2011/2220(DEC)
2010 discharge: European Medicines Agency (EMA)
| CONT | CONT | ENVI | ENVI | |
| Lead Rapporteur | MACOVEI Monica Luisa (EPP) | MACOVEI Monica Luisa (EPP) | ||
| Opinion Rapporteur(s) | HAUG Jutta (S&D) | HAUG Jutta (S&D) |
Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | CONT | MACOVEI Monica Luisa (EPP) | HERCZOG Edit (S&D), GERBRANDY Gerben-Jan (ALDE), STAES Bart (Verts/ALE), CZARNECKI Ryszard (ECR), SØNDERGAARD Søren Bo (GUE/NGL), ANDREASEN Marta (EFD), EHRENHAUSER Martin (NI), HARTONG Lucas (NI) |
| Lead | CONT | MACOVEI Monica Luisa (EPP) | |
| Opinion | ENVI | HAUG Jutta (S&D) | |
| Opinion | ENVI | HAUG Jutta (S&D) |
Activites
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2012/12/20
Final act published in Official Journal
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2012/10/23
Text adopted by Parliament, single reading
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T7-0366/2012
summary
The European Parliament adopted a decision concerning the discharge to be granted to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the Agencys budget for the financial year 2010. The decision to grant the discharge shall also constitute the closure of the accounts for this Agency. To recap, in May 2012, Parliament postponed the discharge decision for the Agency chiefly because there was a problem of conflict of interest of some staff (as reported in the summary dated 10/05/2012). Parliament approved the closure of the Agency accounts for the 2010 financial year and made a series of recommendations to take into account on the granting of the discharge: transparency and management of conflict of interest: Parliament notes that the Agency is organising for November 2012 a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data with a view to strengthening transparency. It also notes that the Agency has improved the scope and methodology of the systematic ex-ante and ex-post controls related to the screening of declaration of interest and that it will perform a yearly evaluation of its revised policy on declaration of interest. It invites the Agency to keep the discharge authority informed on the implementation of its revised policy on a 6-month basis; a revolving door case: Parliament underlines that, in June 2012, a revolving door case occurred in the Agency, the former Head of Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients. It takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service and expects the Agency to inform the discharge authority on the outcomes of this review by the end of 2012; screening process of declarations of interest: Parliament welcomes the fact that the Agency proceeded to a screening process of the declarations of interest of its experts and committee members who have been actively involved in the Agencys activities between 1 January and 31 May 2012 against their curriculum vitae. It also welcomes the Agencys initiative to publish on its website the declarations of interests of its staff occupying management positions as well as other initiatives going in the direction of improved transparency. However, it 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; for steps to be taken in cases of non-compliance: Parliament considers that steps have to be taken should cases of non-compliance with existing rules occur with a view to remedying the shortcomings. Either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes. In the meantime, it calls on the Agency to introduce in each of its annual activity report a special section describing the actions taken to prevent and manage conflict of interest; report on follow-up to the discharge: Parliament calls on the Agency to introduce in its annual activity reports a special section describing the actions taken to prevent and manage conflict of interest, which should include, inter alia: i) the number of alleged cases of conflict of interest verified; ii) the number of revolving door cases; iii) the measures taken in each category of cases; iv) the number of breach of trust procedures launched and their outcomes; and v) the penalties applied. Overall, Parliament welcomes the agreement on the Joint Statement and Common Approach adopted in June 2012 by the European Parliament, the Council and the Commission on decentralised agencies in which certain elements of importance to the discharge have been addressed and taken up.
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T7-0366/2012
summary
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2012/10/02
Committee report tabled for plenary, single reading
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A7-0298/2012
summary
The Committee on Budgetary Control adopted the second reading report of Monica Luisa MACOVEI (PPE, RO) on the discharge of the European Medicines Agency (EMA) which calls on the European Parliament to grant the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agencys budget for the financial year 2010. To recall, in May 2012, Parliament postponed the discharge decision for the Agency chiefly because there was a problem of conflict of interest of some staff (as reported in the summary dated 10/05/2012). Members approved the closure of the Agency accounts for the 2010 financial year and made a series of recommendations to take into account on the granting of the discharge: · transparency and management of conflict of interest: Members take note that the Agency is organising for November 2012 a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data with a view to strengthening transparency. They also note that the Agency has improved the scope and methodology of the systematic ex-ante and ex-post controls related to the screening of declaration of interest and that it will perform a yearly evaluation of its revised policy on declaration of interest. They invite the Agency to keep the discharge authority informed on the implementation of its revised policy on a 6-month basis; · a revolving door case: Members underline that, in June 2012, a revolving door case occurred in the Agency, the former Head of Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients. They take note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service and expect the Agency to inform the discharge authority on the outcomes of this review by the end of 2012; · screening process of declarations of interest: Members welcome that the Agency proceeded to a screening process of the declarations of interest of its experts and committee members who have been actively involved in the Agencys activities between 1 January and 31 May 2012 against their curriculum vitae. They also welcome the Agencys initiative to publish on its website the declarations of interests of its staff occupying management positions as well as other initiatives going in the direction of improved transparency. However, they agree 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; · for steps to be taken in cases of non-compliance: Members consider that steps have to be taken should cases of non-compliance with existing rules occur with a view to remedying the shortcomings. Either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes. In the meantime, Members call on the Agency to introduce in each of its annual activity report a special section describing the actions taken to prevent and manage conflict of interest. In general, Members welcome the agreement on the Joint Statement and Common Approach adopted in June 2012 by the European Parliament, the Council and the Commission on decentralised agencies in which certain elements of importance to the discharge have been addressed and taken up.
