### 19. acknowledges the important contribution of existing certification schemes to the further uptake of sustainable forest management; takes note of the commission’s announcement on developing a ‘closer-to-nature’ certification scheme; encourages the commission to cooperate with existing certification schemes and believes that to create added value , the certification must offer foresters a price premium for the provision of ecosystem services; ### 19. acknowledges the important contribution of existing market-driven certification schemes to the further uptake of sustainable forest management; relies on consumer demand and preferences to shape the development on these schemes also in the future; encourages the commission to cooperate with existing certification schemes and believes that to create added value , the certification must offer foresters a price premium for the provision of ecosystem services;


### 20. highlights that to unlock the full potential of forests to contribute to climate and circular economy targets , further research and development in the field of bio-based alternatives to fossil-based products are required and should be incentivised; underlines that a predictable regulatory environment is a precondition to attracting investments; ### 20. highlights that to unlock the full potential of forests to contribute to climate and circular economy targets , further research and development in the field of bio-based alternatives to fossil-based products are required and should be incentivised; underlines that a predictable regulatory environment is a precondition to attracting investments; stresses that such bio-based alternatives must offer consumers products at affordable prices; stresses that the regulatory environment must not lead to centralised decision-making by the eu


### 20. highlights that to unlock the full potential of forests to contribute to climate and circular economy targets , further research and development in the field of bio-based alternatives to fossil-based products are required and should be incentivised; underlines that a predictable regulatory environment is a precondition to attracting investments; ### 20. highlights that to unlock the full potential of forests to contribute to climate and circular economy targets , further research and development in the field of bio-based alternatives to fossil-based products are required and should be incentivised; underlines that a predictable regulatory environment is a precondition to attracting investments; encourages to continue supporting innovations related to wood , such as wood-based textiles that have high potential to substitute synthetic textile fibres and cotton.


### 21. believes that to improve the coordinated provision of environmental and economic forest services , relevant eu framework programmes must be better aligned; ### 21. believes that to improve the coordinated provision of environmental and economic forest services , relevant eu framework programmes must be better aligned; stresses that such coordination must not overlook the fact that there are significant differences in forest capacities and policies between member states; stresses that the new strategy should be in line with the principle of subsidiarity and with the council conclusions of 10 and 11 november 2020 , and that it should respect the competences of the member states in creating a realistic forest policy;


### 22. stresses that the implementation of the strategy must focus on enabling small-holders to deliver on the multiple forest functions and calls on the commission and the member states to ensure that support programmes , payment for ecosystem services schemes and research funding are attractive and easily accessible; ### 22. stresses that the implementation of the strategy must focus on enabling small-holders to deliver on the multiple forest functions and calls on the commission and the member states to ensure that support programmes , payment for ecosystem services schemes and research funding are attractive understandable and easily accessible;


### 24. stresses the importance of accurate , integrated and up-to-date data on europe’s forests and takes note of the initiative for a legislative proposal for a framework on forest observation , reporting and data collection; underlines that the broad availability , high quality and transparency of data are preconditions to meeting the goals of the strategy and believes that to deliver added value the framework must build on existing mechanisms and processes through a bottom-up approach to best use the expertise and experience present in the member states; ### 24. stresses the importance of accurate , integrated and up-to-date data on europe’s forests and takes note of the initiative for a legislative proposal for a framework on forest observation , reporting and data collection; reminds that the data must be collected from local actors; underlines that the broad availability , high quality and transparency of data are preconditions to meeting the goals of the strategy and believes that to deliver added value the framework must build on existing mechanisms and processes through a bottom-up approach to best use the expertise and experience present in the member states;


### 24. stresses the importance of accurate , integrated and up-to-date data on europe’s forests and takes note of the initiative for a legislative proposal for a framework on forest observation , reporting and data collection; underlines that the broad availability , high quality and transparency of data are preconditions to meeting the goals of the strategy and believes that to deliver added value the framework must build on existing mechanisms and processes through a bottom-up approach to best use the expertise and experience present in the member states; ### 24. stresses the importance of accurate , integrated and up-to-date data on europe’s forests and takes note of the initiative for a legislative proposal for a framework on forest observation , reporting and data collection , while avoiding administrative burdens; underlines that the broad availability , high quality and transparency of data are preconditions to meeting the goals of the strategy and believes that to deliver added value the framework must build on existing mechanisms and processes through a bottom-up approach to best use the expertise and experience present in the member states;


### 26. takes note of the idea to introduce strategic plans for forests under the framework on forest observation , reporting and data collection; further notes that several member states already have national strategies for forests in place; ### 26. takes note of the idea to introduce strategic plans for forests under the framework on forest observation , reporting and data collection; further notes that several member states already have national strategies for forests in place calls on the commission to give priority to the existing national strategies over strategic plans on eu level.


