Amen­de­menten Hazekamp de kwijting van 2023: Algemene begroting van de EU - agent­schappen

Amendments Hazekamp on the 2023 discharge: General budget of the EU - Agencies of the Committee on the Environment, Public Health and Food Safety.

Amendment 1 

Jonas Sjöstedt

Draft opinion 

Paragraph 2

Draft opinion

2.      Considers that regular visits to the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes to this regard the success of the ENVI delegation to EMA in February 2023 and to ECHA in April 2023;

Amendment

2.      Considers that regular visits to and from the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes to this regard the success of the ENVI delegation to EMA in February 2023 and to ECHA in April 2023;

Amendment 2

Jonas Sjöstedt

Draft opinion

Paragraph 4

Draft opinion

4.      Welcomes the measures taken by the agencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, digitalisation, and gender and geographical balance in senior management positions;

Amendment

4.      Welcomes the measures taken by the agencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, Stresses the importance of intensifying efforts to achieve gender and geographical balance among institutional staff and in senior management positions , reminds the agencies in this regard of the importance of protecting the work-life balance not least among parent staff and to continously develope strategies to protect worker health and well-being;

Amendment 3

Jonas Sjöstedt

Draft opinion 

Paragraph 4 - point 1 (new)

Amendment

(1)    Notes the discrepancy between ECDC and ECA on the 2022 qualified opinion provided by ECA demonstrating that that the accounts were reliable but that the transactions underlying the accounts were partly not legal and regular, stresses the importance of such discrepancies to be harmonised, urges ECDC to adhere to the standards provided by ECA 1a;

1ahttps://www.ecdc.europa.eu/sites/default/files/documents/consolidated-annual-activity-report-2023_1.pdf , page 56

Amendment 4

Jonas Sjöstedt

Draft opinion 

Paragraph 5 - point 1 (new)

Amendment

(1)    Encourages ECDC to further cooperate with Member States to ensure an approach based on the solidarity principle in vaccine distribution and preparedness, notes that in the case of Mpox Member States undermined the ECDC capacity to face transmittable diseases by withholding vaccines;

Amendment 5

Jonas Sjöstedt

Draft opinion

Paragraph 3

Draft opinion

3.      Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasks;

Amendment

3.      Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasks, laments indicators from the 2023 internal staff survey showing that only 42% agree fully that their units operate in an efficient matter1b, reiterates the need for ECHA to continuously work with staff satisfaction, worker health and well-being, ensuring gender and geographical balance in the work place and facilitating the participation in the work life by parent staff;

1bhttps://echa.europa.eu/documents/10162/7362407/annual_Report_2023_en.pdf/ca16f5a4-a8ae-ac22-21f1-57af476f0bb1?t=1713865234883 , page 57

Amendment 6

Jonas Sjöstedt

Draft opinion 

Paragraph 6

Draft opinion

6.      Welcomes the ECHA’s efforts to promote the use of alternatives to animal testing for the regulatory assessment of chemicals and to foster understanding of the opportunities and challenges in moving away from animal testing while ensuring a high level of protection of human health and the environment;

Amendment

6.      Welcomes the ECHA’s efforts to promote the use of alternatives to animal testing for the regulatory assessment of chemicals and to foster understanding of the opportunities and challenges in moving away from animal testing while ensuring a high level of protection of human health and the environment, encourages ECHA to promote the use of non-animal testing methods;

Amendment 7 

Jonas Sjöstedt

Draft opinion

Paragraph 7

Draft opinion

7.      Notes with concern the difficulty to recruit sufficient experts from Member States to the ECHA’s Scientific Committees, posing a risk to the ECHA’s ability to meet legal deadlines and targets in regulatory processes that are dependent on the Committees’ outputs, in particular in the light of increasing tasks being attributed to the ECHA;

Amendment

7.      Notes with concern the difficulty to recruit sufficient experts from Member States to the ECHA’s Scientific Committees, posing a risk to the ECHA’s ability to meet legal deadlines and targets in regulatory processes that are dependent on the Committees’ outputs, in particular in the light of increasing tasks being attributed to the ECHA, stresses the importance of the Commission working actively to ensure agencies can recruit adequate competence to fulfil their missions, encourages in this regard an increased cooperation with universities and other relevant institutions;

Amendment 8

Jonas Sjöstedt

Draft opinion

Paragraph 1

Draft opinion

1.      Stresses that the EEA provides sound, independent information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development;

Amendment

1.      Stresses that the EEA provides sound, independent information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development, acknowledges the outmost importance of the EEA to reach the Union’s climate goals;

Amendment 9 

Jonas Sjöstedt

Draft opinion

Paragraph 6 - point 1 (new)

Amendment

(1)    Reiterates the need for EEA to adequately hire staff able to carry out the immense task devoted to the agency, encourages in this regard the Commission to intensify its measures to assist agencies in ensuring the competence required, reminds EEA of the importance of achieving gender and geographical balance among staff, ensuring a healthy work-life balance for everyone but not least for parent staff and to continuously work with improving worker health and well-being;