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A7-0298/2012
summary
- 2012/09/26 Vote in committee, 1st reading/single reading
- 2012/09/12 Amendments tabled in committee
- 2012/06/20 Committee draft report
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2012/05/10
Text adopted by Parliament, single reading
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T7-0175/2012
summary
The European Parliament adopted by 340 votes to 268, with 14 abstentions, a decision to postpone the granting of the discharge to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency's budget for the financial year 2010. The Parliament also postponed the closure of the accounts for this agency. Parliament also adopted by 467 votes to 139, with 23 abstentions, a resolution containing observations that are an integral part of the decision to postpone the discharge. These observations may be summarised as follows: Budget and financial management: Parliament acknowledges that the Agency's budget is financed both from the Union budget and from fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations. It notes that in 2010, 73% of the revenue of the Agency is estimated to have derived from the fee revenue and that, in parallel with the increase in the fee-based revenue, the relative percentage income from the Union contribution fell from 23 % in 2006 to 14 % in 2010. It also notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors and invites the Court of Auditors to verify this issue and inform Parliament in this respect; Carryover appropriations and cancellations: Parliament notes that automatic carryovers to the 2011 financial year totalled EUR 41.6 million or 20.90 % of the appropriation committed, and that one non-automatic carryover to the 2011 financial year was requested totalling EUR 3.5 million or 1.68 % of the final appropriation. It considers that the Agency is not complying with the budgetary principle of annuality. It notes with concern the additional comment from the Court of Auditors that only 36 % of the appropriations carried forward to 2011 correspond to expenditure accrued from 2010, while the remaining 64 % of amounts carried over did not relate to the 2010 financial year. It urges the Agency to take immediate action to reduce the level of cancelled appropriations and to adopt an Action Plan with concrete measures; System of remuneration for services: Parliament urges the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States real costs. It notes in this regard that a new payment system was already presented to the Management Board at its meeting of 10 December 2009 but it, in the end, rejected the proposal. By refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as non-compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation. Parliament is therefore not ready to accept this questionable attitude from the Management Board and calls on the Agency to adopt an Action Plan on this matter and to inform the discharge authority by 30 June 2012; Human resources management: Parliament calls on the Agency to improve the documentation of the recruitment files for contract agents and on the Appointing Authority to adopt the reserve lists proposed by the selection committees. It also calls on the Agency to use employment-agency staff to cover short-term needs only and to grant transparent access for contract staff positions; Management of conflict of interest: Parliament calls on the Agency to report on its involvement in the organisation of conferences by private organisations such as the Organisation for Professionals in Regulatory Affairs. Noting the measures taken in 2012, Parliament invites the Agency to inform the discharge authority of the concrete measures that it has taken to ensure that it can evaluate the procedures in place to manage any eventual conflicts of interest. It notes with concern that in the financial circuits there are also potential conflicts of interests in processing payments due to insufficient segregation of duties and urges the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency. Former director: Parliament considers the opportunity given to the Agencys former Executive Director to engage in new activities that are in conflict with his previous position (he was recruited almost immediately after his departure from the Agency, by a consultancy firm working for pharmaceutical companies) to be a breach of Union rules relating to conflicts of interest in regard to members of scientific committees and experts, as well as a breach of trust procedure for Committee members and experts. It believes that the Agency should verify, during 2012, all declarations of interest of experts and Scientific Committee members and calls on it to provide the discharge authority with detailed information on the verification results and with an Action Plan with a calendar concerning the rest of the verification process for declarations of interest by the end of August 2012. Overall, Parliament has concerns over the actual independence of the Agency. It calls for greater transparency in this regard and welcomes the fact that the Agency has decided to publish on its website the declarations of interest of experts involved in the evaluation of medicinal products even if the Agency's approach vis-à-vis the scrutiny of declarations of interest is primarily based on trust rather than on verification. It also calls on the Agency to establish a genuine mechanism enabling proper scrutiny of the declarations of interest received by the Agency and to inform the discharge authority on this matter by 30 June 2012. Parliament notes that the Agency has been audited by the Court of Auditors in the framework of the Special Report on conflicts of interest management in the Union agencies. The Report will be published by the end of June 2012. It is of the opinion that, given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on discharge should be postponed until the publication of the Special Report to take into account the findings of the Court of Auditors in this respect.
