Changes from report parliamentary committee draft to plenary report

Change 9 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Added7. Reiterates the key role of the Agency in protecting human and animal health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination;

Added8. Notes however that inadequate resources for the Agency may undermine the ability of the Agency to deliver on its mission and calls on the Commission and the Council to allocate adequate Union funding to ensure the Agency has enough resources to carry out all of its activities on the wide range of regulatory mechanisms, including facilitating the development of and access to medicines, supporting research and innovation and its responsibilities for monitoring and mitigating potential or actual shortages of critical medicines without any delay;

Added9. Acknowledges that 2022 was still characterised by a significant level of COVID-19 related activities, with a shift from pre- and initial marketing authorisation activities to post-authorisation activities;

Added10. Welcomes the fact that 52 % of applicants who have been granted a positive opinion for their medicinal product have received scientific advice or protocol assistance from the Agency during the development phase of their product, with this figure rising to 78 % for applicants for medicinal products with new active substances; is of the opinion that early advice has the potential to significantly streamline the approval process and lead to the development of safe and effective medicinal products;

Change 10 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed8.12. Notes thatthat, through the work of its Digital Innovation Lab (DigiLab)(DigiLab), the Agency explored opportunities to realise automations of administrative work; observes that DigiLab initiated 14 automation projects, prioritizedprioritised and endorsed by the Digital Acceleration Leadership Team, alongside the Analytics Center of Excellence,Excellence (ACE), including automations for email categorization,categorisation, clinical breakpoints list generation, and a pilot EU Reference Dates List Database for efficiency gains in maintenance and publication on the Agency's website;takeswebsite; noteobserves that the Digital Innovation Lab (DigiLab)DigiLab also worked with the Analytics Centre of Excellence (ACE)ACE to pilot five potential solutions to business challenges;

Change 11 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed9.13. Welcomes thatthe asfact athat, componentas part of its digitalizationdigitalisation efforts in 2022, the Agency completed the integration of Good Clinicalgood Practiceclinical (GCP)practice and Good Pharmacovigilancegood Practicepharmacovigilance (GVP)practice inspections into its IT portalplatform, IRIS, enhancing efficiency, transparency, and collaborative work in line with the Agency's digital transformation program,programme, which oversees inspections for human and veterinary medicines under the centralizedcentralised procedure or referral process upon request from the Committees for Medicinal Products for Human Use (CHMP) or Veterinary Use (CVMP);Use; invites the institution to find more internal procedures that could be streamlined via digitalization;digitalisation;

Change 12 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed10.14. Notes thatthat, as part of the process improvement dimensions, during 2022 the Agency worked on the Agile transformation, with the aim of providing increased transparency, a reduced administrative burden and clearer accountability, through a new governance model and way of working in Information Management/IT;

Change 13 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed11.15. Points out that in 2022,2022 the Agency gradually resumed on-site activities at its building while sustainingmaintaining flexible working arrangements, allowing up to 60 % teleworking monthly; temporary rules for business travel prioritizedprioritised virtual participation in conferences, meetings, and trainings, with physical attendance considered for added strategic value, and a decision was implemented to alternate virtual and physical settings for scientific committee meetings and working parties to manage on-site capacity and contribute to carbon footprint control, resulting in lower CO2carbon dioxide emissions compared to pre-pandemic years despite the resumption of physical activities;

Change 14 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Added16. Recalls the importance of increasing the digitalisation of the Agency in terms of internal operation and management but also in order to speed up the digitalisation of procedures; stresses the need for the Agency to continue to be proactive in this regard in order to avoid a digital gap between the agencies; draws attention, however, to the need to take all the necessary security measures to avoid any risk to the online security of the information processed; insists on the need to step up action against cyberattacks or infiltration attempts particularly those originating from Russia or China;

Added17. Notes with satisfaction that the Agency cooperates with other agencies, in particular with the European Centre for Disease Prevention and Control and with the European Food Safety Authority, including on the European Vaccination Information Portal, for monitoring vaccine safety and reporting side effects, as well as on antimicrobial consumption and resistance;

Added18. Invites the Agency to continue promoting cooperation with other Union agencies and international organisations, and fostering dialogue with stakeholders and citizens;

Change 15 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed13.20. TakesRegrets notethe oflack theof gender distributionbalance inon the Agency’s management board, where 36 out of 67 (54 %) are men, while for the overall staff, 568 out of 865 (66 %) are women; notesregrets furthermore that in senior management positions, 17 out of 27 (63 %) are men; is strongly of the opinion that the gender balance among the members of the Agency’s senior and middle management and the administrative staff needs to be improved with a faster paste;

