### 4. calls on the commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases; ### 4. calls on the commission to further strengthen the current system of incentives for research and the development of new medicines for unmet therapeutic needs and to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet diagnostic and therapeutic needs , while maintaining the overall stability and predictability of the system , and prioritising projects promoted by the pharmaceutical industry combating rare or chronic diseases such as paediatric cancers , neurodegenerative diseases and amr , with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the commission to promote the creation of an eu framework to guide and regularly evaluate the implementation of national plans to fight these diseases;


### 4. calls on the commission to develop a mandatory european licence in order to be able to respond rapidly to health crises; ### deleted


### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess new criteria for national pricing , such as whether a product is ‘made in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population; ### 5. calls on the commission to promote dialogue with the member states and stakeholders to assess additional criteria for national pricing , such as whether a product is ‘developed in europe’ , whether the eu invested in the product to support research , or whether prices should be adapted to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and to cooperate with relevant stakeholders and member states to identify the root-causes of the unavailability of medicines and to find systematic , safe and sustainable solutions to address this long-standing issue of medicine shortages for patients while promoting a competitive industrial market in the european union;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , ensuring price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; further calls on the commission , especially dg competition , to be alert of anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry;


### 6. stresses , lastly , the importance for european companies , in strategic sectors such as pharmaceuticals , of contractual freedom in the areas of licensing and the protection and effective enforcement of intellectual property rights , including in third countries where they operate; calls on the commission to develop and implement new measures and tools for this purpose and to improve existing ones , such as the intellectual property helpdesk for smes. ### deleted


### 6. calls on the commission to support pricing models based on real production costs; ### 6. calls on the commission to support pricing models which take account of real production costs;


### 7. stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines; ### 7. points out that generic and biosimilar medicines enable treatment efficacy and safety ,increased competition , reduced prices and savings for healthcare systems , thus helping to improve access to medicines for patients ; stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to introduce measures to support a greater market presence of these medicines and to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. draws attention to the possibility for the member states to engage in joint procurement whilst guaranteeing that most economically advantageous tender (meat) criteria are applied;


### 8. regrets the excessive influence of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions. ### deleted


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; stresses that public-private partnership dialogues and academia-pharma cooperation are essential for the exchange of knowledge and information for the benefit of all patients across the union;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. highlights the potential of joint eu public procurement contracts by the commission and the member states; considers that the eu joint procurement has potential as a tool for extraordinary cross-border health threats; suggests that joint public procurement be clearly defined in scope , time , continues to be used on the mandate of member states on a case-by-case basis and it should not create barriers for patient access , medical innovation or fair competition


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. strongly supports the use of joint eu public procurement procedures by the commission and the member states , especially for medicinal products of major therapeutic interest , emergency medicines and unmet therapeutic needs to improve their affordability and their access at eu level;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. welcomes the commission's objective of improving the innovation capacity and competitiveness in the pharmaceutical industry; insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs and that it is in the interest of patients that the industry is in the strongest possible position to meet their diagnostic and therapeutic needs; points out that the industry needs a stable , flexible and agile regulatory environment; underlines that the marketing authorisation system should build on the existing legislative framework and prevent duplication and additional administrative burdens , believes that it can thrive globally with a clear , robust and efficient intellectual property system;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; calls on the commission to develop guidance to promote the secondary use of data for research and to ensure fair , transparent and non-discriminatory access to data throughout europe;


### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; ### 14. underlines that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation; stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the next generation eu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level;


### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; ### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment and skill-building in the pharmaceutical sector , facilitating talent retention and mobility at eu level;


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative have a transformative potential and can bring enormous benefits to patients and societies in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to ensure sufficient regulatory expertise to support dialogue with developers , to develop appropriate regulatory frameworks , to guide new business models without compromising safety standards and product efficacy , and to run information campaigns to raise awareness and encourage the use of these innovations; calls on member states to authorize the use of these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement process for cross-border treatment of patients;


### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring enormous benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; urges the commission to develop appropriate regulatory frameworks , to guide new business models , and to run information campaigns to raise awareness and encourage the use of these innovations; urges the commission to propose adequate resources for the ema to meet these objectives effectively;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9to facilitate the launch of large clinical trials carried out in a harmonized and coordinated manner at european level; stresses that patient associations should be more involved in defining research strategies for public and private clinical trials , in order to ensure that they meet the unmet needs of european patients; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports clinical trials that are more patient-centred as well as a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews and to incorporate lessons learned from the extraordinary and accelerated authorisation process where it is relevant , safe and beneficial for patients and for innovative medicinal products for underserved areas; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu;


### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema to develop the use of electronic product information for all medicines in the eu; ### 17. urges the commission , based on the experience with the authorisation of covid-19 vaccines , to work with the ema to consider extending the application of rolling reviews to other emergency medicines; further calls on the commission to work with the ema and the european regulatory network to develop the use of electronic product information for all medicines in the eu;


### 18. calls on the commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; ### 18. calls on the commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the ema to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years; encourages the commission in cooperation with the ema to consider how already established tools like accelerated authorisation , early dialogue , expanded guidance and the prime scheme can be used to make medicine available to patients at a faster pace , especially medicine that has potential to address an urgent public health threat or an unmet medical need;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; recalls that medicines shortages have a direct impact on patients' health , safety and the continuation of their treatment; stresses that for patients , the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment , avoidable transmission of infectious diseases , increased risk of exposure to falsified medicines and significant psychological distress for patients and their families; notes that the risks are particularly high amongst vulnerable populations such as children , the elderly , pregnant women , people affected by a disability , patients with chronic diseases or cancer or people in intensive care unit (icu); calls on the commission to present a specific strategy for managing shortages of medicines and medical products in europe; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; recognises the multiple drivers of shortages; stresses the importance to involve all stakeholders including manufacturers , wholesalers and pharmacists to prevent and manage medicines’ shortages; recommends , when shortages of medicine occur , to inform healthcare professionals and patients about available alternatives; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines , parallel trade activities , export bans and unexpected manufacturing or quality problems , while limiting the administrative burdens on stakeholders and safeguarding confidentiality; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on a european information network on supply problems , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; ### 19. recalls that the eu’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on improved collection of digital information and digital shortages reporting , and an increased public-private collaboration while monitoring the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;


### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; ### 20. supports the commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain , public authorities , non-governmental patient and health organisations and the research community to address weaknesses and identify opportunities for innovation in the global medicines manufacturing and supply chain;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products and the insurance of access to safe and effective pharmaceutical treatments for patients; calls on the commission to develop a framework for environmental protection while manufacturing medicines; urges the commission to ensure high-quality , safe and environmental sustainable standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles and value chain of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; encourages the commission to consider the potential of e-leaflets to reduce use of paper in packaging while also maintaining equal access to important information; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , while ensuring convenient and safe handling for patients or consumers with limited mobility , and to bring medical prescriptions into line with real therapeutic needs;


### 22. stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs; ### 22. considers that the european green deal constitutes a major opportunity to encourage pharmaceutical manufacturers to participate to the green recovery plan by producing in compliance with environmental and ecological standards; stresses the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the life cycles of medicinal products; calls on the commission to strengthen inspection and auditing throughout the production chain; urges the commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-eu countries; calls on the commission to address the problem of domestic pharmaceutical waste , with measures to reduce packaging and the size of containers to ensure they are no larger than necessary , and to bring medical prescriptions into line with real therapeutic needs;


### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european environmental agency (the ‘agency’) for the financial year 2020 was eur 89 649 723 representing an increase of 18 ,48 % compared to 2019 due to an increase in external assigned revenue; whereas the agency’s budget derives mainly from the union budget (75 ,29 %) and the contributions under specific agreement for the copernicus programme (22 ,68 %); ### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european environmental agency (the ‘agency’) for the financial year 2020 was eur 89 649 723 representing an increase of 18 ,48 % compared to 2019 due to an increase in external assigned revenue; whereas the inflation rate was 0 ,7% in the union in 2020; whereas the agency’s budget derives mainly from the union budget (75 ,29 %) and the contributions under specific agreement for the copernicus programme (22 ,68 %);