- Results of vote in Parliament
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T7-0175/2012
summary
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2012/04/04
Committee report tabled for plenary, single reading
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A7-0107/2012
summary
The Committee on Budgetary Control adopted the report by Monica Luisa MACOVEI (EPP, RO) on discharge to be granted in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010. The committee calls on the Parliament to postpone its decision on granting the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency's budget for the financial year 2010. However, they make a number of recommendations, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies: Budget and financial management: Members acknowledge that the Agency's budget is financed both from the Union budget and from fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations. They state that in 2010, 73% of the revenue of the Agency is estimated to have derived from the fee revenue and that, in parallel with the increase in the fee-based revenue, the relative percentage income from the Union contribution fell from 23 % in 2006 to 14 % in 2010. They also note weaknesses in the Agency's system for validating creditor claims in respect of IT contractors and invite the Court of Auditors to verify this issue and inform Parliament in this respect; Carryover appropriations and cancellations: Members note that automatic carryovers to the 2011 financial year totalled EUR 41 655 049,44, or 20.90 % of the appropriation committed, and that one non-automatic carryover to the 2011 financial year was requested totalling EUR 3 500 000, or 1.68 % of the final appropriation. They state that the Agency is not complying with the budgetary principle of annuality. They note with concern the additional comment from the Court of Auditors that only 36 % of the appropriations carried forward to 2011 correspond to expenditure accrued from 2010, while the remaining 64 % of amounts carried over did not relate to the 2010 financial year. Members urge the Agency to take immediate action to reduce the level of cancelled appropriations and to adopt an Action Plan with concrete measures; System of remuneration for services: Members urge the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States real costs. They note in this regards that a new payment system was already presented to the Management Board at their meeting of 10 December 2009 but it, in the end, rejected the proposal. By refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as non-compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation. Members are therefore not ready to accept this questionable attitude from the Management Board and call on the Agency to adopt an Action Plan on this matter and to inform the discharge authority by 30 June 2012; Human resources management: Members call on the Agency to improve the documentation of the recruitment files for contract agents and on the Appointing Authority to adopt the reserve lists proposed by the selection committees. They also call on the Agency to use employment-agency staff to cover short-term needs only and grant transparent access for contract staff positions; Management of conflict of interest: Members call on the Agency to report on its involvement in the organisation of conferences by private organisations such as the Organisation for Professionals in Regulatory Affairs. They note with concern that in the financial circuits there are also potential conflicts of interests in processing payments due to insufficient segregation of duties and urge the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency. Members urge the Court of Auditors to finalise and present its current audit of conflict of interest in the Agency. They regret the fact that many of the experts failed to publish their declarations of interests, and that the comparison of declarations of interests published by the relevant national agencies and by the Agency shows significant differences in some cases. They deplore, 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, failed to declare his recent management responsibilities in a pharmaceutical firm. They therefore call on the Agency to establish a genuine mechanism enabling proper scrutiny of the declarations of interest received by the Agency and to inform the discharge authority on this matter by 30 June 2012. They also urge the Agency to apply its conflict of interest policy to its Management Board. Lastly, Members are of the opinion that, given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on discharge should be postponed until the publication of the Special Report to take into account the findings of the Court of Auditors in this respect; Internal audit: Members acknowledge from the Agency that 11 "very important" recommendations from the IAS still need to be implemented. Efforts should be made as regards this issue.
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A7-0107/2012
summary
- 2012/03/27 Vote in committee, 1st reading/single reading
- 2012/03/07 Amendments tabled in committee
- 2012/02/13 Committee draft report
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2012/02/08
Document attached to the procedure
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06083/2012
summary
Having examined the revenue and expenditure accounts for the financial year 2010 and the balance sheet at 31 December 2010 of the European Medicines Agency, as well as the Court of Auditors' report on the annual accounts of the Agency for the financial year 2010, accompanied by the Agency's replies to the Court's observations, the Council recommends the European Parliament to give a discharge to the Executive Director of the Agency in respect of the implementation of the budget for the financial year 2010. However, the Council considers that observations made in the Court of Auditor's report call for a certain number of remarks: the Council welcomes the Court's opinion that, in all material respects, the Agency's annual accounts fairly present the financial position as at 31 December 2010 and the results of operations and cash flows for the year then ended, in accordance with the provisions of the Agency's Financial Regulation, and that the underlying transactions for that financial year are legal and regular; the Council is concerned about the high amount of appropriations carried over to the next financial year. It calls upon the Agency to improve programming and monitoring of its activities with the aim to further reduce the amounts carried over to the next financial year, in line with the budgetary principle of annuality; it takes note that the Agency has taken action in order to remedy the weaknesses identified in its system for validating creditor claims. it welcomes the efforts made by the Agency to correct the weaknesses identified in its staff selection procedures, stressing the importance of ensuring transparency in the recruitment process; as regards the Court's observation on the lack of a remuneration system for services provided by Member State authorities, the Council urges the Agency to ensure that measures are taken in the recommended direction.
