### 2. implementing acts referred to in paragraph 1 shall specify measures to be taken to reduce emissions of methyl bromide during use and apply for a period not exceeding 120 days and to a quantity not exceeding 20 metric tonnes of methyl bromide. the commission may include in those implementing acts reporting requirements and may require submission of supporting evidence necessary for monitoring the use of methyl bromide , including evidence on the destruction of substances following the end of the derogation. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### 2. implementing acts referred to in paragraph 1 shall specify measures to be taken to reduce emissions of methyl bromide during use and apply for a period not exceeding 120 days and to a quantity not exceeding 20 metric tonnes of methyl bromide. the commission shall include in those implementing acts reporting requirements and shall require submission of supporting evidence necessary for monitoring the use of methyl bromide , including evidence on the destruction of substances following the end of the derogation. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### the licence referred to in the first subparagraph shall not be required in cases of temporary storage. ### deleted


### any prohibited non-refillable containers referred to in the first subparagraph shall be confiscated , seized , withdrawn or recalled from the market by the customs authorities or the market surveillance authorities for disposal. the re-export of prohibited non-refillable containers is prohibited. ### any prohibited non-refillable containers referred to in the first subparagraph shall be confiscated , seized , withdrawn or recalled from the market and destroyed by the customs authorities or the market surveillance authorities. the re-export of prohibited non-refillable containers is prohibited.


### for the purpose of submitting evidence , importers and producers shall draw up a declaration of conformity and join supporting documentation on the production facility and the mitigation measures adopted to prevent emissions of trifluoromethane. producers and importers shall keep the declaration of conformity and supporting documentation for a period of at least five years after the placing on the market and make them available , upon request , to national competent authorities and to the commission. ### for the purpose of providing that evidence , importers and producers shall draw up a declaration of conformity , verified by an accredited auditor , and join supporting documentation with:


### the commission may , by means of implementing acts , determine the detailed arrangements relating to the declaration of conformity and supporting documentation referred to in the second subparagraph. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### the commission shall , by means of implementing acts , determine the detailed arrangements relating to and the detailed elements of the declaration of conformity and supporting documentation referred to in the second subparagraph. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### containers containing the substances intended for the uses referred to in articles 6 , 7 and 8 shall be labelled with a clear indication that the substance may only be used for the applicable purpose. where such substances are subject to labelling requirements provided for in regulation (ec) no 1272/2008 , such indication shall be included in the labels referred to in that regulation. ### containers of ozone depleting substances shall be labelled. the label shall bear the accepted industry designation for the ozone depleting substance concerned or , if no such designation is available , the chemical name , the ozone depleting potential of the substance concerned , and , where available , its global warming potential expressed on a 100-year time-scale , and , where available , on a 20-year timescale. containers containing the substances intended for the uses referred to in articles 6 , 7 , 8 , 9 and 10 shall be labelled with a clear indication that the substance may only be used for the applicable purpose. where such substances are subject to labelling requirements provided for in regulation (ec) no 1272/2008 , such indication shall be included in the labels referred to in that regulation. reclaimed or recycled ozone depleting substances shall be labelled with an indication that the substance has been reclaimed or recycled , information on the batch number and the name and address of the reclamation or recycling facility in the union. where relevant , refilled containers shall be relabelled with updated information.


### 1. the commission shall set up and ensure the operation of the electronic licensing system for ozone depleting substances listed in annex i and products and equipment containing those substances or whose functioning relies upon those substances ('the licensing system'). ### 1. the commission shall set up and ensure the operation of the electronic licensing system for ozone depleting substances and products and equipment containing those substances or whose functioning relies upon those substances ('the licensing system').


### 1. ozone depleting substances listed in annex i contained in refrigeration , air-conditioning and heat pump equipment , equipment containing solvents or fire protection systems and fire extinguishers shall , during the maintenance or servicing of equipment or before the dismantling or disposal of equipment , be recovered for destruction , recycling or reclamation. ### 1. ozone depleting substances contained in refrigeration , air-conditioning and heat pump equipment , equipment containing solvents or fire protection systems and fire extinguishers shall , during the maintenance or servicing of equipment or before the dismantling or disposal of equipment , be recovered for destruction , recycling or reclamation.


### 2. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of metal-faced panels that contain foams with ozone depleting substances listed in annex i are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein. ### 2. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of metal-faced panels that contain foams with ozone depleting substances are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein.


### 3. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of foams in laminated boards installed in cavities or built-up structures that contain ozone depleting substances listed in annex i are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein. ### 3. building owners and contractors shall ensure that during renovation , refurbishing or demolition activities implying the removal of foams in laminated boards installed in cavities or built-up structures that contain ozone depleting substances are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein.


### 6. ozone depleting substances listed in annex i contained in products and equipment other than those mentioned in paragraphs 1 to 5 shall , if technically and economically feasible , be recovered for destruction , recycling or reclamation , or shall be destroyed without prior recovery. ### 6. ozone depleting substances contained in products and equipment other than those mentioned in paragraphs 1 to 5 shall , if technically and economically feasible , be recovered for destruction , recycling or reclamation , or shall be destroyed without prior recovery.


### 7. ozone depleting substances listed in annex i and products and equipment containing such substances shall only be destroyed by technologies approved by the parties to the protocol or by destruction technologies that are not yet approved , but are environmentally equivalent and comply with union and national legislation on waste and with additional requirements under such legislation. ### 7. ozone depleting substances and products and equipment containing such substances shall only be destroyed by technologies approved by the parties to the protocol or by destruction technologies that are not yet approved , but are environmentally equivalent and comply with union and national legislation on waste and with additional requirements under such legislation.


### 9. member states shall promote the recovery , recycling , reclamation and destruction of ozone depleting substances listed in annex i and shall establish the minimum qualification requirements for the personnel involved. ### 9. member states shall promote the recovery , recycling , reclamation and destruction of ozone depleting substances and shall establish the minimum qualification requirements for the personnel involved. member states shall ensure that training programmes for natural persons carrying out those tasks are available.