### 27. believes that due to the multi-functional contribution of forests to high-level eu goals and the different administrative levels and stakeholder groups involved , the cornerstones of the strategy’s implementation must be close cooperation and the exchange of best practices with national and regional experts , stakeholders , forest managers , scientists and civil society; underlines that governance must take eu and member state engagement in international processes into account; ### 27. believes that due to the multi-functional contribution of forests to high-level eu goals and the different administrative levels and stakeholder groups involved , the cornerstones of the strategy’s implementation must be close cooperation and the exchange of best practices with national and regional experts , stakeholders , forest managers , scientists and civil society; underlines that governance must take eu and member state engagement in international processes into account; reminds that forests should not only be considered as co2 sinks and thereby reducing other sectors' contribution in minimising their emissions.


### b. whereas the tfeu makes no reference to a common eu forest policy; whereas article 4 tfeu provides for a shared competence on environmental policy; whereas due to the specific diversity of the eu’s forests with regard to bio-geography , structure , size , biodiversity and ownership patterns , where environmental policy touches upon forests , it is necessary to duly apply the principle of subsidiarity and proportionality in the development and implementation of the new eu forest strategy (the strategy) and relevant eu legislation; ### b. whereas the tfeu makes no reference to a common eu forest policy and therefore forest policy remains at member states' competence; whereas article 4 tfeu provides for a shared competence on environmental policy; whereas due to the extremely high diversity of the eu’s forests with regard to bio-geography , structure , size , biodiversity and ownership patterns , where environmental policy touches upon forests , it is necessary to duly apply the principle of subsidiarity and proportionality in the development and implementation of the new eu forest strategy (the strategy) and relevant eu legislation;


### c. whereas the principle of the european green deal as a cross-cutting approach to tackle the climate and environmental challenges in a way that creates sustainable growth and jobs in a resource-efficient , circular and competitive economy should guide the implementation of the strategy in managing trade-offs , creating synergies and finding the right balance between the multiple functions of forests including the socioeconomic , environmental and climate functions; ### c. whereas the principle of the european green deal as a cross-cutting approach to tackle the climate and environmental challenges in a way that creates sustainable growth and jobs in a resource-efficient , circular and competitive economy should be preceded by a comprehensive analysis of the cumulative impact of the strategy on the forestry sector , properly balancing environmental and economic aspects , so that it can contribute to creating synergies and finding the right balance between the multiple functions of forests including the socioeconomic , environmental and climate functions;


### d. whereas about 60 % of the eu’s forests are owned by 16 million private forest owners , of whom a significant share are small-holders; whereas involving and motivating these owners through a comprehensive policy and legislative framework , based on the recognition of their property rights , experience as managers and specific challenges , will be key to achieving the strategy’s targets , including the provision of climate and other ecosystem services; ### d. whereas about 60 % of the eu’s forests are owned by 16 million private forest owners , of whom a significant share are small-holders; whereas involving and motivating these owners through a comprehensive policy and legislative framework , based on the recognition of their property rights , experience as managers and specific challenges , will be key to achieving the strategy’s targets , including the provision of climate and other ecosystem services; emphasizes the need to avoid administrational burden on all actors.


### e. whereas most recent data gathered under article 17 of the habitats directive indicates that only 49 % of forests habitats have a good conservation status; whereas focusing solely on aggregated data might be insufficient to identify and address key information on the most urgent issues and it is therefore necessary to consult more specific indicators on trends in condition and pressures; whereas these indicators do not support an overall negative assessment of the state of the eu’s forests , but show both positive and negative trends that require nuanced responses; ### e. whereas most recent data gathered under article 17 of the habitats directive indicates that only 49 % of forests habitats have a good conservation status; whereas focusing solely on aggregated data might be insufficient to identify and address key information on the most urgent issues and it is therefore necessary to consult more specific indicators especially created by forest europe , on trends in condition and pressures; whereas these indicators do not support an overall negative assessment of the state of the eu’s forests , but show both positive and negative trends that require nuanced responses;


