### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014. such an approach would strengthen the research environment in the union , and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations. ### (20) individual research entities may agree together , or with another party , to act as a sponsor in order to prepare one harmonised union-wide clinical trial protocol , yet experience during the covid-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the union , while interacting with multiple member states. it is therefore appropriate for the agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or , where applicable , to define respective responsibilities as co-sponsors in accordance with article 72 of regulation (eu) 536/2014. such an approach would strengthen the research environment in the union , while encouraging the collaboration with external experts including academia , and target recruitment of data scientists , omics specialists , biostatisticians , epidemiologists , and experts in advanced analytics and ai , as well as to promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. a union sponsor could benefit from union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development , application , submission , and running of the trial. this may be particularly valuable for trials established by union or international public health or research organisations.


### (21) with respect to medical devices , an executive steering group on medical devices should be established to coordinate urgent actions within the union in relation to the management of supply and demand issues of medical devices , and to establish a list of critical devices in the case of a public health emergency. ### (21) with respect to medical devices , an executive steering group on medical devices should be established to coordinate urgent actions within the union in relation to the management of supply and demand issues of medical devices , and to establish a list of critical devices and minimum stock levels required in the case of a public health emergency.


### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including the eudamed it platform for medical devices. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data. ### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including the eudamed it platform for medical devices , alongside enhanced protection of data infrastructure and dissemination from possible cyberattacks. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data.


### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including the eudamed it platform for medical devices. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data. ### (25) in order to facilitate the work and the exchange of information under this regulation , provision should be made through further implementing acts with a view to outlining the roles of the actors involved in the processing of personal data for the establishment and management of it infrastructures and synergies with other existing it systems or systems under development , including the eudamed it platform for medical devices and data analysis and real world interrogation network - darwin. that work should also be facilitated by , where appropriate , emerging digital technologies such as computational models and simulations for clinical trials , as well as data from the eu space programme such as the galileo geolocation services , and copernicus earth observation data , while enabling data discoverability.


### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure. ### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure , but with clear rules on controlling access to the data (users with access , data retention period) and ensuring adequate protection of the data.


### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure. ### (26) rapid access and exchange of health data , including real world data i.e. health data generated outside of clinical studies , such as electronic health records , insurance claims data and data from patient registries , is essential to ensure effective management of public health emergencies and other major events. this regulation should allow the agency to use and facilitate such exchange and be part of the establishment and operation of the european health data space infrastructure , while ensuring the applicability of the gdpr and eudpr , and the respect of the principles relating to the processing of personal data (as per article 5 gdpr and 4 eudpr).


### prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices; ### prevent , prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand , that is patient demand together with appropriate buffer stocks , for that medicinal product or medical device;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet patient demand plus the appropriate buffer stocks for that medicinal product or medical device;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device , regardless the cause;


### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand patient and healthcare actors’ needs for that medicinal product or medical device at national level;


### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one member state. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the supply or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of medicinal products in more than one member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection. ### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one member state. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the demand and/or supply , or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of critical medicinal products in more than one member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection.


### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one member state. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the supply or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of medicinal products in more than one member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection. ### ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one member state. such an event concerns a deadly threat or otherwise serious threat to health of biological , chemical , environmental or other origin or incident that can affect the manufacturing , supply or quality , safety , and efficacy of medicinal products. such an event may lead to shortages of medicinal products in more than one member state and necessitates urgent coordination at union level in order to ensure a high level of human health protection.


### 1. the executive steering group on shortages and safety of medicinal products (‘the medicines steering group’) is hereby established as part of the agency. it shall meet either in person or remotely , in preparation for or during a public health emergency or following a request for assistance referred to in article 4(3). the agency shall provide its secretariat. ### 1. the executive steering group on shortages and safety of medicinal products (‘the medicines steering group’) is hereby established as part of the agency. it shall meet as often as needed , either in person or remotely , in preparation for or during a public health emergency or following a request for assistance referred to in article 4(3). the agency shall provide its secretariat.


### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medicines steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state , as well as one alternate for unforeseen circumstances. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields.


### 3. the medicines steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. ### 3. the medicines steering group shall be chaired by the agency. all members of the medicines steering group may propose to the chair to invite third parties , including representatives of medicinal product interest groups , representatives of healthcare professionals , patients and consumers , and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the steering group.


### 5. the medicines steering group shall be supported in its work by a working party comprised of single points of contact related to shortages from national competent authorities for medicinal products established in accordance with article 9(1). ### 5. the medicines steering group shall be supported in its work by a working party comprised of single points of contact related to shortages from industry (ispoc) and a two way communication line need to be established between the medicines steering group and the ispoc.


### where the major event or public health emergency may affect the safety , quality , and efficacy of medicinal products , article 5 shall apply; ### where the major event or public health emergency may affect the manufacturing , safety , quality , and efficacy of medicinal products , article 5 shall apply;


### following the recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety , quality , and efficacy of the medicinal products concerned. ### following the recognition of a public health emergency or a request for assistance referred to in article 4(3) , the medicines steering group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the manufacturing safety , quality , and efficacy of the medicinal products concerned.


### on the basis of the critical medicines lists and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation. ### on the basis of the critical medicines lists , the establishment of two way communication line with industry and the information and data provided in accordance with articles 10 and 11 , the medicines steering group shall monitor supply and demand , based on actual patient’s needs at national level , of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. as part of that monitoring , the medicines steering group shall liaise , where relevant , with the health security committee established in article 4 of regulation (eu) 2020/[…]19 and , in the case of a public health emergency , the advisory committee on public health emergencies established pursuant to article 24 of that regulation.


### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies. ### 3. as part of that reporting , the medicines steering group may also provide recommendations on measures , which may be taken by the commission , member states , marketing authorisation holders and other entities , including healthcare professionals and patients , to prevent or mitigate potential or actual shortages. in that regard the group shall liaise , as relevant , with the health security committee and , in the case of a public health emergency , the advisory committee on public health emergencies.


### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency. ### 5. the medicines steering group may upon request from the commission coordinate measures , where relevant , between the national competent authorities , the marketing authorisation holders and other entities , including healthcare professionals and patients , to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.