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06083/2012
summary
- 2011/10/12 Committee referral announced in Parliament, 1st reading/single reading
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2011/09/06
Court of Auditors: opinion, report
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N7-0010/2012
summary
PURPOSE: presentation of the EU Court of Auditors report on the annual accounts of the European Medicines Agency, together with the Agencys reply. CONTENT: in accordance with the tasks conferred on the Court of Auditors by the Treaty on the Functioning of the European Union, the Court presents to the European Parliament and to the Council, in the context of the discharge procedure, a Statement of Assurance as to the reliability of the annual accounts of each institution, body or agency of the EU, and the legality and regularity of the transactions underlying them, on the basis of an independent external audit. This audit concerned, amongst others, the annual accounts of the European Medicines Agency (EMA). In the Courts opinion, the Agencys Annual Accounts fairly present, in all material respects, its financial position as of 31 December 2010 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation. The Court also considers that the transactions underlying the annual accounts of the Agency for the financial year ended 31 December 2010 are, in all material respects, legal and regular. The report confirms that the Agencys 2010 budget amounted to EUR 208.4 million and that the number of staff employed by the Agency at the end of the year was 698. The report also makes a series of observations on the budgetary and financial management of the Agency, accompanied by the latters response. The main observations may be summarised as follows: The Courts observations: budgetary and financial management: the Agency experienced delays in implementing Administrative expenditure of its budget. Appropriations carried forward to 2011 totalled EUR 17.6 million, 33.3 % of the corresponding appropriations. Just 36 % of the appropriations carried forward correspond to accrued expenditure of the year, meaning 64 % of the amounts carried over did not relate to the 2010 financial year. This situation was at odds with the budgetary principle of annuality; recruitment: the Agency did not distinguish sufficiently between employment-agency staff and contract staff recruitments; follow-up on previous findings: in previous reports, the Court had noted the need for the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States real costs. Up to now, despite some efforts by the Agency, this has not been done. The Agencys response: the Agency indicates that it has continuously improved its administrative carry-over since 2008. The amounts in question for 2010 are for multiannual Telematics ICT projects. These Telematics projects are of an operational nature and as a consequence will be accounted for from 2011. Therefore from 2011/12 the Agency expects a reduction in carry-over in administrative expenditure to a maximum of around 30 % (corresponding to a reduction of EUR 10 million); the Agency notes that action has been taken to improve transparency by ensuring that all contract agent positions are more clearly publicised externally prior to being filled and that the EMA implementing rules on selection and recruitment of contract agents are correctly followed; a proposal for a new payment system was presented to the Management Board at their meeting of 10 December 2009. The Management Board rejected the proposal. EMA will try again to instigate the discussions at forthcoming Management Board meetings and remind the Board of the need to move forward on this topic. Lastly, the Court of Auditors report contains a summary of the Agencys activities in 2010. This is focused on the following: applications for marketing authorisations for 91 medicines for human use ; pharmacovigilance activities; mutual recognition procedures and decentralised procedures: started 21 433; (ended positively 11100); scientific advice finalised; applications for paediatric investigation plans: 326 relating to 403 indications; applications for marketing authorisations for 18 medicinal products for veterinary use; 300 inspections; herbal monographs; 174 applications for orphan medicinal products (123 favourable opinions); requests for SME status: 251 requests and 161 applications for fee reduction or deferrals.
- OJ C 366 15.12.2011, p. 0027
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N7-0010/2012
summary
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2011/07/26
Non-legislative basic document
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COM(2011)0473
summary
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2010, as part of the 2010 discharge procedure. Analysis of the accounts of the European Medicines Agency (EMEA). CONTENT: this Commission document sets out the consolidated annual accounts of the European Union for the financial year 2010 as prepared on the basis of the information presented by the institutions, organisations and bodies of the EU, in accordance with Article 129 (2) of the Financial Regulation applicable to the EU's General Budget, including the European Medicines Agency (EMEA). In 2010, the tasks and budget of this agency were as follows: description of the Agency's tasks: the European Medicines Agency, which is located in London, was created by Council Regulation (EEC) No 2309/93, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council. The Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use; the Agency's budget for the 2010 financial year: the Agency's 2010 budget amounted to EUR 208.4 million, compared with EUR 194.4 million the previous year. The number of staff employed by the Agency at the end of the year was 698, as compared with 664 the previous year. The complete version of the Agency's final accounts may be found at the following address: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500108349.pdf