### 8. recognises the key role of forests in protecting the climate and biodiversity; underlines that the multi-functional role of forests comprises multiple socioeconomic functions , such as the provision of raw materials , which leads to jobs and economic growth in rural areas , the provision of clean water and air , protection against natural hazards and recreational value; stresses that the implementation of the strategy must ensure a balanced provision of all services and maintain competitiveness and innovation; underlines that the successful provision of services requires sustainable active management; ### 8. recognises the key role of forests in protecting the climate and biodiversity; underlines that the multi-functional role of forests comprises multiple socioeconomic functions , such as the provision of raw materials , which leads to jobs and economic growth in rural areas , the provision of clean water and air , protection against natural hazards and recreational value , as well as economic functions and serving to anchor rural populations to the land; stresses that the implementation of the strategy must ensure a balanced provision of all services and maintain competitiveness and innovation; underlines that the successful provision of services requires sustainable active management;


### 9. stresses that forests contribute to climate change mitigation via carbon sequestration , carbon storage and the substitution of wood and wood products for fossil fuels and derived products; notes that the strategy has a particular focus on storage in the construction sector and believes its implementation should support a broader use of different options for substitution , in line with the goals of the bioeconomy strategy; ### 9. stresses that forests contribute to climate change mitigation via carbon sequestration , carbon storage and the substitution of wood and all wood products for fossil fuels and derived products; notes that the strategy has a particular focus on storage in the construction sector and believes its implementation should support a broader use of different options for substitution , in line with the goals of the bioeconomy strategy; emphasizes the role of research on substitution of fossil-based materials and fossil fuels.


### 10. highlights that for wood-based products to contribute optimally to climate change mitigation and a circular economy requires that they be used in the most efficient and sustainable way; believes that the cascading principle8 is a good guideline for efficient use , but must not use a static approach and therefore must be adjusted regularly to reflect innovative uses; stresses that a well-functioning , un-distorted market incentivises the efficient use of wood-based resources; ### 10. highlights that for wood-based products to contribute optimally to climate change mitigation and a circular economy requires that they be used in the most efficient and sustainable way; stresses that a well-functioning , un-distorted market incentivises the efficient use of wood-based resources;


### 11. underlines the importance of a reliable supply of wood , wood-based products and forest-based biomass to achieve the eu’s sustainability goals and notes that the demand is expected to continue to grow; believes that the eu’s forestry sector provide the most sustainably sourced raw materials; calls on the commission to consider displacement effects and monitor any effects on the availability of wood following the implementation of measures under the strategy; ### 11. underlines the importance of a reliable supply of wood , wood-based products and forest-based biomass to achieve the eu’s sustainability goals and notes that the demand is expected to continue to grow; believes that the eu’s forestry sector provide the most sustainably sourced raw materials; calls on the commission to consider displacement effects and monitor any effects on the availability of wood following the implementation of measures under the strategy; after the russian invasion of ukraine on 24 february 2022 , highlights the crucial importance of the eu’s security of supply and own raw material production.


### 12. recalls that 2.1 million people work in the forest-based sector , while the extended forest-based value chain supports 4 million jobs in the green economy; calls on the commission and the member states to assess the effects of a shift in the balance of forest functions on the overall employment situation; ### 12. recalls that 2.1 million people work in the forest-based sector , while the extended forest-based value chain supports 4 million jobs in the green economy; calls on the commission and the member states to assess the effects of a shift in the balance of forest functions on the overall employment situation and the profitability of the local timber sector;


### the amount of waste does not exceed 150 kg or any higher amount agreed on a case-by-case basis by the competent authorities concerned and the notifier. ### the amount of waste does not exceed 150 kg for laboratory analysis , 25 000 kg for experimental treatment trials or any higher amount agreed on a case-by-case basis by the competent authorities concerned and the notifier.


### 1. only notifiers that have received a permit or are registered in accordance with chapter iv of directive 2008/98/ec may submit a prior written notification (‘notification’). ### 1. notifiers that have received a permit or are registered in accordance with chapter iv of directive 2008/98/ec or waste producers or operators of experimental treatment trials may submit a prior written notification (‘notification’).


