extra attention to these","issues, improve its human resources","management and report back to the","discharge authority;"],"old":["14. Notes that, according to the Court\u2019s","report, since 2014 the Agency has","undergone two major re-organisations","including the internal re-allocation of top","and middle management positions; notes","moreover that the re-allocation of key staff","in the area of IT and administration was","not successful, causing material risk of","instability to the Agency and its operations;","notes however that the Agency considers","that no instability was suffered by the","Agency due to organisational changes;","notes moreover that there is no system in","place to analyse skills availability, identify","gaps and to recruit and allocate appropriate","staff; calls on the Agency to pay extra","attention to these issues, improve its human","resources management and report back to","the discharge authority;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"8","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-9","location":[["Motion for a resolution","Paragraph 16"]],"meps":[4751],"meta":{"created":"2019-07-03T06:09:33"},"new":["16. Notes that, according to the Court\u2019s","report, in 2014 the Commission, on behalf","of more than 50 Union Institutions and","bodies (including the Agency) signed a","framework contract with one contractor for","the acquisition of software, licences and","the provision of related IT maintenance","and consultancy; notes that the framework","contractor acts as an intermediary between","the Agency and suppliers that can address","the Agency\u2019s needs; takes note that for","these intermediary services, the framework","contractor is entitled to a commission of","two to nine percent of the suppliers\u2019 prices;","observes that in 2016, total payments to the","framework contractor amounted to EUR 8","900 000; regrets that the Agency did not","systematically check prices and uplifts","charged with the suppliers\u2019 quotes and","invoices issued to the framework","contractor; notes however that, following","the Court's finding in October 2017, the","Agency investigated the case which","resulted in contractor's acknowledgment","of their mistake and an expected recovery","of approximately EUR 12 000; also notes","that, since October 2017, specific internal","guidance has been put in place by the","Agency; that guidance includes systematic","checks of product category and related","uplift for every quotation received from","Comparex with value above EUR 60 000;"],"old":["16. Notes that, according to the Court\u2019s","report, in 2014 the Commission, on behalf","of more than 50 Union Institutions and","bodies (including the Agency) signed a","framework contract with one contractor for","the acquisition of software, licences and","the provision of related IT maintenance","and consultancy; notes that the framework","contractor acts as an intermediary between","the Agency and suppliers that can address","the Agency\u2019s needs; takes note that for","these intermediary services, the framework","contractor is entitled to a commission of","two to nine percent of the suppliers\u2019 prices;","observes that in 2016, total payments to the","framework contractor amounted to EUR 8","900 000; regrets that the Agency did not","systematically check prices and uplifts","charged with the suppliers\u2019 quotes and","invoices issued to the framework","contractor; calls on the Agency to pay","extra attention to such issues, to regularly","check the prices and look at means of","better economising on its operations;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"9","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Dennis de Jong","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-10","location":[[" Motion for a resolution","Paragraph 16 a (new)"]],"meps":[96748],"meta":{"created":"2019-07-03T06:09:33"},"new":["16 a. Acknowledges from the Agency","that pre-submission meetings contribute","to the development of medicines; notes","that in the light of the pre-submission","meetings, the experts of the Committee for","Medicinal Products for Human Use","perform both the role of consultant as of","evaluator of the marketing authorisation","applications; calls upon the Agency to at","least publish a list of pre-submission","activities, once the marketing","authorisation has been given;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"10","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Dennis de Jong","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-11","location":[[" Motion for a resolution","Paragraph 16 b (new)"]],"meps":[96748],"meta":{"created":"2019-07-03T06:09:33"},"new":["16 b. Acknowledges that approvals of","marketing authorisation applications are","based on three criteria: efficacy, quality","and safety; notes that a fourth","requirement should be added: Added","Therapeutic Value (ATV), comparing a","medicine with the best available drug,","instead of comparing it to placebos;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"11","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Monica Macovei, Ryszard Czarnecki, Dennis de Jong, Richard Sul\u00edk, Petri Sarvamaa, Patricija \u0160ulin, Tom\u00e1\u0161 Zdechovsk\u00fd","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-12","location":[["Motion for a resolution","Paragraph 19"]],"meps":[28372,96748,124928,112611,125103,124713],"meta":{"created":"2019-07-03T06:09:33"},"new":["19. Notes with satisfaction that the CVs","and declarations of interests of all","Management Board members are published","on the Agency's website; notes that no","breach of trust procedures were initiated","for Management Board members in 2016;"],"old":["19. Notes with satisfaction that