Aus der Abteilung "Copy & Paste"

In dieser Rubrik finden Sie alle Änderungsanträge, die ich einbringe und die auf Anregungen Dritter beziehungsweise auf deren Formulierungsvorschläge zurückgehen. Dies ist ein Beitrag zur Transparenz meiner Arbeit. Ich behalte mir vor Informanten zu schützen. Eine Veröffentlichung wird mit jedem Einsender abgeklärt.

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16. März 2015

Auf einen Vorschlag der Europäischen Kommission habe ich folgende Änderunganträge (gelb markiert) zu meinem Berichtsentwurf über die Entlastung für die Ausführung des Gesamthaushaltsplans der Europäischen Union für das Haushaltsjahr 2013, Einzelplan III – Kommission und Exekutivagenturen (2014/2075(DEC)) übernommen:

 

Änderungsantrag zu Paragraph 13

Motion for resolution

Amendment

 
13. Considers furthermore that those measures have still a limited impact on the Union budget since more than 40%
of the financial corrections implemented in 2013 are not considered as assigned revenue84 but may be used by the same Member States having caused these corrections in cohesion policy;
 
                            
84 See Commission communication COM(2014)0618,
table 5.2: withdrawals in cohesion (EUR 775 million), rural development recoveries (EUR 129 million) and financial corrections implemented by de commitment /deduction
at closure be it in cohesion policy (EUR 494 million of euro)
or in the other policy areas than agriculture and cohesion policies (EUR 1 million).
 
 
13. Considers furthermore that those measures have still a limited financial impact on the Union budget since more than 40% of the financial corrections implemented in 2013 are not considered as assigned revenue84 but may be used by the same Member States having caused these corrections in cohesion policy;
 
                           
84 See Commission communication COM(2014)0618, table 5.2: withdrawals in cohesion (EUR 775 million), rural development recoveries (EUR 129 million) and financial corrections implemented by de commitment /deduction at closure be it in cohesion policy (EUR 494 million of euro) or in the other policy areas than agriculture and cohesion policies (EUR 1 million).

 

Änderungsantrag zu Paragraph 14

Motion for resolution

Amendment

 
14. Notes that approximately 1 % of the financial corrections implemented in 2013 involved a net reduction of Union funding to the programme and the Member State concerned
in cohesion policy;
 
 
14. Notes that approximately 28 % of the financial corrections implemented in 2013 involved a net reduction of Union funding to the programme and the Member State concerned in cohesion policy;
 

 

Änderungsantrag zu Paragraph 64

Motion for resolution

Amendment

 
64. Deplores that persistent weaknesses in excluding
ineligible land from the Landfill Parcel Identification System (LPIS) and in the administrative treatment claims from farmers contribute significantly to the material level of error remaining in EAGF payments;
 
 
64. Deplores that persistent weaknesses in excluding ineligible land from the Land Parcel Identification System (LPIS) and in the administrative treatment claims from farmers contribute significantly to the material level of error remaining in EAGF payments; 
 

 

Änderungsantrag zu Paragraph 65

Motion for resolution

Amendment

 
65. Stresses once again the horizontal dimension of the deficiencies detected in the LPIS; notes that since 2007 the Court of Auditors examined IACS in 38 paying agencies in all 28 Member States and deeply regrets that only seven of the control systems were assessed as effective, 22 were found to partially effective and nine control systems were considered as ineffective;
 

65. Stresses once again the horizontal dimension of the deficiencies detected in the LPIS; notes that since 2007 the Court of Auditors examined IACS in 38 paying agencies in all 28 Member States and deeply regrets that only seven of the control systems were assessed as effective, 22 were found to partially effective and nine control systems were considered as ineffective; invites the Commission to endure the financial risk to the budget to be covered by net financial corrections;

 

Änderungsantrag zu Paragraph 150

Motion for resolution

Amendment

 
150. Deplores the fact that the Declaration of assurance of Directorate-General for Enlargement is irregular as it stated on 31 March 2014 that all procedures were in place to ensure the legality and regularity of transactions even though, at that time, 20 % of all expenditure booked by that DG was based on estimates;
 

