Awaiting committee decision
Next event: Vote in committee, 1st reading/single reading 2015/03/23 more...
- Indicative plenary sitting date, 1st reading/single reading 2015/04/28
Role | Committee | Rapporteur | Shadows |
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Lead | CONT | CZARNECKI Ryszard (ECR) | ZDECHOVSKÝ Tomáš (EPP), VAUGHAN Derek (S&D), ALIOT Louis (NI), DE JONG Dennis (GUE/NGL), VALLI Marco (EFD) |
Opinion | ENVI | LA VIA Giovanni (EPP) |
Activites
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2015/04/28
Indicative plenary sitting date, 1st reading/single reading
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2015/03/23
Vote in committee, 1st reading/single reading
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2014/10/20
Committee referral announced in Parliament, 1st reading/single reading
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2014/07/30
Non-legislative basic document published
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COM(2014)0510
summary
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2013, as part of the 2013 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 2013 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). The document contains the figures on which the discharge procedure is based. Discharge procedure of the EU agencies: the EU Budget finances a wide range of policies and programmes throughout the EU. In accordance with the priorities set by the European Parliament and the Council in the multi-annual financial framework (MFF), the European Commission carries out specific programmes, activities and projects in the field with the technical support of some specialised agencies. The consolidated annual accounts of the EU provide information on the activities of the institutions, agencies and other bodies of the EU from a budgetary and accrual accounting perspective. The consolidated reports on the implementation of the general budget of the EU include the budget implementation of all Institutions. Agencies do not have a separate budget inside the EU budget; and they are partially financed by a Commission budget subsidy. Each agency is subject to its own discharge procedure. EMEA: in 2013, 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 and its role is the coordination of 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 on the basis of a centralised procedure; the Agency's budget for the 2013 financial year: the Agency’s budget for 2013, as presented in the Commission document on the consolidated annual accounts of the European Union, gives the following figures: § Commitment appropriations: - committed : EUR 252 million; - paid : EUR 243 million; - carried over : 0. § Payment appropriations: - committed : EUR 292 million; - paid : EUR 249 million; - carried over : EUR 33 million. See also the final accounts of the EMA.
- DG {'url': 'http://ec.europa.eu/dgs/budget/', 'title': 'Budget'}, GEORGIEVA Kristalina
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COM(2014)0510
summary
Documents
- Non-legislative basic document published: COM(2014)0510
Amendments | Dossier |
21 |
2014/2102(DEC)
2014/12/12
ENVI
3 amendments...
Amendment 1 #
Draft opinion Paragraph 2 2. Notes that in 2013, out of the total resources available to the Agency of EUR 251 560 000, 16,3% (EUR 40 937 454) had been EU budget contributions (including an important and essential special contribution for orphan medicines fee reductions of EUR 6 509 360); likes to stress that this amount represents 0.027% of the overall EU budget;
Amendment 2 #
Draft opinion Paragraph 3 a (new) 3a. Welcomes that a new procedure entered into force in 2014 which corrected the former irregular practice, whereby the Agency paid education contributions directly to schools for staff, in contravention of the Staff Regulations;
Amendment 3 #
Draft opinion Paragraph 4 4. Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use; welcomes the annual declarations and the policy on the handling of conflict of interests, last updated and endorsed by the Management Board in March 2012, and invites the Agency to further strengthen its policy on the management and handling of conflicts of interests in order to ensure independence and transparency in all work areas of the Agency;
source: 544.370
2015/03/06
CONT
18 amendments...