### 2. undertakings shall take all necessary precautions to prevent and minimise any unintentional release of ozone depleting substances listed in annex i during production , including inadvertently produced in the course of the manufacture of other chemicals , equipment manufacturing process , use , storage and transfer from one container or system to another or transport. ### 2. undertakings shall take all necessary precautions to prevent and minimise any unintentional release of ozone depleting substances during production , including inadvertently produced in the course of the manufacture of other chemicals , equipment manufacturing process , use , storage and transfer from one container or system to another or transport.


### 3. undertakings operating equipment containing ozone depleting substances listed in annex i , shall ensure that any detected leakage is repaired without undue delay , without prejudice to the prohibition to use the ozone depleting substances. ### 3. undertakings operating equipment containing ozone depleting substances , shall ensure that any detected leakage is repaired without undue delay , without prejudice to the prohibition to use the ozone depleting substances.


### 5. member states shall establish the minimum qualification requirements for the personnel carrying out activities referred to in paragraph 3. ### 5. member states shall establish the minimum qualification requirements for the personnel carrying out activities referred to in paragraph 3. member states shall ensure that training programmes for natural persons carrying out those activities are available.


### 3. the commission is empowered to adopt delegated acts in accordance with article 29 to amend annexes i and ii as regards the global warming potential and the ozone depleting potential of the listed substances , where it is necessary in the light of new assessments reports by the intergovernmental panel on climate change or new reports of the sap , established under the protocol. ### 3. the commission is empowered to adopt delegated acts in accordance with article 29 to amend annexes i and ii to update the global warming potential and the ozone depleting potential of the listed substances , where it is necessary in the light of new assessments reports by the intergovernmental panel on climate change or new reports of the sap , established under the protocol , and to add the global warming potential of those substances on a 20-year timescale.


### in cases of unlawful production , import , export , placing on the market , or use of ozone depleting substances listed in annex i or of products and equipment containing those substances or whose functioning relies upon those substances , member states shall envisage maximum administrative fines of at least five times the market value of the concerned substances or products and equipment concerned. in case of a repeated infringement within a five-year period , the member states shall envisage maximum administrative fines of at least eight times the market value of the concerned substances or products and equipment concerned. ### in cases of unlawful production , import , export , placing on the market , or use of ozone depleting substances listed in annex i or of products and equipment containing those substances or whose functioning relies upon those substances , member states shall envisage minimum administrative fines of at least five times the market value of the concerned substances or products and equipment concerned. in case of a repeated infringement within a five-year period , the member states shall envisage minimum administrative fines of at least eight times the market value of the concerned substances or products and equipment concerned.


### by 1 january 2033 , the commission shall publish a report on the implementation of this regulation. ### by 1 january 2027 , the commission shall publish a report on the implementation of this regulation. the european scientific advisory board on climate change established under article 10a of regulation(ec) no 401/2009 of the european parliament and of the council1a (the "advisory board") may , on its own initiative , provide scientific advice or issue reports on the coherence of this regulation with the objectives of regulation(ec) no 401/2009 and with the union’s international commitments under the paris agreement , and inform any future review of this regulation. the commission shall provide public explanations on how it has taken into account such advice and reports when reviewing this regulation.


### any quantities destroyed , including quantities contained in products or equipment; ### any quantities destroyed , including quantities contained in products or equipment and quantities destroyed as by-product , and the technology used for destruction;


### each undertaking destroying ozone depleting substances listed in annex i and not covered by point 2(e) of this annex shall also communicate data on any purchases from and sales to other undertakings in the union. ### each undertaking destroying ozone depleting substances and not covered by point 2(e) of this annex shall also communicate data on any purchases from and sales to other undertakings in the union.


### the processes and any emissions , including those linked to transport and storage , including the transfer from one container to another. ### the types of feedstock uses and processes and any emissions , including those linked to transport and storage , including the transfer from one container to another.


### each undertaking using as feedstock or process agents ozone depleting substances listed in annex i shall also communicate data on any purchases from and sales to other undertakings in the union. ### each undertaking using as feedstock or process agents ozone depleting substances shall also communicate data on any purchases from and sales to other undertakings in the union.


### (10) the reporting requirements should apply at ‘installation level’ in order to implement synergies between the portal and databases on environmental pressures from industrial installations , including those covered by directive 2010/75/eu , and to ensure coherence with , and support to , the implementation of that directive. ### (10) the reporting requirements should apply at ‘installation level’ in order to implement synergies between the portal and databases on environmental pressures from industrial installations , including those covered by directive 2010/75/eu , and to ensure coherence with , and support to , the implementation of that directive. article 4(2) of directive 2010/75/eu allows member states to cover two or more installations or parts of installations operated by the same operator on the same site with the same permit , only provided that the permit contains conditions to ensure that each installation complies with the requirements of that directive. hence , even in those cases , operators have to produce and report data at installation level.


### (12) in order to monitor the environmental performance of industrial installations , the data to be included in the portal should cover , above quantitative thresholds , releases to the environment of certain pollutants , off-site transfers of waste water containing these pollutants and off-site transfers of waste. ### (12) in order to monitor the environmental performance of industrial installations , the data to be included in the portal should cover releases to the environment of certain pollutants , off-site transfers of waste water containing these pollutants and off-site transfers of waste.


### (13) the portal should also include data on the use of water , energy and raw materials by the concerned installations to allow monitoring of progress towards a circular , highly resource-efficient economy ### (13) the portal should also include data on the use of fresh and waste water , primary and waste energy and primary and secondary raw materials by the concerned installations to allow monitoring of progress towards a circular , highly resource-efficient economy


### (15) operators of installations should also report information concerning the production volume , number of employees and operating hours of the concerned installation as well as information on accidents that have led to releases , in order to enable the contextualisation of reported data on pollutant releases and off-site transfers of waste and waste water. ### (15) operators of installations should also report information , where applicable expressed in the same format as in the permits and bat conclusions , concerning the production volume , number of employees and operating hours of the concerned installation as well as information on accidents and near-misses that have led and could have led to releases , in order to enable the contextualisation of reported data on pollutant releases and off-site transfers of waste and waste water and to allow to draw comparisons , benchmark installations and track progress.