the","declarations of interests of all Management","Board members are published on the","Agency's website; notes that no breach of","trust procedures were initiated for","Management Board members in 2016;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"12","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Dennis de Jong","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-13","location":[["Motion for a resolution","Paragraph 20 a (new)"]],"meps":[96748],"meta":{"created":"2019-07-03T06:09:33"},"new":["20 a. Asks the Agency for clarification","concerning the hiring of and dependence","on IT consultants for IT projects; notes","that no methodology had been put in","place prior to the start of the projects,","affecting the supervision and monitoring","by the management; is concerned about","the limited supervision of the external","consultants as a result of the contracts","used and the fact that performance takes","place off-site and in other Member States,","resulting, therefore, in delays in the","projects\u2019 implementation;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"13","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Monica Macovei, Dennis de Jong","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-14","location":[[" Motion for a resolution","Paragraph 20 a (new)"]],"meps":[96748],"meta":{"created":"2019-07-03T06:09:33"},"new":["20 a. Notes that the relocation of the","Agency could lead to staff leaving the","Agency; calls therefore on the Agency to","make sure that revolving door rules are","strictly applied in each case;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"14","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Monica Macovei","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-15","location":[[" Motion for a resolution","Paragraph 22"]],"meta":{"created":"2019-07-03T06:09:33"},"new":["22. Takes note that the Agency has","adopted the Commission guidelines on","internal whistleblowing in November","2014; welcomes the adoption by the","Agency\u2018s Management Board of a policy","to handle external sources\u2019 reports on","matters within the scope of its","responsibilities (i.e. external","whistleblowing rules) in March 2017; calls","on the Internal Control Unit to perform","random verifications in cooperation with","heads of divisions to strengthen measures","for detection of suspicious behaviors and","deterrence; recommends that the Agency","subjects its conflict of interest policies to","an independent assessment;"],"old":["22. Takes note that the Agency has","adopted the Commission guidelines on","internal whistleblowing in November","2014; welcomes the adoption by the","Agency\u2018s Management Board of a policy","to handle external sources\u2019 reports on","matters within the scope of its","responsibilities (i.e. external","whistleblowing rules) in March 2017;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"15","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Benedek J\u00e1vor, Bart Staes on behalf of the Verts/ALE Group","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-16","location":[[" Motion for a resolution","Paragraph 22 a (new)"]],"meps":[124721,4751],"meta":{"created":"2019-07-03T06:09:33"},"new":["22 a. Expresses the need to establish an","independent disclosure, advice and","referral body with sufficient budgetary","resources, in order to help whistleblowers","use the right channels to disclose their","information on possible irregularities","affecting the financial interests of the","Union, while protecting their","confidentiality and offering needed","support and advice;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"16","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Monica Macovei","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-17","location":[["Motion for a resolution","Paragraph 23"]],"meta":{"created":"2019-07-03T06:09:34"},"new":["23. Acknowledges from the Agency","that in 2016, it recorded no internal","whistleblower case and received 18 reports","from an external source concerning alleged","improprieties of a regulatory nature,","potentially adversely affecting public","health; notes that the Agency followed-up","on each of these reports but did not identify","any safety/efficacy concerns entailing the","need to take specific regulatory action;","acknowledges that internal procedures","are not sufficient to identify concerns or","irregularities; calls on the Agency to refer","those cases to an independent authority;"],"old":["23. Acknowledges from the Agency","that in 2016, it recorded no internal","whistleblower cases and received 18","reports from an external source concerning","alleged improprieties of a regulatory","nature, potentially adversely affecting","public health; notes that the Agency","followed-up on each of these reports but","did not identify any safety/efficacy","concerns entailing the need to take specific","regulatory action;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"17","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-18","location":[["Motion for a resolution","Paragraph 24"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:34"},"new":["24. Notes that in 2016 the Agency","received 823 requests for access to","documents which represent a 20 %","increase compared to 2015; notes that the","Agency replied to 678 requests and granted","full access to 542 requests, 17 requests","were granted only partial access and 44","requests were refused; notes that the reason","given by the Agency for refusing 21","requests to access to documents was the","protection of commercial interests; calls on","the Agency to ensure that, when deciding","on limiting the access to documents due to","protection of commercial interests, it also","considers