### 9. notes , regarding the observations in the 2019 discharge on limited assets , that the agency continues to report its assessment of resource needs to the commission; further notes that these resources are not always met or included in the draft budget put forward by the commission; calls on the commission and the agency to report back on the developments in this regard to the discharge authority; ### 9. notes , regarding the observations in the 2019 discharge on limited assets , that the agency continues to report its assessment of resource needs to the commission; further notes that these resources are not always met or included in the draft budget put forward by the commission; calls on the commission and the agency to work out a sustainable plan to provide the agency with resources according to its needs and tasks and to report back on the developments in this regard to the discharge authority;


### 14. notes , with regard to the follow-up to the 2019 discharge report , that the agency’s management board members are continuously reminded of the request to provide cvs and declarations of interest for publication on the agency’s website; calls on the agency to report to the discharge authority on the developments in this regard; ### 14. notes , with regard to the follow-up to the 2019 discharge report , that the agency’s management board members are continuously reminded of the request to provide cvs and declarations of interest for publication on the agency’s website; is strongly of the opinion that the publication of cvs and declarations of interest of management board members should be obligatory and not done on a voluntary basis; calls on the agency to make sure that management board members meet this requirement and report to the discharge authority on the developments in this regard;


### 18. notes , regarding the follow-up observations on cost efficiency and environmentally friendly practices , that the agency’s office building dates back to the 19th century and the options to improve the energy efficiency of the premises are therefore limited; notes that , as part of its environmental management system , the agency is committed to continuously improve its overall energy performance by replacing selected windows in the building and moving to an activity-based workspace on several floors that will deliver additional improvements of the energy performance per unit area; notes , in addition , that the agency purchases 100 % of electricity from renewable sources; calls on the agency to report to the discharge authority on the developments in this regard; ### 18. welcomes the efforts made by the agency to create an environment-friendly working frame and all the measures taken by the agency to reduce its carbon footprint , its energy consumption and to develop a paperless workflow; notes , regarding the follow-up observations on cost efficiency and environmentally friendly practices , that the agency’s office building dates back to the 19th century and the options to improve the energy efficiency of the premises are therefore limited; notes that , as part of its environmental management system , the agency is committed to continuously improve its overall energy performance by replacing selected windows in the building and moving to an activity-based workspace on several floors that will deliver additional improvements of the energy performance per unit area; notes , in addition , that the agency purchases 100 % of electricity from renewable sources; calls on the agency to report to the discharge authority on the developments in this regard;


### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; ### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the implementation of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular;


### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible; ### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services , such as sharing the internal audit capability (iac) with the eu agency for the space programme (euspa) , and encourages cooperation among the union agencies where and when possible;


### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european chemicals agency (the ‘agency’) for the financial year 2020 was eur 109 362 158 representing a decrease of 3 ,08 % compared to 2019; whereas approximately 29 ,41% of the agency’s budget derives from fees and charges and 67 ,48% from the union and third countries (in 2019 39 ,51 % from fees and charges and 57 ,61 % from the union and third countries); ### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european chemicals agency (the ‘agency’) for the financial year 2020 was eur 109 362 158 representing a decrease of 3 ,08 % compared to 2019; whereas approximately 29 ,41% of the agency’s budget derives from fees and charges and 67 ,48% from the union and third countries (in 2019 39 ,51 % from fees and charges and 57 ,61 % from the union and third countries); whereas the inflation rate was 0 ,7% in the union in 2020;