- DG {u'url': u'http://ec.europa.eu/dgs/budget/', u'title': u'Budget'}, ŠEMETA Algirdas
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COM(2011)0473
summary
Documents
- Non-legislative basic document published: COM(2011)0473
- Court of Auditors: opinion, report: N7-0010/2012
- Court of Auditors: opinion, report: OJ C 366 15.12.2011, p. 0027
- Document attached to the procedure: 06083/2012
- Committee draft report: PE473.975
- Amendments tabled in committee: PE483.611
- Committee report tabled for plenary, single reading: A7-0107/2012
- Decision by Parliament, 1st reading/single reading: T7-0175/2012
- Results of vote in Parliament: Results of vote in Parliament
- Committee draft report: PE491.065
- Amendments tabled in committee: PE494.821
- Committee report tabled for plenary, single reading: A7-0298/2012
- Decision by Parliament, 1st reading/single reading: T7-0366/2012
Votes
A7-0107/2012 - Monica Luisa Macovei - Décision
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 340 | 6 | 42 | 28 | 24 | 20 | 165 | 4 | 51 | 2 |
| Against | 268 | 65 | 0 | 3 | 1 | 3 | 60 | 136 | 0 | 4 |
| Abstain | 14 | 0 | 0 | 0 | 0 | 2 | 1 | 11 | 0 | 1 |
A7-0107/2012 - Monica Luisa Macovei - Decision
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 340 | 6 | 42 | 28 | 24 | 20 | 165 | 4 | 51 | 2 |
| Against | 268 | 65 | 0 | 3 | 1 | 3 | 60 | 136 | 0 | 4 |
| Abstain | 14 | 0 | 0 | 0 | 0 | 2 | 1 | 11 | 0 | 1 |
A7-0107/2012 - Monica Luisa Macovei - Am 2
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 231 | 70 | 0 | 1 | 1 | 2 | 4 | 153 | 0 | 1 |
| Against | 404 | 4 | 42 | 30 | 28 | 22 | 224 | 2 | 52 | 0 |
| Abstain | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Amendment 2
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 231 | 70 | 0 | 1 | 1 | 2 | 4 | 153 | 0 | 1 |
| Against | 404 | 4 | 42 | 30 | 28 | 22 | 224 | 2 | 52 | 0 |
| Abstain | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Am 3 S
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 227 | 72 | 0 | 0 | 0 | 3 | 15 | 136 | 1 | 1 |
| Against | 396 | 1 | 40 | 29 | 28 | 21 | 212 | 16 | 49 | 0 |
| Abstain | 4 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Amendment 3 S
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 227 | 72 | 0 | 0 | 0 | 3 | 15 | 136 | 1 | 1 |
| Against | 396 | 1 | 40 | 29 | 28 | 21 | 212 | 16 | 49 | 0 |
| Abstain | 4 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Am 4
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 251 | 71 | 1 | 0 | 0 | 7 | 25 | 147 | 0 | 2 |
| Against | 377 | 1 | 41 | 30 | 28 | 16 | 206 | 4 | 51 | 1 |
| Abstain | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Amendment 4
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 251 | 71 | 1 | 0 | 0 | 7 | 25 | 147 | 0 | 2 |
| Against | 377 | 1 | 41 | 30 | 28 | 16 | 206 | 4 | 51 | 1 |
| Abstain | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
A7-0107/2012 - Monica Luisa Macovei - Résolution
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 467 | 72 | 40 | 27 | 26 | 18 | 219 | 13 | 52 | 0 |
| Against | 139 | 1 | 1 | 2 | 0 | 2 | 9 | 124 | 0 | 0 |
| Abstain | 23 | 0 | 0 | 0 | 1 | 5 | 2 | 15 | 0 | 1 |
A7-0107/2012 - Monica Luisa Macovei - Resolution
| Position | Total | ALDE | ECR | EFD | GUE/NGL | NI | PPE | S&D | Verts/ALE | correctional |
| For | 467 | 72 | 40 | 27 | 26 | 18 | 219 | 13 | 52 | 0 |
| Against | 139 | 1 | 1 | 2 | 0 | 2 | 9 | 124 | 0 | 0 |
| Abstain | 23 | 0 | 0 | 0 | 1 | 5 | 2 | 15 | 0 | 1 |
| Amendments | Dossier |
| 157 |
2011/2220(DEC) 2010 discharge: European Medicines Agency (EMA)
2011/12/21
ENVI
7 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1.
Amendment 2 #
Draft opinion 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) 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 6 a (new) 6a. Calls for the Internal Audit Report of the Commission's services of the European Medicines Agency for the year 2010 to be made available to Members of Parliament without any delay in the light of the serious problems found with regard to the assessment of the independence of experts involved in the evaluation of medicinal products in the audit report for 2009;
Amendment 5 #
Draft opinion Paragraph 6 b (new) 6b. Calls on the Commission to publish a list of all authorised medicinal products for which the internal auditors found inadequate assessment of the independence of the experts in the assessment team; calls on the Executive Director of EMA to report how EMA intends to rectify these procedures;
Amendment 6 #
Draft opinion 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 8 8.
source: PE-478.634
2012/07/03
CONT
43 amendments...
Amendment 1 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 3 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 4 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 5 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 6 #
Motion for a resolution Paragraph 2 2. Calls on the Agency and on the IAS to immediately verify whether all the actions mentioned in the audit reports, including the one for 2010, were fully implemented and to inform the discharge authority accordingly;
Amendment 7 #
Motion for a resolution Paragraph 3 3.
Amendment 8 #
Motion for a resolution Paragraph 3 3.
Amendment 9 #
Motion for a resolution Paragraph 8 8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors;
Amendment 10 #
Motion for a resolution Paragraph 8 8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors; calls therefore on the Agency to
Amendment 11 #
Motion for a resolution Paragraph 10 10.
Amendment 12 #
Motion for a resolution Paragraph 11 11. Notes
Amendment 13 #
Motion for a resolution Paragraph 13 13. Establishes from the Agency's Report on budgetary and financial management that, in 2010, appropriations totalling EUR 9 074 296
Amendment 14 #
Motion for a resolution Paragraph 13 13. Establishes from the Agency's Report on budgetary and financial management that, in 2010, appropriations totalling EUR 9 074 296
Amendment 15 #
Motion for a resolution Paragraph 16 16.