the Union and its citizens\u2019","interest in health with seriousness, while","applying relevant rules and regulations;"],"old":["24. Notes that in 2016 the Agency","received 823 requests for access to","documents which represent a 20 %","increase compared to 2015; notes that the","Agency replied to 678 requests and granted","full access to 542 requests, 17 requests","were granted only partial access and 44","requests were refused; notes that the reason","given by the Agency for refusing 21","requests to access to documents was the","protection of commercial interests; calls on","the Agency to ensure that, when deciding","on limiting the access to documents due to","protection of commercial interests, it also","considers the Union and its citizens\u2019","interest in health with utmost seriousness;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"18","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-19","location":[[" Motion for a resolution","Subheading 9"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:34"},"new":["Main achievements"],"old":["Performance-based budgeting"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"19","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-20","location":[[" Motion for a resolution","Paragraph 30"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:34"},"new":["30. Notes in particular that the Agency","will be facing an additional workload and","budgetary needs throughout the 2018-2020","relocation and transition period as a","consequence of the decision of the United","Kingdom (UK) to withdraw from the","Union; calls on the Commission to make","available adequate staff and budget","resources during this period to ensure that","the Agency can both continue to carry out","its tasks effectively and launch all required","activities in preparation of its relocation in","2019; proposes in addition that the Agency,","limited by legislation and in line with the","principle of sound financial management,","be authorised to maintain a budgetary","reserve generated from revenue fees to","respond to unforeseen costs and","unfavourable exchange rate fluctuations","that may be incurred in 2018 and beyond;"],"old":["30. Notes in particular that the Agency","will be facing an additional workload and","budgetary needs throughout the 2018-2020","relocation and transition period as a","consequence of the decision of the United","Kingdom (UK) to withdraw from the","Union; calls on the Commission to make","available additional staff and budget","resources during this period to ensure that","the Agency can both continue to carry out","its tasks effectively and launch all required","activities in preparation of its relocation in","2019; proposes in addition that the Agency,","limited by legislation and in line with the","principle of sound financial management,","be authorised to maintain a budgetary","reserve generated from revenue fees to","respond to unforeseen costs and","unfavourable exchange rate fluctuations","that may be incurred in 2018 and beyond;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"20","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Monica Macovei","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-21","location":[["Motion for a resolution","Paragraph 31 a (new)"]],"meta":{"created":"2019-07-03T06:09:34"},"new":["31 a. Welcomes the Parliament's","mission to Amsterdam, at the temporary","and future headquarters of the Agency, to","gather up-to-date information on the","progress of the double transfer and on the","development of the real estate project and","underlines the role of the Parliament in","the decision-making process regarding","the new headquarters;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"21","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Petri Sarvamaa","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-22","location":[["Motion for a resolution","Paragraph 33"]],"meps":[112611],"meta":{"created":"2019-07-03T06:09:34"},"new":["33. Notes that the Court issued an","emphasis of matter paragraph for the two","London-based agencies, concerning the","UK\u2019s decision to withdraw from the","Union; notes that in view of the decisions","on the future location of the Agency, it has","disclosed in its financial statements an","estimated EUR 448 000 000 rent for the","remaining rental period between 2017 and","2039 as a contingent liability, as the rental","contract does not include any exit clause;","urges the Commission to take","responsibility of these absurdly high","liabilities and, together with the Agency,","negotiate an acceptable deal with the","lessor; notes moreover that contingent","liabilities in relation to other costs","associated with a removal such as, for","example the relocation of staff together","with their families, actions to mitigate a","potential loss of internal and UK-based","external expertise, and consequent risk to","business continuity, are yet to be","determined; calls on the Agency to report","to the discharge authority on an updated","estimate of relocation costs, which includes","liability of the current premises;"],"old":["33. Notes that the Court issued an","emphasis of matter paragraph for the two","London-based agencies, concerning the","UK\u2019s decision to withdraw from the","Union; notes that in view of the decisions","on the future location of the Agency, it has","disclosed in its financial statements an","estimated EUR 448 000 000 rent for the","remaining rental period between 2017 and","2039 as a contingent liability, as the rental","contract does not include any exit clause;","notes moreover that contingent liabilities in","relation to other costs associated with a","removal such as, for example the relocation","of staff together with