150. Deplores the fact that the Declaration of assurance of Directorate-General for Enlargement is erroneous as it stated on 31 March 2014 that all procedures were in place to ensure the legality and regularity of transactions even though, at that time, 20 % of all expenditure booked by that DG was based on estimates; underlines that this proceeding is a violation of the Financial Regulation which has taken place a lot of years; Welcomes that in 2014 the Commission put a system in place, and implemented it without delay, to ensure that the clearing of pre-financing is made from now on the basis of correctly incurred and reported costs; 

 

Änderungsantrag zu Paragraph 153

Motion for resolution

Amendment

 
153. Asks the Commission to modify the standing
instructions given by the Secretariat General of the Commission so as to make it possible when the financial impact exceeds the materiality threshold for the whole budget under a DG's responsibility, that an adverse opinion
be given;
 

153. Asks the Commission to clarify the standing instructions given by the Secretariat General of the Commission so as to make it possible when the financial impact exceeds the materiality threshold for the whole budget under a DG's responsibility, that an adverse opinion be given;

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9. November 2013

Auf einen Vorschlag der Firma Weleda aus meinem Wahlkreis zusammen mit dem europäischen Verband ECHAMP (Lobbyregisternummer: 85825114058-57) hin und nach Diskussionen mit dem Kollegen MdEP Thomas Ulmer, haben wir uns entschlossen folgende Änderungsanträge im Umweltausschuss zum Bericht von MdEP Linda McAvan über den „Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über die Gebühren, die der Europäischen Arzneimittelagentur für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind“ einzubringen:

Änderungsantrag zu Artikel 4 Absatz 1

Text proposed by the Commission

Amendment

The Agency shall levy a fee for the assessment of periodic safety update reports referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004.

The Agency shall levy a fee for the assessment of periodic safety update reports referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004 on medicinal products with assessment criteria according to Annex I of Directive 2001/83/EC.

 

Justification

The Agency is an international EU entity. It does have a legal base to assess concerning periodic safety update reports, when the concerning technical criteria are in force EU wide.

 

Änderungsantrag zu Teil IV des Anhangs:

Text proposed by the Commission

Amendment

3. Holders of marketing authorisations for medicinal products referred to in Article 7(5) shall pay 80 % of the amount applicable to the chargeable units corresponding to those products.

3. Holders of marketing authorisations for medicinal products (other than authorised homeopathic medicinal products) referred to in Article 7(5) shall pay 80 % of the amount applicable to the chargeable units corresponding to those products. Holders of marketing authorisations for homeopathic medicinal products shall pay the percentage equivalent to  the ICT services  applicable to the chargeable unit corresponding to those products.

 

Justification

For authorised homeopathic medicinal product, from the services listed in Annex Nr. 4 of the Regulation (“Other costs of the Agency related to Pharmacovigilance”), only IT services for establishment and maintenance of the database apply;  It is necessary to explicitly mention the kind of costs, because there are no other services rendered in return for the flat fee.

Wir bedanken uns für den Vorschlag von Weleda und ECHAMP für die guten Vorschläge. Ursprünglich lautete der Vorschlag von Weleda und ECHAMP den Erwägungsgrund 17 zu ändern, anstatt des Absatz 1 des Artikel 4. Die Änderung des Teil IV des Anhangs wurde von uns ohne Änderung übernommen.

Änderungsantrag des Erwägungsgrundes 17:

(17) Homeopathic and herbal medicinal products registered in accordance with Article 14 and Article 16a of Directive 2001/83/EC should be excluded from this Regulation as the pharmacovigilance activities for these products are carried out by the Member States. As the rules for pre‐clinicial tests and clinical trials of authorised homeopathic medicinal products are not harmonised between the Member States due to the application of Article 16(2) of Directive 2001/83/EC, a single PSUR assessment based on harmonised criteria is not possible for medicinal products referred to in Article 16(2) of Directive 2001/83/EC which are authorised in more than one Member State. Therefore these products do not fall within the ambit of Article 107e and Article 107g of Directive 2001/83/EC and Article 4(1) of this Regulation shall not apply to authorised homeopathic medicinal products.