### (16) the overall benefit of the portal for access to environmental information concerning industrial installations should be maximised by including links to other information flows that stem from union environmental legislation on climate change , air , water and land protection and on waste management , including reporting under directive 2012/18/eu of the european parliament and of the council41 , directive 2008/98/ec of the european parliament and of the council42 and directive 2010/75/eu. moreover , in order to maximise the portal’s value to users , it should be designed to facilitate future integration with other relevant environmental data flows. ### (16) the overall benefit of the portal for access to environmental information concerning industrial installations should be maximised by publishing information within short delays , incorporating permitting and compliance information produced under directive 2010/75/eu , providing information on the level of ambition of the permits compared to the bat conclusions under that directive , displaying information expressed in the same format as in the permits and bat conclusions under that directive , and by including links to other information flows that stem from union environmental legislation on climate change , air , water and land protection and on waste management , including reporting under directive 2012/18/eu of the european parliament and of the council41 and directive 2008/98/ec of the european parliament. moreover , in order to maximise the portal’s value to users , it should be designed to facilitate future integration with other relevant environmental data flows.


### (17) for the purpose of legal certainty , operators of installations should be required to enter a nil return when releases and off-site transfers of waste and of waste water from their installations are below reporting thresholds. ### (17) operators of installations should be required to report releases and off-site transfers of waste and of waste water from their installations even when such releases are minimal. this will help identify progress and best practices and steer industries towards zero pollution levels. this aligns with the ambition to build a union's knowledge system driving the zero pollution ambition towards 2050. finally , this makes reporting simpler than if there were reporting thresholds , as thresholds would need to be checked by operators and their respect would need to be verified by the competent authorities.


### (20) in order to ensure uniform conditions for the implementation of the provisions of this regulation regarding reporting by member states , implementing powers should be conferred on the commission to establish the type and format of information to be provided and the reporting deadlines. those powers should be exercised in accordance with regulation (eu) no 182/2011 of the european parliament and of the council43 . ### (20) in order to ensure uniform conditions for the implementation of the provisions of this regulation regarding reporting by operators and member states , implementing powers should be conferred on the commission to establish the type and format of information to be provided and the reporting deadlines. those powers should be exercised in accordance with regulation (eu) no 182/2011 of the european parliament and of the council43 .


### (21) given the importance for the union citizens of quick access to environmental information , it is essential that member states and the commission make data publicly available as fast as technically feasible. to that end , whereas the precise reporting deadline is to be established in an implementing act , it should be no later than 11 months after the end of the reporting year. ### (21) given the importance for the union citizens of quick access to environmental information , it is essential that operators , member states and the commission make data publicly available as fast as technically feasible. to that end , operators , or the member states on their behalf , should report the data to the commission using an electronic input form , at least annually , and , with respect to monitoring data , the should report with the same frequency required in case of periodic monitoring , and , where continuous monitoring is required , they should report data at least on a monthly basis. the commission should publish the received data within 1 month after it has been inserted in the portal by the operators or the member states on their behalf.


### (23) data reported by the member states should be of high quality in particular as regards their accuracy , completeness , consistency and credibility. competent authorities should therefore assess the quality of the data provided by operators. ### (23) data reported by the operators and member states should be of high quality in particular as regards their accuracy , completeness , consistency and credibility. competent authorities should therefore assess the quality of the data provided by operators.


### (24) public access to environmental information reported by member states should be unrestricted and exceptions from this rule should only be possible in accordance with directive 2003/4/ec of the european parliament and of the council44 or with regulation (ec) no 1049/2001 of the european parliament and of the council45 , as appropriate. ### (24) public access to environmental information reported by member states should be unrestricted and exceptions from this rule should only be possible in accordance with directive 2003/4/ec of the european parliament and of the council44 or with regulation (ec) no 1049/2001 of the european parliament and of the council45 , as appropriate. information on emissions which is relevant for the protection of the environment should not be considered as confidential , in line with the aarhus convention.


### (27) it should be possible for the commission to update the list of industrial or agricultural activities in relation to which reporting requirements apply. the commission should therefore be empowered to adopt delegated acts in accordance with article 290 of the treaty amending annex i to this regulation to add activities that have , or are expected to have , an impact on health or the environment and to align the annex with amendments to the protocol. ### (27) it should be possible for the commission to extend the list of industrial or agricultural activities in relation to which reporting requirements apply. the commission should therefore be empowered to adopt delegated acts in accordance with article 290 of the treaty amending annex i to this regulation to add activities that have , or are expected to have , an impact on health or the environment and to align the annex with amendments to the protocol.


### (28) the commission should also be empowered to adopt delegated acts in accordance with article 290 of the treaty to amend annex ii to this regulation to determine reporting thresholds , to add pollutants which are subject to specific regulatory measures under union law on water and air quality and on chemicals , including regulation (ec) no 1907/2006 of the european parliament and of the council46 , directives 2000/60/ec47 , 2004/107/ec48 , 2006/118/ec49 , 2008/50/ec50 and 2008/105/eu51 of the european parliament and of the council , to reflect changes made to the protocol with regard to the pollutants to be reported or their reporting thresholds , and to adapt that annex to scientific or technical progress. ### (28) pollutants which are subject to specific regulatory measures under union law on water and air quality and on chemicals , including regulations (ec) no 1907/200646 and 1272/2008/ec46a of the european parliament and of the council , directives 2000/60/ec47 , 2004/107/ec48 , 2006/118/ec49 , 2008/50/ec50 and 2008/105/eu51 of the european parliament and of the council should be reported. moreover , the commission should also be empowered to adopt delegated acts in accordance with article 290 of the treaty to amend annex ii to this regulation to reflect changes made to the protocol with regard to the additional pollutants to be reported , and to adapt that annex to scientific or technical progress.


