### 6. recalls that , in 2020 , the eea provided assessments and briefings on topics such as biowaste management and treatment , biodegradable plastics , the emerging challenges of waste management in europe , and how europe will be affected by key climate hazards such as droughts , floods , forest fires and sea level rise during the 21st century and beyond; ### 6. recalls that , in 2020 , the eea provided the state of the environment report 20201a , alongside assessments and briefings on topics such as biowaste management and treatment , biodegradable plastics , the emerging challenges of waste management in europe , and how europe will be affected by key climate hazards such as droughts , floods , forest fires and sea level rise during the 21st century and beyond;


### (2) the unprecedented experience of the covid-19 pandemic has demonstrated that the union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states. ### (2) the unprecedented experience of the covid-19 pandemic has shown the difficulties of member states to cope with a cross-border or global health emergency , and has therefore demonstrated the need to strengthen the competences of the union in order to be more effective , efficient and expeditious in managing the availability of medicinal products and medical devices , in asserting supply chains of medicinal products and medical devices , and in developing medical countermeasures to address the threats posed to public health. the unprecedented experience of the covid-19 pandemic has also underlined the risks to human health posed by zoonotic spill-overs triggered by global biodiversity loss and wildlife over-exploitation. the union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic , and also by the limited degree of union preparedness in case of a public health emergency impacting a majority of member states.


### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s ability to rapidly and effectively react to such challenges during public health crises. ### (5) the covid-19 pandemic has exacerbated the problem of shortages for certain medicinal products , devices and services considered as critical in addressing the pandemic , and has highlighted the structural limitations in the union’s ability to rapidly , efficiently and effectively react to such challenges during public health crises


### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. ### (6) the rapid evolution of covid-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators , surgical masks , and covid-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices , led to a negative impact on supply. those issues resulted in new entities being involved in the production of those products , which subsequently resulted in bottlenecks in conformity assessment , as well as the prevalence of non-compliant , unsafe , and in some cases counterfeit products. it is therefore appropriate to establish long-term structures within an appropriate union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. these structures should , among other obligations , assess supply chain resilience and reliance.


### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. ### (9) during the covid-19 pandemic ad hoc solutions , including contingent arrangements between the commission , the european medicines agency (‘the agency’) , marketing authorisation holders , manufacturers and member states , had to be found to achieve the objective of making available safe and efficacious medicinal products to treat covid-19 or prevent its spread , and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. these ad-hoc solutions should be taken into account as well as all the lessons learned during the pandemic in order to better use the agency’s potential to face future outbreaks.


### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises. ### (10) in order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection , it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices , and to facilitate the research and development of medicinal products , which may have the potential to treat , prevent , or diagnose diseases that cause public health crises. the union's actions should be consistent with the who’s one health approach , as well as with the health in all policies principle , recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.


### (11) this regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices , with a high level of human health protection being fundamental in those aims. moreover , this regulation aims to ensure the quality , safety and efficacy of medicinal products with the potential to address public health emergencies. both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. as regards article 114 tfeu , this regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. as regards article 168(4)(c) tfeu , this regulation provides for a strengthened union framework ensuring the quality and safety of medicinal products and medical devices. ### (11) this regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices , as well as a high level of human health protection being fundamental in those aims. moreover , this regulation aims to ensure the quality , safety and efficacy of medicinal products with the potential to address public health emergencies. both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. as regards article 114 tfeu , this regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. as regards article 168(4)(c) tfeu , this regulation provides for a strengthened union framework ensuring the quality and safety of medicinal products and medical devices.


### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic. ### (12) in order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the union , the procedures and the respective roles and obligations of different concerned entities involved should be clarified. the framework should build on the ad hoc solutions identified so far in the response to the covid-19 pandemic that have proven effective and operative and that can provide foundational protocols on which to build upon.


### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask and obtain information and data from the concerned marketing authorisation holders , manufacturers and member states through designated points of contact. ### (13) a harmonised system of monitoring of shortages of medicinal products and medical devices should be established , which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and access to critical medicinal products , devices and applications in major events , which may have a serious impact on public health. that system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research , innovation and development of medicinal products which may have the potential to address public health emergencies. in order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices , the agency should be able to ask demand and obtain information and data from the concerned marketing authorisation holders , manufacturers and member states through designated points of contact. should any of the aforementioned stakeholders not give information to the agency in the time lapse established by the agency , the commission should assist the agency in obtaining such information , with the prospect of an eventual sanction , which should also be duly made available to the public.


### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection. ### (15) with respect to medicinal products , an executive steering group should be established within the agency to ensure a robust response to major events and to coordinate urgent actions within the union in relation to the management of issues relating to the supply of medicinal products. the steering group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality , safety , and efficacy of medicinal products and ensure a high level of human health protection. the world health organization model list of essential medicines for adults and for children is the best base for the identification of critical medicinal products at union level.


### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products. ### (17) in order to ensure that safe , high quality , and efficacious medicinal products , which have the potential to address public health emergencies , can be developed and made available within the union as soon as possible during public health emergencies , an emergency task force should be established within the agency to provide advice on such medicinal products. the emergency task force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols , to those organisations involved in their development , such as marketing authorisation holders , clinical trial sponsors , public health bodies , and academia , irrespective of their exact role in the development of such medicinal products. the lessons learned during the covid pandemic should be taken into account in order to better use the agency’s potential to face future health crises.


### (18) the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees. the emergency task force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation. ### (18) the work of the emergency task force should be separate from the work of the scientific committees of the agency and should be carried out without prejudice to the scientific assessments of those committees , although communication between these two bodies should be guaranteed. the emergency task force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. the committee for medicinal products for human use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.


### (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 in the case of a public health emergency. the executive steering group on medical devices should be managed by the commission and the agency.


### 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. each member state shall appoint their representative. those member states with devolved competences in health may appoint a representative from a regional competent authority who will represent the whole member state. members may be accompanied by experts in specific scientific or technical fields. the steering group shall also include a representative of the patients’ and consumers’ working party as well as a representative of the healthcare professionals’ working party as observers.


### 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 national , and where applicable regional , competent authorities for medicinal products established in accordance with article 9(1).


### 1. the agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency. ### 1. the agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the national and regional competent authorities.


### 2. to facilitate the monitoring task referred to in paragraph 1 , the national competent authorities , through the single points of contact referred to in article 3(5) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report to the agency on any event , including a shortage of a medicinal product in a given member state , that is likely to lead to a major event or a public health emergency. where a national competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national competent authorities , through the working party referred to in article 3(5). ### 2. to facilitate the monitoring task referred to in paragraph 1 , the national , and where applicable regional , competent authorities , through the single points of contact referred to in article 3(5) or the digital interoperable database referred to in article 1(b) and article 12(g) , shall , based on the reporting criteria specified by the agency pursuant to article 9(1)(b) , report to the agency on any event , including a shortage of a medicinal product in a given member state , that is likely to lead to a major event or a public health emergency. where a national , and where applicable regional , competent authority informs the agency of a shortage of a medicinal product in a given member state , it shall provide the agency with any information received from the marketing authorisation holder pursuant to article 23a of directive 2001/83/ec. based on a report of an event from a national or regional competent authority and in order to understand the impact of the event in other member states , the agency may request information from the national and where applicable regional , competent authorities , through the working party referred to in article 3(5).


### 3. where the agency considers that an actual or imminent major event needs to be addressed , it shall inform the commission and the member states thereof. the commission , on its own initiative or following a request from one or more member states , or the executive director of the agency may request the assistance of the medicines steering group to address the major event. ### 3. where the agency considers that an actual or imminent major event needs to be addressed , it shall inform the commission and the member states thereof. the commission , or the executive director of the agency shall request the assistance of the medicines steering group to address the major event.


### 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 production , manufacturing , safety , quality , distribution and efficacy of medicinal products , devices and applications article 5 shall apply;


### evaluation of information and the provision of advice on action in relation to the safety , quality , and efficacy of medicinal products related to public health emergencies and major events ### evaluation of information and the provision of advice on action in relation to the production , manufacturing , safety , quality , distribution and efficacy of medicinal products , devices and applications related to public health emergencies and major events


### 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 production , manufacturing , safety , quality , distribution and efficacy of medicinal products , devices and applications concerned.


### 2. immediately following the recognition of a public health emergency and after consultation of its working party , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). the list shall be updated whenever necessary until the termination of the recognition of the public health emergency. ### 2. immediately following the recognition of a public health emergency and after consultation of its working party , the medicines steering group shall adopt a list of medicinal products authorised in accordance with directive 2001/83/ec or regulation (ec) no 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). the world health organization model list of essential medicines for adults and for children shall be used as the base for its identification of critical medicinal products at union level. the agency shall make the public health emergency critical medicines list within 12 months after the entry into force of this regulation. the list shall be updated whenever necessary until the termination of the recognition of the public health emergency as well as with the commission and the european centre for disease prevention and control.


### 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 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. the medicines steering group shall provide the aggregated data and demand forecasts from the digital interoperable platform referred to in article1(b) and article 12(g).


### 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 , and where applicable regional , 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.


### specify the procedures for establishing the critical medicines lists; ### specify the procedures for establishing the critical medicines lists , ensuring adequate consultation with consumers , patients and healthcare professionals and a high level of transparency;


### establish and maintain membership of the working party referred to in article 3(5) comprised of single points of contacts from national competent authorities for medicinal products; ### establish and maintain membership of the working party referred to in article 3(5) comprised of single points of contacts from national , and where applicable regional , competent authorities for medicinal products;


### request information from the single points of contact from member states’ national competent authorities based on the set of information agreed on by the medicines steering group and set a deadline for its submission. ### request information from the single points of contact from member states’ national , and where applicable regional , competent authorities based on the set of information agreed on by the medicines steering group and set a deadline for its submission.