### 3. notes that the court made one observation on the clarity of the tender specifications in a procurement procedure and another observation on the completeness of the audit trail in recruitment procedures; notes that , as regards the years 2017 and 2018 , the implementation of three of the court’s recommendations is still ongoing , namely recommendations related to launching a discussion with the commission and the budgetary authority about a viable new financing model , collecting outstanding administrative charges and publishing vacancy notices on the european personnel selection office website; calls on the agency to complete the follow-up of those recommendations; ### 3. notes that the court made one observation on the clarity of the tender specifications in a procurement procedure and another observation on the completeness of the audit trail in recruitment procedures in 2019; notes that , as regards the years 2017 and 2018 , the implementation of three of the court’s recommendations is still ongoing , namely recommendations related to launching a discussion with the commission and the budgetary authority about a viable new financing model , collecting outstanding administrative charges and publishing vacancy notices on the european personnel selection office website; calls on the agency to complete the follow-up of those recommendations;


### 7. notes that the agency , with regard to senior management positions , reports that 23 (76 ,6 %) positions are occupied by men and 7 (23 ,33 %) by women; notes that the agency reports , for the management board , a gender balance distribution of 14 men (37 ,8 %) and 23 women (62 ,2 %) and , for staff overall , 266 men (46 ,7 %) and 306 women (53 ,3 %); ### 7. regrets that the agency , with regard to senior and middle management positions , reports that 23 (76 ,6 %) positions are occupied by men and 7 (23 ,33 %) by women; notes that the agency reports , for the management board , a gender balance distribution of 14 men (37 ,8 %) and 23 women (62 ,2 %) and , for staff overall , 266 men (46 ,7 %) and 306 women (53 ,3 %); reiterates its call on the agency to take pro-active measures to achieve gender balance among management positions;


### 13. notes that the agency’s internal audit capability conducted an audit on the ‘harmonised classification and labelling’ activity and that there were six important recommendations , namely to improve working methods , to improve knowledge management and consistency , to improve feedback mechanisms , to ensure sufficient resources for the agency’s secretariat and committees , to clarify the roles and responsibilities within the agency , and to consider further process simplification and efficiency gains; ### 13. notes that the agency’s internal audit capability conducted an audit on the ‘applications for authorisation’ activity and that there were six important recommendations , namely to improve working methods , to improve knowledge management and consistency , to improve feedback mechanisms , to ensure sufficient resources for the agency’s secretariat and committees , to clarify the roles and responsibilities within the agency , and to consider further process simplification and efficiency gains;


### (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 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 from an early stage and in coordination with the national authorities , the industry and other entities of the pharmaceutical supply chain. 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.


### (3) the often complex supply chains of medicinal products and medical devices , national export restrictions and bans , border closures impeding the free movement of those goods , and uncertainty related to their supply and demand in the context of the covid-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the union. ### (3) the often complex supply chains of medicinal products and medical devices , national export restrictions and bans , border closures impeding the free movement of those goods , and uncertainty related to their supply and demand in the context of the covid-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the union , with dire consequences for its citizens.


### (4) dealing with the issue of shortages of medicinal products has been a long-standing priority for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union. ### (4) the issue of shortages of medicinal products has been a long-standing and insufficiently addressed priority for the member states and european parliament as illustrated by several reports from the european parliament11 as well as discussions under recent presidencies of the council of the european union.


### (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 and placed member states in competition with each other to respond to the legitimate needs of their citizens , contributing to uncoordinated actions at national levels such as national hoarding and stockpiling. those issues further resulted in new entities being involved in the rushed 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 , as well as increased and early dialogue with the industry to prevent and mitigate these shortages.


### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices. ### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices in the most efficient way and so as to avoid creating unnecessary burdens for stakeholders which may strain resources and cause additional delays.


### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices. ### (7) uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the covid-19 pandemic can trigger export restrictions amongst member states and other national protective measures , which can seriously impact the functioning of the internal market as well as lead to the need for temporary export transparency and export authorisation mechanisms. furthermore , shortages of medicinal products can result in serious risks to the health of patients in the union due to their lack of availability , which can cause , medication errors , increased duration of hospital stays , and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. with respect to medical devices , shortages can lead to a lack of diagnostic resources with negative consequences for public health measures , a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. those shortages can also have a significant impact on controlling the spread of a given pathogen caused by , for example , an insufficient supply of covid-19 test kits. it is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.


