### if the competent authorities of dispatch and of destination cannot agree on the classification as regards the distinction between waste and non-waste , the object or substance shall be treated as if it were waste for the purpose of the shipment. this shall be without prejudice to the right of the country of destination to deal with the shipped material in accordance with its national legislation , following arrival of the shipped material and where such legislation is in accordance with union or international law. ### if the competent authorities of dispatch and of destination cannot agree on the classification as regards the distinction between waste and non-waste , the object or substance shall be treated as if it were waste for the purpose of the shipment. however , in the absence of harmonized end-of-waste criteria under union legislation , where objects or substances meet national end-of-waste criteria in the country of dispatch or of destination in accordance with article 6(3) of directive 2008/98/ec , or meet the criteria on a case-by-case basis in the country of dispatch or of destination in accordance with article 6(4) of directive 2008/98/ec , the classification as end-of-waste shall prevail. this classification shall also prevail for authorities in the country of transit. this shall be without prejudice to the right of the country of destination to deal with the shipped material in accordance with its national legislation , following arrival of the shipped material and where such legislation is in accordance with union or international law.


### if the competent authorities of dispatch and of destination cannot agree on the classification as regards the distinction between waste and non-waste , the object or substance shall be treated as if it were waste for the purpose of the shipment. this shall be without prejudice to the right of the country of destination to deal with the shipped material in accordance with its national legislation , following arrival of the shipped material and where such legislation is in accordance with union or international law. ### if the competent authorities of dispatch and of destination cannot agree on the classification as regards the distinction between waste and non-waste , the object or substance shall be treated as if it were waste for the purpose of the shipment. this shall be without prejudice to the right of the country of destination to deal with the shipped material in accordance with its national legislation , following arrival of the shipped material and where such legislation is in accordance with union or international law.


### 4. in order to facilitate the harmonised classification of waste listed in annex iii , annex iiia , annex iiib or annex iv in the union , the commission is empowered to adopt delegated acts in accordance with article 76 to supplement this regulation by establishing criteria , such as contamination thresholds , on the basis of which certain wastes shall be classified in annex iii , iiia , iiib or iv. ### 4. in order to facilitate the harmonised classification of waste listed in annex iii , annex iiia , annex iiib or annex iv in the union , the commission shall adopt delegated acts in accordance with article 76 , not later than two years after entry into force of this regulation , to supplement this regulation by establishing criteria , such as contamination thresholds , on the basis of which certain wastes shall be classified in annex iii , iiia , iiib or iv and the thresholds for characterising physical and chemical characteristics as being essentially similar. contamination thresholds shall be based on weight of the transported load.


### the commission is also empowered to adopt delegated acts in accordance with article 76 to supplement this regulation by establishing criteria to distinguish between used goods and waste , for specific categories of commodities for which this distinction is of particular importance for the export of waste from the union. ### the commission shall also adopt delegated acts in accordance with article 76 , not later than two years after entry into force of this regulation , to supplement this regulation by establishing criteria to distinguish between used goods and waste , for specific categories of commodities for which this distinction is of particular importance for the export of waste from the union. the criteria provided for in those delegated acts and those provided for in directive 2008/98/ec and other relevant union legislation shall be uniform.


### 1. in exceptional cases , and where the specific geographical or demographical situation warrants such a step , member states may conclude bilateral agreements making the notification procedure for shipments of specific flows of waste less stringent in respect of cross-border shipments to the nearest suitable facility located in the border area between the two member states concerned. ### 1. where the specific geographical or demographical situation warrants such a step , member states may conclude multilateral agreements making the notification procedure for shipments of specific flows of waste less stringent in respect of cross-border shipments to the nearest suitable facility located in the border area between the two member states concerned.


### waste listed in annex iii , annex iiia or annex iiib; ### waste listed under entries b1090 (batteries) , b1110 (electrical and electronic assemblies) , b1250 (end-of-life motor vehicles) , and b3140 (pneumatic tyres) in annex iii , annex iiia or annex iiib;


### 2. paragraph 1 shall not apply to exports of waste destined for recovery to a country included in the list of countries established in accordance with article 38 for the waste specified in that list. ### 2. paragraph 1 shall not apply to exports of:


### 2. paragraph 1 shall not apply to exports of waste destined for recovery to a country included in the list of countries established in accordance with article 38 for the waste specified in that list. ### 2. paragraph 1 shall not apply to exports of waste , listed under paragraph 1 of this article that has been obtained from recovery operations consisting of mechanical treatment and that meets quality specifications set by the industry or by relevant european standards , destined for recovery to a country included in the list of countries established in accordance with article 38 for the waste specified in that list.