### (29) the commission should also be empowered to adopt delegated acts in accordance with article 290 of the treaty to amend annex ii to this regulation to determine reporting thresholds , to add pollutants which are subject to specific regulatory measures under union law on water and air quality and on chemicals , including regulation (ec) no 1907/2006 of the european parliament and of the council52 , directives 2000/60/ec53 , 2004/107/ec54 , 2006/118/ec55 , 2008/50/ec56 and 2008/105/eu57 of the european parliament and of the council , to reflect changes made to the protocol with regard to the pollutants to be reported or their reporting thresholds , and to adapt that annex to scientific or technical progress. ### deleted


### (31) in order to ensure effective implementation of this regulation , member states should lay down rules on penalties applicable to its infringements and should ensure that they are implemented. ### (31) in order to ensure effective implementation of this regulation , member states should lay down rules on penalties applicable to its infringements and should ensure that they are implemented , based on the principles and minimum amounts specified in this regulation.


### this regulation implements the unece protocol on pollutant release and transfer registers (‘the protocol’) by laying down rules on the collection and reporting of environmental data on industrial installations and establishes an industrial emissions portal (‘portal’) at union level in the form of an online database giving access to such data. ### this regulation implements the unece protocol on pollutant release and transfer registers (‘the protocol’) by laying down rules on the collection and reporting of environmental data on industrial installations and establishing an industrial emissions portal (‘portal’) at union level in the form of an online , publicly accessible , database. this regulation aims to enhance public access to environmental information , hereby facilitating public participation in environmental decision-making , better informing environmental decision-making , encouraging better environmental performance , and tracking trends and progress in pollution reduction , notably by enabling the public to compare pollution data from industrial installations and verify compliance by industrial installations with environmental legislation.


### (14) ‘recovery’ means any of the operations referred to in annex ii to directive 2008/98/ec; ### (14) ‘recovery’ means the operations referred to in annex ii to directive 2008/98/ec , disaggregated by relevant r code;


### (15) ‘disposal’ means any of the operations referred to in annex i to directive 2008/98/ec; ### (15) ‘disposal’ means the operations referred to in annex i to directive 2008/98/ec , disaggregated by relevant d code;


### 1. the portal shall include data on: ### 1. the portal shall include data at installation level , including data from installations under the scope of directive 2010/75/ec expressed in the same format as in the permits granted under that directive and the relevant bat conclusions , on:


### 2. the portal shall include links to the following: ### 2. the portal shall integrate data from the following:


### 1. the commission shall make the portal publicly accessible , presenting the data in both aggregated and non-aggregated forms with a view to enabling searches by: ### 1. the commission , assisted by the agency , shall make the portal publicly and easily accessible , user-friendly , presenting the data in both aggregated and non-aggregated forms with a view to enabling searches and query-based downloads of datasets by:


### installation , including the installation's parent company where applicable , and its geographical location , including the river basin; ### installation , including the installation's parent company where applicable , and its geographical location , including the river basin , including in circumstances where a permit covers two or more installations or parts of installations operated by the same operator on the same site , in accordance with article 4(2) of directive 2010/75/eu;


### off-site transfers of waste and , as appropriate , their destination; ### off-site transfers of waste , disaggregated by relevant r or d code , and differentiated by eu waste code , and , as appropriate , their destination;


### 5 reporting by operators to competent authorities ### 5 reporting by operators


### 1. the operator of each installation that undertakes one or more of the activities specified in annex i , which meet the applicable capacity thresholds specified in that annex , shall report annually , to its competent authority , the following data , unless that data is already available to the competent authority: ### 1. the operator of each installation that undertakes one or more of the activities specified in annex i , which meet the applicable capacity thresholds specified in that annex , shall report the data listed in points (a) to (f) to the commission , using an electronic input form. operators of installations under the scope of directive 2010/75/ec shall ensure that reported data is expressed in the same format as in permits and relevant bat conclusions. operators shall report monitoring data with the same frequency required in case of periodic monitoring , and , where continuous monitoring is required , they shall report data at least on a monthly basis.


### releases to air , water and land of any pollutant specified in annex ii for which the applicable threshold value specified in annex ii is exceeded; ### releases to air , water and land of any pollutant specified in annex ii;


### off-site transfers of hazardous waste exceeding 2 tonnes per year or of non-hazardous waste exceeding 2 000 tonnes per year , for any operations of recovery or disposal with the exception of the disposal operations of land treatment and deep injection disposal operations , as specified in annex i to directive 2008/98/ec , indicating with ‘r’ or ‘d’ respectively whether the waste is destined for recovery or disposal and , for transboundary movements of hazardous waste , the name and address of the recoverer or the disposer of the waste and the actual recovery or disposal site. waste which is subject to land treatment or deep injection disposal operations shall be reported as a release to land only by the operator of the installation from which the waste originates; ### off-site transfers of hazardous waste exceeding 1 tonne per year or of non-hazardous waste exceeding 1 000 tonnes per year , for any operations of recovery or disposal , indicating whether the waste is destined for recovery or disposal , the name and address of the recoverer or the disposer of the waste and the actual recovery or disposal site , with the respective r of d codes and the eu waste code(s). waste which is subject to land treatment or deep injection disposal operations shall be reported as a release to land only by the operator of the installation from which the waste originates;


### off-site transfers of any pollutant specified in annex ii in waste water destined for waste water treatment for which the threshold value specified in annex ii , column 1b , is exceeded; ### off-site transfers of any pollutant specified in annex ii in waste water destined for waste water treatment;


### use of water , energy and raw materials; ### use of fresh and waste water , primary and waste energy and primary and secondary raw materials;


### information allowing contextualisation of the data reported under points (a) to (d) , including production volume , number of employees , number of operating hours , and information on accidents that have led to releases; ### information allowing contextualisation , comparability , and progress tracking within sectors and across the union , of the data reported under points (a) to (d) , including production volume , number of employees , number of operating hours , compliance and monitoring information generated pursuant to directive 2010/75/eu , expressed in the same format as in the permit conditions and bat conclusions , and information on accidents and near-misses that have led or could have led to releases;


### 2. where the releases referred to in paragraph 1 , point (a) , or off-site transfers of pollutants referred to in paragraph 1 , point (c) , do not exceed the applicable threshold values specified in annex ii , or where off-site transfers of waste do not exceed the thresholds set out in paragraph 1 , point (b) , the operator of the installation concerned shall declare , in its report , that releases or off-site transfers are below those values or thresholds. ### 2. where off-site transfers of waste do not exceed the thresholds set out in paragraph 1 , point (b) , the operator of the installation concerned shall declare , in its report , that releases or off-site transfers are below those values or thresholds.