Amendment 16 #
Motion for a resolution Paragraph 17 Amendment 17 #
Motion for a resolution Paragraph 17 17. Notes that by refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as the non- compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation
Amendment 18 #
Motion for a resolution Paragraph 17 17. Notes that by refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as the non- compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation; is therefore not ready to accept this questionable attitude from the Agency's
Amendment 19 #
Motion for a resolution Paragraph 21 21. U
Amendment 20 #
Motion for a resolution 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 23.
Amendment 22 #
Motion for a resolution Paragraph 23 23.
Amendment 23 #
Motion for a resolution Paragraph 24 Amendment 24 #
Motion for a resolution 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 25 #
Motion for a resolution Paragraph 25 Amendment 26 #
Motion for a resolution Paragraph 25 a (new) 25 a. Recalls that, following the employment of the Agency's former Executive Director by a consultancy that advises, among others, pharmaceutical companies almost immediately after he left the Agency, the discharge authority raised concerns on the actual independence of the Agency and the way its Management Board implemented Article 16 of the Staff Regulations; is furthermore concerned by the allegations that the Agency's former Executive Director created his own consultancy firm while still in office; calls on the Agency to provide the discharge authority with further information on this matter by 30 June 2012;
Amendment 27 #
Motion for a resolution Paragraph 25 a (new) 25 a. Urges the Court of Auditors to finalise and present its current audit on conflict of interest in the Agency in order to provide Parliament with an objective assessment;
Amendment 28 #
Motion for a resolution 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 29 #
Motion for a resolution Paragraph 25 b (new) 25 b. Welcomes the Agency's initiative to publish the declarations of interests of its staff members occupying management positions and of the experts involved in the evaluation of medicinal products on its website; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; believes that at least the previous working places – professional background – should also be publish along with the declarations of interest to allow verification of the declarations of interest and identify possible conflicts; invites therefore the Agency to provide the Parliament information on the status of implementation of these measures by 30 June 2012;
Amendment 30 #
Motion for a resolution 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 31 #
Motion for a resolution Paragraph 25 c (new) 25 c. Is nevertheless concerned by the Agency's approach vis-à-vis the scrutiny of declarations of interest which is primarily based on trust rather than on verification; is notably concerned by the fact that the comparison of the experts' declaration of interest published by the relevant national agency and by the Agency reveals significant differences in some cases; calls therefore on the Agency to establish a genuine mechanism enabling for a proper scrutiny of the declarations of interest received by the Agency and to inform the discharge authority on this matter by 30 June 2012;
Amendment 32 #
Motion for a resolution Paragraph 25 c (new) 25 c. Urges the Agency to apply its conflict of interest policy to its Management Board ;
Amendment 33 #
Motion for a resolution Paragraph 25 d (new) 25 d. Notes that the Agency has been audited by the Court of Auditors in the framework of the Special Report on conflicts of interest management in the Union agencies; acknowledges from the Court of Auditors that the aforementioned Special Report will be published by the end of June 2012; is of the opinion that, given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on the discharge should be postponed until the publication of the Special Report to take into account the findings of the Court of Auditors on this matter;
Amendment 34 #
Motion for a resolution 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;
Amendment 35 #
Motion for a resolution Paragraph 28 – introductory part 28.
Amendment 36 #
Motion for a resolution Paragraph 28 – indent 1 Amendment 39 #
Motion for a resolution Paragraph 28 – indent 4 Amendment 40 #
Motion for a resolution Paragraph 28 – indent 5 Amendment 41 #
Motion for a resolution Paragraph 28 – indent 6 Amendment 42 #
Motion for a resolution Paragraph 28 – indent 7 Amendment 43 #
Motion for a resolution Paragraph 28 – subparagraph 2 source: PE-483.611
2012/08/31
ENVI
13 amendments...
Amendment 1 #
Draft opinion 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 and its implementation should be monitored by the European Parliament and either the European Parliament or the European legislator has to address, as a matter of priority, these problems by changing the existing rules and regulations to eliminate possible loopholes;
Amendment 2 #
Draft opinion 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 3 #
Draft opinion Paragraph 5 5.
Amendment 4 #
Draft opinion Paragraph 5 5. Has already addressed the problematic of high carry-overs, the subsequent new professional activities of the former Executive Director
Amendment 5 #
Draft opinion 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) 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 7 #
Draft opinion 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 8 #
Draft opinion Paragraph 6 6. Points out again that the Court of Auditors made observations on carryovers, IT contracts and the payment system for services provided by national authorities but despite these inconsistencies, considered the Agency's accounts of 2010 reliable, legal and regular;
Amendment 9 #
Draft opinion Paragraph 8 8. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up;
Amendment 10 #
Draft opinion Paragraph 9 Amendment 11 #
Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA
Amendment 12 #
Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA cannot be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedure; invites the European institutions to examine, as a matter of priority, whether it is advisable to incorporate and to commit to additional guidelines in a possible common framework for all European institutions and bodies;
Amendment 13 #
Draft opinion Paragraph 10 10. Is of the opinion that, on the basis of the information available, discharge
source: PE-494.704
2012/12/09
CONT
94 amendments...