### 1. where waste listed in annex iii , iiia , iiib or iv , waste not classified or mixtures of wastes not classified under one entry in either annex iii or annex iv are exported from the union and destined for recovery in countries to which the oecd decision applies , with or without transit through countries to which the oecd decision applies , the provisions of title ii shall apply mutatis mutandis , with the adaptations and additional provisions listed in paragraphs 2 , 3 and 5. ### 1. where waste listed in annex iii , iiia , iiib or iv , waste not classified or mixtures of wastes not classified under one entry in either annex iii or annex iv are exported from the union and destined for recovery in countries to which the oecd decision applies , with or without transit through countries to which the oecd decision applies , the provisions of title ii shall apply mutatis mutandis , with the adaptations and additional provisions listed in paragraphs 2 , 3 and 5 and subject to the periodic monitoring as referred to in article 41a and article 41b and the safeguard mechanism as referred to in article 42.


### 1. the commission shall monitor the levels of export of waste from the union to countries to which the oecd decision applies , with a view to ensuring that such exports do not lead to serious environmental or human health damages in the country of destination. as part of such monitoring , the commission shall assess requests from natural or legal persons which are accompanied by relevant information and data showing that export of waste from the union leads to serious environmental or human health damages in a country to which the oecd decision applies. ### 1. the commission shall monitor the levels of export of waste from the union to countries to which the oecd decision applies , with a view to ensuring that increase in exports do not lead to environmental or human health damages in the country of destination. as part of such monitoring , the commission shall assess requests from natural or legal persons which are accompanied by relevant information and data showing that export of waste from the union leads to environmental or human health damages in a country to which the oecd decision applies.


### 2. in cases where the export of waste from the union to a country to which the oecd decision applies has considerably increased within a short period of time , and there is insufficient evidence available demonstrating that the country concerned has the ability to recover this waste in an environmentally sound manner as referred to in article 56 , the commission shall request the competent authorities of the country concerned to provide , within 60 days , information on the conditions under which the waste in question is recovered and the ability of the country concerned to manage the waste in question. the commission may grant an extension of this time limit if the country concerned makes a reasoned request for an extension thereof. ### 2. in cases where the export of waste from the union to a country to which the oecd decision applies has increased by more than 100% within a period of one year , and there is insufficient evidence available demonstrating that the country concerned has the ability to recover this waste in an environmentally sound manner as referred to in article 56 , the commission shall request the competent authorities of the country concerned to provide , within 60 days , information on the conditions under which the waste in question is recovered and the ability of the country concerned to manage the waste in question. the commission may grant an extension of this time limit if the country concerned makes a reasoned request for an extension thereof.


### 2. in cases where the export of waste from the union to a country to which the oecd decision applies has considerably increased within a short period of time , and there is insufficient evidence available demonstrating that the country concerned has the ability to recover this waste in an environmentally sound manner as referred to in article 56 , the commission shall request the competent authorities of the country concerned to provide , within 60 days , information on the conditions under which the waste in question is recovered and the ability of the country concerned to manage the waste in question. the commission may grant an extension of this time limit if the country concerned makes a reasoned request for an extension thereof. ### 2. in cases where the export of any category of waste listed in annex ix to the basel convention from the union to a country to which the oecd decision applies has increased by a volume of 20% in tonnes in one month when compared to an average volume of last6 months period and there is insufficient evidence available demonstrating that the country concerned has the ability to recover this waste in an environmentally sound manner as referred to in article 56 , the commission shall request the competent authorities of the country concerned to provide , within 30 days , information on the ability of the country concerned to manage the waste in question.


### 2. in order to fulfil the obligation referred to in paragraph 1 , a natural or legal person intending to export waste from the union shall ensure that the facilities which will manage the waste in the country of destination have been subject to an audit by an independent and accredited third party with appropriate qualifications. ### 2. in order to fulfil the obligation referred to in paragraph 1 , a natural or legal person intending to export waste from the union shall ensure that the facilities which will manage the waste in the country of destination have been subject to an audit by an independent and accredited third party with appropriate qualifications according to national legislation.


### 3. the audit referred to in paragraph 2 shall verify compliance of the facility concerned with the criteria laid down in annex x. a legal or natural person shall not export waste to a facility which does not comply with those criteria. ### 3. the audit referred to in paragraph 2 shall verify compliance of the facility concerned , respectively for each relevant individual unit , with the criteria laid down in annex x. a legal or natural person shall not export waste to a facility which does not comply with those criteria.