### 1. in order to prepare for fulfilling the tasks referred to in articles 4 to 8 , the agency shall: ### 1. in order to prepare for fulfilling the tasks referred to in articles 4 to 8 and also consulting representatives from national competent authorities and from industries representatives , as well as other stakeholders in the medicines supply chain , the agency shall:


### specify the procedures for establishing the critical medicines lists; ### specify the procedures for establishing the critical medicines lists and the minimum stock levels required to ensure continuity of medical care;


### specify the procedures for establishing the critical medicines lists; ### specify the procedures and criteria for establishing the critical medicines lists;


### develop streamlined electronic monitoring and reporting systems; ### develop a streamlined and eu harmonized electronic monitoring and reporting systems. the harmonised system prevent any duplication of the reporting process by industry;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;


### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders based on the medicinal products included on the critical medicines lists; ### establish and maintain for the duration of the public health emergency or major event , a sub-network of single points of contact from marketing authorisation holders and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public , based the medicinal products included on the critical medicines lists;


### mitigation plans including production and supply capacity; ### prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients , potential alternative production sites , minimum stock levels , etc.


### information from the wholesale distributors and legal person entitled to supply the medicinal product to the public. ### deleted


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities , including healthcare professionals to support them in their work and in the communication with patients;


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the emergency task force is hereby established as part of the agency. it shall be convened as often as needed during public health emergencies , either in person or remotely. the agency shall provide its secretariat.


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the emergency task force is hereby established as a permanent structure as part of the agency it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat.


### cooperating with union bodies and agencies , the world health organization , third countries , and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies , as necessary. ### cooperating with national competent authorities , union bodies and agencies , the world health organization , third countries , and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies , as necessary.


### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , and interest groups representing patients and healthcare professionals to attend its meetings. ### 5. the chair may invite representatives of member states , members of scientific committees of the agency and working parties , and third parties , including representatives of medicinal product interest groups , marketing authorisation holders , developers of medicinal products , clinical trial sponsors , representatives of clinical trial networks , independent clinical trial experts and researchers , and interest groups representing patients and healthcare professionals to attend its meetings.


### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability. ### 2. in preparation of the review , the emergency task force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. the emergency task force may also , where available , make use of observational studies of health data generated outside of clinical studies taking into account their reliability , while applying state-of-the-art pseudonymisation , including encryption.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force , as well as its decisions , proposals and recommendations to the national and european authorities.


### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies; ### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies , while ensuring processing of patients' personal data is in compliance with the european data protection framework;


### coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities. such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform; ### coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities , while taking into consideration the priority recommendations of the hma-ema joint big data task force. such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform;


### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies; ### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (qci) , which would allow the transmission of sensitive information , using an ultra-secure form of encryption to shield against cyberattacks;


### 1. the executive steering group on medical devices (‘the medical devices steering group’) is hereby established as part of the agency. it shall meet either in person or remotely , in preparation for or during a public health emergency. the agency shall provide its secretariat. ### 1. the executive steering group on medical devices (‘the medical devices steering group’) is hereby established as part of the agency. it shall meet as often as needed , either in person or remotely , in preparation for or during a public health emergency. the agency shall provide its secretariat.


### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. ### 2. the medical devices steering group shall be composed of a representative of the agency , a representative of the commission and one senior representative per member state , including one alternate in case of unforeseen circumstances. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields.


### 1. immediately following the recognition of a public health emergency and after consultation of its working party , the medical devices steering group shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). the list shall be updated whenever necessary until the termination of the recognition of the public health emergency. ### 1. immediately following the recognition of a public health emergency and after consultation of its working party , the medical devices steering group shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’) as well as minimum necessary stock levels. the list shall be updated whenever necessary until the termination of the recognition of the public health emergency.


### specify the procedures for establishing the public health emergency critical devices list; ### specify the procedures and criteria for establishing the public health emergency critical devices list;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems , including for existing or potential stock levels;


### develop streamlined electronic monitoring and reporting systems; ### develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;


### mitigation plans including production and supply capacity; ### mitigation plans including production and supply capacity , so as to ensure the minimum stock levels required;


### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746; ### take all necessary action within the limits of the powers conferred on it , with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , including , where necessary , granting temporary exemptions at union level pursuant to article 59(3) of regulation (eu) 2017/745 or article 54(3) of regulation (eu) 2017/746 , while at the same time ensuring both patient and product safety;


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group and its proposals and recommendations.


### personal data in accordance with article 32; ### personal data in accordance with article 32 and article 4(1) of regulation (eu) 2016/679 (‘gdpr’) and article 3(1) eudpr;


### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. ### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. recalls that transfers of personal data to third countries or international organisations must comply with chapter v of the eudpr , relevant provisions of the gdpr , the led and the charter of fundamental rights and take into account the recommendations and guidelines of the edpb.


### 6. where a developer is the recipient of scientific advice , the developer shall subsequently submit the data resulting from clinical trials to the agency following a request made pursuant to article 16. ### 6. where a developer is the recipient of scientific advice , the developer shall subsequently submit the data resulting from clinical trials to the agency following a request made pursuant to article 16. in order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply , including encryption.


### 1. emphasises the important role of the european medicines agency (‘the ema') in protecting and promoting public and animal health by making independent , science-based recommendations on the quality , safety and efficacy of medicines , and providing scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines; ### 1. emphasises the important role of the european medicines agency (‘the ema') in protecting and promoting public human and animal health by making independent , science-based recommendations on the quality , safety and efficacy of medicines , and providing scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines;


### 6. welcomes the ema’s decision to waive all fees for scientific advice applications from developers of potential covid-19 therapeutics or vaccines as of 13 march 2020 , and to waive all fees for provision of scientific advice to academic researchers developing orphan medicines from 19 june 2020; ### 6. notes the ema’s decision to waive all fees for scientific advice applications from developers of potential covid-19 therapeutics or vaccines as of 13 march 2020 , and welcomes the waiving of all fees for provision of scientific advice to academic researchers developing orphan medicines from 19 june 2020; highlights that other instances of waiving fees subject to specific criteria set out by the ema notably regarding smes should follow;