### 10. the commission shall , at the latest by [op: please insert date of two years after the date of entry into force of this regulation] , assess the feasibility of establishing a harmonised calculation method for determining the amount of financial guarantees or equivalent insurances and , if appropriate , adopt an implementing act to establish such a harmonised calculation method. that implementing act shall be adopted in accordance with the examination procedure referred to in article 77(2). ### 10. the commission shall , at the latest by [op: please insert date of one year after the date of entry into force of this regulation] , assess for shipments within the union the feasibility of establishing a harmonised less financially burdensome system to replace conventional financial guarantees as established in this article and adopt an implementing act to establish such a harmonised less financially burdensome system for financial guarantees. that implementing act shall be adopted in accordance with the examination procedure referred to in article 77(2).


### 2. the competent authorities of destination , and , where appropriate , dispatch and transit , shall transmit their decision and the reasons thereof to the notifier within the 30-day time limit referred to in paragraph 1. that decision shall be available to all competent authorities concerned. ### 2. the competent authorities of destination , and , where appropriate , dispatch and transit , shall transmit their decision and the reasons thereof to the notifier within the 30-day time limit referred to in paragraph 1. that decision shall be available to all competent authorities concerned. the competent authorities of dispatch and destination have the responsibility to complete the notification within 30 days of submission. once this period has expired , the shipment is considered as approved and tacit approval is granted.


### where , within 30 days after submission of the notification , the competent authority of destination has not taken a decision under paragraph 1 , it shall provide the notifier with a motivated explanation upon request. ### deleted


### the routing of the different shipments , in particular the points of exit from and entry into each country concerned , as indicated in the notification document is the same. ### the routing of the different shipments as indicated in the notification document is the same.


### 3. within one day of the receipt of the waste by the facility which carries out the interim recovery operation or interim disposal operation , that facility shall provide confirmation to the notifier that the waste has been received. this confirmation shall be supplied on , or annexed to , the movement document. ### 3. within 7 days and up to 30 days of the receipt of the waste by the facility which carries out the interim recovery operation or interim disposal operation , that facility shall provide confirmation to the notifier that the waste has been received. this confirmation shall be supplied on , or annexed to , the movement document.


### 1. waste referred to in article 4(3) and (4) that is intended to be shipped shall be subject to the general information requirements set out in paragraphs 2 to 7 of this article. ### 1. waste referred to in article 4(3) and (4) that is intended to be exported out of the union shall be subject to the general information requirements set out in paragraphs 2 to 7 of this article. for shipments within the union , paragraphs 3 and 7 – 11 apply accordingly.


### 3. the person referred to in paragraph 2 shall ensure that the information referred to in that paragraph is made electronically available , including during the time of the transport , to the relevant authorities. ### 3. the person referred to in paragraph 2 shall ensure that the information referred to in that paragraph is made electronically available , including during the time of the transport , to the relevant authorities. sentence one shall not apply in the case of waste shipments of green listed waste in the union according to annex iii.


### 4. the recovery facility or the laboratory and the consignee or , in case they have no access to a system referred to in article 26 , the person referred to in paragraph 2 shall , within one day of receipt of the waste , provide confirmation to the notifier and the relevant authorities that the waste has been received by completing the relevant information contained in annex vii. ### 4. the recovery facility or the laboratory and the consignee or , in case they have no access to a system referred to in article 26 , the person referred to in paragraph 2 shall , within three days of receipt of the waste , provide confirmation to the notifier and the relevant authorities that the waste has been received by completing the relevant information contained in annex vii.


### the competent authorities of dispatch or destination shall make publicly available by appropriate means information on notifications of shipments they have consented or objected to , as well as on shipments of waste subject to the general information requirements , where such information is not confidential under national or union legislation. ### the competent authorities of dispatch or destination shall make publicly available by appropriate means information on notifications of shipments they have consented or objected to , as well as on shipments of waste subject to the general information requirements , where such information is not confidential under national or union legislation. sentence one shall not apply in the case of waste shipments in the union or shipments of green listed waste in accordance to annex iii.


### 1. any notification , information , documentation or other communication submitted pursuant to the provisions of this title shall be provided in a language acceptable to the competent authorities concerned. ### 1. any notification , information , documentation or other communication submitted pursuant to the provisions of this title shall be provided in a language acceptable to the competent authorities concerned , as well as in english.


### 2. the notifier shall provide the competent authorities concerned with authorised translations of the documents referred to in paragraph 1 into a language which is acceptable to them , where they so request. ### 2. any information provided should be machine translated by the centralized database system established in article 26 of this regulation.


### 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.


### 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. member states may conclude bilateral or multilateral agreements making the notification procedure for shipments of specific flows of waste less stringent in respect of cross-border shipments to a suitable facility located in the border area between the two or more member states concerned.