### 4. a natural or legal person intending to export waste shall ensure that the facility which will manage the waste in the country of destination has been subject to an audit referred to in paragraph 2 prior to exporting waste to the facility concerned and that the audit is repeated at regular intervals , following a risk-based approach , with a minimum frequency of every three years after the first audit. ### 4. facilities intending to accept and treat waste exported from the union shall provide documentary evidence to the commission that they have been subject to an audit referred to in paragraph 2 prior to the import of the respective waste. such documentary evidence shall be provided in english and submitted to the european commission. such audit have to be repeated at regular intervals , following a risk-based approach , with a minimum frequency of every three years after the first audit.


### 5. a natural or legal person that has commissioned or carried out an audit for a given facility in accordance with paragraph 2 shall ensure that such audit be made available to other natural or legal person intending to export waste to the facility in question , under fair commercial conditions. ### deleted


### 5. a natural or legal person that has commissioned or carried out an audit for a given facility in accordance with paragraph 2 shall ensure that such audit be made available to other natural or legal person intending to export waste to the facility in question , under fair commercial conditions. ### 5. a natural or legal person that has commissioned or carried out an audit for a given facility in accordance with paragraph 2 shall ensure that such audit be made available to other natural or legal person intending to export waste to the facility in question , under fair commercial conditions. when making such information publicly available , the disclosure of confidential business information shall be prevented and personal data protected in accordance with the general data protection regulation (eu) 2016/679 (gdpr).


### 8. where an international agreement between the union and a third country to which the oecd decision applies recognises that the facilities in that third country will manage waste in an environmentally sound manner , in accordance with the criteria laid down in annex x , natural and legal persons which intend to export waste to that third country shall be exempted from the obligation in paragraph 2. ### deleted


### 9. upon request by a competent authority or an authority involved in inspections , a natural or legal person that is exempted pursuant to paragraph 8 , shall provide documentary evidence of the relevant international agreement as mentioned in that paragraph in a language acceptable to the competent authorities concerned. ### deleted


### 4. the waste shipment enforcement group shall meet at least twice a year. in addition to the members referred to in paragraph 2 , the chairperson may invite to the meetings , where appropriate , representatives of other relevant institutions , bodies , offices , agencies or networks. ### 4. the waste shipment enforcement group shall meet at least twice a year. in addition to the members referred to in paragraph 2 , the chairperson may invite to the meetings , where appropriate , representatives of other relevant institutions , bodies , offices , agencies , trade or industrial associations and civil society organisations , or networks.


### 2. the delegation of power referred to in articles 14(3) , 28(4) , 38(1) , 42(4) and 75 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation. the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period. ### 2. the delegation of power referred to in articles 14(3) , 28(4) , 38(1) , 41b(1) , 42(4) and 75 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation. the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period.


### 3. the delegation of power referred to in articles 14(3) , 38(1) , 42(4) and 75 may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force. ### 3. the delegation of power referred to in articles 14(3) , 38(1) , 41b(1) , 42(4) and 75 may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force.


### 6. a delegated act adopted pursuant to articles 14(3) , 28(4) , 38(1) , 42(4) and 75 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by two months at the initiative of the european parliament or of the council. ### 6. a delegated act adopted pursuant to articles 14(3) , 28(4) , 38(1) , 41b(1) , 42(4) and 75 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by two months at the initiative of the european parliament or of the council.


### by 31 december 2035 , the commission shall , taking into account , inter alia , the reports drawn up in accordance with article 69 , and the review referred to in article 59(5) , carry out a review of this regulation and submit a report on the results thereof to the european parliament and to the council , accompanied , if the commission deems it appropriate , by a legislative proposal. ### by 31 december 2030 , the commission shall , taking into account , inter alia , the reports drawn up in accordance with article 69 , and the review referred to in article 59(5) , carry out a review of this regulation and submit a report on the results thereof to the european parliament and to the council , accompanied , if the commission deems it appropriate , by a legislative proposal.


### however , the provisions set out in articles 4 , 7 , 8 and 9 , article 14(4) and (5) , and articles 15 , 16 , 18 , 26 , 35 , 38 , 41 , 42 , 43 , 44 , 45 , 47 and 48 , 50 , 51 , 54 and 55 of regulation (ec) no 1013/2006 shall continue to apply until [op: please insert the date two years after the date of entry into force of this regulation] and article 37 of that regulation shall continue to apply until [op: please insert the date three years after the date of entry into force of this regulation ]. ### however , articles 5 , 8 and 9 , article 14(14) and (15) , articles 15 , 16 ,18 , article 26(1) , (2) and (3) , and articles 35 , 41 , 47 , 48 , 49 , 50 , 51 , 54 and 55 from [op: please insert the date two years after the date of entry into force of the regulation] and articles 37 , 38 , 39 and 40 shall apply from [op: please insert the date 15 month years after the date of entry into force of the regulation] , and 43 and 44 shall apply from [op: please insert the date two years after the date of entry into force of the regulation].