Amendment 1 #
Proposal for a decision 1 Citation 11 a (new) - having regard to the Joint Statement and Common Approach adopted (in June 2012) by the European Parliament, the Council and the Commission, resulting from the work of the Inter Institutional Working Group on decentralised agencies, and in particular the sections on governance, operations, programming, accountability and transparency,
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 3 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 4 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 5 #
Motion for a resolution Recital A Amendment 6 #
Motion for a resolution Recital A a (new) A a. whereas on 10 May 2012, the European Parliament postponed its decision on the discharge and closure of the accounts of the Agency for the financial year 2010,
Amendment 7 #
Motion for a resolution Recital A b (new) A b. whereas the Agency addressed to a large extent the weaknesses highlighted in the report of 10 May 2012 and provided the discharge authority with substantial information by letters of 2 and 6 July 2012 and of 2, 7 and 24 August 2012,
Amendment 8 #
Motion for a resolution Recital B Amendment 9 #
Motion for a resolution Recital C Amendment 10 #
Motion for a resolution Recital D Amendment 11 #
Motion for a resolution Recital E Amendment 12 #
Motion for a resolution Recital F Amendment 13 #
Motion for a resolution Paragraph 1 Amendment 14 #
Motion for a resolution Paragraph 1 – introductory part 1.
Amendment 15 #
Motion for a resolution Paragraph 2 Amendment 16 #
Motion for a resolution Paragraph 3 – introductory part 3. Notes
Amendment 17 #
Motion for a resolution Paragraph 3 – indent 1 Amendment 18 #
Motion for a resolution Paragraph 3 – indent 2 Amendment 19 #
Motion for a resolution Paragraph 3 – indent 3 Amendment 20 #
Motion for a resolution Paragraph 3 – subparagraph 1 Amendment 22 #
Motion for a resolution Paragraph 4 Amendment 23 #
Motion for a resolution Paragraph 5 Amendment 24 #
Motion for a resolution Paragraph 6 Amendment 25 #
Motion for a resolution Paragraph 7 Amendment 26 #
Motion for a resolution Paragraph 8 Amendment 27 #
Motion for a resolution Paragraph 9 Amendment 28 #
Motion for a resolution Paragraph 10 10.
Amendment 29 #
Motion for a resolution Paragraph 11 Amendment 30 #
Motion for a resolution Paragraph 12 Amendment 31 #
Motion for a resolution Paragraph 13 Amendment 32 #
Motion for a resolution Paragraph 13 13. Establishes from the Agency's Report on budgetary and financial management that in 2010, appropriations totalling EUR 9 074 296,49 were cancelled compared with EUR 7 693 276,58 in 2009; notes the Agency's reply that the level of cancelled expenditure appropriations is a result of stringent monitoring of actual revenue and adjustments to expenditure;
Amendment 33 #
Motion for a resolution Paragraph 13 13.
Amendment 35 #
Motion for a resolution Paragraph 14 Amendment 36 #
Motion for a resolution Paragraph 15 Amendment 37 #
Motion for a resolution Paragraph 15 15. Notes from the Agency's Report on budgetary and financial management that, in line with the Financial Regulation, during 2010, 13 transfers of a total amount of EUR 13 714 500 (15,29 % of the final appropriations) were approved; further notes that the Agency already adopted 10 transfers of a total amount of EUR 9 609 000 in 2009;
Amendment 38 #
Motion for a resolution Paragraph 16 Amendment 39 #
Motion for a resolution Paragraph 17 17.
Amendment 40 #
Motion for a resolution Paragraph 18 Amendment 42 #
Motion for a resolution Paragraph 19 Amendment 43 #
Motion for a resolution Paragraph 20 Amendment 44 #
Motion for a resolution Subheading 7 Transparency and Management of conflict of interest
Amendment 45 #
Motion for a resolution Paragraph 21 Amendment 46 #
Motion for a resolution Paragraph 21 a (new) 21 a. Takes note that the Agency is organising in November a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data and that the selection and training of the Agency's scientific staff aimed at strengthening the analysis of raw data is well advanced;
Amendment 47 #
Motion for a resolution Paragraph 22 Amendment 48 #
Motion for a resolution Paragraph 22 22.