### mitigation plans including production and supply capacity; ### mitigation plans containing preventative measures that help ensure the continued supply of critical medicines , such as diversification of supply chains , as well as including production and supply capacity;


### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists are in possession of any additional information , which provides evidence of a potential or actual shortage they shall immediately provide such information to the agency. ### 5. where marketing authorisation holders for medicinal products included on the critical medicines lists are in possession of any additional information , which provides evidence of a potential or actual shortage they shall immediately provide such information to the agency. national , or where applicable regional , competent authorities shall facilitate patient and consumer reporting of medicine shortages through the digital interoperable database referred to in article 1(b) and article 12(g). aggregated data from these reports shall be shared by the sub-network of single points of contact from national , or where applicable regional , competent authorities referred to in article 3(5) with the steering group to inform recommendations on medicine shortage management.


### the agency shall , via its web-portal and other appropriate means , in conjunction with national competent authorities , inform the public and interest groups with regard to the work of the medicines steering group. ### the agency shall , via its web-portal and other appropriate means , in conjunction with national , or where applicable regional , competent authorities , inform the public and interest groups with regard to the work of the medicines steering group , ensuring the sharing of information by the patients’ and consumers’ working party as well as a representative of the healthcare professionals’ working party as observers. the agency shall assess the transparency of the undertakings of the medicines steering group , taking into account principles of transparency and accountability.


### 1. during a public health emergency , the emergency task force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process. ### 1. during a public health emergency , the emergency task force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process , taking into account possible innovative medicinal products , devices , applications or developments that are still not harmonised throughout the union , such as plasma-derived products.


### 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. each member state shall appoint their representative. members may be accompanied by experts in specific scientific or technical fields. the steering group shall also include a representative of the patients’ and consumers’ working party as well as a representative of the healthcare professionals’ working party as observers. the agency shall assess the transparency of the undertakings of the executive steering group on medical devices , taking into account principles of transparency and accountability.


### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings. ### 3. the medical devices steering group shall be chaired by the agency. the chair may invite third parties , including representatives of medical device interest groups to attend its meetings ensuring the sharing of information by the patients’ and consumers’ working party as well as a representative of the healthcare professionals’ working party as observers.


### 5. the medical devices steering group shall be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with article 23(1). ### 5. the medical devices steering group shall be supported in its work by a working party comprised of single points of contact from national , and where applicable regional , competent authorities for medical devices established in accordance with article 23(1).


### 5. the medical devices steering group may , upon request from the commission coordinate measures , where relevant , between the national competent authorities , manufacturers of medical devices , notified bodies , and other entities to prevent or mitigate potential or actual shortages in the context of a public health emergency. ### 5. the medical devices steering group may , upon request from the commission coordinate measures , where relevant , between the national , and where applicable regional , competent authorities , manufacturers of medical devices , notified bodies , and other entities to prevent or mitigate potential or actual shortages in the context of a public health emergency.


### specify the procedures for establishing the public health emergency critical devices list; ### specify the procedures for establishing the public health emergency critical devices list , ensuring adequate consultation with consumers , patients and healthcare professionals and a high level of transparency;


### establish and maintain membership of the working party referred to in article 19(5) comprised of single points of contact from member states’ national competent authorities for medical devices; ### establish and maintain membership of the working party referred to in article 19(5) comprised of single points of contact from member states’ national , and where applicable regional , competent authorities for medical devices;


### request information from the single points of contact from member states’ national competent authorities based on the set of information agreed on by the medical devices steering group and set a deadline for its submission. ### request information from the single points of contact from member states’ national , and where applicable regional , competent authorities based on the set of information agreed on by the medical devices steering group and set a deadline for its submission.


### mitigation plans including production and supply capacity; ### mitigation plans , containing preventative measures to ensure the continued supply of critical medical devices as well as including production and supply capacity;


### (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 potential 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’.


### 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 , in line with the goals of the paris agreement; whereas methane emissions also contribute to air pollution and it is therefore necessary to tackle these emissions in order to protect the health of eu citizens;


### 4. stresses the importance of developing an inventory of best practices and available technologies to promote the wider uptake of innovative mitigating actions; ### 4. stresses the importance of developing an inventory of best practices and available technologies to promote the wider uptake of innovative mitigating actions and abatement options;


### 6. recognises the importance of voluntary industry initiatives aimed at reducing methane emissions and considers that any regulatory initiatives should build upon best practices from existing voluntary actions and must be duly preceded by thorough impact assessments; ### 6. recognises the importance of voluntary industry initiatives aimed at reducing methane emissions and considers that any regulatory initiatives should build upon best practices from existing actions and must be duly preceded by thorough impact assessments;


### 10. calls on the commission to support the establishment of an independent international methane emissions observatory , in partnership with the united nations environmental programme , the climate and clean air coalition and the international energy agency , tasked with collecting , reconciling , verifying and publishing anthropogenic methane emissions data at a global level; ### 10. calls on the commission to support the establishment of an independent international methane emissions observatory , in partnership with the united nations environmental programme , the intergovernmental panel on climate change , the climate and clean air coalition and the international energy agency , tasked with collecting , reconciling , verifying and publishing anthropogenic methane emissions data at a global level;