### it shall apply from two months after the entry into force of the regulation. ### it shall apply from one year after the entry into force of the regulation.


### 1. the audit referred in article 43(2) verifies that the facility managing the waste in the country of destination complies with the following conditions: ### 1. the audit referred in article 43(2) verifies that the facility , in the meaning of article 3 (28) , which is managing the waste in the country of destination complies with the following conditions:


### (ii) adverse effects on the environment caused by its activities (in particular through adequate measures taken to monitor and address soil , water and air pollution , and other nuisances (odour , noise)); ### (ii) adverse effects on the environment caused by its activities (in particular through adequate measures taken to monitor and address soil , water and air pollution , and other nuisances (odour , noise)); to this end , the facility's actual performance , including emissions levels , must be reviewed and compared to particular requirements mandated by eu legislation , as well as appropriate bat related emission thresholds specified in the eu under directive 2010/75/eu.


### it establishes and is able to provide records of its waste management and waste shipment activities for the last five years; ### it establishes and is able to provide records of its waste management and waste shipment activities for the last five years , or , where constructed less than five years prior to the audit , it establishes and is able to provide records of its waste management and waste shipment activities for the time operating;


### 2. upon verifying compliance of a facility against the above criteria , the independent third party performing the audit must in particular take into account , as a point of reference and where relevant: ### 2. upon verifying compliance of a facility against the above criteria , the independent third party performing the audit must verify that all the activities carried out by the facility complies with:


### (2) the ozone layer protects humans and other living beings from harmful ultra-violet (uv) radiation from the sun. it is scientifically well established that continuous emissions of ozone depleting substances cause significant damage to the ozone layer , leading to significant adverse impacts on human health and ecosystems , the biosphere as well as to large economic implications if left unaddressed. ### (2) the ozone layer protects humans and other living beings from harmful ultra-violet (uv) radiation from the sun. it is scientifically well established that continuous emissions of ozone depleting substances cause significant damage to the ozone layer , leading to significant adverse impacts on human health and ecosystems , the biosphere as well as to large negative economic implications if left unaddressed.


### 2. this regulation also applies to products and equipment , and parts thereof , containing ozone depleting substances or whose functioning relies upon those substances. ### 2. this regulation also applies to products and equipment , and parts thereof , containing ozone depleting substances or whose functioning relies partly or entirely on those substances.


### by way of derogation from article 5(2) , the commission may , by means of implementing acts , following a request by a competent authority of a member state , authorise the export of products and equipment containing hydrochlorofluorocarbons where it is demonstrated that in view of the economic value and the expected remaining lifetime of the specific good , the prohibition of export would impose a disproportionate burden on the exporter , and such export is in line with national legislation in the destination country. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### by way of derogation from article 5(2) , the commission may , by means of implementing acts , following a request by a competent authority of a member state , authorise the export of products and equipment containing hydrochlorofluorocarbons where it is demonstrated that in view of the economic value and the expected remaining lifetime of the specific good , the prohibition of export would impose a disproportionate burden on the exporter , such export is in line with national legislation in the destination country and such products and equipment would , after the end of their life cycle and on the basis of national legislation , be handled by the given third country in such a way that would not give rise to the release of substances damaging to the ozone layer into the external environment. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### applications for licences shall be processed within 30 days. licences shall be issued in accordance with the rules and procedures laid down in annex vii. ### applications for licences shall be processed within 60 days. licences shall be issued in accordance with the rules and procedures laid down in annex vii.


### 5. each undertaking that holds a licence shall , during the period of validity of the license , notify the commission of any changes which might occur during the period of validity of the licence in relation to the information submitted in accordance with annex vii. ### 5. each undertaking that holds a licence shall , during the period of validity of the license , notify the commission without undue delay of any changes which might occur during the period of validity of the licence in relation to the information submitted in accordance with annex vii.


### 3. in cases of imports of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies upon those substances the importer , or where not available the declarant , indicated in the customs declaration or in the temporary storage declaration and in cases of exports the exporter indicated in the customs declaration , shall provide to customs authorities in the declaration the following , where relevant: ### 3. in cases of imports of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies partly or entirely on those substances the importer , or where not available the declarant , indicated in the customs declaration or in the temporary storage declaration and in cases of exports the exporter indicated in the customs declaration , shall provide to customs authorities in the declaration the following , where relevant:


### member states customs authorities shall designate or approve customs offices or other places and shall specify the route to those offices and places , in accordance with articles 135 and 267 of regulation (eu) no 952/2013 , for the presentation to customs of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies upon those substances at their entry into or at their exit from the customs territory of the union. those customs offices or places shall be sufficiently equipped to carry out the relevant physical controls based on risk analysis , and shall be knowledgeable on matters related to the prevention of illegal activities under this regulation. ### member states customs authorities shall designate or approve customs offices or other places and shall specify the route to those offices and places , in accordance with articles 135 and 267 of regulation (eu) no 952/2013 , for the presentation to customs of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies upon those substances at their entry into or at their exit from the customs territory of the union. those customs offices or places shall be sufficiently equipped with the necessary human and material resources to carry out the relevant physical controls based on risk analysis , and shall be knowledgeable on matters related to the prevention of illegal activities under this regulation.