### 4. operators shall specify in the report the methods used for obtaining the data. where the data were obtained by measurement , the analytical method shall be indicated. where the data were obtained by calculation , the method of calculation shall be indicated. ### 4. operators shall specify in the report the methods used for obtaining the data. the measurement and/or analytical and/or calculation methods shall be indicated including the related uncertainty.


### 11. having regard to the requirements set out in article 6 , member states shall determine a date by when operators shall provide the data referred to in this article to its competent authority. ### 11. the commission , assisted by the agency , shall make the necessary arrangements so that operators , and member states pursuant to paragraph 10 of this article , are able to report the data to the commission using an electronic input form.


### 6 reporting by member states to the commission ### 6 validation of reported data by national competent authorities


### 1. member states shall provide , each year , to the commission , by electronic means , a report containing all the data referred to in article 5 in a format and by a date to be established by the commission by means of implementing acts. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 17(2). the reporting date shall be , in any case , no later than 11 months after the end of the reporting year. ### deleted


### 2. the commission services , assisted by the european environment agency (‘the agency’) shall incorporate the data reported by member states into the portal within 1 month of completion of reporting by member states in accordance with paragraph 1. ### 2. the commission , assisted by the agency , shall make the necessary arrangements so that member states are able to modify and validate the data inserted in the portal based in their territories and are notified of new data having been submitted.


### 1. the commission , assisted by the agency , shall include in the portal data on releases of pollutants from diffuse sources where such data exists and has already been reported by member states. ### 1. the commission , assisted by the agency , shall include in the portal all data on releases of pollutants from diffuse sources where such data exists and has already been reported by member states.


### 2. the competent authorities shall assess the quality of the data provided by the operators of the installations referred to in paragraph 1 , in particular as to their accuracy , completeness , consistency and credibility. ### 2. the competent authorities shall assess the quality of the data provided by the operators of the installations referred to in paragraph 1 , in particular as to their accuracy , completeness , consistency and credibility. they shall validate the data related to activities falling under the scope of directive 2010/75/ec within 6 months following the submission by operators and they shall validate the data related to other activities within up to 12 months.


### 1. the commission , assisted by the agency , shall make the data contained in the portal publicly accessible and free of charge on the internet within 1 month of completion of reporting by member states in accordance with article 6(1). ### 1. the commission , assisted by the agency , shall make the data contained in the portal publicly accessible and free of charge on the internet within 1 month of the submission of the data in accordance with article 5. the commission shall make the necessary arrangements so that it is clear to the public whether the data has been validated or not by the relevant competent authorities.


### when data is considered confidential by a member state in accordance with article 4(2) of directive 2003/4/ec , the report referred to in article 6(2) of this regulation for the reporting year concerned shall indicate separately for each installation which data cannot be made public and provide the reasons for this. ### when data is declared as confidential by a member state in accordance with article 4(2) of directive 2003/4/ec , the report referred to in article 6(2) of this regulation for the reporting year concerned shall indicate separately for each installation which data cannot be made public and provide the reasons for this. information on emissions which is relevant for the protection of the environment shall not be considered as confidential , in line with the aarhus convention.


### guidance ### implementation


### member states and the commission shall promote public awareness of the portal and understanding and use of the data contained in it. ### member states and the commission shall promote public awareness of the portal and understanding and use of the data contained in it. they shall seek advice and gather input from the public on how to improve and expand the content of the portal.


### to add an industrial or agricultural activity which has , or is expected to have , an impact on health or the environment as a consequence of its pollutant releases , waste or waste water transfers or resource use; releases or transfers above the respective reporting thresholds , as set out in article 5(1) , point (b) and in annex ii , will be a primary factor in determining impact on health or the environment; ### to add an industrial or agricultural activity which has , or is expected to have , an impact on health or the environment as a consequence of its pollutant releases , waste or waste water transfers or resource use;


### to align it with the protocol following the adoption of amendment to its annexes. ### to add an industrial or agricultural activity which has been added to the annexes of the protocol.


### to add pollutants , the release of which to air , water and land has , or may have , an adverse impact on the environment or human health , including those that are released from activities referred to in annex i to this regulation , and that meet one of the following conditions: ### to add pollutants , the release of which to air , water and land has , or may have , an adverse impact on the environment or human health , including those that are released from activities referred to in annex i to this regulation.


### are designated as substances of very high concern in annex xiv to regulation (ec) no 1907/2006; ### deleted


### (ii) are designated as priority substances under directives 2000/60/ec or 2008/105/ec , ### deleted


### (iii) are included in the watch lists established in the framework of directives 2006/118/ec or 2008/105/ec; ### deleted


### (iv) are subject to limit values or other restrictions under directives 2008/50/ec , 2004/107/ec or 2006/118/ec; ### deleted


### to set and update thresholds for releases so as to achieve the goal of capturing at least 90% of releases of each pollutant to air , water and land from activities referred to in annex i; including thresholds of zero for substances displaying a particularly high hazard to the environment or human health; ### deleted


### to align it with the protocol following the adoption of amendment to its annexes. ### to add pollutants which have been added to the annexes of the protocol.