### (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 , with a view to strategically complement the efforts of the commission and other existing agencies to that end , as well as that of future key agencies such as the proposed european health emergency preparedness and response authority (hera).


### (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 , while remaining flexible enough to tackle any future health crisis in the most efficient way to the benefit of public health and patients.


### (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 single european lists of critical medicinal products in consultation with the industry and healthcare professionals , 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.


### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies. ### (19) the establishment of the emergency task force should build on the support provided by the agency during the covid-19 pandemic , notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis , of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies while guaranteeing a high level of human health protection.


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


### (27) during a public health emergency or in relation to a major event , the agency should ensure cooperation with the european centre for disease prevention and control and other union agencies as appropriate. such cooperation should include data sharing , including data on epidemiological forecasting , regular communication at an executive level , and invitations to representatives of the european centre for disease prevention and control and other union agencies to attend meetings of the emergency task force , the medicines steering group , and the medical devices steering group , as appropriate. ### (27) during a public health emergency or in relation to a major event , the agency should ensure cooperation with the european centre for disease prevention and control and other union agencies as appropriate. such cooperation should include data sharing , including data on epidemiological forecasting , regular communication at an executive level , and invitations to representatives of the european centre for disease prevention and control and other union agencies to attend meetings of the emergency task force , the medicines steering group , and the medical devices steering group , as appropriate. this cooperation should also include strategic discussions with relevant entities of the union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event , or prevent future similar public health emergencies or major events , such as the proposed european health emergency preparedness and response authority (hera).


### (29) in order to ensure that sufficient resources are available for the work provided for under this regulation , expenditure of the agency should be covered by the contribution from the union to the agency’s revenue. ### (29) in order to ensure that sufficient resources , including appropriate staffing and adequate expertise , are available for the work provided for under this regulation , expenditure of the agency should be covered by the contribution from the union to the agency’s revenue.


### d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device; ### d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet patients’ needs for that medicinal product or medical device at national level;


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


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


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


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


### 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 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 potential shortage of a medicinal product in a given member state , that is likely to jeopardise a timely and appropriate response 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 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 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 without delay 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).


### 1. following a request for assistance referred to in article 4(3) 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 major event (‘the major event critical medicines list ’). the list shall be updated whenever necessary until the major event has been sufficiently addressed. ### 1. following a request for assistance referred to in article 4(3) 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 major event (‘the major event critical medicines list ’). the list shall be updated whenever necessary until the major event has been sufficiently addressed and it is confirmed that the assistance of the medicines steering group is no longer needed as per article 4(4).


### 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 industry and representatives of health professionals , 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.


### 4. the agency shall immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in article 26 of regulation (ec) no 726/2004. ### 4. the agency shall make available the critical medicines lists and any updates to those lists to the representatives of the member states and the commission.


### 4. the agency shall immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in article 26 of regulation (ec) no 726/2004. ### 4. the agency shall make available to the representatives of the member states and the commission the critical medicines lists and any updates to those lists;


### 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 single european critical medicines lists and the information and data provided in accordance with articles 10 and 11 , , and the database established in accordance with article 12a once fully operational , 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 , as well as with the european centre for disease prevention and control. the medicines steering group shall also guarantee an open communication and close cooperation with the industry , relevant entities of the pharmaceutical supply chain , and representatives of healthcare professionals , patients and consumers with a view to enable early notification or identification of potential or actual shortages of critical medicines.


### 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 , based on patients’ actual and potential needs , 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/[…]19and , 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 , based on the actual and potential needs of patients , 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.


### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. ### 2. where requested by the commission or the sub-network referred to in article 9(2) , the medicines steering group shall provide aggregated data and forecasts of demand to substantiate its findings. in that regard , the medicines steering group shall liaise with the european centre for disease prevention and control to obtain epidemiological data to help forecast medicinal product needs , and with the executive steering group on shortages of medical devices referred to in article 19 where medicinal products included on the critical medicines lists are administered with a medical device. the aggregated data and forecasts of demand shall also be made available to industry and other entities of the pharmaceutical supply chain , where relevant , with the view to better prevent or mitigate potential or actual shortages.