### 8. is pleased that the ema successfully maintained the quality and continuity of its operations whilst relocating its seat to its final premises in amsterdam following the united kingdom’s withdrawal from the union; notes that potential liabilities arising from the lease on the ema’s former office premises in london remain a matter of concern; ### 8. is pleased that the ema successfully maintained the quality and continuity of its operations whilst relocating its seat to its final premises in amsterdam following the united kingdom’s withdrawal from the union; notes that potential liabilities arising from the lease on the ema’s former office premises in london remain a matter of concern; recognises that the ema was able to respond effectively to the workload associated with the covid-19 pandemic and welcomes the work on facilitating access to new vaccines and therapeutics to treat and prevent the spread of covid-19;


### 14. notes , in addition , that the court identified irregularities in a catering and restaurant services framework contract , including a failure to verify that the amounts invoiced were correct; ### 14. notes , that the court identified public procurement weaknesses and also irregularities in a catering and restaurant services framework contract , including a failure to verify that the amounts invoiced were correct;


### 1. observes that the mission of the european centre for disease prevention and control (the 'centre') is to identify , assess and communicate current and emerging threats to human health from communicable diseases; emphasises that thecovid-19 outbreak and subsequent pandemic in 2020 was the most serious public health event that the centre has had to respond to since it became operational in 2005; ### 1. observes that the mission of the european centre for disease prevention and control (the 'centre') is to identify , assess and communicate current and emerging threats to human health from communicable diseases; emphasises that the covid-19 outbreak and subsequent pandemic in 2020 was the most serious public health event that the centre has had to respond to since it became operational in 2005; recognises that the centre activated its public health event operations plan on 9 january 2020 and , specifically , that teams working on public health emergencies contibuted positively to the union and national governance frameworks for the covid-19 pandemic;


### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’. ### (3) in its communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 , entitled ‘the european green deal’ the commission committed itself to consider revising regulation (ec) no 1367/2006 to improve access to administrative and judicial review at union level for citizens and environmental non-governmental organisations who have concerns about the compatibility with environmental law of decisions with effects on the environment. the commission also committed to take action to improve their access to justice before national courts in all member states; to this end , it issued a communication on ‘improving access to justice in environmental matters in the eu and its member states’ in which it affirms that “access to justice in environmental matters , both via the court of justice of the eu (cjeu) and the national courts as union courts , is an important support measure to help deliver the european green deal transition and a way to strengthen the role which civil society can play as watchdog in the democratic space”.


### (4) taking into account the provisions of article 9(3) of the aarhus convention , as well as concerns expressed by the aarhus convention compliance committee5 , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters in a way that is compatible with the fundamental principles of union law and with its system of judicial review. ### (4) taking into account the provisions of article 9(3) and (4) of the aarhus convention , union law should be brought into compliance with the provisions of the aarhus convention on access to justice in environmental matters , the findings5 and the advice5a of the aarhus convention compliance committee , as the main body for the review of compliance with the aarhus convention5b , in a way that is compatible with the fundamental principles of union law and with its system of judicial review. this regulation therefore amends regulation (ec) no 1367/2006 in order to fulfil the union’s obligations under international law to implement article 9(3) and (4) of the aarhus convention as regards the union’s institutions and bodies.


### b. whereas the european climate law commits the eu to reaching climate neutrality by 2050 with increased emission reductions by 2030; whereas addressing energy-related methane emissions is a key component of the european green deal , as are measures in the agriculture and waste sectors; whereas the eu strategy to reduce methane emissions notes that the eu should also play a role in ensuring methane emission reductions at global level , as the largest global importer of fossil fuels and a significant player in the agriculture sector; ### b. whereas the european climate law sets the ghg emissions reduction objective of at least 55% by 2030 and the goal of a climate-neutral economy by 2050 at the latest , in line with the paris agreement; whereas addressing energy-related methane emissions as the sector where more cost-effective methane emissions saving can be achieved , is a key component of the european green deal , as are measures in the agriculture and waste sectors; whereas the eu strategy to reduce methane emissions notes that the eu should take the leadership in ensuring methane emission reductions at global level , as the largest global importer of fossil fuels and a significant player in the agriculture sector;


### c. whereas reducing methane emissions is indispensable in the fight against climate change , in line with the goals of the paris agreement; whereas methane emissions contribute to air pollution and it is therefore necessary to tackle these emissions in order to protect the health of eu citizens; ### c. whereas reducing methane emissions is indispensable in the fight against climate change , as indicated in the impact assessment of the 2030 climate target plan (swd(2020)176 final) which indicates that the target of at least 55% of greenhouse gas emissions reduction by 2030 requires to tackle methane emissions in line with the goals of the paris agreement; whereas methane emissions are the second largest contributor to climate change and to tropospheric ozone formation which contribute to air pollution and whereas it is therefore necessary to tackle these emissions in order to protect the health of eu citizens;


### d. whereas cutting methane emissions can have a quicker impact on slowing the rate of global warming than reducing co2 emissions , since methane does not stay in the atmosphere for as long , and it could therefore be one of the most cost-effective strategies to rapidly reduce the rate of warming and avoid some tipping points for global warming; ### d. whereas cutting methane emissions can have a quicker impact on slowing the rate of global warming than reducing co2 emissions , since methane does not stay in the atmosphere for as long , and it could therefore be one of the most cost-effective strategies to rapidly reduce the rate of warming and avoid some tipping points for global warming; complementary to the efforts that we must continue to make to reduce co2 emissions , across all sector affected in order to achieve a climate-neural economy by 2050.


### 1. welcomes the cross-sectoral approach outlined in the eu strategy to reduce methane emissions and fully supports a fair framework covering the agriculture , waste and energy sectors; ### 1. welcomes the cross-sectoral approach outlined in the eu strategy to mitigate methane emissions and fully supports a clear framework and pathway covering the agriculture , waste and energy sectors , which allow to create synergies between these sectors and the related socio-economical aspect and to achieve the eu decarbonisations objectives throughout europe and international business.