 

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9. November 2013

Auf einen Vorschlag des Verbands der Chemischen Industrie (Lobbyregisternr: 15423437054-40) zusammen mit dem Bundesverband der Pharmazeutischen Industrie (Lobbyregisternr: 76399831150-89) hin und nach Diskussionen mit dem Kollegen MdEP Thomas Ulmer, haben wir uns dazu entschlossen folgende Änderungsanträge im Umweltausschuss zum Bericht von MdEP Linda McAvan über den „Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über die Gebühren, die der Europäischen Arzneimittelagentur für die Durchführung von Pharmakovigilanz-Tätigkeiten in Bezug auf Humanarzneimittel zu entrichten sind“ einzubringen:

Änderungsantrag zum Erwägungsgrund 2:

Text proposed by the Commission

 

(2) The provisions on pharmacovigilance relating to medicinal products of human use laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use12 were amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use13, Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products14, Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance16. Those amendments only cover medicinal products for human use. Those amendments provide for new pharmacovigilance tasks for the Agency including Union-wide pharmacovigilance procedures, the monitoring of literature cases, the improved information technology tools and the provision of more information to the general public. Furthermore, the pharmacovigilance legislation stipulates that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. New categories of fees should therefore be created to cover the new and specific tasks of the Agency.

Proposal

 

(2) The provisions on pharmacovigilance relating to medicinal products of human use laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use12 were amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use13, Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products14, Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance16. Those amendments only cover medicinal products for human use. Those amendments provide for new pharmacovigilance tasks for the Agency including Union-wide pharmacovigilance procedures, the monitoring of literature cases, the improved information technology tools and the provision of more information to the general public. Furthermore, the pharmacovigilance legislation stipulates that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. However, taking into account the benefit for society as a whole, due respect should be given to pharmacovigilance as a sovereign task. Therefore, the percentage share of EU funding in the financing of the EMA budget should be kept, at least, at the status quo before the implementation of this Regulation. The contribution should be used to reduce the costs for financing the routine tasks and hence the annual flat fee. New categories of fees should therefore be created to cover the new and specific tasks of the Agency.

 

 

 

Justification

 

The protection of public health is a sovereign task. Pharmacovigilance activities serve this purpose. Currently, the financing of the EMA consist of a contribution from the Union and fees paid by industry. The proposal of the Commission foresees, however, that the additional tasks are financed solely by industry. Full fee-financed pharmacovigilance exposes the system to the danger of no longer being seen as independent from the interests of the pharmaceutical industry. Therefore, the established co-financing of pharmacovigilance tasks should be kept also when establishing new fees, especially in regard to routine tasks which do not benefit an individual company but the pharmacovigilance system as a whole. Therefore, the contribution percentage of EU funding concerning the EMA budget must remain at the same level as before the implementation of this Regulation.

 

Änderungsantrag zu Artikel 4 Absatz 2:

 

Text proposed by the Commission

 

2. The amount of the fee is laid down in Part I of the Annex.

 

Proposal

 

2. The amount of the fee is laid down in Part I of the Annex. The EMA shall define 3 clusters of PSUR assessments reflecting the workload.

 

 

 

Justification

 

One single assessment fee for PSURs – utterly irrespective of the workload involved – is inadequate. Up to a certain extent, it is legitimate to pursue a standardised method in fee calculation. But in the concrete case, it would be appropriate to categorise the relevant active substances into three clusters for PSUR assessment, depending on the assessment workload involved – and with differentiated fees. This would be a well-balanced approach between a prerequisite standardised method on the one hand and avoiding unequal treatment on the other.

 

 

Änderungsantrag zu Artikel 4 Absatz 3:

Text proposed by the Commission

 

3. Where only one marketing authorisation holder is subject to the obligation to submit

a periodic safety update report in the context of the procedures referred to in

paragraph 1, the Agency shall levy the total amount of the applicable fee on that

marketing authorisation holder.

 

Proposal

 

 3. Where only one marketing authorisation holder is subject to the obligation to submit

a periodic safety update report in the context of the procedures referred to in

paragraph 1, the Agency shall levy the total amount of the applicable fee on that

marketing authorisation holder. However, in hardship cases, e.g. economic reasons related to the concerned product, a maximum upper limit of the fee shall apply.

 

 

Justification

 

According to the Commission proposal, a procedure-based fee is planned for the PSUR assessment: 19,500 EUR per active substance. In cases, where only one marketing authorisation holder is affected this fee could be unjustifiably high, especially in hardship cases. Such cases could be, inter alia, when the annual turnover with the concerned product is low and the additional costs would lead to a situation that the marketing authorisation would have to be given up due to economic reasons. In order to prevent the loss of therapy options in the short term and possible drug shortages in the medium term, a reduced fee must apply in such cases.