Amendment 49 #
Motion for a resolution Paragraph 23 Amendment 50 #
Motion for a resolution Paragraph 24 Amendment 51 #
Motion for a resolution Paragraph 25 25. Takes note from the Agency of the adoption on 1 February 2012 of the ‘Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency’ by the Management Board and of the ‘Decision on rules concerning the handling of declared interests of national experts on secondment, visiting experts, trainees and interims of the European Medicines Agency’ by the Executive Director; calls on the Agency to inform the discharge authority of the concrete measures undertaken to implement these decisions
Amendment 52 #
Motion for a resolution Paragraph 25 25. Takes note
Amendment 53 #
Motion for a resolution Paragraph 25 a (new) 25 a. Notes with satisfaction that the Agency has started publishing the minutes of some Scientific Committees' meetings, starting with the Paediatric Committee (PDCO) in July 2012; takes note that the publication process of the minutes for all Scientific Committee meetings will be completed only by the end of 2013;
Amendment 54 #
Motion for a resolution Paragraph 26 26. Notes
Amendment 55 #
Motion for a resolution Paragraph 26 26. Notes
Amendment 56 #
Motion for a resolution Paragraph 27 Amendment 57 #
Motion for a resolution Paragraph 27 27. Notes that the former Executive Director of the Agency wrote to the Agency on 28 December 2010 outlining the activities which he was intending to take up at the end of his term of office; considers the first decision of 11 January 2011, taken by the Chairman of the Agency Management Board, to authorise the new activities of the former Executive Director of the Agency to be 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 the Conditions of Employment of Other Servants of the European Communities, this provision 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 - to be 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;
Amendment 58 #
Motion for a resolution Paragraph 27 a (new) 27 a. Underlines that in June 2012 a 'revolving door' case occurred in the Agency, the former Head of Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients; takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service; invites the Agency to inform the discharge authority on the outcomes of this review by the end of 2012;
Amendment 59 #
Motion for a resolution Paragraph 28 Amendment 60 #
Motion for a resolution Paragraph 28 28.
Amendment 61 #
Motion for a resolution Paragraph 28 a (new) 28 a. Takes note that the Agency proceeded to a screening process of the 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; notes that around 54% of the experts and committee members provided the Agency with updated curriculum vitae; calls on the Agency to inform the discharge authority on the timeframe and outcomes of the screening process for the remaining 46% by the start of the next discharge procedure;
Amendment 62 #
Motion for a resolution Paragraph 29 Amendment 63 #
Motion for a resolution Paragraph 30 Amendment 64 #
Motion for a resolution Paragraph 31 Amendment 65 #
Motion for a resolution Paragraph 32 32. Welcomes the Agency's initiative to publish the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products on its website; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; believes that at least the previous working places – professional background – should also be published along with the declarations of interest to allow verification of the declarations of interest and identify possible conflicts;
Amendment 66 #
Motion for a resolution Paragraph 32 32. Welcomes the Agency's initiative to publish on its website the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products
Amendment 67 #
Motion for a resolution Paragraph 33 Amendment 68 #
Motion for a resolution Paragraph 34 Amendment 69 #
Motion for a resolution Paragraph 34 34. Is nevertheless concerned by the Agency's approach vis-à-vis the scrutiny of declarations of interest, which is primarily based on trust rather than on verification; is notably concerned by the fact that the comparison of the experts' declaration of interest published by the relevant national agencies and by the Agency reveals significant discrepancies in some cases;
Amendment 70 #
Motion for a resolution Paragraph 34 34.
Amendment 71 #
Motion for a resolution Paragraph 34 a (new) 34 a. Acknowledges the Agency's efforts to address the discharge authority's concerns with regards to the prevention and management of conflict of interest; notes in particular the reports of 29 June 2012 and 7 August 2012 received by the discharge authority on the review of the conflict of interest management cases identified by the IAS and on the review of potential conflicts of interest of experts involved in assessing the medicinal product Pandemrix;
Amendment 72 #
Motion for a resolution Paragraph 34 b (new) 34 b. Calls on the Agency to introduce in each of its annual activity report a special section describing the actions taken to prevent and manage conflict of interest, which shall 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;
Amendment 73 #
Motion for a resolution Paragraph 35 Amendment 74 #
Motion for a resolution Paragraph 35 35.
Amendment 75 #
Motion for a resolution Paragraph 36 Amendment 76 #
Motion for a resolution Paragraph 36 Amendment 77 #
Motion for a resolution Paragraph 37 Amendment 78 #
Motion for a resolution Paragraph 38 Amendment 79 #
Motion for a resolution Paragraph 39 Amendment 80 #
Motion for a resolution Paragraph 39 – point 2 (new) (2) Invites the European institutions to examine if it is advisable to incorporate and to commit to additional guidelines, legislation and procedures in a possible common framework for all European institutions and bodies;
Amendment 82 #
Motion for a resolution Paragraph 40 Amendment 83 #
Motion for a resolution Paragraph 41 Amendment 85 #
Motion for a resolution Paragraph 42 Amendment 86 #
Motion for a resolution Paragraph 42 42. Acknowledges from the Agency that 9 out of 11 ‘very important’ recommendations from the IAS
Amendment 87 #
Motion for a resolution Paragraph 43 Amendment 88 #
Motion for a resolution Paragraph 43 – introductory part 43. Is
Amendment 89 #
Motion for a resolution Paragraph 43 – subparagraph 1 Amendment 90 #
Motion for a resolution Paragraph 44 Amendment 91 #
Motion for a resolution Paragraph 44 – subparagraph 1 Amendment 92 #
Motion for a resolution Paragraph 45 Amendment 93 #
Motion for a resolution Paragraph 46 Amendment 94 #
Motion for a resolution Paragraph 47 source: PE-494.821
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History
(these mark the time of scraping, not the official date of the change)
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| procedure/stage_reached | changed |
Old
Procedure completed, awaiting publication in Official JournalNew
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