### 1. welcomes the cross-sectoral approach outlined in the eu strategy to reduce methane emissions and fully supports a fair framework covering the agriculture , waste and energy sectors; ### 1. welcomes the cross-sectoral approach outlined in the eu strategy to reduce methane emissions and fully supports a fair framework covering the agriculture and livestock , waste and energy sectors;


### 2. underlines the importance of improving measurement , reporting and verification (mrv) as well as leak detection and repair (ldar) standards; ### 2. underlines the importance of adopting strong mandatory rules on monitoring , reporting and verification (mrv) in all the energy-related methane emissions including imports as well in the agriculture and waste sector and mandatory leak detection and repair (ldar) programs , covering the full supply chain , up to the point of production , in all sectors (energy , agriculture and waste);


### 7. welcomes the upcoming legislative proposal on compulsory mrv for all energy-related methane emissions; ### 7. welcomes the upcoming legislative proposal on compulsory mrv for all energy-related methane emissions and calls for the implementation of a compulsory and continuous mrv framework and ldar system across the whole supply chain , of fossil gas , oil , coal , biogas , including imports from third countries with a third-party verifier system combined with other monitoring methods , to promote the detection , repair and control for all the methane leaks and the reduction of methane-intensive imports , based on quarterly surveys with state-of-the-art technologies , and with clear deadlines for repairs and resurvey;


### 8. welcomes the commission’s proposal to consider legislation on venting and flaring in the energy sector covering , if feasible , the full supply chain; considers that existing national legislation addressing routine venting and flaring , taking into account complex safety and environmental aspects , must be taken into consideration when developing eu legislation; ### 8. calls on the commission to propose a ban on venting and flaring in the energy sector covering the full supply chain , by making new legislative proposals in this regard; considers that existing national legislation addressing routine venting and flaring , taking into account complex safety and environmental aspects , must be taken into consideration when developing eu legislation;


### 9. acknowledges that imports comprise over four fifths of the oil and gas consumed in the eu and that most methane emissions associated with oil and gas occur outside eu borders; calls on the commission to explore regulatory tools for fossil energy imports , including extending forthcoming obligations on mrv , ldar , venting and flaring to imports; ### 9. acknowledges that imports comprise over four fifths of the oil and gas consumed in the eu and that most methane emissions associated with oil and gas occur outside eu borders; underscores the urgency to reduce all methane emissions linked to oil and gas consumption in the eu and calls on the commission to ensure the scope of the obligations in its proposal for a legislative act to reduce methane emissions in the oil , gas and coal sectors applies across the supply chain including imports , up to the point of production; stresses that mitigation measures must not substitute an ambitious and swift transition to an energy system based on renewable energy and energy efficiency; calls on the commission to implement regulatory tools for fossil energy imports and to extend forthcoming obligations on mrv , ldar , venting and flaring to the whole fossil gas and oil supply chain , including on imports up to and including production;


### 12. stresses that technologies and practices to limit methane emissions from agriculture are developing at a fast pace; calls on the commission to ensure that proven effective and cost-efficient innovations are quickly implemented in the eu and integrated into eu agriculture policies; ### 12. stresses that technologies and practices to limit methane emissions from agriculture , such as sustainable management practices of livestock , should be developed and implemented as soon as possible; calls on the commission to ensure that proven effective and cost-efficient innovations such as precision farming , nitrification inhibitors and advanced animal nutrition to reduce the methane , are quickly implemented and the ones already available must to be integrated by eu producers , in order to continue with reductions of methane emissions in the eu and integrated into eu agriculture policies as other sectors-affected are currently achieving;


### 13. underlines the key role that the eu should play in supporting research , innovation and development , as well as in scaling up new technologies to help address methane emissions from livestock agriculture , while protecting animal health and welfare; points especially to the need for multigenerational studies on feed additives; ### 13. underlines the key role that the eu should play in supporting research , innovation and development , as well as in scaling up new technologies by improving the measurement , reporting and verification of methane emissions in this sector to follow the progress towards these targets and applying the ones currently available such as mrv related , to help address methane emissions from livestock agriculture , while protecting animal health and welfare; points especially to the need for multigenerational studies on feed additives;


### 15. calls on the member states to fully comply with the existing requirements of the landfill directive , including the objective for 2035 , by which date the amount of municipal waste landfilled is to be reduced to 10 % or less of the total amount of municipal waste generated , by weight; calls on the commission to develop a comprehensive strategy to ensure that member states that are likely to miss that target take corrective measures and actions; ### 15. calls on the member states to fully comply with the existing requirements of the landfill directive , including the objective for 2035 , by which date the amount of municipal waste landfilled is to be reduced to 10 % or less of the total amount of municipal waste generated , by weight; calls on the commission to develop a comprehensive strategy to ensure that member states that are likely to miss that target take corrective measures and actions; calls on the commission to be more ambitious by setting binding targets for commercial and industrial waste , which still do not have any specific ones;


### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific incentives suited to the conditions of each member state in order to ensure , to the greatest extent possible , separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure a high degree of separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill; ### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific incentives suited to the conditions of each member state in order to ensure , to the greatest extent possible , separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure a high degree of separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill; calls on the commission to promote the treatment of the biodegradable part of the non-recyclable waste remaining after separate collection , adapting it to the specific situation of each member state;


### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific incentives suited to the conditions of each member state in order to ensure , to the greatest extent possible , separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure a high degree of separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill; ### 16. emphasises that closure and after-care procedures for landfill cells are key to reducing leakages , taking into account the entire life cycle of landfill sites; calls on the commission to provide specific incentives suited to the conditions and particular features of each member state , such as outermost regions , in order to ensure , to the greatest extent possible , separate collection of bio-waste , including by encouraging cooperation between the public and private sectors to secure a high degree of separate collection , recycling and recovery of biodegradable waste , leading to efficient diversion from landfill;


### 4. highlights that , in 2020 , the authority finalised 697 questions through scientific opinions , technical reports and supporting publications; ### 4. highlights that , in 2020 , the authority finalised 697 questions through scientific opinions , technical reports and supporting publications; welcomes the authority's timely support to policy makers in providing scientific outputs following on mandates given by the european parliament , mainly in the areas of animal health and welfare , bee health , welfare of rabbits , animal transport and antimicrobial resistance;


### 7. notes with satisfaction that the authority is moving towards cutting-edge technologies , incorporating new approach methodologies and artificial intelligence to avoid animal testing methods; ### 7. notes with satisfaction that the authority is moving towards cutting-edge technologies , incorporating new alternative methodologies and artificial intelligence to supplement animal testing methods; recognizes that the authority along with echa and ecdc and five other agencies performed stress tests of their information and communications technology (ict) systems before launching full teleworking arrangements which gave further assurance on the functioning of the ict systems before the move to comprehensive teleworking;


