19 Amendments of Corinne LEPAGE related to 2011/2220(DEC)
Amendment 1 #
Proposal for a decision 1
Paragraph 1
Paragraph 1
1. ...Calls on the Agency to inform the discharge authority by the 30 June 2012 of the measures taken and of the improvements made in respect of all the areas of concern and decides to postpone the discharge to the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency's budget for the financial year 2010 ;
Amendment 1 #
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes clearlyNotes the work of the European Medicines Agency in evaluating and supervising medicines for human and veterinary use in the Union;
Amendment 2 #
Draft opinion
Paragraph 3
Paragraph 3
3. Is firmly convinced that necessary steps have to be taken should cases of non- compliance with existing rules occur; believes that, in such cases, the Agency has to draw up an action plan aiming to remedy the shortcomings, with a precise timetable, and its implementation should be monitored by the European Parliament and either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes;
Amendment 2 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Acknowledges the EMA’s willingness to publish the declarations of interests of experts involved in the evaluation of medicinal products, but deplores the fact that many of the experts have yet to publish their declarations of interests and that, when the declarations published for individual experts by the relevant national agency and by the EMA are compared, significant differences are apparent in some cases; deplores, furthermore, the fact that at least one member of the Management Board has failed to declare recent links with the pharmaceutical industry; urges the EMA accordingly to carry out detailed checks on the declarations of interests submitted to it and to implement a system under which declarations of interests are cross-checked against information held by industry and by the relevant national agencies;
Amendment 3 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that the former Executive Director of EMA wrote to the Agency on 28 December 2010 outlining the activities he was intending to take up at the end his term of office; considers the decision dated 11 January 2011 taken by the Chairman of the European Medicines Agency's (EMA) Management Board to authorize the new activities of its former Executive Director a breach of EU rules relating to conflicts of interest, in particular with regard to Title II, Article 16 of the Staff Regulations of the Officials of the European Communities; considers the fact that the Management Board adopted limitations on the future activities of the former Executive Director on 17 March 2011 - only after strong public protest - a clear proof that EMA did initially not apply the Staff Regulations properly in this high-profile case, which in turn raises serious questions about their application of the rules in general; considers that the limitations set out therein as regards the former Executive Director are not sufficient, in particular in the light of recent reports that the former Executive Director set up his new activities as early as November 2010, while he was still in office; asks the Executive Director of EMA to present a detailed report of the implementation of Article 16 of the Staff Regulations within the Agency;
Amendment 4 #
Draft opinion
Paragraph 5
Paragraph 5
5. Has already addressed the problematic of high carry-overs, the subsequent new professional activities of the former Executive Director, the missing which infringe Article 16 of the Staff Regulations of Officials and Conditions of Employment of Other Servants of the European Communities , the missing, incomplete or incorrect Declarations of Interests by a number of experts involved in the evaluation of medicinal products also mentioned in the Internal Audit Service follow-up report and by the Management Board, and the overdue decision by the Management Board to reform the payment system for services provided by Member States' authorities in its first opinion to the responsible committee; is of the opinion that EMA has already made significantmade efforts to strengthen its internal procedures to assure the independence of its experts and its staff and has asked to be informed twice a year about the improved implementation of the measures taken in this regard;
Amendment 5 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Welcomes the announcement by the Agency that it plans to introduce an ex- ante and ex-post system for Declarations of Interest, notably by means of comparison with CVs and information furnished by experts at national level; asks the Agency to provide the budgetary control authority with a precise timetable for the implementation of this new system;
Amendment 6 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Agrees with the Agency that a high level of reliability and honesty concerning the declaration of interests can only be achieved if pharmaceutical companies themselves make public the list of experts and research centres with which they work, and the sums concerned in their financial links with them; agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent;
Amendment 6 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers inappropriate the co- organisation by EMA with the Organisation for Professionals in Regulatory Affairs (TOPRA) of annual conferences presented as reviews of the year; asks the EMA to report on potential financial participation to co-organise these events;
Amendment 7 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Recognises that it is important for the Agency to have exchanges with stakeholders, but considers that insufficient information has been furnished about its involvement in the organisation of conferences by private bodies such as TOPRA (The Organisation for Professionals in Regulatory Affairs); asks the Agency to make it clear to the budgetary control authority whether or not it contributes financially to the organisation of events with this organisation;
Amendment 7 #
Draft opinion
Paragraph 8
Paragraph 8
8. ICalls ofn the opinion, on the basis of the data available, that discharge can be grantedAgency, therefore, to inform the discharge authority by June 2012 of the measures taken and the improvements made in respect of all these areas of concern and considers that discharge to the Executive Director of the European Medicines Agency in respect of the implementation of the Agencuthority's budget for the financial year 2010 should be postponed until the problems mentioned above have been resolved..
Amendment 10 #
Draft opinion
Paragraph 9
Paragraph 9
Amendment 20 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls the Agency to report on its involvement in the organization of conferences by private organizations such as the Organisation for Professionals in Regulatory Affairs (TOPRA) ;
Amendment 21 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls onUrges the Agency to provide the discharge authority with the guidelines and assessment criteria on handling potential conflicts of interest of staff members, experts and members of the Management Board;
Amendment 24 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Notes that the former Executive Director of the Agency wrote to the Agency on 28 December 2010 outlining the activities he was intending to take up at the end of his term of office; considers the first decision dated 11 January 2011 taken by the Chairman of the Agency Management Board to authorize the new activities of its former Executive Director a breach of Union rules relating to conflicts of interest, in particular with regard to Title II, Article 16 of the Staff Regulations of the Officials of the European Communities; recalls that according to Title II article 11 and title IV article 91 of Conditions of Employment of Other Servants of the European Communities, this disposal applies by analogy to temporary agents and to contract employees ; considers the fact that the Management Board adopted limitations on the future activities of the former Executive Director on 17 March 2011 - only after strong public protest - a clear proof that the Agency did initially not apply the Staff Regulations properly, which in turn raises serious questions about their application of the rules in general; asks the Executive Director of the Agency to present a detailed report of the implementation of Article 16 of the Staff Regulations within the Agency;
Amendment 28 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Regrets the fact that many of the experts failed to publish their declarations of interests (DoI), and that the comparison of DoI published by the relevant national agency and by the Agency shows significant differences in some cases; deplores, furthermore, the fact that at least one member of the Management Board of the Agency, also substitute member of the Committee for Medicinal Products for Human Use (CHMP), failed to declare his recent management responsibilities in a pharmaceutical firm ;
Amendment 30 #
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25 b. Urges the Agency to carry out checks on the declarations of interests submitted to it, and a detailed check on a random basis, notably in implementing a system under which declarations are cross-checked against information held by industry and by the relevant national agencies;
Amendment 32 #
Motion for a resolution
Paragraph 25 c (new)
Paragraph 25 c (new)
25 c. Urges the Agency to apply its conflict of interest policy to its Management Board ;
Amendment 34 #
Motion for a resolution
Paragraph 25 e (new)
Paragraph 25 e (new)
25 e. Considers that the effective management of conflict of interest is crucial to maintain public trust in the work of the Agency;