### 2. the bilateral agreements referred to in paragraph 1 may also be concluded where waste is shipped from and treated in the country of dispatch but transits another member state. ### 2. the agreements referred to in paragraph 1 may also be concluded where waste is shipped from and treated in the country of dispatch but transits another member state.


### 3. member states may also conclude bilateral agreements referred to in paragraph 1 with countries that are parties to the agreement on the european economic area. ### 3. member states may also conclude agreements referred to in paragraph 1 with countries that are parties to the agreement on the european economic area.


### 15. waste recovered at the recovery facility: ### deleted


### 3. the list referred to in paragraph 1 shall be adopted by [op please insert the date 30 months after the date of entry into force of this regulation] , unless no country submits a request pursuant to article 39(1) or no country complies with the requirements set out in article 39(3) at that time. ### 3. the list referred to in paragraph 1 shall be adopted by [op please insert the date 15 months after the date of entry into force of this regulation] , unless no country submits a request pursuant to article 39(1) or no country complies with the requirements set out in article 39(3) at that time.


### in order to be included in the list of countries to which exports are authorised adopted by [op please insert the date 30 months after the date of entry into force of this regulation] , the countries to which the oecd decision does not apply shall submit their request pursuant to article 39(1) by [op please insert the date 9 months after the date of entry into force of this regulation]. ### in order to be included in the list of countries to which exports are authorised adopted by [op please insert the date 15 months after the date of entry into force of this regulation] , the countries to which the oecd decision does not apply shall submit their request pursuant to article 39(1) by [op please insert the date 6 months after the date of entry into force of this regulation].


### 4. the commission shall regularly , and at least every two years following its establishment , update the list of countries to which exports are authorised , in order to: ### 4. the commission shall regularly , and at least every year following its establishment , update the list of countries to which exports are authorised , in order to:


### the countries included in the list referred to in paragraph 1 shall in any case , on the fifth year after their initial inclusion , provide to the commission an update of the information specified in the form set out in annex viii , together with relevant supporting evidence. ### the countries included in the list referred to in paragraph 1 shall in any case , on the second year after their initial inclusion , provide to the commission an update of the information specified in the form set out in annex viii , together with relevant supporting evidence.


### 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 plastic 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.


### 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 plastic 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.


### 4. where , further to the request referred to in paragraph 2 , the country concerned does not provide sufficient evidence as referred to in paragraph 3 that the waste is managed in an environmentally sound manner in accordance with article 56 , the commission is empowered to adopt delegated acts in accordance with article 76 to supplement this regulation by prohibiting the export of the waste concerned to this country. ### 4. where , further to the request referred to in paragraph 2 , the country concerned does not provide sufficient evidence as referred to in paragraph 3 that the waste is managed in an environmentally sound manner in accordance with article 56 , the commission is empowered to adopt delegated acts in accordance with article 76 to supplement this regulation by subjecting the export of the waste concerned to this country to the procedure of prior written notification and consent or to an audit demonstrating that the facilities which are to receive the waste in the country of destination will manage it in environmentally sound manner.


### this prohibition shall be lifted by the commission , when the commission has sufficient evidence that the waste concerned will be managed in an environmentally sound manner. ### this requirement shall be lifted by the commission , when the commission has sufficient evidence that the waste concerned will be managed in an environmentally sound manner.


### 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 , which are internationally recognised , accepted and certified using specific standards such as iso 19011 or equivalents. the auditing company and the auditor shall have experience and solid capacity in conducting due diligence-like audits.


### 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. ### 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 , equivalent in scope and objectives to the human health , environmental protection and social requirements laid down in union legislation and , 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


### 2. for the purposes of export of waste , the waste shipped shall be deemed to be managed in an environmentally sound manner as regards the recovery or disposal operation concerned , where it can be demonstrated that the waste will be managed in accordance with human health and environmental protection requirements that are broadly equivalent to the human health and environmental protection requirements laid down in union legislation. when assessing such broad equivalence , full compliance with requirements stemming from union legislation shall not be required , but it should be demonstrated that the requirements applied in the country of destination ensure a similar level of protection of human health and the environment than the requirements stemming from union legislation. ### 2. for the purposes of export of waste , the waste shipped shall be deemed to be managed in an environmentally sound manner as regards the recovery or disposal operation concerned , where it can be demonstrated that the waste will be managed in accordance with human health and environmental protection requirements that are equivalent in scope and objectives to the human health and environmental protection and social requirements laid down in union legislation. when assessing such equivalence , full compliance with requirements stemming from union legislation shall not be required , but it should be demonstrated that the requirements are legally enforced in the country of destination and ensure a similar level of protection of human health and the environment than the requirements stemming from union legislation.