their families, actions","to mitigate a potential loss of internal and","UK-based external expertise, and","consequent risk to business continuity, are","yet to be determined; calls on the Agency","to report to the discharge authority on an","updated estimate of relocation costs, which","includes liability of the current premises;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"22","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":" Dennis de Jong","changes":{},"committee":["CONT"],"date":"2018-03-02T00:00:00","id":"PE618.255-23","location":[[" Motion for a resolution","Paragraph 34"]],"meps":[96748],"meta":{"created":"2019-07-03T06:09:34"},"new":["34. Points out from the Court\u2019s report","that the Agency\u2019s 2016 budget was","financed 95 % by fees from pharmaceutical","companies and 5 % from Union funds;","stresses that the funding from","pharmaceutical companies has increased","in 2016, comparing to 2015 and is","concerned about the influence of the","industry on the Agency as of this","dependence;"],"old":["34. Points out from the Court\u2019s report","that the Agency\u2019s 2016 budget was","financed 95 % by fees from pharmaceutical","companies and 5 % from Union funds;","takes note that a future decrease of the","Agency\u2019s revenue resulting from the UK\u2019s","decision to leave the Union is possible;"],"orig_lang":"en","peid":"PE618.255v01-00","reference":"2017/2154(DEC)","seq":"23","src":"http://www.europarl.europa.eu/doceo/document/CONT-AM-618255_EN.pdf"},{"authors":"Luke Ming Flanagan","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-1","location":[["Draft opinion","Paragraph 1 a (new)"]],"meps":[124985],"meta":{"created":"2019-07-03T06:24:51"},"new":["1 a. Notes with regret the numerous","criticisms of the Agency contained in the","European Court of Auditors (ECA)","Report on the annual accounts of the","European Medicines Agency for the","financial year 2016;notes also with regret","the Agency's tepid response to those","criticisms and recommends that it should","be far more receptive of the constructive","criticisms and recommendations offered","by the Court, and act accordingly to take","whatever corrective and preventative","measures are necessary;"],"orig_lang":"en","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"1","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":"Mireille D'Ornano","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-2","location":[["Draft opinion","Paragraph 2"]],"meps":[124750],"meta":{"created":"2019-07-03T06:24:51"},"new":["2. Notes that in 2016 the total budget","of the Agency was EUR 308 422 000;","highlights that 89,4 % of the Agency\u2019s","revenue came from fees paid by the","pharmaceutical industry for services","provided, 5,5 % from the Union budget and","5 % from external assigned revenue; points","out that the share of the Agency\u2019s revenue","that comes from fees paid by the","pharmaceutical industry, which is now","very high, should be accompanied by","increased requirements regarding the","Agency's independence from the","pharmaceutical industry;"],"old":["2. Notes that in 2016 the total budget","of the Agency was EUR 308 422 000;","highlights that 89,4 % of the Agency\u2019s","revenue came from fees paid by the","pharmaceutical industry for services","provided, 5,5 % from the Union budget and","5 % from external assigned revenue;"],"orig_lang":"fr","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"2","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":" Claudiu Ciprian T\u0103n\u0103sescu","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-3","location":[[" Draft opinion","Paragraph 2 a (new)"]],"meps":[96847],"meta":{"created":"2019-07-03T06:24:51"},"new":["2a. Points out that the Agency","monitors budget consumption through a","robust monitoring process;"],"orig_lang":"ro","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"3","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":" Mireille D'Ornano","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-4","location":[[" Draft opinion","Paragraph 5"]],"meps":[124750],"meta":{"created":"2019-07-03T06:24:51"},"new":["5. Welcomes the launch of the clinical","data website in October 2016, which","represents an important step towards higher","transparency; notes that the website gives","open access to clinical reports for new","medicines for human use authorised in the","Union; notes that the Agency is the first","regulatory authority worldwide to provide","such broad access to clinical data;","nevertheless encourages the Agency to","continue this important work of providing","information for the general public;"],"old":["5. Welcomes the launch of the clinical","data website in October 2016, which","represents an important step towards higher","transparency; notes that the website gives","open access to clinical reports for new","medicines for human use authorised in the","Union; notes that the Agency is the first","regulatory authority worldwide to provide","such broad access to clinical data;"],"orig_lang":"fr","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"4","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":" Mireille D'Ornano","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-5","location":[[" Draft opinion","Paragraph 6"]],"meps":[124750],"meta":{"created":"2019-07-03T06:24:51"},"new":["6. Notes that the Agency set up a","taskforce dedicated to \u2018Brexit\u2019, which in","2016 was focused on assessing the impact","of Brexit on the Agency, with the aim of","identifying the main risks, and propose","possible mitigating measures; invites this","taskforce to work constructively, and to","take account of all the positive","implications of Brexit for the functioning","of the Agency;"],"old":["6. Notes