### 3. by way of derogation from paragraph 1 , trade with any state or regional economic integration organisation subject to paragraph 1 in ozone depleting substances listed in annex i and equipment containing those substances or whose functioning relies upon those substances or which are produced by means of one or more such substances may be authorised by the commission , by means of implementing acts , to the extent that the state or regional economic integration organisation is determined by a meeting of the parties to the protocol pursuant to article 4(8) of the protocol to be in full compliance with the protocol and has submitted data to that effect as specified in article 7 of the protocol. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### 3. by way of derogation from paragraph 1 , trade with any state or regional economic integration organisation subject to paragraph 1 in ozone depleting substances listed in annex i and equipment containing those substances or whose functioning relies partly or entirely on those substances or which are produced by means of one or more such substances may be authorised by the commission , by means of implementing acts , to the extent that the state or regional economic integration organisation is determined by a meeting of the parties to the protocol pursuant to article 4(8) of the protocol to be in full compliance with the protocol and has submitted data to that effect as specified in article 7 of the protocol. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### 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 listed in annex i are avoided to the greatest 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 listed in annex i are avoided to the greatest extent possible by recovery for reuse or destruction of the foams and the substances contained therein.


### 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 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 , new reports of the sap , established under the protocol , or reports by another recognised agency of similar status.


### 1. the competent authorities of member states shall carry out checks to establish whether undertakings comply with their obligations under this regulation. ### 1. the competent authorities of member states shall carry out regular checks to establish whether undertakings comply with their obligations under this regulation.


### the economic benefits derived or expected to be derived from the infringement. ### the economic benefits derived or expected to be derived from the infringement.


### (2) the aarhus convention , ratified by the european community on 17 february 2005 by council decision 2005/370/ec , recognises that increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters , a free exchange of views , more effective participation by the public in environmental decision-making and , eventually , to a better environment. ### (2) the aarhus convention , ratified by the european community on 17 february 2005 by council decision 2005/370/ec , recognises that increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters , a free exchange of views , more effective participation by the public in environmental decision-making and , eventually , to a better environment. it can also be concluded that good public access to environmental information helps to improve the quality and effectiveness of regulation.


### (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 systematized information , provided by the member states , on the available scientific data on typically consistent causality links between certain pollutants and certain health conditions.


### (14) the aarhus convention , ratified by the european community on 17 february 2005 by council decision 2005/370/ec40 , recognises that increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters , a free exchange of views , more effective participation by the public in environmental decision-making and , eventually , to a better environment. ### 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 effective and dissuasive penalties applicable to its infringements and should ensure that they are implemented.


### use of water , energy and raw materials; ### information on the use of water , energy and raw materials;


### 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 services , assisted by the european environment agency (‘the agency’) shall incorporate the data reported by member states into the portal within 1 month of reporting by the member state concerned in accordance with paragraph 1.


### 3. each member state shall make available to the public its data , reported in accordance with article 5 and , where available , article 7(1) , in a continuous manner , free of charge and without restricting access to registered users. ### 3. each member state shall make available , without undue delay , to the public its data , reported in accordance with article 5 and , where available , article 7(1) , in a continuous manner , free of charge and without restricting access to registered users.


### 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 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 specific reasons for that particular situation.


### 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 , by appropriate means , public awareness of the portal and understanding and use of the data contained in it.


### — having regard to the un environment programme (unep) latest emissions gap report 2021 entitled ‘the heat is on’ of 26 october 2021 , ### — having regard to the un environment programme (unep) latest emissions gap report 2021 entitled ‘the heat is on’ of 26 october 2021 and adaptation gap report 2021 of 1 november 2021 entitled 'the gathering storm';


### — having regard to the european council conclusions of … , ### — having regard to the european council conclusions of 21 february 2022 on "eu climate diplomacy: accelerating the implementation of glasgow outcomes";


### 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; whereas this target has been inscribed in union law through regulation (eu) 2021/1119; whereas parliament has adopted its position on legislative acts implementing this target;


### (3) under article 118(1) of regulation (eu) 2019/6 , third country operators exporting animals and products of animal origin to the union are required to respect the prohibition of the use of antimicrobials for growth promotion and yield increase , as well as the prohibition of the use of antimicrobials reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials. ### (3) under article 118(1) of regulation (eu) 2019/6 , third country operators exporting animals and products of animal origin to the union are required to respect union standards and the prohibition of the use of antimicrobials for growth promotion and yield increase , as well as the prohibition of the use of antimicrobials reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials.