Amendment 10

Jonas Sjöstedt

Draft opinion

Paragraph 1

Draft opinion

1.      Welcomes the EFSA's' contribution to the safety of the Union food and feed chain, and its considerable efforts in providing risk managers with comprehensive, independent and up-to-date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputs and the information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system;

Amendment

1.      Welcomes the EFSA's' contribution to the safety of the Union food and feed chain, however expresses deep concern over some of the aspects of the agency's work relating to inadequate actualisation of regulation regarding pesticides and other toxins, deplores the close ties between the agency and agrochemical industry and reiterates the need for a thorough investigation into these ties;

Amendment 11

Jonas Sjöstedt

Draft opinion

Paragraph 2 - point 1 (new)

Amendment

(1)    Believes that EFSA should continue to pay special attention to the public opinion, and commit itself to increased openness, transparency and scrutiny to and by the public and independent scientists;

Amendment 12 

Jonas Sjöstedt

Draft opinion

Paragraph 3 - point 1 (new)

Amendment

(1)    Reiterates its regrets that the EFSA, in relation to the two-year cooling off period, still includes in its independence policy the obligation to screen experts' interests only in relation to the mandate of the scientific group to which the expert is applying, and reiterates its regrets that the research funding from companies in the Authority's remit is not considered relevant to the cooling off period as long as amounts at stake do not rise above 25 % of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined; highlights that the Authorities refusal to address these two very serious issues in relation to the Authorities prevention and management of conflicts of interests is unacceptable and needs to be resolved immediately;

Amendment 13

Jonas Sjöstedt

Draft opinion

Paragraph 5

Draft opinion

5.      Highlights the need for the EFSA to develop strong cooperation with all its stakeholders, including the other Agencies for better connection and outputs dissemination; welcomes the fact that the EFSA developed cooperation with Member States, including with the increase support of focal points, mainly focusing on support in the area of data collection and communication;

Amendment

5.      Highlights the need for the EFSA to develop strong cooperation with all its stakeholders, including the other Agencies for better connection and outputs dissemination; welcomes the fact that the EFSA developed cooperation with Member States, including with the increase support of focal points, mainly focusing on support in the area of data collection and communication; encourages EFSA to even further increase its efforts to protect animal welfare and promote the use of non-animal testing methods, also in its cooperation with other institutions;

Amendment 14

Jonas Sjöstedt

Draft opinion

Paragraph 1 - point 1 (new)

Amendment

(1)    Expresses deep concern over reports of conflict of interest and influence of the pharmaceutical industry over EMA 1d, reiterates that the agency serves the public interest of safe and affordable medicine, regrets inaction shown by the agency to tackle accusations of "revolving doors" in the case of scientific experts and their involvement with big pharmaceutical companies, regrets with profound concern the unwillingness of the agency to challenge financial interests and to properly prioritise public health concerns;

1dhttps://www.investigate-europe.eu/posts/deadly-prices-big-pharma-influence-hangs-over-europes-medicines-regulator

Amendment 15

Jonas Sjöstedt

Draft opinion

Paragraph 4

Draft opinion

4.      Welcomes the EMA’s efforts to contribute to Union priorities, including via inter alia the implementation of the Union Beating Cancer Plan, the Union Chemical Strategy for Sustainability and the European One Health Action Plan against Antimicrobial Resistance.

Amendment

4.      Welcomes the EMA’s efforts to contribute to Union priorities, including via inter alia the implementation of the Union Beating Cancer Plan, the Union Chemical Strategy for Sustainability and the European One Health Action Plan against Antimicrobial Resistance; urges the EMA to further cooperate with relevant agencies and actors to combat new, rare and difficult to diagnose cancers; reiterates the need to pay special attention to often misdiagnosed conditions among women and girls and to be conscious of class bias in health related issues and pharmacological needs;

Amendment 16

Jonas Sjöstedt

Draft opinion

Paragraph 5

Draft opinion

5.      Recalls that the EMA is a fee-funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post-authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; highlights the need to ensure transparency of these revenues and welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/5682 ;

2 Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).

Amendment

5.      Recalls that the EMA is a fee-funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post-authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; highlights the need to ensure transparency of these revenues and welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/5682; reiterates the importance of scientific integrity and patient safety, commits to supporting the EMA to guard these principles regardless of the levels of fee-based incomes to the agency;

2 Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).

Amendment 17

Jonas Sjöstedt

Draft opinion 

Paragraph 6 - point 1 (new)

Amendment

(1)    Acknowledges that accessibility to medicine at affordable rates is a national competence, commits however to assuring that the EMA contributes to these ends, encourages the agency to find methods and practices that manages development costs of new pharmacological products;

Amendment 18

Jonas Sjöstedt

Draft opinion

Paragraph 1

Draft opinion

1.      Recommends, based on the facts available, that discharge be granted to the Executive Directors of the Agencies in respect of the implementation of the budget of the EU agencies for the financial year 2023.

Amendment

1.      Recommends, based on the facts available, that discharge should not be granted to the Executive Directors of the Agencies EFSA and EMA in respect of the implementation of the budget of the EU agencies for the financial year 2023, recommends that discharge be granted to all other Executive Directors of the Agencies .