### 9. supports the authority’s strategic objective to further foster partnerships with other agencies , as well as with international organisations and third countries , towards an one health union ecosystem , while continuing its engagement with its stakeholders and the public through appropriate platforms and fora , which should result in further economies of scale; ### 9. encourages higher transparency towards stakeholders especially from the ngo community; supports the authority’s strategic objective to further foster partnerships with other agencies , as well as with international organisations and third countries , towards an one health union ecosystem , while continuing its engagement with its stakeholders and the public through appropriate platforms and fora , which should result in further economies of scale;


### 1. stresses that all the conditions necessary to guarantee animal welfare during transport must be ensured at all times , regardless of their species , age , physical condition or the means and length of the journey; ### 1. stresses that all the conditions necessary to guarantee animal welfare during transport must be ensured at all times for all the animals transported , regardless of their species , age , category , physical condition , or the means of transport and length of the journey; information , such as the termination or suspension of a recipient’s account;


### 2. agrees with the court of auditors that the eu3 has some of the world’s highest animal welfare standards , but insists that these only become effective if they are fully enforced; considers that the eu needs to step up its efforts to ensure that animal welfare during transport is fully respected everywhere , at all times , and by every party concerned , from the origin until the final destination; ### 2. agrees with the court of auditors that the eu3 has some of the world’s highest animal welfare standards , but notice that recently some countries/regions went further by banning any live export and the transport of specific animal categories;


### 27. draws attention to the fact that , under the current framework , the certificate of competence for the drivers and attendants of the means of transport can be valid for life , without any mandatory requirement set at european level for refresher courses and skills updates; ### 27. regrets the fact that , under the current framework , the certificate of competence for the drivers and attendants of the means of transport can be valid for life , without any mandatory requirement set at european level for refresher courses and skills updates;


### 28. recognises that training and education are essential to safeguarding the welfare of animals during transport , to guaranteeing that transport operators are well-prepared for activating contingency planning and ensuring that species-specific requirements are properly met; recognises that the workers responsible for the handling of animals in the ports , in particular , do not always receive appropriate training; ### 28. recognises that training and education are essential to safeguarding the welfare of animals during transport , to guaranteeing that transport operators are well-prepared for activating contingency planning and ensuring that species-specific requirements are properly met; recognises that the workers responsible for the handling of animals in the ports , in particular , do not always receive appropriate training; recalls the fact that the rest period of the driver and of the animals often do not fit together;


### 29. recalls that the official controls regulation (eu) no 2017/625 will replace , as of 15 december 2022 , several provisions of regulation (ec) no 1/2005 , namely on checks on long journeys , training of the competent authorities’ staff , checks at exit points , emergency measures in the case of non-compliance , mutual assistance and exchange of information , infringements and on-the-spot checks by the commission; ### 29. recalls that the official controls regulation (eu) no 2017/625 will replace , as of 15 december 2022 , several provisions of regulation (ec) no 1/2005 , namely on checks on long journeys , training of the competent authorities’ staff , checks at exit points , emergency measures in the case of non-compliance , mutual assistance and exchange of information , infringements and on-the-spot checks by the commission; emphasises the need for frequent and thorough inspections;


### 32. notes that further improvements to data collection systems and to traces can be made in the current legislative framework , to help harmonise procedures between member states’ competent authorities; ### 32. notes that further improvements to data collection systems and to traces can and should be made in the current legislative framework , to help harmonise procedures between member states’ competent authorities;


### 35. highlights the complexity of the reporting systems , involving several entities at local and national level in each member state; is aware that this results in communication difficulties between central , regional and local authorities , and among member states; ### 35. highlights the complexity , ineffectiveness and poor digitalization of the reporting systems , involving several entities at local and national level in each member state; is aware that this results in communication difficulties between central , regional and local authorities , and among member states;


### 36. points out that member states are solely responsible for creating sanction systems , which ultimately leaves each of them to define their own administrative and sanctioning procedures , as well as the level of penalties for infringements in the event of animal welfare violations during transport , thereby resulting in very different systems all across the eu; ### 36. points out that member states are solely responsible for creating sanction systems , which ultimately leaves each of them to define their own administrative and sanctioning procedures , as well as the level of penalties for infringements in the event of animal welfare violations during transport , thereby resulting in very different systems all across the eu; therefore notes that the eu commission must revise regulation 1/2005 in this respect and introduce a single , binding and eu-wide system of penalties;


### a. whereas , following the entry into force of the multiannual financial framework (mff) for 2021-2027 , the commission published a roadmap and launched a public consultation with a view to aligning the financial regulation , where appropriate , with the rules agreed by the legislator as part of the mff 2021-2027 package , and to proposing limited and targeted improvements required by the evolving situation , for instance following the covid-19 crisis or in the context of the growing opportunities for digitalisation; ### a. whereas , following the entry into force of the multiannual financial framework (mff) for 2021-2027 , the commission published a roadmap and launched a public consultation with a view to aligning the financial regulation , where appropriate , with the rules agreed by the legislator as part of the mff 2021-2027 package , and to proposing limited and targeted improvements required by the evolving situation , for instance following the covid-19 crisis or in the context of the growing opportunities for digitalisation , as well as improvements regarding crisis management , administrative simplifications for eu funds recipients , and protection of eu financial interests in accordance with the general principles embedded in the union treaties , in particular the values laid down in article 2 teu , as well as in accordance with the principle of sound financial management enshrined in article 317 tfeu and in the rule of law conditionality regulation;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to strengthen public procurement rules avoiding any potential conflict of interests , including professional conflict of interests , whether immediately apparent or not and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase respect of the eu values , protection of the financial interests of the eu , parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs quickly , particularly in times of crises;


### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs; ### 2. believes that the revision should seek to modernise the rules applicable to the eu budget in line with its latest evolutions and in line with the budgetary principles , to strengthen the performance of spending with a view to achieving greater european added-value , and to increase parliamentary oversight , democratic accountability and the ability to respond to citizens’ needs;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements; red tape reduction and simplifications , in particular where they increase transparency and democratic scrutiny; increase the accessibility to the eu funding for the citizens , smes , local and regional authorities;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny and enhance the protection of eu financial interests;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny , as well as performance of eu spending;


### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase transparency and democratic scrutiny; ### 3. is of the opinion that , while a global overhaul of the rules applicable to the budget is not needed at this time , the financial regulation must be subject to targeted improvements and simplifications , in particular where they increase rule of law , transparency and democratic scrutiny;


### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , by greatly , if temporarily , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality; ### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , increasing the magnitude of the eu budget in the form of external assigned revenue; notes that ngeu , financed through the eu budget is the largest amount the eu has ever proposed to redress its economy after the impact of covid-19 pandemic; expresses its confidence that in crises , innovative instruments like ngeu will be used in order to enable the european union to act and support its member states; invites the commission to propose a more transparent system of governance for the off-budget instruments , that involves both arms of budgetary authority , the european parliament and the council; warns that the risks of fraud and misuse of these funds is significant; calls that the modifications of the financial regulation should reinforce the link between ngeu-funded recovery measures and the eu's objectives and values;


### 4. notes that the number and scope of off-budget instruments have grown significantly in the past decade , and that ngeu has taken this practice to the next level , by greatly , if temporarily , increasing the magnitude of the eu budget in the form of external assigned revenue , and creating liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure; warns that these developments put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality; ### 4. welcomes that ngeu has greatly increased the magnitude of the eu budget allowing the union to face one of its greatest challenges of its existence; notes that it has created liabilities until 2058 through borrowing for lending and borrowing for direct eu expenditure;


### 5. is concerned that these mechanisms pose a serious challenge to the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; strongly believes that eu financial rules must be updated as regards the role of the budgetary authority in relation to these mechanisms , in order to bring them closer to the principles and responsibilities set out in the treaties; ### 5. notes that the number and scope of off-budget instruments have grown significantly in the past decade; believes that off-budget instruments funded by external assigned revenues limit the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions; strongly believes that eu financial rules must be updated as regards the role of the budgetary authority in relation to these mechanisms , in order to bring them closer to the principles and responsibilities set out in the treaties;


### 6. believes that parliament , as one arm of the budgetary authority , should be able to scrutinise and authorise as appropriate the commission’s plans with respect to the management of external assigned revenue and of its borrowing and lending operations; suggests that relevant articles of the financial regulation , including articles 7 , 46 and 56 , be revised to clarify that assets and liabilities linked to borrowing and lending operations are included in the eu budget; ### 6. believes that parliament , as one arm of the budgetary authority , must be able to scrutinise and authorise appropriately the commission’s plans with respect to the management of external assigned revenue and of its borrowing and lending operations; suggests that relevant articles of the financial regulation , including articles 7 , 46 and 56 , be revised to clarify that assets and liabilities linked to borrowing and lending operations are included in the eu budget;


### 8. calls for the revision of reporting requirements on the commission’s debt management strategy , including maturity and schedule of payments , to adapt them to the increased complexity and risk of borrowing and lending operations; ### 8. calls for the revision of reporting requirements on the commission’s debt management strategy , including maturity and schedule of payments and including the role of new own resources in the repayment of the debt , to adapt them to the increased complexity and risk of borrowing and lending operations;


### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments; ### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; underlines that sound financial management is based on the effective pursuit of cases of fraud , including tax fraud , tax evasion , corruption and conflicts of interest , as well as the judicial review of public authorities' decisions by independent courts; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments;


### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments; ### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the article 2 teu and the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision and urges the commission to make this proposal; calls on the commission to examine possibilities to strengthen coherence between all eu instruments that allow the protection of the financial interests of the union , the respect of the eu values and rule of law , including the recommendations from the rule of law reports;


### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen coherence between the two instruments; ### 9. emphasises the clear link between respect for the rule of law and the efficient implementation of the union budget in accordance with the principles of sound financial management: economy , efficiency and effectiveness , as laid down in the financial regulation; recalls that , upon adoption of the conditionality regulation , parliament , the council and the commission agreed to consider including the content of the conditionality regulation into the financial regulation upon its next revision; calls on the commission to examine possibilities to strengthen alignment between the two instruments;


### 10. stresses that it is important to know who benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12 ; considers that the centralisation of the information in a single , interoperable eu database with information on direct and ultimate beneficiaries would overcome the identified fragmentation and lack of transparency; ### 10. stresses that it is important to know who benefits from eu funds in order to protect the financial interests of the eu and to detect fraud , corruption and conflicts of interest in particular; notes that data for identifying economic operators and their beneficial owners is not easily , or not at all , accessible12 ; considers that the centralisation of the information in a single , interoperable eu database with information on direct and ultimate beneficiaries would overcome the identified fragmentation and lack of transparency; notes that digitalisation of the management of eu funds coupled with a comprehensive definition of conflict of interest at the european level will increase the efficiency for the protection of the financial interests of the eu;


### 11. emphasises that the financial regulation should include provisions that require the responsible actors to gather and keep uniform records of economic operators and beneficial owners in order to allow identification across eu programmes , regardless of who implements these programmes and of management mode; considers that these requirements should be balanced to reflect strictly relevant information items; underlines that data may only be published in line with data protection requirements and the standing jurisprudence of the court of justice of the european union; considers that compulsory information items collected for audit and control purposes need to include as a minimum the registration number of legal entities , national identification number for natural persons , an indication of the type of beneficiary , sub-contractors , beneficial owners , whether the beneficiary also receives state aid and contact information; underlines that the system needs to facilitate the aggregation of individual amounts concerning the same direct or ultimate beneficiary; considers that publicly accessible systems should facilitate both individual searches through a web-based tool and systemic analysis through bulk downloads; ### 11. emphasises that the financial regulation should include provisions that require the responsible actors to gather and keep uniform records of economic operators and beneficial owners in order to allow identification across eu programmes , regardless of who implements these programmes and of management mode; considers that these requirements should be balanced to reflect strictly relevant information items; underlines that data may only be published in line with data protection requirements and the standing jurisprudence of the court of justice of the european union; considers that compulsory information items collected for audit and control purposes need to include as a minimum the registration number of legal entities , national identification number for natural persons , an indication of the type of beneficiary , sub-contractors , beneficial owners , whether the beneficiary also receives state aid and contact information; underlines that the system needs to facilitate the aggregation of individual amounts concerning the same direct or ultimate beneficiary and that it needs to be accessible in all eu languages; considers that publicly accessible systems should facilitate both individual searches through a web-based tool and systemic analysis through bulk downloads;