### (4) article 118 of regulation (eu) 2019/6 builds on the one health action plan against antimicrobial resistance (‘amr’)9 , by enhancing the prevention and control of amr and promoting a more prudent and responsible use of antimicrobials in animals. this is also reflected in the commission’s farm to fork strategy10 , in which the commission has set the ambitious target of reducing by 50% overall eu sales of antimicrobials used for farmed animals and in aquaculture by 2030. ### (4) article 118 of regulation (eu) 2019/6 builds on the one health action plan against antimicrobial resistance (‘amr’)9 , by enhancing the prevention and control of amr and promoting a more prudent and responsible use of antimicrobials in animals. moreover , the medically indicated use of antimicrobials contributes to animal welfare by ensuring healthy animals as well as providing safe and nutritious food , thus complementing the one health approach. in this regard , the decrease in antimicrobial sales in livestock farming since 2011 is acknowledged1a. this is also reflected in the commission’s farm to fork strategy10 , in which the commission has set the ambitious target of reducing by 50% overall eu sales of antimicrobials used for farmed animals and in aquaculture by 2030.


### 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 is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas the pandemic has demonstrated the weakness of european health care systems; whereas safe , innovative , 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 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 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 , and in every aspect of the medicine regulatory lifecycle;


### 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 is fundamental to the well-being of europeans and equitable access to healthcare is a pillar of the eu; whereas safe , affordable and innovative 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 revealed the strengths and 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 development , production and delivery of accessible , affordable , and available medicines can be supported by applying a predictable eu policy framework that fosters public and private investments benefitting both patients and society as a whole;


### 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 cooperation is necessary as well as a greater sharing of epidemiological and health data at european level; 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 , 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 cooperation and coordination is necessary; whereas a european health union , which contributes to these objectives , is key in this process;


### 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 equal accessibility , affordability , and availability of medicines and medicinal products is essential; whereas the eu can support this by applying a predictable policy framework that fosters public and private investments ensuring affordable patient access to medicines and benefit to society as a whole;


### 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 can only be achieved through policy which incentivises medical innovation , to the benefit of patients and society as a whole;


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


### 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 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; underlines that women are under-represented in clinical trials , resulting in late-stage studies with no sound data on the efficacy or side-effects of a drug in the female population , and that it is therefore necessary to differentiate safety data and analyses by sex;


### 1. stresses the importance of developing a new eu pharmaceutical strategy which is consistent with the union’s competences under the treaties and with the principles of proportionality and subsidiarity , as a means of stimulating the development of european enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; ### 1. stresses the importance of developing a new eu pharmaceutical strategy which is consistent with the union’s competences under the treaties and with the principles of proportionality and subsidiarity , as a means of stimulating the development of european enterprises and making them competitive at global level , of paving the way for scientific progress and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; stresses the need to draw up future european framework provisions for regulatory approval , access and incentives for innovation , accompanied by vigorous industrial policies , with attractiveness and predictable rules being regarded as the key to innovation , and to facilitate patients’ access to medicines; notes that eu pharmaceutical strategy and legislative measures must support european developers and producers in guiding scientific progress and remaining globally competitive; draws attention to the need to develop production chains within europe through the formulation of rational regulatory framework provisions that are compatible between the member states , thereby ensuring the supply of medicines by safeguarding the entire production process;


### 1. stresses the importance of developing a new eu pharmaceutical strategy which is consistent with the union’s competences under the treaties and with the principles of proportionality and subsidiarity , as a means of stimulating the development of european enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; ### 1. stresses that the eu has to build a stronger european health union in particular by supporting closer eu cooperation in research and development and by sharing health data;


### 1. stresses the importance of developing a new eu pharmaceutical strategy which is consistent with the union’s competences under the treaties and with the principles of proportionality and subsidiarity , as a means of stimulating the development of european enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more effective responses to future health emergencies; ### 1. stresses the need for and importance of introducing a new eu pharmaceutical strategy which is consistent with the union’s competences under the treaties and with the principles of proportionality and subsidiarity , as a means of stimulating the development of european enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more efficient and rapid responses to future health emergencies;


### 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. 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; considers that hera should closely collaborate with public and private entities to plan , coordinate and build an ecosystem of private and public capabilities which can provide suitable emergency frameworks for eu access to key raw materials in case of global supply chocks;