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


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


### details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause; ### details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause at each stage of the supply chain;


### mitigation plans including production and supply capacity; ### mitigation plans , including production and supply capacity , with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;


### mitigation plans including production and supply capacity; ### mitigation plans including enhanced production , supply capacity sourcing diversification and where applicable outsourcing plans;


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


### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency. they shall submit the information through the points of contact designated in accordance with article 9(2) and using the reporting methods and system established pursuant to article 9(1). they shall provide updates where necessary. ### 1. in order to facilitate the monitoring referred to in article 7 and following a request from the agency , marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in article 9(3) by the deadline set by the agency.


### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities; ### consider the need for guidelines addressed to member states , marketing authorisation holders , and other entities , including healthcare professionals;


### 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 competent authorities , inform without delay the public and interest groups with regard to the work of the medicines steering group , and respond to disinformation as appropriate.


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the permanent emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. the emergency task force shall cooperate with eu bodies and agencies , the world health organization , third countries and international scientific organisations in preparing timely and appropriate responses to health emergencies. the agency , working together with the member states , shall undertake to develop the protocols and expertise necessary for a timely and appropriate response to health crises , including for sectors other than the health sector , in order to improve crisis response capacity.


### 1. the emergency task force is hereby established as part of the agency. it shall be convened during public health emergencies , either in person or remotely. the agency shall provide its secretariat. ### 1. the permanent emergency task force is hereby established as part of the agency. it shall be convened either in person or remotely. the agency shall provide its secretariat. the emergency task force shall cooperate with eu bodies and agencies , the world health organisation , third countries and international scientific organisations in preparing timely and appropriate responses to health emergencies. the agency , working together with the member states , shall apply itself to developing the protocols and expertise necessary for a timely and appropriate response to health crises , including for sectors other than the health sector , in order to improve crisis response capacity.


### 3. the emergency task force shall be composed of representatives of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established in accordance with article 85 of regulation (eu) 536/2014.21 external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency. ### 3. the emergency task force shall be composed of representatives of the member states , of the scientific committees , working parties , and staff members of the agency , the coordination group established in accordance with article 27 of directive 2001/83/ec , and the clinical trials coordination and advisory group established under heads of medicines agencies. each member state may appoint one representative. a member state may delegate its tasks in the emergency task force to another member state. external experts may be appointed and representatives of other union bodies and agencies be invited on an ad hoc basis , as necessary. it shall be chaired by the agency.


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


### 5. when authorising a clinical trial application for which scientific advice has been given , member states shall take that advice duly into account. ### 5. when authorising a clinical trial application for which scientific advice has been given , member states shall take that advice duly into account. the scientific advice provided by the emergency task force and endorsed by the committee for medicinal products for human use referred to in paragraph 2 shall have no binding force on the opinion of an independent ethics committee issued within authorisation of a clinical trial application.


### 4. following receipt of the recommendation , the committee for medicinal products for human use shall adopt an opinion on the conditions for use , the conditions for distribution and the patients targeted. the opinion shall be updated where necessary. ### 4. following receipt of the recommendation , the committee for medicinal products for human use shall adopt an opinion on the conditions for use , the conditions for distribution and the patients targeted. the opinion shall be updated where necessary , and made public on the agency's web-portal.


### 7. the agency shall publish the opinions adopted pursuant to paragraph 4 including any updates on its web-portal. ### 7. the agency shall publish the recommendations provided pursuant to paragraph 3 and the opinions adopted pursuant to paragraph 4 including any updates on its web-portal.


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the emergency task force. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform without delay the public and relevant interest groups with regard to the work of the emergency task force , and respond to disinformation as appropriate.