### 2. the penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person who has committed the infringement. the level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the infringement of the economic benefits derived from that infringement. the level of the fines shall be gradually increased for repeated infringements. ### 2. the penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person having committed the infringement. the level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the violation of the direct and indirect economic benefits derived from that violation. the level of the fines shall be gradually increased for repeated infringements. in the case of a violation committed by a legal person , the minimum amount of such fines shall be at least 20 ,000 eur or at least 10% whichever the higher of the operator’s annual global turnover in the preceding business year. these penalties shall be calculated and applied independently from any remedial payments for environmental or other damage. the calculation of the turnover of the legal person shall include the turnover of all entities belonging to the same legal person irrespective of where those entities are established.


### the population or the environment affected by the infringement , bearing in mind the impact on the objective of achieving a high level of protection of human health and the environment. ### the population or the environment directly and indirectly affected by the violation , or could have been affected by the violation if it was not stopped in due time , bearing in mind the impact of the infringement on the objective of achieving a high level of protection of human health and the environment.


### — having regard to the 26th conference of the parties to the unfccc (cop26) , the 16th session of the meeting of the parties to the kyoto protocol (cmp16) , and the third session of the conference of the parties serving as the meeting of the parties to the paris agreement (cma3) , held in glasgow , uk , from 31 october to 13 november 2021 , ### — having regard to the 26th conference of the parties to the unfccc (cop26) , the 16th session of the meeting of the parties to the kyoto protocol (cmp16) , and the third session of the conference of the parties serving as the meeting of the parties to the paris agreement (cma3) , held in glasgow , uk , from 31 october to 13 november 2021 , and to the glasgow climate pact adopted on 13 november 2021;


### — having regard to the world meteorological organisation (wmo) report on the state of the global climate in 2020 of april 2021 , ### — having regard to the world meteorological organisation (wmo) report on the state of the global climate in 2021 of may 2022;


### b. whereas on 17 december 2020 , the eu and its member states submitted their updated intended nationally determined contributions (ndcs) to the unfccc , which commits the eu to a binding target of an economy-wide net domestic reduction of at least 55 % in greenhouse gas emissions by 2030 compared to 1990 levels; ### b. whereas on 17 december 2020 , the eu and its member states submitted their updated intended nationally determined contributions (ndcs) to the unfccc , which commits the eu to a binding target of an economy-wide net domestic reduction of at least 55 % in greenhouse gas emissions by 2030 compared to 1990 levels , without contribution from international credits;


### b. whereas on 17 december 2020 , the eu and its member states submitted their updated intended nationally determined contribution (ndc) to the unfccc , which commits the eu to a binding target of an economy wide net domestic reduction of at least 55% in greenhouse gas emissions by 2030 compared to 1990 levels; ### b. whereas on 17 december 2020 , the eu and its member states submitted their updated nationally determined contribution (ndc) to the unfccc , which commits the eu to a binding target of an economy wide net domestic reduction of at least 55% in greenhouse gas emissions by 2030 compared to 1990 levels without contribution from international credits;


### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; ### a. whereas the charter of fundamental rights of the european union recognises the fundamental right of citizens to health , quality of life and medical treatment and public health systems are crucial to guaranteeing equitable access to health care and safe , effective and affordable medicines; whereas patients should be at the centre of all health policies and involved throughout the medicines regulatory pathway; whereas access inequalities exist between and within member states and special regard should be paid to people in vulnerable situation with specific health risks , including women , children , the elderly , pregnant women , persons with disabilities , patients with chronic conditions and comorbidities , patients in intensive care units (icu) and persons on long-term medication;


### a. whereas health is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research; ### a. whereas health and equitable access to healthcare are fundamental to the well-being of europeans; whereas safe , affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies , alongside investment and research;


### a. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines; ### a. whereas the pandemic has reaffirmed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;


### b. whereas covid-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats , more european integration is necessary; whereas a european health union , which contributes to an increasingly social union , is key in this process; ### b. whereas covid-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats , more european integration is necessary; whereas a european health union should contribute to and foster closer cooperation , coordination and knowledge sharing on health between member states and relevant stakeholders;


### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; ### b. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit; whereas innovation and development and allocation of essential pharmaceuticals should be driven by medical and social needs , and governed by public mechanisms , particularly during health emergencies;


### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; ### c. whereas , in the spirit of the ‘one health’ approach , the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; whereas animal welfare should be ensured by meeting the goal of directive 2010/63/eu for full replacement of all animals that are used for scientific purposes;


### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation and climate neutrality; ### c. whereas the pharmaceutical strategy covers the full cycle of medicines , including research , testing , authorisation , consumption and disposal , and contributes to meeting the objectives of the european green deal , the digital transformation , the circular economy and climate neutrality;


### putting patients at the centre of all health policies ### putting patients and public health at the centre of pharmaceutical research and decision-making


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that public and private investment in research , including the development of innovative treatments , shall be driven by public health and unmet medical needs , defined with the involvement of regulators , academia , healthcare professionals , patients and payers at early stages of r&d , to ensure research priorities respond to societal needs and enable access to safe , effective , high-quality and affordable medicines , while ensuring collaboration and minimum duplication in ongoing studies;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research and the development of innovative medicines and treatments , as well as equal access to safe , effective , affordable and high-quality medicines , are essential for making progress in the prevention and treatment of diseases;


### 1. stresses that investment in research into and the development of innovative medicines and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases; ### 1. stresses that investment in research into and the development of innovative medicines , diagnostics and treatments , as well as access to safe , effective and high-quality medicines , are essential for making progress in the prevention and treatment of diseases;