### 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 research and scientific progress have not yet been sufficient for the underserved areas of rare diseases , paediatric cancers and neurodegenerative diseases , or to deal with antimicrobial resistance (amr) concerning all amr concerning all amr pathogens , or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;


### 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. stresses that investments in research should prioritise the needs of patients and health systems and focus on the greatest unmet 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); ### 2. considers that investment in research and scientific progress have 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); ### 2. considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases , paediatric cancers , obesity 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 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; stresses that compulsory licensing should only be possible in exceptional cases , where no other solution can be found and where it appears to be justified and necessary to increase production capacity effectively;


### 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 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;


### 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 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 , aimed at promoting innovation and the availability and affordability of medicines across the eu;


### 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. points out that a strong eu intellectual property regime is essential for the continued innovation of medicines and vaccines , acknowledges that policy which incentivises medical innovation is in the interest of patients and society at large , including by ensuring that europe continues tobe competitive and an attractive location for r&;d investment;


### 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. points out that the protection of the social contract between european pharmaceutical companies , patients and society as a whole rests on the eu intellectual property framework; points out that the intellectual property framework acts as a driver of investments in research and development , which is essential to innovation;


### 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 investment and support for 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 , to be decided in close collaboration with interested parties , that is to say patients , consumers , healthcare professionals and not-for-profit researchers , and based on the added value to the patient , taking into account the severity of the disease , the costs and the alternative treatments possible; notes that public research should focus particularly on areas of low commercial interest; 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 , 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 facilitating and supporting research in the eu , in order to be world market leader in improving existing and developing new medicines which could then lead to an increase of the number of patents filed in the member states in this area; 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. 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 develop new targeted incentives to ensure equitable access to medicines also in areas where the development of products would otherwise not be sustainable;


### 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 build on the existing incentives regime , and improve it with additional incentives , such as transferable exclusivity extensions , for underserved therapeutic and prophylactic areas where the development of products would otherwise not be sustainable for companies , prioritising projects and amr , with the aim of finding more therapeutic and prophylactic options and meeting the needs of patients and health systems; calls on the commission to target its framework programme funding into projects where there is insufficient basic science to develop treatments , such as neurodegenerative disease; 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 strengthen the criteria in 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; emphasizes that eu funding should be steered towards projects where research is needed the most; invites the commission to evaluate 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 projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers (especially to incentivise first-in-child development of paediatric anticancer medicines) , 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 projects promoted by the pharmaceutical industry combating rare diseases , paediatric cancers , neurodegenerative diseases , obesity and the interlinkages with other noncommunicable 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; ### 4. draws attention to differences in the validity of patents and supplementary protection certificates in the various member states; stresses in this context 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;


### 4. calls on the commission to develop a mandatory european licence in order to be able to respond rapidly to health crises; ### 4. welcomes the commission's proposal to foster production and investment in europe as well as to simplify and streamline relevant procedures in order to be able to respond rapidly to health crises; points out that a regulatory framework which supports the open strategic autonomy of the eu will benefit patients also outside times of crises;


### 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 a well-structured and institutionalised dialogue with the member states and stakeholders to assess how national pricing may encourage investment in r&d in the eu , and guide a harmonised transformation towards an approach based on results and on the basic and most extensive needs of the population , considering 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 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 how to ensure a resilient , diversified and sustainable value chain that meets that delivers on the member states' healthcare objectives and meets the primary and broader needs of the population;


### 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 a high level dialogue with the member states and stakeholders , including patients and representatives from the health sector 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 such as quality and capacity of supply;


### 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 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 , or whether it is a generic or biosimilar medicine , and the primary and broader needs of the population;


### 5. calls on the commission to use all the means at its disposal to prevent counterfeit products from entering the market and so protect intellectual property rights holders and european citizens , as these products are often of low quality and pose a danger to health; ### 5. calls on the commission to use all the means at its disposal to prevent counterfeit products from entering the market and so protect intellectual property rights holders and european citizens , as these products are often of low quality and pose a danger to health; notes that this is compounded by the heavy economic impact , estimated at a loss of at least eur 10 billion for the european pharmaceutical industry and 37 000 jobs; notes that it is necessary to provide technical assistance to the member states for the proper implementation of the emvs;


### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; ### deleted


### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and pricing; ### 5. calls for public investment in r&d to be made transparent and for it to be reflected in product availability and affordability;