### 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 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 and duly financed by eu programs and tools;


### — having regard to the treaty on the functioning of the european union , and in particular article 191 thereof , ### — having regard to the treaty on the functioning of the european union , and in particular articles 2 and 191 thereof ,


### 68. denounces in the strongest terms the alleged attempts by qatar to influence members , former members and staff of the european parliament through acts of corruption , which constitute serious foreign interference in the eu’s democratic processes; underlines the need to step up efforts aimed at combating corruption and influence campaigns; reiterates its call for updated transparency rules , mapping foreign funding for eu-related lobbying , including funding for non-profit organisations and proper regulation and monitoring of friendship groups; ### 68. denounces in the strongest terms the alleged attempts by qatar among other countries , including morocco , to influence members , former members and staff of the european parliament through acts of corruption , which constitute serious foreign interference in the eu’s democratic processes; underlines the need to firmly tackle every form of corruption , including by imposing sufficiently effective and dissuasive sanctions against those responsible for corrupt acts and influence campaigns; decides to set up specific courses for parliament's members and officials to raise awareness about the modus operandi with regard to foreign interference , including grooming strategies and possible 'honey traps'; reiterates its call for updated transparency rules , mapping foreign funding for eu-related lobbying , including funding for non-profit organisations; stresses the urgent need to review the functioning of friendship groups , regulating them and properly monitoring their work , clearly identifying when their action overlaps with that of official bodies and when their existence is justified by exceptional circumstances in which cooperation would not otherwise be possible; calls , further , for the parliamentary delegations , their role and the scope of their action to be streamlined urgently , and takes the view that the scope of their action should always be in the utmost coherence with the other parliamentary bodies responsible for setting the european union's external action;


### 26. considers that equipping the means of transport with a cctv system , with a particular focus on the loading and unloading operations , should be promoted for the sake of animal welfare protection and in order to safeguard operators who comply with the rules; stresses that data protection and privacy rights must be ensured by the competent authorities throughout the entire process; ### 26. considers that equipping the means of transport with a control system should be promoted for the sake of animal welfare protection and in order to safeguard operators who comply with the rules throughout the journey; stresses that protection of data collected solely for the purposes of animal control and monitoring and privacy rights must be ensured by the competent authorities throughout the entire process , in particular by excluding audio and video content in the transporter’s cabin;


### 34. is aware that , despite the high level of non-compliance during animal transport , reporting of infringements between the member states is poor and that effective and dissuasive sanctions against those who violate the regulation are lacking; ### 34. is aware that reporting of infringements between the member states is poor and that effective and dissuasive sanctions against those who violate the regulation are lacking;


### 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 , 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; is of the opinion that these developments may put at risk central budgetary principles such as unity and budgetary accuracy , equilibrium and universality;


### 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. is concerned that these mechanisms pose a challenge to the ability of the parliament to fulfil its decision-making , scrutiny and discharge functions;


### 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 , should be informed in due time about the commission’s plans with respect to the management of external assigned revenue and of its borrowing and lending operations;


### 7. believes that external assigned revenue pursuant to article 21 of the financial regulation , and assets and liabilities deriving from off-budget operations , including borrowing on capital markets , should be allocated to the relevant budget lines in line with article 8 of the financial regulation and classified in accordance with the budget nomenclature; suggests that they should form an integral part of the eu budget and be adopted by the budgetary authority as part of that budget; ### deleted


### 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. recommends 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;


### rule of law ### deleted


### 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; ### deleted


### 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 aggregation 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;


### 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 equality between men and women 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 equality between men and women , 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 consider the integration of gender mainstreaming and gender budgeting in the relevant provisions of the financial regulation;


### — 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;


### 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 can serve as 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;


### 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


### 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; ### 6. warns that as a result of these and other threats to our democracy and prosperity , the global tech race has become a priority; 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;


### 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;


### 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; notes that ai is the key tool for managing , modelling and interpreting large-scale data nationally and globally; 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 competition for ai leadership within the global tech race; points out that the countries that invest in ai will gain key advantages;


### 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;


### 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. observes that the implications of ai are such that there is a competition for ai leadership within the global tech race; points out that the countries with sufficient ai capabilities will gain key advantages; highlights , however , that ai is not an omnipotent technology but rather an efficient tool that should be put to good use for the benefit of society; states that the rise of ai likewise does not require us to completely rewrite all our laws but requires an update of relevant legislation; believes that although ai is indeed reshaping the world as we know it , many developments in the field of ai are positive;


### 9. explains that ai is actually an umbrella term that covers a wide range of old and new technologies that often have little more in common than being guided by a given set of human-defined objectives and having some degree of autonomy in their actions; notes that while some of these technologies are already in widespread use , others are still under development or are even just speculative concepts that may or may not exist in the future; ### 9. explains that the term "ai" is actually an umbrella term that covers a wide range of old and new techniques and approaches better understood as "artificial intelligence systems" that refer to any machine-based system that can , for a given set of human-defined objectives , make predictions , recommendations , or decisions influencing real or virtual environments. ai systems are designed to operate with varying levels of autonomy9a; notes that while some of these technologies are already in widespread use , others are still under development or are even just speculative concepts that may or may not exist in the future;