### 12. considers that article 63 of the financial regulation should be modified to include arachne as a compulsory risk scoring tool made available by the commission to member states and other implementing partners; considers that the financial regulation should also indicate which indicators arachne uses to determine the risk score of economic operators; considers that any additional administrative burden , from inserting information multiple times in various it systems , including arachne , must be avoided; ### 12. considers that article 63 of the financial regulation should be modified to include arachne as a compulsory risk scoring tool made available by the commission to member states and other implementing partners; considers that the financial regulation should also indicate which indicators arachne uses to determine the risk score of economic operators; emphasises that arachne enriches data provided by managing authorities with publicly available information in order to identify the projects , beneficiaries , contracts and contractors that might be susceptible not only to risk of fraud but conflicts of interest as well; considers that any additional administrative burden , from inserting information multiple times in various it systems , including arachne , must be avoided;


### 13. calls for the use of the early detection and exclusion system (edes) to be made compulsory under shared management; further notes that edes does not distinguish between subsidiaries of larger corporations; calls on the commission to make this distinction and to specify in the rules for early detection and for exclusion which entity of a multi-national or multi-company corporation is registered for early detection or exclusion; ### 13. calls for the use of the early detection and exclusion system (edes) to be made compulsory under shared management; further notes that edes does not distinguish between subsidiaries of larger corporations; calls on the commission to make this distinction and to specify in the rules for early detection and for exclusion which entity of a multi-national or multi-company corporation is registered for early detection or exclusion; highlights that in 2020 , the edes panel handled 20 cases while 28 cases were in the pipeline; stresses the importance of allocating sufficient resources to the panel in line with any extension of responsibilities;


### 14. insists that gender mainstreaming be better reflected in the drafting and implementation of the budget , including through targeted incentives; calls for the systematic and comprehensive collection of data in the context of all eu policies and programmes in order to measure the impact on gender equality , while avoiding any unnecessary administrative burden; expects the commission to develop a methodology to measure the relevant expenditure at programme level in the mff 2021-2027 , in line with the iia; calls on the commission to integrate gender mainstreaming and gender budgeting in the relevant provisions of the financial regulation; ### 14. regrets that under the previous mff only 21 ,7 % of eu programmes had gender-related indicators; insists that gender mainstreaming be better reflected in the drafting and implementation of the budget , including through targeted incentives; calls for the systematic and comprehensive collection of data in the context of all eu policies and programmes in order to measure the impact on gender equality; expects the commission to develop a methodology to measure the relevant expenditure at programme level in the mff 2021-2027 , in line with the iia; calls on the commission to integrate gender mainstreaming and gender budgeting in the relevant provisions of the financial regulation;


### 14. insists that gender mainstreaming be better reflected in the drafting and implementation of the budget , including through targeted incentives; calls for the systematic and comprehensive collection of data in the context of all eu policies and programmes in order to measure the impact on gender equality , while avoiding any unnecessary administrative burden; expects the commission to develop a methodology to measure the relevant expenditure at programme level in the mff 2021-2027 , in line with the iia; calls on the commission to integrate gender mainstreaming and gender budgeting in the relevant provisions of the financial regulation; ### 14. insists that gender mainstreaming be better reflected in the drafting and implementation of the budget , including through targeted incentives; calls for the systematic and comprehensive collection of gender-disaggregated data in the context of all eu policies and programmes in order to measure the impact on gender equality , while avoiding any unnecessary administrative burden; expects the commission to develop a methodology to measure the relevant expenditure at programme level in the mff 2021-2027 , in line with the iia; calls on the commission to integrate gender mainstreaming and gender budgeting in the relevant provisions of the financial regulation;


### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; ### 16. insists that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up , supervision and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; reiterates that parliament should be involved as observer , and able to monitor the activities of the governing bodies of a trust fund; stresses that timely , regular and figure-based information on the implementation of a trust fund is essential to allow parliament to exercise its democratic oversight and scrutiny role;


### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; ### 16. suggests that the financial regulation be revised to guarantee the appropriate role of parliament in the setting up and scrutiny of any new trust fund , including in the drawing up of the constitutive agreement and the mobilisation of the union’s contribution , the implementation , continuation and possible liquidation; recalls that the effective scrutiny of existing trust funds by the discharge authority requires complete , detailed and timely provision of information through respective reporting frameworks;


### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020; notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; ### 17. notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; believes that such a revised definition should take into account the risk of conflict of interests of a performer that is developing sectoral guidelines it will have to comply with , with particular scrutiny when it comes to policy-related projects and studies;


### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020; notes that the current definition of ‘professional conflict of interest’ is limited to a conflicting interest that affects the capacity of an economic operator to perform a contract; calls on the commission to provide for a more explicit definition and to ensure that its implementation rules on public procurement do not permit the awarding of policy-related service contracts to undertakings that are under the economic control of a parent company or a group that owns shares related to activities that are not in line with the eu’s environmental , social and green deal objectives; ### 17. notes that the commission’s vademecum on public procurement was last updated in january 2020 but has not been made public nor shared with the european parliament for opinion; requests that the parliament should be able to formulate an opinion on future revision of the commission’s vademecum on public procurement; calls on the commission to share regular updates with the parliament’s relevant committees on the revision of its vademecum before it is finalised either through the discharge procedure of the european commission or during dedicated hearings;


### — having regard to articles 4 , 26 , 114 , 169 , 173 , 179 , 180 , 181 and 187 of the treaty on the functioning of the european union (tfeu) , ### — having regard to articles 4 , 16 , 26 , 114 , 169 , 173 , 179 , 180 , 181 and 187 of the treaty on the functioning of the european union (tfeu) ,


### 1. notes that the world stands on the verge of the fourth industrial revolution; points out that in comparison with the three previous waves , initiated by the introduction of steam , electricity , and then computers , the fourth wave draws its energy from an abundance of data combined with powerful algorithms; stresses that today’s digital revolution is shaped by its unprecedented scale , fast convergence , and the enormous impact of emerging technological breakthroughs on states , economies and societies; ### 1. notes that the world stands on the verge of the fourth industrial revolution; points out that in comparison with the three previous waves , initiated by the introduction of steam , electricity , and then computers , the fourth wave draws its energy from an abundance of data combined with powerful algorithms and outstanding computational resources; stresses that today’s digital revolution is shaped by its unprecedented scale , fast convergence , and the enormous impact of emerging technological breakthroughs on states , economies and societies;