### 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 work with member states and relevant union and member state agencies to assess the root causes of shortages of pharmaceuticals and medicinal products within the union; and propose sustainable solutions that promote competition and preserves and strengthens the union's strong basis for innovation;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; calls on the commission to collaborate with member states and ema to identify and address the causes of shortages of medicines , find solutions and guarantee effective patient access to medicine;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to review the incentive system , increase price transparency , while taking into account the overall r&d efforts of the pharmaceutical industry and its implicit failure rate , 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 support pricing models based on real production costs; ### 6. calls on the commission to support pricing models based on real production costs , innovation and value to patients; calls also on the commission to investigate novel pricing and payment models and their possible impact on patient access to innovative 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. emphasizes that competition leads to lower prices and greater affordability; calls on the commission 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 take action that promotes research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines , emphasizes that such proposals must respect the individual needs and preferences of patients and their clinicians;


### 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 offer accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the commission to provide measures to support a greater market presence of these medicines , to harmonise and enlarge at european level the interpretation of the so-called “bolar provision ,” concerning possible exemptions on patents regulatory framework for generic drug manufacturers; further calls on the commission to design rules for the industry that promote research , development and production of generic and biosimilar medicines in europe and to promote harmonized european and member states guidelines for the implementation of physician-led switching of biologic medicines , including biosimilar medicines as defined by the european medicines agency;


### 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; 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;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. considers that the commission and member states could consider launching joint public procurement-procedures in times of health crises , as has been done during the covid-19 crisis , with simplified and transparent procedures in the interest of improved response times; highlights that joint public procurement should not hinder patient access , medical innovation or competition;


### 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; calls on the commission to look at the huge differences across eu of the average number of days between approval of a medicine and the moment it is available to the patients and to propose new ways to speed up the regulatory process;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; 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. strongly 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; calls on the commission to implement innovative solutions to reduce medicine shortage; 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; 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; 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 , diagnostic services and prevention measures 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; 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; stresses the need to reduce medicine approval times , setting a time limit for approval 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. regrets the excessive influence of industry interest groups , which is detrimental to public-health , patient and consumer associations and to trade unions. ### deleted


### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines; ### 9. highlights the benefits of public-private partnership tenders for national health systems in funding research into and the production of innovative medicines , only if driven by public interest considerations;


### 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; stresses that joint eu procurement should be implemented only in exceptional circumstances and for extraordinary cross-border public health threats , such as the covid-19 pandemic , if the purchase of products cannot be secured as efficiently by other means , to ensure patient’s access to 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 and unmet therapeutic needs; ### 10. notes the value of new joint eu public procurement contracts by the commission and the member states for emergency medicines and unmet therapeutic needs; stresses that such joint procurement initiatives should be undertaken only under exceptional circumstances and in situations where such action has a clear and demonstrable added value , such as serious cross-border health threats;


### 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 such as extraordinary health threats like the covid-19 pandemic; stresses that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the eu;


### 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. calls on the commission to assess the impact of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; stresses that joint public procurement should not hinder patient access , medical innovation or competition;


### 10. stresses the importance of new joint eu public procurement contracts by the commission and the member states , especially for emergency medicines and unmet therapeutic needs; ### 10. 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; research funding should focus on the objective of increasing patients innovative medicines;


### 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 challenge for national health systems , and that equitable access to innovative medicines is a challenge across member states; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition; highlights that decisions on the pricing and reimbursement of medicines are the purview of member states;


### 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 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 ensure equal access to medicines and medical products across the member states and stabilise and balance national drug pricing systems;


### 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 challenge for national health systems , and that innovative medicines are expensive; takes note of the commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing systems;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; calls on the commission to establish a unified supplementary protection certificate (spcs) for the internal market , following the excellent results achieved on national basis; welcomes the initiative to build interoperable digital infrastructure for the european health data space;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 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 only thrive globally with a clear , robust and efficient intellectual property system and that the framework for intellectual property must therefore be protected and preserved; welcomes the initiative to build interoperable digital infrastructure for the european health data space;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 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 , which will integrate data from real-world evidence;


### 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 , self-sufficient and sustainable 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 the european health data space and interoperable digital infrastructure;


### 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 , fosters innovation and is more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space;


### 12. insists that a competitive eu pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable , flexible and agile regulatory environment; believes that it can thrive globally with a clear , robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the european health data space; ### 12. insists that a competitive eu pharmaceutical industry based on research 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;


### 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; highlights that ehealth , home care , and technological innovation in addition to education campaigns are key weapons in infection control , treatment of covid-19 and other infectious 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; ### 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 promote sufficient expertise and to develop appropriate regulatory frameworks , to guide new business models and consistently ensure high standards for safe products , 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; ### 15. highlights the fact that gene and cell therapies , personalised medicine , nanomedicines and nanotechnology , next-generation vaccines , including the m-rna derivatives , 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;