### 9. explains that ai is actually an umbrella term that covers a wide range of old and new technologies that often have little more in common than being guided by a given set of human-defined objectives and having some degree of autonomy in their actions; notes that while some of these technologies are already in widespread use , others are still under development or are even just speculative concepts that may or may not exist in the future; ### 9. points out that ai is actually an umbrella term that covers a wide range of old and new technologies that often have little more in common than being guided by a given set of human-defined objectives and having some degree of autonomy in their actions; notes that while some of these technologies are already in widespread use , others are still under development or are even just speculative concepts that may or may not exist in the future;


### 11. notes that in the second wave , the automated learning processes of algorithms based on the processing of large amounts of high-quality data , the ability to bring together inputs from multiple radars , lidars and cameras to form a single image of the environment , and the identification of patterns made ai systems more complex , autonomous and opaque; stresses that current ai can therefore be broken down into many different sub-domains and techniques , whereby deep learning is for instance a subfield of machine learning , which itself is a subfield of ai; ### 11. notes that in the second wave , the automated learning processes of algorithms based on the processing of large amounts of high-quality data , the ability to bring together inputs from multiple radars , lidars and cameras to form a single image of the environment , and the identification of patterns made ai systems more complex , autonomous and opaque , which leads to less explainable outcomes; stresses that current ai can therefore be broken down into many different sub-domains and techniques , whereby deep learning is for instance a subfield of machine learning , which itself is a subfield of ai;


### 12. notes that although today’s ai has become much more powerful than symbolic ai , it can still only solve tasks in domain-specific niches such as chess or facial recognition and does not understand the actions it performs; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still not more than a tool that provides recommendations and predictions; explains that self-driving cars operate , for instance , through a combination of various one-task ai systems that together are able to provide a three-dimensional map of the surroundings of the vehicle so that its operating system can make the appropriate decisions; ### 12. notes that although today’s ai has become much more powerful than symbolic ai , thanks to the significant increases in computing capacities , it can still only solve clearly defined tasks in domain-specific niches such as chess or image recognition , does not understand the actions it performs nor context and can therefore make mistakes , for example identifying patterns in spurious correlations; adds that ai should not be anthropomorphised with misleading metaphors; notes that ai is not capable of feeling emotions nor having a conscience , nor can it communicate with other “narrow” ai applications; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still only a tool that provides recommendations and predictions;


### 12. notes that although today’s ai has become much more powerful than symbolic ai , it can still only solve tasks in domain-specific niches such as chess or facial recognition and does not understand the actions it performs; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still not more than a tool that provides recommendations and predictions; explains that self-driving cars operate , for instance , through a combination of various one-task ai systems that together are able to provide a three-dimensional map of the surroundings of the vehicle so that its operating system can make the appropriate decisions; ### 12. notes that although today’s ai has become much more powerful than symbolic ai , it can still only solve tasks in domain-specific niches such as chess or facial recognition and its programming is not designed to fully recognise the actions that the ai system performs; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still not more than a tool that provides recommendations and predictions; explains that self-driving cars operate , for instance , through a combination of various one-task ai systems that together are able to provide a three-dimensional map of the surroundings of the vehicle so that its operating system can make the appropriate decisions;


### 12. notes that although today’s ai has become much more powerful than symbolic ai , it can still only solve tasks in domain-specific niches such as chess or facial recognition and does not understand the actions it performs; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still not more than a tool that provides recommendations and predictions; explains that self-driving cars operate , for instance , through a combination of various one-task ai systems that together are able to provide a three-dimensional map of the surroundings of the vehicle so that its operating system can make the appropriate decisions; ### 12. notes that although today’s ai is based on data processing and has become much more effective than symbolic ai , it can still only solve tasks in domain-specific niches such as chess or facial recognition and does not understand the actions it performs; points out that it is therefore referred to as ‘narrow’ or ‘weak’ ai and is still not more than a tool that provides recommendations and predictions; explains that self-driving cars will operate , for instance , through a combination of various one-task ai systems that together are able to provide a three-dimensional map of the surroundings of the vehicle so that it can make the appropriate decisions;


### 13. highlights that many fears linked to ai are based on hypothetical concepts such as general ai , artificial superintelligence and singularity which could , in theory , lead to a power shift from humans to ai and create machines that could even break free from human control; stresses , however , that there are significant doubts as to whether this speculative ai can even be achieved with our technologies and scientific laws; ### 13. underlines that although the possibility of a general artificial intelligence is remote for the foreseeable future , ai-based decision-making can present risks that need to be seriously addressed by legislators; points out that several ai experts believe that marginal improvements to current machine learning systems may be able to supersede the human intellectual capacities in a wide range of tasks if given more data and computing power;