that the Agency set up a","taskforce dedicated to \u2018Brexit\u2019, which in","2016 was focused on assessing the impact","of Brexit on the Agency, with the aim of","identifying the main risks, and propose","possible mitigating measures;"],"orig_lang":"fr","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"5","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":"Claudiu Ciprian T\u0103n\u0103sescu","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-6","location":[["Draft opinion","Paragraph 6 a (new)"]],"meps":[96847],"meta":{"created":"2019-07-03T06:24:51"},"new":["6a. Notes that setting up a fully","transparent reporting system is costly and","complicated, owing to the complexity of","the system and the significant number of","transactions processed every year;"],"orig_lang":"ro","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"6","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":"Karin Kadenbach","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-7","location":[["Draft opinion","Paragraph 7 a (new)"]],"meps":[97014],"meta":{"created":"2019-07-03T06:24:51"},"new":["7 a. Is concerned that in the case of","fee-funded agencies, like the Agency, the","staff cuts imposed in recent years have","meant a reduction in staff working on","tasks that are actually funded by","applicants' fees and not by the Union","budget;that has been done without taking","into consideration the extra workload","created by increasing numbers of","applications, nor the corresponding","increase in income from fees paid by","applicants for the services provided,","which could have allowed staff increases","without any impact on the Union","budget;notes that the need for additional","staff and budget resources will become","particularly acute for the Agency during","the 2018-2020 preparation and relocation","phase to its new seat in Amsterdam,","during which the Agency will have to","continue fulfilling its key public health","tasks as well as the additional tasks linked","to the relocation itself;"],"orig_lang":"en","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"7","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":" Mireille D'Ornano","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-8","location":[[" Draft opinion","Paragraph 9"]],"meps":[124750],"meta":{"created":"2019-07-03T06:24:51"},"new":["9. Stresses that the policy on the","handling of competing interests of","scientific committees' members and experts","was updated in October 2016; notes that it","includes a clarification on the restrictions","regarding the expert's potential","employment in a pharmaceutical company","and aligns the rules relating to close family","members' interests for scientific committee","and working party members, with those for","the Management Board members;","nevertheless encourages the Agency","further to strengthen its internal policy on","combating conflicts of interest and its","independence from the pharmaceutical","industry;"],"old":["9. Stresses that the policy on the","handling of competing interests of","scientific committees' members and experts","was updated in October 2016; notes that it","includes a clarification on the restrictions","regarding the expert's potential","employment in a pharmaceutical company","and aligns the rules relating to close family","members' interests for scientific committee","and working party members, with those for","the Management Board members;"],"orig_lang":"fr","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"8","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"},{"authors":" Claudiu Ciprian T\u0103n\u0103sescu","changes":{},"committee":["ENVI"],"date":"2017-12-13T00:00:00","id":"PE615.425-9","location":[[" Draft opinion","Paragraph 11 a (new)"]],"meps":[96847],"meta":{"created":"2019-07-03T06:24:51"},"new":["11a. Notes that the Agency has been","facing a significant risk of instability,","owing to the unsuccessful process of","reallocating key staff in the area of IT","and administration;"],"orig_lang":"ro","peid":"PE615.425v01-00","reference":"2017/2154(DEC)","seq":"9","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-615425_EN.pdf"}],"changes":{"2017-09-13T03:05:17":[{"data":[{"body":"EC","commission":[],"date":"2017-06-26T00:00:00","docs":[{"celexid":"CELEX:52017DC0365:EN","title":"COM(2017)0365","type":"Non-legislative basic document published","url":"http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2017/0365/COM_COM(2017)0365_EN.pdf"}],"type":"Non-legislative basic document published"}],"path":["activities"],"type":"added"},{"data":[],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"CONT","committee_full":"Budgetary Control","responsible":true},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","date":"2017-08-31T00:00:00","rapporteur":[{"group":"EPP","mepref":"4f1adc41b819f207b300010c","name":"V\u0102LEAN Adina-Ioana"}],"responsible":false}],"path":["committees"],"type":"added"},{"data":{},"path":["links"],"type":"added"},{"data":{"reference":"2017/2154(DEC)","stage_reached":"Preparatory phase in Parliament","subject":["8.70.03.06 2016 discharge"],"title":"2016 discharge: European Medicines Agency (EMA)","type":"DEC - Discharge procedure"},"path":["procedure"],"type":"added"}],"2017-09-15T02:53:04":[{"data":[{"group":"EPP","mepref":"4f608bacb819f2787f000000","name":"SARVAMAA Petri"},{"group":"S&D","mepref":"4f1ad25ab819f2759500001d","name":"LIBERADZKI Bogus\u0142aw"},{"group":"ALDE","mepref":"51ec2b0eb819f26b6e000015","name":"ALI Nedzhmi"},{"group":"GUE/NGL","mepref":"4f1ac952b819f25efd00012c","name":"DE JONG Dennis"},{"group":"EFD","mepref":"53ba8254b819f24b330001a9","name":"VALLI Marco"}],"path":["committees",0,"shadows"],"type":"added"},{"data":"2017-09-14T00:00:00","path":["committees",0,"date"],"type":"added"},{"data":[{"group":"Verts/ALE","mepref":"4f1adb8fb819f207b30000cf","name":"STAES