### develop and maintain electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies; ### develop and maintain highly secure and resilient electronic tools for the submission of information and data , including electronic health data generated outside the scope of clinical studies;


### coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities. such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform; ### coordinate independent utilisation , effectiveness and safety monitoring studies of medicinal products intended to treat , prevent or diagnose a disease using relevant data held by public authorities; for vaccines , such coordination shall be conducted jointly with the european centre for disease prevention and control and notably through a new vaccine monitoring platform;


### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies , and the exchange of such data between member states , the agency , and other union bodies; ### as part of its regulatory tasks , make use of digital infrastructures or tools , to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of interventional clinical studies , and the exchange of such data between member states , the agency , and other union bodies;


### 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 , representatives of patients and healthcare professionals , to attend its meetings.


### mitigation plans including production and supply capacity; ### mitigation plans including production and supply capacity , with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;


### mitigation plans including production and supply capacity; ### mitigation plans including enhanced production , supply capacity , sourcing diversification and where applicable outsourcing plans;


### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list; ### consider the need to provide for temporary exemptions at member state level pursuant to article 59(1) of regulation (eu) 2017/745 or article 54(1) of regulation (eu) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list , while at the same time ensuring a high level of patient and product safety;


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


### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform the public and relevant interest groups with regard to the work of the medical devices steering group. ### the agency shall , via its web-portal and other appropriate means and , in conjunction with national competent authorities , inform without delay the public and relevant interest groups with regard to the work of the medical devices steering group , and respond to disinformation.


### the agency shall , on behalf of the commission , from 1 march 2022 onwards , provide the secretariat of the expert panels designated in accordance with implementing decision (eu) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in article 106(9) and (10) of regulation (eu) 2017/745. the agency shall: ### the agency shall , on behalf of the commission , provide the secretariat of the expert panels designated in accordance with implementing decision (eu) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in article 106(9) and (10) of regulation (eu) 2017/745. the agency shall:


### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. ### 5. the commission , the agency , and member states may exchange commercially confidential information and , where necessary to protect public health , anonymised and aggregated sensitive personal data , with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.


### 31 entry into force ### 31 entry into force and date of application


### liaise with third countries and relevant international organisations , as appropriate , to mitigate potential or actual shortages of medicinal products included on the critical medicines list or their active pharmaceutical ingredients , where those products or ingredients are imported into the union and where such potential or actual shortages have international implications. ### liaise with third countries and relevant international organisations , as appropriate , to mitigate potential or actual shortages of medicinal products included on the critical medicines list or their active pharmaceutical ingredients , where those products or ingredients are imported into or exported from the union and where such potential or actual shortages have international implications , including potential introduction of temporary export transparency and export authorisation mechanisms.


### details of the potential or actual shortage such as actual or estimated start and end dates , and the known or suspected cause; ### details of the potential or actual shortage such as actual or estimated start and end dates , and the known or suspected cause at each level of the supply chain;


### liaise with third countries and relevant international organisations , as appropriate , to mitigate potential or actual shortages of medical devices included on the critical devices list or their component parts , where those devices or parts are imported into the union , and where such potential or actual shortages have international implications. ### liaise with third countries and relevant international organisations , as appropriate , to mitigate potential or actual shortages of medical devices included on the critical devices list or their component parts , where those devices or parts are imported into or exported from the union , and where such potential or actual shortages have international implications , including potential introduction of temporary export transparency and export authorisation mechanisms.


### 2. notes that , despite the difficulties caused by the global pandemic , the agency continued to act in the interests of a functioning single market for human and veterinary medicines , by acting as the hub of the european network of regulatory medicines authorities that implements the applicable union legislative framework for such products; ### 2. notes that , despite the difficulties caused by the global pandemic , the agency continued to act in the interests of a functioning single market for human and veterinary medicines , by acting as the hub of the european network of regulatory medicines authorities that implements the applicable union legislative framework for such products; praises the agency for its efforts to effectively analyse and to quickly approve vaccines against covid-19 in the member states;


### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european medicines agency (the ‘agency’) for the financial year 2020 was eur 369 749 000 , representing an increase of 6 ,63 % compared to 2019; whereas the agency is a fee-funded agency , with approximately 84 ,00 % of its 2020 revenue stemming from fees paid by the pharmaceutical industry for services provided , 15 ,92 % stemming from the union budget and 0 ,08 % stemming from external assigned revenue; ### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european medicines agency (the ‘agency’) for the financial year 2020 was eur 369 749 000 , representing an increase of 6 ,63 % compared to 2019; whereas the inflation rate in the union was 0 ,7% in 2020; whereas the agency is a fee-funded agency , with approximately 84 ,00 % of its 2020 revenue stemming from fees paid by the pharmaceutical industry for services provided , 15 ,92 % stemming from the union budget and 0 ,08 % stemming from external assigned revenue;


### 20. notes with regret that the agency was the victim of a cyberattack in december 2020; notes that a full criminal investigation was undertaken by law enforcement authorities , in cooperation with cert-eu and europol , as well as an external third-party service provider with specific expertise in it security-incident response; notes that the agency’s defensive cybersecurity capabilities have been enhanced since then , with further investment to protect the agency from future attacks; welcomes the efforts made by the agency and calls on the agency to also take account of the reputational risks and the destabilising effects on public opinion when information obtained through such an attack is abused; ### 20. notes with regret that the agency was the victim of a cyberattack in december 2020; notes that a full criminal investigation was undertaken by law enforcement authorities , in cooperation with cert-eu and europol , as well as an external third-party service provider with specific expertise in it security-incident response; notes that the agency’s defensive cybersecurity capabilities have been enhanced since then , with further investment to protect the agency from future attacks; welcomes the efforts made by the agency and calls on the agency to also take account of the reputational risks and the destabilising effects on public opinion when information obtained through such an attack is abused; calls on the agency to further strengthen its cybersecurity policy and report back on that to the discharge authority;


### 21. welcomes the efforts made by the agency to put in place a comprehensive strategy for sustainable development , including steps to reduce co2 emissions and ensure that the agency is a cost-effective and environment-friendly working place; calls on the agency to report to the discharge authority on the developments in this regard; ### 21. welcomes the efforts made by the agency to put in place a comprehensive strategy for sustainable development , including steps to reduce co2 emissions and energy consumption and ensure that the agency is a cost-effective and environment-friendly working place; encourages the agency to further strengthen its efforts for sustainability; calls on the agency to report to the discharge authority on the developments in this regard;


### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european centre for disease prevention and control (the ‘centre’) for the financial year 2020 was eur 62 490 000 , representing an increase of 5 ,55 % compared to 2019; whereas approximately 97 ,62 % of the centre’s budget derives from the union budget; ### a. whereas , according to its statement of revenue and expenditure1 , the final budget of the european centre for disease prevention and control (the ‘centre’) for the financial year 2020 was eur 62 490 000 , representing an increase of 5 ,55 % compared to 2019; whereas the inflation rate was 0 ,7 % in the union in 2020; whereas approximately 97 ,62 % of the centre’s budget derives from the union budget;


### 9. notes that the centre has adopted a policy on protecting the dignity of the person and preventing harassment; takes note that two cases of alleged harassment have been reported and one case was brought to the court of justice of the european union in 2020; ### 9. notes that the centre has adopted a policy on protecting the dignity of the person and preventing harassment; takes note that two cases of alleged harassment have been reported and one case was brought to the court of justice of the european union in 2020; calls on the centre to report to the discharge authority on the developments in this regard;


### 19. notes that the centre reported an unprecedentedly high number of outputs in 2020 in response to the covid-19 pandemic , and had the highest visibility since its creation; notes that the centre’s main activities during this period were related to the support of vaccination strategies , the dissemination of evidence-based information , the application of surveillance and epidemic intelligence , the implementation of guidance for scientific and technical topics , and the establishment of networking and exchange practices across europe; ### 19. welcomes that the centre reported an unprecedentedly high number of outputs in 2020 in response to the covid-19 pandemic , and had the highest visibility since its creation; notes that the centre’s main activities during this period were related to the support of vaccination strategies , the dissemination of evidence-based information , the application of surveillance and epidemic intelligence , the implementation of guidance for scientific and technical topics , and the establishment of networking and exchange practices across europe;