Change 16 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Removed14. Acknowledges the Agency is implementing various initiatives in addressing the gender gap in senior management positions, including a management development program, internal mobility opportunities, and the creation of management communities to encourage and support female staff; notes that, a pipeline is being built from Heads of Office/Service/Work stream, with a progressive increase in female managers; notes furthermore that the retirement of key senior male managers provides recruitment opportunities for females, complemented by an enhanced Employer Branding strategy, targeted recruitment marketing, the establishment of Diversity and Inclusion Working Group and the endorsement of the D&I charter in March 2022;

Added21. Raises concerns about the geographical balance among the Agency’s senior and middle management having only one managerial member of staff from Central-Eastern Europe; insists that improvements have to be made; asks the Agency to report back on this to the discharge authority;

Removed15. Notes that in 2022 the overtime declared of 72 463 hours was 30 % lower compared to 102 912 hours reported in 2021; notes furthermore that the average overtime in 2022 was 4,3 % compared to the 6,3 % reported in 2021, which is close to the average of 4,0 % recorded during the period 2016-2019; highlights the importance of good work-life balance to improve the wellbeing of the staff;

Added22. Recalls the importance of ensuring gender balance and acknowledges in this regard that the Agency is implementing various initiatives in addressing the gender gap in senior management positions, including a management development programme, internal mobility opportunities, and the creation of management communities to encourage and support female staff; notes that a pipeline is being built from the Heads of Office/Service/Work stream, with a progressive increase in female managers; notes furthermore that the retirement of key senior male managers provides recruitment opportunities for females, complemented by an enhanced employer branding strategy, targeted recruitment marketing, the establishment of a Diversity and Inclusion Working Group and the endorsement of the diversity and inclusion charter in March 2022;

Removed16. Welcomes that in 2022, the Agency conducted a comprehensive well-being survey, and the resulting recommendations have been integrated into the Agency HR Strategy for 2023-2025;

Added23. Notes that in 2022 the overtime declared of 72 463 hours was 30 % lower compared to 102 912 hours reported in 2021; notes furthermore that the average overtime in 2022 was 4,3 % compared to the 6,3 % reported in 2021, which is close to the average of 4,0 % recorded during the period 2016-2019; highlights the importance of a good work-life balance, flexible working hours, teleworking, and the right to disconnect, in relation to improving the wellbeing of the staff;

Change 17 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed17. Takes26. noteObserves thatthat, to maintain impartiality and objectivity in the Agency's operations, it regularly adjusts the policies’ scope and implementing processes vis-à-vis emerging risks stemming from new activities and/or interactions with new categories of stakeholders; takes notenotes that in 20222022, as a result of the Agency’s new responsibilities in the area of medical devices, in vitro medical devicesdevices, as well as fromthe responsibilities under its extended mandate, the policy on competing interestinterests for members of the Management Board, policy on competing interestinterests for experts, and the Implementingimplementing rules on handling declared interests of staff and candidates before recruitment, have been revised;

Change 18 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed18.27. Notes that the Agency has a breach of trust (BoT) procedure, which sets out how it deals with incorrect or incomplete e-DoIs by experts and committee members, as well with disclosure of confidential information; observes that the BoT procedure was revised in December 2022; highlights the fact that the revised BoT procedure states that it also applies to the other bodies that have been established within the Agency under the Extendedextended Mandatemandate (e.g. Emergency TaskETF Force,and both Shortages Steering Groups);

Change 19 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed20.29. Highlights that departing Agency staff sought permission for post-employment occupations, with 22 applications in 2022 resulting in varied authorizations,authorisations, including both unrestricted and restricted cases; acknowledges that the Agency has been publishing decisions on senior departingmembers fromof staff that leave the organizationorganisation on its corporate website since December 2020, contributing significantly to transparency in handling competing interests;

Change 20 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed21.30. Notes with satisfaction that the Commission’s Internal Audit Service reportreport, thatwhich tookwas placepublished during 2022 focusingand focused on HRhuman mattersresource matters, confirmed the robustness of the system in place based on a very high staff awareness of the risks involved and the maturity of the internal controls to manage potential conflicts of interests;interest;

Change 21 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed22.31. Notes that, as a technical, scientific body of the EU,Union, the Agency does not formally engage or meet with lobbyists, however, the Agency does engage and meet with stakeholders in accordance with its formal stakeholder frameworks; notes furthermore that meetings with external stakeholders are public and the details are published on the events page of EMA’sAgency’s website;

Change 22 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Added32. Acknowledges the visibility that the Agency has achieved; is of the opinion that there is still room for it to achieve greater visibility in the media, internet, and social media in order to make its work and the dangers to our environment known to the citizens;

Added33. Notes that in 2022 the Agency received 676 requests for access to documents, fewer than the number of requests received in 2019 (783 requests) or 2021 (710 requests) and released 216 666 pages, more than compared to 165 943 in 2021 but considerably fewer than the 318 013 pages in 2019; notes that the Agency applies a queuing mechanism to manage the processing of multiple access to documents requests from the same requester representing a bottleneck for timely access to documents held by the Agency and discouraging requesters from introducing new requests; calls on the Agency to provide detailed information on the number of access to documents requests remaining inactivated in the queuing system and the average time spent in the queuing system before being activated; calls for the launch of an audit on the Agency’s rules to process access to documents requests, the queuing mechanism, the evolution of requests over time and the effects on applicants;