Bart"}],"path":["committees",0,"rapporteur"],"type":"added"}],"2017-09-16T04:14:22":[{"data":{"body":"EP","committees":[{"body":"EP","committee":"CONT","committee_full":"Budgetary Control","date":"2017-09-14T00:00:00","rapporteur":[{"group":"Verts/ALE","mepref":"4f1adb8fb819f207b30000cf","name":"STAES Bart"}],"responsible":true,"shadows":[{"group":"EPP","mepref":"4f608bacb819f2787f000000","name":"SARVAMAA Petri"},{"group":"S&D","mepref":"4f1ad25ab819f2759500001d","name":"LIBERADZKI Bogus\u0142aw"},{"group":"ALDE","mepref":"51ec2b0eb819f26b6e000015","name":"ALI Nedzhmi"},{"group":"GUE/NGL","mepref":"4f1ac952b819f25efd00012c","name":"DE JONG Dennis"},{"group":"EFD","mepref":"53ba8254b819f24b330001a9","name":"VALLI Marco"}]},{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","date":"2017-08-31T00:00:00","rapporteur":[{"group":"EPP","mepref":"4f1adc41b819f207b300010c","name":"V\u0102LEAN Adina-Ioana"}],"responsible":false}],"date":"2017-09-13T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},"path":["activities",1],"type":"added"},{"data":"CONT/8/10788","path":["procedure","dossier_of_the_committee"],"type":"added"},{"data":["Preparatory phase in Parliament","Awaiting committee decision"],"path":["procedure","stage_reached"],"type":"changed"}],"2017-09-22T06:02:05":[{"data":{"Commissioner":"OETTINGER G\u00fcnther","DG":{"title":"Budget","url":"http://ec.europa.eu/info/departments/budget_en"}},"path":["activities",0,"commission",0],"type":"added"},{"data":{"body":"EC","commissioner":"OETTINGER G\u00fcnther","dg":{"title":"Budget","url":"http://ec.europa.eu/info/departments/budget_en"}},"path":["other",0],"type":"added"}],"2017-10-05T06:44:29":[{"data":{"group":"ENF","mepref":"53b2dbc9b819f205b0000096","name":"KAPPEL Barbara"},"path":["activities",1,"committees",0,"shadows",5],"type":"added"},{"data":{"group":"ENF","mepref":"53b2dbc9b819f205b0000096","name":"KAPPEL Barbara"},"path":["committees",0,"shadows",5],"type":"added"}],"2017-11-07T06:00:23":[{"data":["
PURPOSE: presentation by the Commission of the\nconsolidated annual accounts of the European Union for the\nfinancial year 2016, as part of the 2016 discharge\nprocedure.
\nAnalysis of the accounts of the European Medicines\nAgency (EMA).
\nCONTENT: the organisational governance of the EU\nconsists of institutions, agencies and other EU bodies whose\nexpenditure is included in the general budget of the\nUnion.
\nThis Commission document concerns the EU's\nconsolidated accounts for the year 2016 and details how spending by\nthe EU institutions and bodies was carried out. The consolidated\nannual accounts of the EU provide financial information on the\nactivities of the institutions, agencies and other bodies of the EU\nfrom an accrual accounting and budgetary perspective.
\nIt is the responsibility of the Commission's\nAccounting Officer to prepare the EU's consolidated annual accounts\nand ensure that they present fairly, in all material aspects, the\nfinancial position, the result of the operations and the cashflows\nof the EU institutions and bodies, including the European\nMedicines Agency (EMA), with a view to granting\ndischarge.
\nDischarge procedure: the\nfinal step of a budget lifecycle is the discharge of the budget for\na given financial year. It represents the political aspect of the\nexternal control of budget implementation and is the decision by\nwhich the European Parliament, acting on a Council recommendation,\n\"releases\" the Commission (and other EU bodies) from its\nresponsibility for management of a given budget by marking the end\nof that budget's existence. The European Parliament is the\ndischarge authority within the EU.
\nThe discharge procedure may produce three outcomes:\n(i) the granting; (ii) postponement or; (iii) the refusal of the\ndischarge.
\nThe final discharge report including specific\nrecommendations to the Commission for action is adopted in plenary\nby the European Parliament and are subject to an annual follow up\nreport in which the Commission outlines the concrete actions it has\ntaken to implement the recommendations made.
\nEach agency is subject to its own discharge procedure,\nincluding the European Medicines Agency (EMA).
\nThe European Medicines Agency: the Agency, which is located in London (UK), was\ncreated by Council\nRegulation (EEC) No 2309/93, which was replaced by Regulation\n(EC) No 726/2004 of the European Parliament and of the\nCouncil and its role is the coordination of the scientific\nresources made available by the national authorities in order to\nensure the evaluation and supervision of medicinal products for\nhuman or veterinary use on the basis of a centralised\nprocedure.
\nAs regards Agencys accounts, these are presented in detail in the document on the\nconsolidated annual accounts of the European Union for\n2016:
\nCommitment appropriations:
\nPayment\nappropriations:
\nFor further details on expenditure, please refer to\nthe final\naccounts of the EMA.
\nThe Committee on Budgetary Control adopted the\nreport by Bart STAES (Greens/EFA, BE) on discharge in respect of\nthe implementation of the budget of the European Medicines Agency\n(EMA) for the financial year 2016.
\nThe committee called on the European Parliament\nto grant the Executive Director of the Agency discharge in respect\nof the implementation of the agencys budget for the financial\nyear 2016.
\nNoting that the Court of Auditors stated that\nit had obtained reasonable assurance that the annual accounts of\nthe Agency for the financial year 2016 were reliable and that the\nunderlying transactions were legal and regular, Members called on\nParliament to approve the closure of the Agencys\naccounts.