Amendment 1 #
Proposal for a decision 1 Paragraph 1 1. Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year
Amendment 10 #
Motion for a resolution Paragraph 7 7. Acknowledges from the Agency that the transparency criteria for partner, patient, healthcare and consumer organisations has been revised during 2014 in order to increase the transparency of funding; notes the adoption of the document with detailed criteria regarding the evaluation of financial information from patients, consumers and healthcare professionals organisations; notes furthermore that this document is used for assessing the organisations’ eligibility to participate in the dialogue with the Agency; recalls that the document also states that the organisations have to declare any conflict of interests at the start of the meetings through which the dialogue is commenced; further calls on the Agency to introduce a list of the patients´ organizations it is working with and to place it on its website, linking it to the funding sources of these organizations in order to enhance transparency;
Amendment 11 #
Motion for a resolution Paragraph 7 a (new) 7 a. Acknowledges that the Agency complied with the recommendation of the discharge authority to devote a specific part of its Annual Activity Report on the prevention and management of conflict of interests;
Amendment 12 #
Motion for a resolution Paragraph 8 8. Notes that the Agency's Management Board has endorsed
Amendment 13 #
Motion for a resolution Paragraph 8 a (new) 8 a. Notes with satisfaction that this policy entered into force on 30.01.2015;
Amendment 14 #
Motion for a resolution Paragraph 8 b (new) 8 b. Welcomes that the revised policy includes a better distinction of the declared interest: a person with an executive or leading role in the development of a medicine during a previous employment has a lifetime bar of non-involvement with the concerned company or product. For the majority of declared interests, a three-year cooling-off period is foreseen;
Amendment 15 #
Motion for a resolution Paragraph 8 c (new) 8 c. Notes with regret the Agency's understanding of what constitutes commercial confidential information (CCI) is far too broad and includes companies to redact key data about the trial design, methods, and calls on the Agency to properly implement the provisions of the Clinical Trials Regulation (EU) No 536/2014 especially with regard to clinical trial data not to be considered CCI;
Amendment 16 #
Motion for a resolution Paragraph 8 d (new) 8 d. Regrets that the policies on proactive publication of clinical trial data recently adopted by the Agency go against the transparent provisions of the Clinical Trials Regulation endorsed by the European Parliament by allowing companies to redact data based on potential jeopardy of commercial interests; calls on the Agency to report to the discharge Authority on this issue;
Amendment 17 #
Motion for a resolution Paragraph 8 e (new) 8 e. Calls on the Agency to publish on its website detailed reports of the scientific advice provided by the Agency to pharmaceutical companies during the drug development and pre-registration process at the time of trial authorization and in any case not later than 12 months after the end of the trial; notes that advice provided by regulators to companies on drug development and pre-registration plans cannot be considered commercially confidential information since there is an overriding public interest in disclosure;
Amendment 18 #
Motion for a resolution Paragraph 9 a (new) 9 a. Takes note that the Agency has adopted a set of internal-control standards (ICS) which are intended to guarantee a consistent level of internal control of all business activities throughout the Agency, and define the management rules that all services must follow in their management of resources;
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1. Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year
Amendment 3 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 4 #
Proposal for a decision 2 Paragraph 2 2. Approves the closure of the accounts of the European Medicines Agency for the financial year
Amendment 5 #
Proposal for a decision 2 Paragraph 2 2.
Amendment 6 #
Motion for a resolution Paragraph 2 – indent 3 – in order to improve its communication with Union citizens, the Agency has recently implemented several initiatives such as publication of strategic documents including summaries for the public, meeting highlights, newsletters or annual reports; notes furthermore in this regard the development of IT communication tools such as ‘Public health communication’ which provides the public with key information on medicines, mainly on their safety; in this regard encourages the Agency to set the pharmacovigilance public hearings;
Amendment 7 #
Motion for a resolution Paragraph 3 a (new) 3 a. Notes that 83% of Agency´s budget comes from the industry fees, representing gradual increase; requires complete transparency about this aspect of budget to avoid any risks for consumers´ rights or Agency´s reputation;
Amendment 8 #
Motion for a resolution Paragraph 6 a (new) 6 a. Notes that the Agency faced some controversy regarding several cases of recruitment procedures in the past; calls on the Agency to always ensure complete transparency and clarification with regard to the recruitment procedures;
Amendment 9 #
Motion for a resolution Paragraph 7 7. Acknowledges from the Agency that the transparency criteria for partner, patient, healthcare and consumer organisations has been revised during 2014 in order to increase the transparency of funding; notes the adoption of the document with detailed criteria regarding the evaluation of financial information from patients, consumers and healthcare professionals organisations; notes furthermore that this document is used for assessing the organisations’ eligibility to participate in the dialogue with the Agency; recalls that the document also states that the organisations have to declare any conflict
source: 539.758
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