### 1 eu legislation designed to ensure the environmentally sound management of waste ### deleted


### (21) the licensing system on imports and exports of ozone depleting substances is an essential requirement under the protocol for monitoring trade and preventing illegal activities in this respect. in order to ensure automatic , real-time , customs controls , at shipment level as well as an electronic exchange and storing of information on all shipments of substances and products and equipment covered by this regulation presented to customs it is necessary to interconnect the electronic licensing system for ozone depleting substances with the european union single window environment for customs established by regulation (eu) no …/… of the european parliament and of the council [full reference to be inserted once that regulation has been adopted].25 given this interconnection with the european single windows environment for customs it is disproportionate to provide for a shipment licencing system in the union. ### (21) the licensing system on imports and exports of ozone depleting substances is an essential requirement under the protocol for monitoring trade and preventing illegal activities in this respect. in order to ensure automatic , real-time , customs controls , at shipment level as well as an electronic exchange and storing of information on all shipments of substances and products and equipment covered by this regulation presented to customs it is necessary to interconnect the electronic licensing system for ozone depleting substances with the eu single window environment for customs established by regulation (eu) no …/… of the european parliament and of the council [full reference to be inserted once that regulation has been adopted].25 an adaptation period is required for this interconnection with the national customs authorities systems via the eu single window environment for customs as through this interconnection , the validity of licences will be automatically checked at customs for every single shipment. until the eu single window environment for customs is fully operable in all member states , the current licensing system should continue.


### this regulation lays down rules on the production , import , export , placing on the market , further supply as well as use , recovery , recycling , reclamation and destruction of ozone depleting substances , on the reporting of information related to those substances and on the import , export , placing on the market , further supply and use of products and equipment containing ozone depleting substances or whose functioning relies upon on those substances. ### this regulation lays down rules on the production , import , export , placing on the market , further supply as well as use , recovery , recycling , reclamation and destruction of ozone depleting substances , on the reporting of information related to those substances and on the import , export , placing on the market , further supply and utilisation of products and equipment containing ozone depleting substances or whose functioning relies upon on those substances.


### (5) ‘placing on the market’ means the supplying or making available to another person within the union , for the first time , for payment or free of charge , the customs release for free circulation in the union , and the use of substances produced or the use of products or equipment manufactured for own use; ### (5) ‘placing on the market’ means the supplying or making available to another person within the union , for the first time , for payment or free of charge , the customs release for free circulation in the union , and the use of substances produced or the utilisation of products or equipment manufactured for own purposes;


### (11) ‘products and equipment’ means all products and equipment , including parts thereof , except containers , used for the transportation or storage of ozone depleting substances; ### (11) ‘products and equipment’ means all products and equipment , including parts thereof , except containers , utilised for the transportation or storage of ozone depleting substances;


### 2. the commission may , by means of implementing acts , determine any essential laboratory and analytical uses for which the production and import of ozone depleting substances may be permitted in the union , the period for which the exemption is valid and those users which may take advantage of those essential laboratory and analytical uses. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2). ### 2. the commission may , by means of implementing acts , determine any essential laboratory and analytical uses for which the production and import of ozone depleting substances listed in annex i may be permitted in the union , the period for which the exemption is valid and those users which may take advantage of those essential laboratory and analytical uses. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 28(2).


### amounts supplied or used; ### amounts received from suppliers and used;


### 1. in case of an emergency , where unexpected outbreaks of particular pests or diseases so require , the commission may , at the request of the competent authority of a member state , by means of implementing acts , authorise the temporary production , placing on the market , and use of methyl bromide , provided that the placing on the market and use of methyl bromide are allowed respectively under regulation (ec) no 1107/2009 and regulation (eu) no 528/2012. any unused quantities of methyl bromide shall be destroyed. ### 1. in case of an emergency , where unexpected outbreaks of particular pests or diseases so require , the commission may , at the request of the competent authority of a member state , by means of implementing acts , and upon notification to the ozone secretariat in accordance with decision ix/7 of the parties to the protocol , authorise the temporary production , placing on the market , and use of methyl bromide , provided that the placing on the market and use of methyl bromide are allowed respectively under regulation (ec) no 1107/2009 and regulation (eu) no 528/2012. any unused quantities of methyl bromide shall be destroyed.