### 14. underlines that , on the contrary , the vast majority of ai systems currently in use , are almost or even completely risk-free; refers , for instance , to automatic translations , ‘eureka machines’ , gaming machines and robots that execute repetitive manufacturing processes; concludes that only a very small number of use cases can be categorised as risky and that only such cases require regulatory action and effective safeguards; ### 14. underlines that , on the contrary , the majority of ai systems currently in use , is low-risk; refers , for instance , to automatic translations , video games and robots that execute repetitive manufacturing processes;


### 14. underlines that , on the contrary , the vast majority of ai systems currently in use , are almost or even completely risk-free; refers , for instance , to automatic translations , ‘eureka machines’ , gaming machines and robots that execute repetitive manufacturing processes; concludes that only a very small number of use cases can be categorised as risky and that only such cases require regulatory action and effective safeguards; ### 14. underlines that , on the contrary , the vast majority of ai systems currently in use , are almost or even completely risk-free; refers , for instance , to automatic translations , ‘eureka machines’ , gaming machines and robots that execute repetitive manufacturing processes;


### 15. considers that the public debate should therefore be more focused on the enormous potential of ai; believes that ai offers humankind the unique chance to improve almost every area of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to enhancing quality of life through personalised medicine , fitness programmes and assisted living; ### 15. considers that the public debate should therefore be more focused on the enormous potential of ai; believes that ai offers humankind the unique chance to improve almost every area of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to enhancing quality of life through personalised medicine , fitness programmes and assisted living; is of the opinion that the public debate should continue focusing on the development of trustworthy ai based on fundamental european values and the principle that ai and robotics should be developed to complement humans and prioritise and promote sustainable human-centred development; highlights that the agreed ai ethical principles and requirements should be operationalised in all domains of ai application15a;


### 15. considers that the public debate should therefore be more focused on the enormous potential of ai; believes that ai offers humankind the unique chance to improve almost every area of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to enhancing quality of life through personalised medicine , fitness programmes and assisted living; ### 15. believes that ai offers humankind the unique chance to improve a significant number of areas of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to enhancing quality of life through personalised medicine , fitness programmes and assisted living; stresses that in most of those areas , ai should be seen as an auxiliary tool for users and professionals , augmenting the capabilities of humans without impeding their ability to freely act and decide;


### 15. considers that the public debate should therefore be more focused on the enormous potential of ai; believes that ai offers humankind the unique chance to improve almost every area of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to enhancing quality of life through personalised medicine , fitness programmes and assisted living; ### 15. considers at the same time that ai holds enormous potential , as it offers countless opportunities to improve many areas of our lives , from combating global societal challenges such as climate change , pandemics and starvation , to contributing to the sdgs , to enhancing quality of life through personalised medicine and assisted living;


### 16. explains that the present report addresses six ai case studies in detail , outlining the opportunities offered by ai in the respective sector , the risks to be addressed and the obstacles currently preventing us from fully harnessing the benefits of ai; highlights that the case studies represent some of the most important ai use cases and , at the same time , reflect the main topics of the public hearings held by the aida committee during its mandate , namely health , the green deal , external policy and security , competitiveness , the future of democracy and the labour market; ### 16. illustrates that the present report addresses six ai case studies in detail , outlining the opportunities offered by ai in the respective sector , the risks to be addressed and the obstacles currently preventing from fully harnessing the benefits of ai; highlights that the case studies represent some of the currently most important ai use cases and , at the same time , reflect some of the main topics of the public hearings held by the aida committee during its mandate , namely health , the green deal , external policy and security , competitiveness , the future of democracy and the labour market;


### 17. stresses that ai can unlock solutions in the health sector that could save millions of lives , improve our standards of living and bring a competitive edge to the european ict sector; ### 17. stresses that ai can unlock solutions in the health sector that could save millions of lives , improve our standards of living and bring a competitive edge to the european ict sector; highlights in this respect the potential of ai-based solutions in reinforcing the resilience and sustainability of eu’s healthcare systems , while offering innovative therapies and better diagnosis using real-world data;


### 17. stresses that ai can unlock solutions in the health sector that could save millions of lives , improve our standards of living and bring a competitive edge to the european ict sector; ### 17. stresses that ai can unlock solutions in the health sector that could enormously speed up scientific research , save millions of lives and improve our quality of life , if the inherent risks are appropriately managed;


### 17. stresses that ai can unlock solutions in the health sector that could save millions of lives , improve our standards of living and bring a competitive edge to the european ict sector; ### 17. stresses that ai can unlock solutions in the health sector that could save millions of life-years and improve quality of life , while at the same time bringing a competitive edge to the european ict sector;


### 17. stresses that ai can unlock solutions in the health sector that could save millions of lives , improve our standards of living and bring a competitive edge to the european ict sector; ### 17. stresses that ai could unlock solutions in the health sector that could save human lives , improve our standards of living and bring a competitive edge to the european ict sector;