### 1. calls on the commission to work towards a european public biomedical infrastructure covering the entire medicines value chain and to develop the prospective european health emergency response authority (hera) along those lines; ### 1. states that the current covid-19 crisis shows the need for more european cooperation in the health sector , calls for more eu competences in the sector; calls on the commission to take greater responsibility for investing in and shaping pharmaceutical innovation and work towards a european public biomedical infrastructure covering the entire medicines value chain and to develop the prospective european health emergency response authority (hera) along those lines; calls on the commission to ensure that beneficiaries of funding disbursed through the hera incubator commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new covid-19 variants;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); acknowledges the need to find innovative financing models for incentivizing research and development of novel medicine for diseases that are otherwise perceived as being unattractive to industry due to potentially low market value and revenue;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient in relation to quality of life and late effects of treatments , to meet the specific therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance(amr); calls for gender equality and additional research inpatient populations regularly excluded from clinical studies , such as children , pregnant women and the elderly;


### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr); ### 2. considers that investment in research has not been sufficient to meet the diagnostic and therapeutic needs of patients with rare or chronic diseases such as paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (amr);


### 2. emphasises the key importance of intellectual property protection in the eu , which is essential if the eu is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving european , national and regional institutions , along with health professionals , industry representatives and stakeholders , with a view to identifying shared approaches , in particular to the challenges posed by the covid-19 pandemic; ### 2. emphasises the key importance of an adapted intellectual property protection regime in the eu in order to respond to urgent health needs in the eu and worldwide; calls on the commission to authorise state aid and to supervise public funding as an incentives for manufacturers to relocate the manufacture of the active ingredients of medicinal products to europe , so that the eu is not dependent on third countries and has the means to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving european , national and regional institutions , along with health professionals , industry , research and patient representatives , as well as other civil society stakeholders , with a view to identifying shared approaches and best practices with short-term and long-term effect , in particular to the challenges posed by the covid-19 pandemic;


### 2. calls on the commission to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; ### 2. calls on the commission to pursue a public-driven model of r&d that ensures health innovations responding to real public health needs , to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; calls on the commission to promote the use of trips flexibilities to improve access to medicines;


### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced and that communication campaigns on amr be coordinated through a single calendar at eu level; ### 3. considers it imperative that the ‘one health’ approach guides reduction and use optimisation for antimicrobials , as well as the development of new medicines , including antimicrobial agents; stresses the importance of investment into the development of new non-animal methodologies , such as in silico and organoids , to shorten pre-clinical observation periods , increase efficiency in research and reduce unnecessary and often less reliable experiments on animals;


### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced and that communication campaigns on amr be coordinated through a single calendar at eu level; ### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced , setting up traceable antimicrobial use reduction targets at eu level and that communication campaigns on amr be coordinated through a single calendar at eu level;


### 3. stresses the importance of supporting research in the eu , not least in order to increase the number of patents filed in the member states; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention , in that connection , to the key role played by ai and its potential as a driver of research and development in the health and pharmaceutical sector; ### 3. stresses the importance of supporting research in the eu; further emphasises that public and private investment in research , including into and the development of innovative medicines and treatments , shall be driven by public health and unmet medical needs , with the involvement of regulators , academia , healthcare professionals and patients at early stages of r&d , to ensure research priorities respond to societal needs and enable as well as access to safe , effective and high-quality medicines; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low , such as orphan and paediatric drugs; whereas high degree of transparency should apply in publicly funded medical research from decision-making to investment and open science;


### 3. calls on the commission to develop a new incentive model , look into decoupling mechanisms as an alternative to exclusive protections , and attach strict conditions to public funds in accordance with the principle of fair return on investment; ### 3. calls on the commission to , attach strict conditions , including on pricing , transparency and availability , to public funds , incentives and rewards , in accordance with the principle of fair return on investment;


### 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. welcomes the intention to revise pharmaceutical legislation for orphan and paediatric medicines and addressing amr , with the aim of finding more affordable therapeutic options and meeting the needs of patients and health systems; calls on the commission to provide public research funding to investigate the use of repurposed , off-label and off-patent products that can be used safely and effectively in patients; stresses that medicines resulting from publicly funded research must be equally available across the union for a fair and affordable price; 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 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 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 incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising 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. stresses the importance of launching the unitary patent without delay , in order to create a one-stop shop for patent protection and enforcement across the eu and to do away with the fragmentation of the patent market and the obstacle that may pose to research and innovation; ### 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 facilitate and enable dialogue among the member states to steer cooperation in horizon scanning , pricing and reimbursement , including best practice and information exchange related to national pricing strategies , taking into account levels of public investment , cost of r&d , added therapeutic benefit and cost-effectiveness; such dialogue should further encourage cooperation in pricing negotiations and joint procurement and guidance on principles and costing methods for establishing r&d costs of medicines and their use at the national level; calls on the commission to promote information sharing among member states on medicine net prices through the euripid collaboration;


### 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;


### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; ### 5. stresses that public trust relies on full transparency; calls on the commission to ensure that ema has sufficient public funding and human capacity to sustainably cope with its transparency policy and obligations , both in normal times and in crisis situations; calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing;


### 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 periodically evaluate and review the incentive system and its criteria , increase price transparency ,highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote on and off-patent competition and the timely entry to market of generics and biosimilars; stresses the right balance between awarding incentives in medicines development , particularly where there exist no treatment alternatives , and preventing competition distortion and unintended effects on affordability and availability of medicinal products;


### 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. ### 6. stresses , lastly , the importance for european companies , in strategic sectors such as pharmaceuticals , and of effective and balanced enforcement of intellectual property rights , including in third countries where they operate;


### 6. calls on the commission to support pricing models based on real production costs; ### 6. calls on the commission to implement transparency obligations on research and development and production cost and to support pricing models based on these 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. 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; calls on the commission to address the misuse of the ipr (intellectual property rights) system to delay market entry of generic and biosimilar medicines; 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. 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. stresses that timely access to generic and biosimilar medicines is key to ensure 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. calls on the commission to draw conclusions from the experience of joint negotiations gained during the pandemic , to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently;


### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times at national level and align them with european medicines agency (ema) times , in order to ensure rapid and equal access to medicines for everyone in the eu; ### 8. welcomes the fact that the commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; welcomes and supports commission action against abuses of dominant positions in the pharmaceutical sector;