Added34. Calls on the Commission to ensure that the Agency receives adequate resources to implement the tasks that were assigned to the Agency by the adoption of Regulation (EU) No 536/2014 and avoid staff shortages that will negatively affect the Agency’s transparency policy, including with regard to timely publication of clinical data, meeting minutes and timely responses to access to documents requests;

Change 23 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed23.35. Observes that a questionnaire was prepared to assess the implementation, functioning, and improvement of the 17 principles within the internal control framework; notes that managers and staff members responsible for specific principles or elements received the questionnaire, and interviews were conducted for further clarification; notes furthermore that the overall conclusion is that the internal control system is deemed to be effective and efficient, its components,components and principles are generally present and functioning reasonably wellwell, while some principles maycould benefit from minor clarifications or additional information, and adjustments and improvements are suggested;

Change 24 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed24.36. Draws attention to the fact thatthat, as result of its relocation in 2019, the Agency leased a building in Amsterdam, which was fully fitted and furnished using the Dutch government’s EUR 15 million incentive scheme, including the donation of furniture and catering equipment; takes notenotes that the Court found that the Agency had not assigned clear identification (such as labels with bar codes) to some of thesethose assets, mainly furniture; notes furthermore that four inventory counts the Agency had carried out since relocation repeatedly showed discrepancies (which, with time, decreased from EUR 534 331 to EUR 15 000) between the list of assets donated by the Dutch government, the Agency’s asset register and the assets found on the premises; highlights the fact that the absence of a complete and updated inventory list, specifying the location of tangible assets, goesis againstcontrary to Article 87 of the Financial Regulation, and adversely affects the Agency’s ability to ensure the safeguardingits ofassets itsare assets;safeguarded; welcomes thatthe fact that, with a view to continuously improving its processes, the Agency will release an updated internal guidance for the management of its assets inventory, adopt a risk-based approach to the labelling of furniture and release a rolling physical checks plan to continuously confirm the accuracy of its inventory;

Change 25 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed25. Takes note37. ofNotes the observation from the Court’s report regarding the Agency’s contribution towards certain types of staff childcare costs, such as pre- and after-school care in the Netherlands; notes that for school meals, the Court found that the Agency was not able to provide full evidence of the checks done to ensure that the costs of school meals were excluded, therefore putting into question whether such checks were systematically carried out; observes from the Agency’s reply that mealsmeal costs are excluded from school fees and the Agency will file the evidence that school meal costs are excluded from the calculation of the contribution;

Change 26 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed26.38. Notes the result of the activities carried out by the Agency’s internal audit capability, with 6 critical and 19 very important recommendations were issued in 2022; calls on the Agency to address the 14 major recommendations awaiting an improvement actionsaction plan as of 31 December 2022 and report back to the discharge authority on the developments in this regard;

Change 27 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed27.39. Welcomes the fact that the Agency aligned its long-term climate objectives with the Europeantarget Climatelaid Law’sdown targetin Regulation (EU) 2021/1119 of a 55 % net reduction of greenhouse gas emissions by 2030 (compared to 1990 levels) and achieving climate neutrality by 2050; notes that for energy and water consumption, the Agency translated thesethose objectives into a 15 % reduction per square metre of office space to be achieved between 2012 and 2021; observes that this target took into account the Agency’s growth in that period, and the fact that it had moved into a bigger but also more energy-efficient building, following its relocation from London to Amsterdam; notes that the target was exceeded both for energy and water achieving a 45 % reduction in energy consumption and 63 % in water use per square metre;

Change 28 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed28. Takes40. noteNotes that the Agency is in preparationpreparing for the Eco-Management and Audit Scheme (EMAS) certification;

Change 29 under “3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION”

Changed29.41. Welcomes the fact that in 20222022, in order to increase the cyber securitycybersecurity, the Agency adopted the Information Security Strategy and the related implementation plan aiming to enhance the existing safeguards and security processes to protect the Agency’s information assets whilst supporting new business and technological challenges; notes that other important measures were also implemented in 2022 including the establishment of the security training and awareness programme and the implementation of the Security Operation CentreCentre, which aims to continuously monitor and improve the Agency’s security posture while preventing, detecting, analysing, and responding to cybersecurity incidents; notes furthermore that the Agency has been working in close collaboration with CERT-EUthe Computer Emergency Response Team for the EU institutions, bodies and ENISAagencies and the European Union Agency for Cybersecurity covering many aspects of the information security and cybersecurity domains, also including discussions and regular updates on the upcoming cybersecurity regulation for EUUnion institutions, agencies, and bodies;