### 18. underlines that ai is already being used to detect diseases and abnormalities at an early stage and more accurately through real-time pattern recognition and image processing , thus speeding up diagnosis and treatment and reducing unnecessary biopsies; ### 18. underlines that ai is already being used to detect diseases and abnormalities at an early stage and more accurately through real-time pattern recognition and image processing , thus speeding up diagnosis and treatment and reducing unnecessary invasive exams; notes , moreover , that ai can enhance personalised medicine and patient care , speed up delivery of care , and help manage population’s health proactively , by empowering citizens and promoting healthy habits and healthier choices;


### 18. underlines that ai is already being used to detect diseases and abnormalities at an early stage and more accurately through real-time pattern recognition and image processing , thus speeding up diagnosis and treatment and reducing unnecessary biopsies; ### 18. underlines that ai already helps medical personnel to detect diseases and abnormalities at an early stage and more accurately through real-time pattern recognition and image processing , thus speeding up diagnosis and treatment and reducing unnecessary biopsies;


### 18. underlines that ai is already being used to detect diseases and abnormalities at an early stage and more accurately through real-time pattern recognition and image processing , thus speeding up diagnosis and treatment and reducing unnecessary biopsies; ### 18. underlines that ai is already being experimented with in clinical settings with the aim of preventing and detecting diseases at an early stage and more accurately through , for example , real-time pattern recognition and image processing;


### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care; ### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care; underlines in this respect the importance of ensuring interoperability of hpc with ai as major economic sectors relying on hpc include manufacturing , health and pharmaceuticals;


### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care; ### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care on the condition that all ethical requirements concerning privacy , data protection and informed consent are met;


### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care; ### 19. highlights that ai could hold the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process , but the results so far have proven its limits; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care;


### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help predict the outcome of and responses to treatments with increasing levels of accuracy when based on high-quality data , thus increasing the effectiveness of preventive care; ### 19. highlights that ai has the potential to speed up the development of new drugs , treatments and vaccines , and at a lower cost , while improving the quality and overall safety of the production process; finds that ai can help adjust therapeutic strategies according to individual genetic , physiological and social characteristics , if based on high-quality data and sound assumptions;


### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; ### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to anonymised datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; highlights that citizens from all the member states should be able to share their health data with healthcare providers and authorities of their choice; notes that ai must have an assistive role in healthcare , and that professional human oversight should be maintained;


### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; ### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; underlines in this regard the need to create incentives for up-skilling , re-skilling and out-skilling of workers for health care careers;


### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; ### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to relevant , updated and high-quality datasets , in line with the eu rules on personal data protection , increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support;


### 20. underlines that ai has the potential to tailor treatments and drug development to specific patient needs and enhance engagement with stakeholders and participants in the healthcare system; finds that ai and access to datasets increase the potential for healthcare professionals to better understand the patterns and symptoms of their patients and therefore provide better feedback , guidance and support; ### 20. finds that ai and access to good quality , representative datasets increase the potential for health professionals to better understand and care for their patients and therefore provide better feedback , guidance and support; highlights that this may be particularly helpful in selecting and reviewing the increasing amounts of scientific knowledge to extract relevant insights for health professionals;


### 21. finds that the fight against covid-19 has both accelerated research into and the deployment of new technologies , notably ai applications , in the quest for improved case detection , and heightened the need for industry and publicly funded research to be able to deploy ai to strengthen the monitoring and modelling of the spread of future pandemics , without excessive limitations on freedom of movement , the infringement of data protection principles or the risk of establishing excessive surveillance regimes; ### deleted


### 21. finds that the fight against covid-19 has both accelerated research into and the deployment of new technologies , notably ai applications , in the quest for improved case detection , and heightened the need for industry and publicly funded research to be able to deploy ai to strengthen the monitoring and modelling of the spread of future pandemics , without excessive limitations on freedom of movement , the infringement of data protection principles or the risk of establishing excessive surveillance regimes; ### 21. finds that the fight against covid-19 has both accelerated research into and the deployment of new technologies , notably ai applications , in the quest for improved case detection , and heightened the need for industry and publicly funded research to be able to deploy ai to strengthen the monitoring and modelling of the spread of future pandemics , without excessive limitations on freedom of movement , the infringement of data protection principles or the risk of establishing excessive surveillance regimes; notes , however , that the experience with the ai applications covid-19 has revealed some of the limitations of the use of ai in medical diagnostics;19b and calls for the ai tools to be used as a support , not as a replacement for human clinical decision making;


### 21. finds that the fight against covid-19 has both accelerated research into and the deployment of new technologies , notably ai applications , in the quest for improved case detection , and heightened the need for industry and publicly funded research to be able to deploy ai to strengthen the monitoring and modelling of the spread of future pandemics , without excessive limitations on freedom of movement , the infringement of data protection principles or the risk of establishing excessive surveillance regimes; ### 21. finds that the fight against covid-19 has both accelerated research into new technologies , notably ai applications , in the quest for improved clinical care and therapeutics research , and highlighted the usefulness of ai to strengthen the monitoring and modelling of the spread of future infectious disease outbreaks , without excessive limitations on freedom of movement , the infringement of data protection principles or the risk of establishing excessive surveillance regimes;