### 8. regrets the excessive influence of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions. ### 8. regrets the excessive influence to public authorities of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions; calls the commission and member states for a wide , comprehensive and genuine involvement of all relevant stakeholders , including patient and consumer groups to ensure balance between the public and commercial interests;


### 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 role of public-private partnerships in funding research into and the production of innovative medicines; stresses that such collaboration must guarantee that research priorities are driven by patient and public health needs and public funds are invested in a transparent manner , ensuring availability and affordability of products resulting from these partnerships and other public funds; calls on the commission to ensure that the european partnership for health innovation is driven by public interest considerations and to maximise public return on public investment; calls on the commission to adopt and implement a general policy on such conditionalities under horizon europe;


### 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. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for ,but not limited to , emergency medicines and unmet therapeutic needs; calls for exploration of such practices in areas of high priced medicines , including for rare diseases and cancer with a clear outline of milestones , objectives and commitments undertaken by all parties involved; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of covid-19 products;


### 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. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines , orphan medicines and unmet therapeutic needs;


### 11. is concerned that the affordability of medicines remains a challenge for national health systems , and that innovative medicines are expensive; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems; ### 11. is concerned that the affordability of medicines remains a systemic challenge for national health systems , a key access barrier for patients and that innovative medicines are expensive with often uncertain added clinical benefit; stresses the need for solid evidence , based on well-designed comparative randomised clinical trials to meet health needs with meaningful endpoints and to evaluate medicine; stresses that the regulatory framework must facilitate the best possible outcomes for patients and public interest;


### supporting a competitive and innovative eu pharmaceutical industry ### supporting a transparent competitive and innovative eu pharmaceutical industry to respond to public health needs


### 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 and predictable regulatory environment; welcomes the initiative to support real world evidence generation and to build interoperable digital infrastructure within the european health data space , while ensuring privacy and security of health data;


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### deleted


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### 13. calls on the commission to revise the use of supplementary protection certificates to prevent generic and biosimilar medicines from becoming competitive inside and outside the eu;


### 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 recognition and creating quality jobs in the eu along the entire pharmaceutical value chain and the medical field , including the health workforce , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the medical 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; ### deleted


### 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 gene sequencing 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; calls on the commission to encourage enhanced data generation on these new products through improved cooperation among regulatory agencies , hta bodies and patients organizations , healthcare professionals and pharmaceutical companies;


### 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. 16. calls on the commission to fully implement the clinical trials regulation9; welcomes the revision of pharmaceutical legislation , including for blood , tissues and cells products; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the re-purposing 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; stresses the need for more comparative and collaborative , multi-centre platform trials; stresses that comparative randomised double-blind well-designed clinical trials with relevant endpoints are necessary to meet the health needs and respond to questions or regulators , health technology assessment and health payers;


### 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 to develop the use of electronic product information for all medicines in the eu; stresses that electronic product information should complement , but not replace , the package information leaflet as a primary source of information for patients;


### 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 essential 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;


### 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;


### increasing resilience: secure supply chains , sustainable medicines , crisis preparedness and response mechanisms ### increasing resilience: prevention of medicine shortages , secure supply chains , sustainable medicines , crisis preparedness and response mechanisms


### 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. calls on the commission to heed the recommendations of the european parliament stated in resolution of 17 september 2020 on the shortage of medicines; recalls that the eu’s open strategic autonomy , particularly focused on production of critical products , contributes to the availability of medicines in all member states; calls on the commission to develop an early warning system for drug shortages , based on transparency of medicines' stocks and on a centralised european information network on medicine shortages , to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability and stocks of medicines; calls on the commission to develop a mechanism to safeguard transparency in production and supply chains and impose dissuasive sanctions in the event of non-compliance;


### 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. considers it essential to improve early communication with healthcare professionals and patients on the availability of medicines; supports the commission in its efforts to conduct a transparent and inclusive structured dialogue with players in the pharmaceutical value chain , public authorities , healthcare professionals , non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; calls on the commission to ensure a balanced representation of stakeholders;


### 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; calls on the commission to heed the calls of the european parliament in its resolution of 17september 2020 on a strategic approach to pharmaceuticals in the environment , in particular to revise the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of approval and use for medicines by including the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines; 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;


### the eu is leading the world in healthcare ### needs-driven and sustainable healthcare in the eu and the world


### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; ### 23. calls on the commission to further facilitate access to global markets for the eu pharmaceutical industry , including small and medium-sized enterprises , through a level playing field and a regulatory framework facilitating trade agreements that prize innovation-based competitiveness , in order to make the pharmaceutical sector a strategic pillar of the eu; calls on the commission to ensure that trade agreements contribute to improved access to safe , affective and affordable medicines in the eu and in third countries;


### 24. reiterates its commitment to continue working with the commission and the world health organization to standardise effective , safe and sustainable regulatory frameworks for medicinal products; ### 24. reiterates its commitment to continue working with the commission and the world health organization to improve access to safe , effective and affordable medicines;


### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; notes that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations; notes that any future cuts will negatively impact the functioning of the eea and the delivery of the european green deal; ### 3. notes that in 2020 , the eea's total budget was eur 63 229 066 (a 21 ,5% increase on 2019 although still below the 2018 figure) , of which eur 41 972 000 (representing an increase of 5 ,6 % compared to 2019) came from the general budget of the union; deplores the unsatisfactory level of funding for the eea which could have negative impacts on its performance; stresses that the eea is expected to play a key role (monitoring , reporting and validating) in supporting the european green deal actions and the 8th general union environment action programme1 ; insists therefore that the staff budget for the eea should be increased to meet these obligations and that the existing gaps between additional tasks and the funding of those obligations should be closed; insists that the increase in budget should not come at the expanse of the programmes , particularly the life programme; notes that any future cuts will negatively impact the functioning of the eea and the delivery of the european green deal;