### 2. observes that the digital revolution has , at the same time , triggered a global tech race , in which digital sovereignty is seen as a prerequisite for great-power status in both political and economic terms; stresses the growing realisation among decision makers that emerging technologies could lead to a global power shift away from the western world; ### deleted


### 3. points out that europe , which for centuries set international standards , dominated technological progress and led in high-end manufacturing and deployment , has therefore fallen behind in a new ‘winner-takes-most’ or ‘superstar’ economy; underlines the risk of european values being globally replaced , our companies becoming marginalised and our living standards being drastically reduced; ### deleted


### 4. highlights , firstly , that digital tools are increasingly becoming an instrument of manipulation in the hands of authoritarian states and their proxies , used to trigger a clash between political systems; explains that digital espionage , low-scale warfare and disinformation campaigns are deployed in order to pose an existential threat to our democratic societies and question the european way of life; ### deleted


### 4. highlights , firstly , that digital tools are increasingly becoming an instrument of manipulation in the hands of authoritarian states and their proxies , used to trigger a clash between political systems; explains that digital espionage , low-scale warfare and disinformation campaigns are deployed in order to pose an existential threat to our democratic societies and question the european way of life; ### 4. highlights , firstly , that digital tools are increasingly becoming an instrument of manipulation in the hands of authoritarian states and their proxies , as well as in the hands of corporate actors , used to trigger a clash between political systems; explains that digital espionage , low-scale warfare and disinformation campaigns are deployed in order to pose an existential threat to our democratic societies and question the european way of life;


### 5. underlines , secondly , that the eu is failing to commercialise its ground-breaking technological innovations , thereby enabling fast-growing non-european corporations to take our best ideas , talent and companies; points out that , as a result , only eight of today’s top 200 digital companies are domiciled in the eu , while our economic growth is constantly declining; notes that europe’s high wages and the world’s most generous social welfare systems are financially dependent on us competing with the rest of the world; ### deleted


### 6. warns that as a result of these and other existential threats to our democracy and prosperity , the global tech race has become a fight for survival for the eu; stresses that if the eu does not act swiftly and courageously , it will end up becoming a digital colony of china , the us and other states and risk losing its political stability , social security and individual liberties; ### deleted


### 7. argues that artificial intelligence (ai) is the key emerging technology within the fourth industrial revolution; notes that ai is the control centre of the new data layer that surrounds us and which can be thought of as the fifth element after air , earth , water and fire; states that by 2030 , ai is expected to contribute more than eur 11 billion to the global economy , an amount that almost matches china’s gdp in 2020; ### 7. argues that artificial intelligence (ai) is the key emerging technology within the fourth industrial revolution; states that by 2030 , ai's contribution to the global economy has been estimated to amount to eur 2.2 trillion;


### 7. argues that artificial intelligence (ai) is the key emerging technology within the fourth industrial revolution; notes that ai is the control centre of the new data layer that surrounds us and which can be thought of as the fifth element after air , earth , water and fire; states that by 2030 , ai is expected to contribute more than eur 11 billion to the global economy , an amount that almost matches china’s gdp in 2020; ### 7. argues that artificial intelligence (ai) is the key emerging technology within the fourth industrial revolution; states that by 2030 , ai is expected to contribute more than eur 11 billion to the global economy , an amount that almost matches china’s gdp in 2020;


### 8. explains that there is therefore a race for ai leadership within the global tech race; points out that the countries that master ai will gain key advantages; highlights , however , that ai is not a technology with magical powers but rather an efficient tool that we can put to good use; states that the rise of ai likewise does not require us to completely rewrite our laws to counter new kind of threats or to prevent intelligent machines from taking over; believes that although ai is indeed reshaping the world as we know it , the reality is much less dramatic and most developments in the field of ai are positive; ### 8. explains that there is therefore a race for ai leadership within the global tech race; points out that the countries that master ai will gain key advantages; highlights , however , that ai is not a technology with magical powers but rather a tool that we can direct towards good uses; states that the rise of ai likewise does not require us to completely rewrite our laws to counter new kind of threats or to prevent intelligent machines from taking over; believes that the reality is much less dramatic and most developments in the field of ai are positive; stresses that certain uses of ai may pose individual and societal risks that can endanger fundamental rights and therefore should be addressed by policymakers;


### 8. explains that there is therefore a race for ai leadership within the global tech race; points out that the countries that master ai will gain key advantages; highlights , however , that ai is not a technology with magical powers but rather an efficient tool that we can put to good use; states that the rise of ai likewise does not require us to completely rewrite our laws to counter new kind of threats or to prevent intelligent machines from taking over; believes that although ai is indeed reshaping the world as we know it , the reality is much less dramatic and most developments in the field of ai are positive; ### 8. highlights that ai is not a technology with magical powers but rather an efficient tool that we can put to good use; believes that although ai is indeed reshaping the world as we know it , the reality is much less dramatic and most developments in the field of ai are positive; stresses that the union should aim to pursue global leadership in human-centric ai , anchored in human rights and guided by ethical guidelines , allowing ai to effectively become an instrument that serves peoples and society , pursuing the common good and the general interest; recalls that the union has declared its intention to be pioneering a regulatory framework on ai , the first of its kind in the world;


### 8. explains that there is therefore a race for ai leadership within the global tech race; points out that the countries that master ai will gain key advantages; highlights , however , that ai is not a technology with magical powers but rather an efficient tool that we can put to good use; states that the rise of ai likewise does not require us to completely rewrite our laws to counter new kind of threats or to prevent intelligent machines from taking over; believes that although ai is indeed reshaping the world as we know it , the reality is much less dramatic and most developments in the field of ai are positive; ### 8. explains , that europe should pursue its aim for global leadership in human-centric ai; highlights , however , that ai is not a technology with magical powers but rather an efficient tool that we can put to good use; states that the rise of ai likewise does not require us to completely rewrite our laws to counter new kind of threats or to prevent intelligent machines from taking over; believes that although ai is indeed reshaping the world as we know it , the reality is much less dramatic and most developments in the field of ai are positive;