### 22. highlights the potential of ai systems to relieve healthcare systems , and especially medical staff , by supporting routine tasks such as patient transport and reminding patients of their medication , and to remedy challenges posed by rapidly ageing populations; ### 22. highlights the potential of ai systems to relieve healthcare systems , and especially medical staff from the inevitable pressure coming from increasingly ageing populations as well as protect them from dangerous diseases , by supporting routine tasks such as disinfection of facilities , patient transport or by assisting doctors in high-precision diagnostic exams and complex surgeries;


### 22. highlights the potential of ai systems to relieve healthcare systems , and especially medical staff , by supporting routine tasks such as patient transport and reminding patients of their medication , and to remedy challenges posed by rapidly ageing populations; ### 22. highlights the potential of ai systems to relieve health systems , and health professionals , by supporting routine tasks such as patient transportation and monitoring , clinical notetaking , and reminding patients of their medication , as well as by shifting care to maintaining health and preventing disease;


### 23. stresses that consumer health applications based on ai can help to track an individual’s health status , yield data which can apply to early triage questions and encourage healthy behaviour , thus reducing the need to seek advice from a healthcare professional; ### 23. stresses that consumer health applications based on ai can help track an individual’s health status , yield data which can apply to early triage questions and encourage healthy behaviour , thus reducing the need to seek advice from a healthcare professional; points out , however , the particular sensitivity of personal health data and to the risk of data breaches or misuses in this regard;


### 23. stresses that consumer health applications based on ai can help to track an individual’s health status , yield data which can apply to early triage questions and encourage healthy behaviour , thus reducing the need to seek advice from a healthcare professional; ### 23. stresses that consumer health applications based on ai can help to track an individual’s health status , yield data which can apply to early triage questions and encourage healthy behaviour , thus supporting healthcare professionals and equipping patients with additional means to monitor their own health;


### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; stresses the need to combat mistrust and to educate and better inform citizens about the benefits of ai in the field of health; ### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health and welcomes the creation of a european health data space in order to build-in very high quality data to be used in the health sector; believes that ethical requirements will contribute to combat mistrust among citizens , notwithstanding the need to promote an ai illustration that will inform citizens on the benefits and risk of ai , also in the field of health;


### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; stresses the need to combat mistrust and to educate and better inform citizens about the benefits of ai in the field of health; ### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; stresses the need to combat mistrust by introducing binding ethical and legal standards and meaningful rights and redress for people impacted by ai systems and to educate and better inform citizens about the benefits of ai in the field of health as well as ai developers about the challenges and the risks of processing sensitive data in this domain;


### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; stresses the need to combat mistrust and to educate and better inform citizens about the benefits of ai in the field of health; ### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking , while putting in place robust ethical requirements; stresses the need to combat mistrust and to educate and better inform citizens about the benefits of ai in the field of health;


### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; stresses the need to combat mistrust and to educate and better inform citizens about the benefits of ai in the field of health; ### 24. stresses that ai in the health sector is particularly dependent on large amounts of personal data , data sharing , data accessibility and data interoperability to realise the full potential of ai and health , which are currently lacking; underlines that the very same data can be used , for example , by insurance companies to price-discriminate;


### 25. stresses that additional legal steps , time and purpose limitations introduced by the gdpr , and differing interpretations across member states have led to legal uncertainty and a lack of cooperation in the health sector; underlines that specific consent obligations hinder the processing of used medical data for further analysis and studies; stresses that this leads to lengthy delays to scientific discoveries and a significant bureaucratic burden in health research20 ; ### deleted


### 25. stresses that additional legal steps , time and purpose limitations introduced by the gdpr , and differing interpretations across member states have led to legal uncertainty and a lack of cooperation in the health sector; underlines that specific consent obligations hinder the processing of used medical data for further analysis and studies; stresses that this leads to lengthy delays to scientific discoveries and a significant bureaucratic burden in health research20 ; ### 25. recognises that the obligations and safeguards introduced by the gdpr , and differing interpretations across member states have changed the way data is shared in the health sector , leading in some cases to lengthy delays in scientific discoveries and bureaucratic burden in health research20; stresses that the creation of a european health data space , in combination with the deployment of blockchain infrastructure and open id that guarantees patients' rights and data portability , can increase cooperation and stimulate data sharing for research and innovation in the european health sector;


### 25. stresses that additional legal steps , time and purpose limitations introduced by the gdpr , and differing interpretations across member states have led to legal uncertainty and a lack of cooperation in the health sector; underlines that specific consent obligations hinder the processing of used medical data for further analysis and studies; stresses that this leads to lengthy delays to scientific discoveries and a significant bureaucratic burden in health research20 ; ### 25. stresses that an efficient and uniform application of the gdpr across the eu is needed to overcome challenges such as legal uncertainty and a lack of cooperation in the health sector; underlines that specific consent obligations hinder the processing of used medical data for further analysis and studies; stresses that this leads to lengthy delays to scientific discoveries and a significant bureaucratic burden in health research20;