\nThey made, however, a number of recommendations\nthat needed to be taken into account when the discharge is granted,\nin addition to the general recommendations that appear in the draft\nresolution on performance, financial management and control of EU\nagencies:
\nImpact of Brexit: Members stressed that the Agency will be\nfacing an additional workload and additional budgetary needs\nthroughout the 2018-2020 relocation and transition period, as a\nconsequence of the decision of the United Kingdom (UK) to withdraw\nfrom the Union. The Commission is called on to provide adequate\nstaff and budgetary resources in preparation for its relocation in\n2019. They proposed in addition that the Agency be authorised to\nmaintain a budgetary reserve generated from revenue fees to respond\nto unforeseen costs and unfavourable exchange rate fluctuations that may be incurred\nin 2018 and beyond. They also stressed the need for the accelerated\nbuilding approval so as to avoid any delays in the start of the\nconstruction of the new Agencys premises in Amsterdam. The\nAgency has disclosed in its financial statements an estimated EUR\n448 million in rent for the remaining rental period between 2017\nand 2039 as a contingent liability, as the rental contract does\nnot include any exit clause.
\nThe European Parliament decided to grant\ndischarge to the Director of the European Medicines Agency\n(EMA) in regard to the implementation of the agencys budget\nfor the 2016 financial year and to approve the closure of the\naccounts for the financial year in question.
\nNoting that the Court of Auditors has stated\nthat it has obtained reasonable assurances that the agencys\nannual accounts for the financial year 2016 are reliable and that\nthe underlying transactions are legal and regular,\nParliament adopted by 534 votes to 45 with 18 abstentions, a\nresolution containing a series of recommendations, which form an\nintegral part of the decision on discharge and which add to the\ngeneral recommendations set out in the resolution on performance, financial management and\ncontrol of EU agencies:
\nFollow-up to the 2014\ndischarge: Members noted with concern that some of the\nCourts comments from the 2014 discharge are still not marked\nas completed, in particular the evaluation of the\nweaknesses in management control, the dissemination of\nappropriate pharmacovigilance information to the Member States\nand to the general public. They called on the agency to complete\nthe corrective actions as soon as possible in 2018 and to report to\nthe discharge authority on their implementation.
\nImpact of Brexit: Members stressed that the agency\nwill be facing an additional workload and additional budgetary\nneeds throughout the 2018-2020 relocation and transition period, as\na consequence of the decision of the United Kingdom (UK) to\nwithdraw from the Union. They called on the Commission to provide\nadequate staff and budgetary resources in preparation for\nits relocation in 2019.
\nParliament also proposed that the agency be\nauthorised to maintain a budgetary reserve generated from revenue\nfees to respond to unforeseen costs\nand unfavourable exchange rate fluctuations that may be\nincurred in 2018 and beyond. They also stressed the need for the\naccelerated building approval so as to avoid any delays in the\nstart of the construction of the new agency premises in Amsterdam.\nThe agency has disclosed in its financial statements an estimated\nEUR 448 million in rent for the remaining rental period between\n2017 and 2039 as a contingent liability, as the rental\ncontract does not include any exit clause.
\nPURPOSE: presentation by the Commission of the\nconsolidated annual accounts of the European Union for the\nfinancial year 2016, as part of the 2016 discharge\nprocedure.
\nAnalysis of the accounts of the European Medicines\nAgency (EMA).
\nCONTENT: the organisational governance of the EU\nconsists of institutions, agencies and other EU bodies whose\nexpenditure is included in the general budget of the\nUnion.
\nThis Commission document concerns the EU's\nconsolidated accounts for the year 2016 and details how spending by\nthe EU institutions and bodies was carried out. The consolidated\nannual accounts of the EU provide financial information on the\nactivities of the institutions, agencies and other bodies of the EU\nfrom an accrual accounting and budgetary perspective.
\nIt is the responsibility of the Commission's\nAccounting Officer to prepare the EU's consolidated annual accounts\nand ensure that they present fairly, in all material aspects, the\nfinancial position, the result of the operations and the cashflows\nof the EU institutions and bodies, including the European\nMedicines Agency (EMA), with a view to granting\ndischarge.
\nDischarge procedure: the\nfinal step of a budget lifecycle is the discharge of the budget for\na given financial year. It represents the political aspect of the\nexternal control of budget implementation and is the decision by\nwhich the European Parliament, acting on a Council recommendation,\n\"releases\" the Commission (and other EU bodies) from its\nresponsibility for management of a given budget by marking the end\nof that budget's existence. The European Parliament is the\ndischarge authority within the EU.
\nThe discharge procedure may produce three outcomes:\n(i) the granting; (ii) postponement or; (iii) the refusal of the\ndischarge.