 

Änderungsantrag zu Artikel 7 Absatz 5:

Text proposed by the Commission

 

5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in

respect of medicinal products referred to in Article 10(1) and Article 10a of Directive

2001/83/EC and in respect of authorised homeopathic medicinal products and

authorised herbal medicinal products, as defined respectively in Article 1(5) and

Article 1(30) of Directive 2001/83/EC.

 

Proposal

 

 5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in

respect of medicinal products referred to in Article 10(1) and Article 10a of Directive

2001/83/EC as well as medicinal products containing active substances meeting the criteria of Part II (1) lit a of Annex I of Directive 2001/83/EC and in respect of authorised homeopathic medicinal products and

authorised herbal medicinal products, as defined respectively in Article 1(5) and

Article 1(30) of Directive 2001/83/EC.

 

Justification

 

The rigid linkage to the legal basis of the marketing authorisation application causes unequal treatment due to the fact that the safety profile of a substance is linked to the substance and not to the legal basis of the marketing authorization. Hence, it is justified that for originator medicinal products containing well-established active substances the reduced fees apply in the same way as for medicinal products authorized under Article 10a of Directive 2001/83/EC. Given the identical safety profile, the fee reductions should be linked to the concept of “well-established use” and not to the concrete legal basis of the marketing authorisation application.

 

 

Änderungsantrag zu Annex Teil I neuer Absatz:

 

Text proposed by the Commission

 

 

 

Proposal

 

1a In application of Article 4(2), the following fees apply:

Category 1: 100 % of the applicable amount

Category 2: 50 % of the applicable amount

Category 3: 10 % of the applicable amount.

 

Justification

 

One single assessment fee for PSURs – utterly irrespective of the workload involved – is inadequate. Up to a certain extent, it is legitimate to pursue a standardised method in fee calculation. But in the concrete case, it would be appropriate to categorise the relevant active substances into three clusters for PSUR assessment, depending on the assessment workload involved – and with differentiated fees. This would be a well-balanced approach between a prerequisite standardised method on the one hand and avoiding unequal treatment on the other.

 

Änderungsantrag zu Annex Teil I neuer Absatz:

Text proposed by the Commission

 

 

 

Proposal

 

 2a In application of Article 4(3), in hardship cases, the concerned marketing authorisation holder shall pay a maximum fee of 40 % of the applicable amount.

 

Justification

According to the Commission proposal, a procedure-based fee is planned for the PSUR assessment: 19,500 EUR per active substance. In cases, where only one marketing authorisation holder is affected this fee could be unjustifiably high, especially in hardship cases. Such cases could be, inter alia, when the annual turnover with the concerned product is low and the additional costs would lead to a situation that the marketing authorisation would have to be given up due to economic reasons. In order to prevent the loss of therapy options in the short term and possible drug shortages in the medium term, a reduced fee must apply in such cases.

Wir bedanken uns beim VCI für die guten Vorschläge.

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26. Februar 2013

Auf einen Vorschlag der Lufthansa (Lobbyregisternr.: 0714344663-32) hin, habe ich mich entschlossen folgenden Änderungantrag in den Entlastungsbericht 2011 zur Leistung, dem Finanzmanagement und der Kontrolle der Agenturen (Berichterstatter MdEP Gebrandy) einzubringen:

erwartet eine engere Abstimmung der Agenturen untereinander, insbesondere für Entscheidungen, die sich auf Geschäftsbereiche einer anderen Agentur auswirken; schlägt vor, dass die betroffenen Agenturen sich unter Einbeziehung der Betroffenen abstimmen um konkurrierende Gesetzgebung zu vermeiden; fordert die Agenturen auf in solchen Fällen stets die kompetenten Ausschüsse des Parlaments zu informieren;

Wir bedanken uns für den sehr guten Vorschlag bei der Lufthansa, der ursprünglich lautete:

Fordert die Agenturen auf, bei Gesetzesvorschlägen, die sich auf Vorschriften einer anderen Agentur auswirken, sich unter Einbeziehung der Betroffenen abzustimmen und insbesondere sich widersprechende Vorschriften zu vermeiden.

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