\nThe final discharge report including specific\nrecommendations to the Commission for action is adopted in plenary\nby the European Parliament and are subject to an annual follow up\nreport in which the Commission outlines the concrete actions it has\ntaken to implement the recommendations made.
\nEach agency is subject to its own discharge procedure,\nincluding the European Medicines Agency (EMA).
\nThe European Medicines Agency: the Agency, which is located in London (UK), was\ncreated by Council\nRegulation (EEC) No 2309/93, which was replaced by Regulation\n(EC) No 726/2004 of the European Parliament and of the\nCouncil and its role is the coordination of the scientific\nresources made available by the national authorities in order to\nensure the evaluation and supervision of medicinal products for\nhuman or veterinary use on the basis of a centralised\nprocedure.
\nAs regards Agencys accounts, these are presented in detail in the document on the\nconsolidated annual accounts of the European Union for\n2016:
\nCommitment appropriations:
\nPayment\nappropriations:
\nFor further details on expenditure, please refer to\nthe final\naccounts of the EMA.
\nThe Committee on Budgetary Control adopted the\nreport by Bart STAES (Greens/EFA, BE) on discharge in respect of\nthe implementation of the budget of the European Medicines Agency\n(EMA) for the financial year 2016.
\nThe committee called on the European Parliament\nto grant the Executive Director of the Agency discharge in respect\nof the implementation of the agencys budget for the financial\nyear 2016.
\nNoting that the Court of Auditors stated that\nit had obtained reasonable assurance that the annual accounts of\nthe Agency for the financial year 2016 were reliable and that the\nunderlying transactions were legal and regular, Members called on\nParliament to approve the closure of the Agencys\naccounts.
\nThey made, however, a number of recommendations\nthat needed to be taken into account when the discharge is granted,\nin addition to the general recommendations that appear in the draft\nresolution on performance, financial management and control of EU\nagencies:
\nImpact of Brexit: Members stressed that the Agency will be\nfacing an additional workload and additional budgetary needs\nthroughout the 2018-2020 relocation and transition period, as a\nconsequence of the decision of the United Kingdom (UK) to withdraw\nfrom the Union. The Commission is called on to provide adequate\nstaff and budgetary resources in preparation for its relocation in\n2019. They proposed in addition that the Agency be authorised to\nmaintain a budgetary reserve generated from revenue fees to respond\nto unforeseen costs and unfavourable exchange rate fluctuations that may be incurred\nin 2018 and beyond. They also stressed the need for the accelerated\nbuilding approval so as to avoid any delays in the start of the\nconstruction of the new Agencys premises in Amsterdam. The\nAgency has disclosed in its financial statements an estimated EUR\n448 million in rent for the remaining rental period between 2017\nand 2039 as a contingent liability, as the rental contract does\nnot include any exit clause.
\nThe European Parliament decided to grant\ndischarge to the Director of the European Medicines Agency\n(EMA) in regard to the implementation of the agencys budget\nfor the 2016 financial year and to approve the closure of the\naccounts for the financial year in question.
\nNoting that the Court of Auditors has stated\nthat it has obtained reasonable assurances that the agencys\nannual accounts for the financial year 2016 are reliable and that\nthe underlying transactions are legal and regular,\nParliament adopted by 534 votes to 45 with 18 abstentions, a\nresolution containing a series of recommendations, which form an\nintegral part of the decision on discharge and which add to the\ngeneral recommendations set out in the resolution on performance, financial management and\ncontrol of EU agencies:
\nFollow-up to the 2014\ndischarge: Members noted with concern that some of the\nCourts comments from the 2014 discharge are still not marked\nas completed, in particular the evaluation of the\nweaknesses in management control, the dissemination of\nappropriate pharmacovigilance information to the Member States\nand to the general public. They called on the agency to complete\nthe corrective actions as soon as possible in 2018 and to report to\nthe discharge authority on their implementation.
\nImpact of Brexit: Members stressed that the agency\nwill be facing an additional workload and additional budgetary\nneeds throughout the 2018-2020 relocation and transition period, as\na consequence of the decision of the United Kingdom (UK) to\nwithdraw from the Union. They called on the Commission to provide\nadequate staff and budgetary resources in preparation for\nits relocation in 2019.
\nParliament also proposed that the agency be\nauthorised to maintain a budgetary reserve generated from revenue\nfees to respond to unforeseen costs\nand unfavourable exchange rate fluctuations that may be\nincurred in 2018 and beyond. They also stressed the need for the\naccelerated building approval so as to avoid any delays in the\nstart of the construction of the new agency premises in Amsterdam.\nThe agency has disclosed in its financial statements an estimated\nEUR 448 million in rent for the remaining rental period between\n2017 and 2039 as a contingent liability, as the rental\ncontract does not include any exit clause.
\n