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


### 3. products and equipment containing ozone depleting substances or whose functioning relies upon those substances shall be decommissioned when they reach the end of their life. ### 3. products and equipment containing ozone depleting substances listed in annex i or whose functioning relies upon those substances shall be decommissioned when they reach the end of their life.


### the licence referred to in the first subparagraph shall not be required in cases of temporary storage. ### the licence referred to in the first subparagraph shall not be required in cases of temporary storage as laid out in regulation (eu) no 952/2013.


### the licence referred to in the first subparagraph shall not be required in cases of re-export subsequent to temporary storage. ### the licence referred to in the first subparagraph shall not be required in cases of re-export subsequent to temporary storage as laid out in regulation (eu) no 952/2013.


### ozone depleting substances produced or placed on the market as feedstock , as process agents , or for essential laboratory and analytical uses as referred to in articles 6 , 7 and 8 may only be used for those purposes. ### ozone depleting substances listed in annex i produced or placed on the market as feedstock , as process agents , for destruction or reclamation or for essential laboratory and analytical uses as referred to in articles 6 , 7 , 8 and 12 may only be used for those purposes.


### containers containing the substances intended for the uses referred to in articles 6 , 7 and 8 shall be labelled with a clear indication that the substance may only be used for the applicable purpose. where such substances are subject to labelling requirements provided for in regulation (ec) no 1272/2008 , such indication shall be included in the labels referred to in that regulation. ### containers holding the substances intended for the uses referred to in articles 6 ,7 , 8 and 12 shall be labelled with a clear indication that the substance may only be used for the applicable purpose. where such substances are subject to labelling requirements provided for in regulation (ec) no 1272/2008 , such indication shall be included in the labels referred to in that regulation.


### customs authorities shall confiscate or seize substances , the substances and products and equipment that are prohibited by this regulation is prohibited for their disposal in accordance with articles 197 and 198 of regulation (eu) no 952/2013. market surveillance authorities shall also withdraw or recall from the market such substances and products and equipment in accordance with article 16 of regulation (eu) no 2019/1020 of the european parliament and the council33 . ### customs authorities shall confiscate or seize ozone depleting substances and products and equipment that are prohibited by this regulation for their disposal in accordance with articles 197 and 198 of regulation (eu) no 952/2013. market surveillance authorities shall also withdraw or recall from the market such substances and products and equipment in accordance with article 16 of regulation (eu) no 2019/1020 of the european parliament and the council33.


### 1. import and export of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies upon those substances from and to any state or regional economic integration organisation that has not agreed to be bound by the provisions of the protocol applicable to a particular controlled substance shall be prohibited. ### 1. import and export of ozone depleting substances listed in annex i and of products and equipment containing those substances or whose functioning relies upon those substances from and to any state or regional economic integration organisation that has not agreed to be bound by the provisions of the protocol applicable to a particular ozone depleting substance as listed in annex i shall be prohibited.


### 4. undertakings referred to in paragraph 3 shall retain records on the quantity and type of ozone depleting substances added and the quantity recovered during maintenance , servicing and final disposal of the equipment or system. they shall also retain records of other relevant information including the identification of the company or technician which performed the maintenance or servicing , as well as the dates and results of the leakage checks carried out. these records shall be retained for a minimum period of five years and shall be made available , upon request , to the competent authority of a member state and to the commission. ### 4. undertakings referred to in paragraph 3 and 3a shall retain records on the quantity and type of ozone depleting substances added and the quantity recovered during maintenance or servicing and final disposal of the equipment or system. they shall also retain records of other relevant information including the identification of the company or technician which performed the maintenance or servicing , as well as the dates and results of the leakage checks carried out. these records shall be retained for a minimum period of five years and shall be made available , upon request , to the competent authority of a member state and to the commission.


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


### 2. ozone depleting substances referred to in point 1 and mixtures containing those substances shall be supplied only in re-closable containers or high pressure cylinders smaller than three litres or in 10 millilitre or smaller glass ampoules , marked clearly as substances that deplete the ozone layer , restricted to laboratory and analytical uses and specifying that used or surplus substances are to be collected and recycled , if practical. the material shall be destroyed if recycling is not practical. ### 2. ozone depleting substances referred to in point 1 and mixtures containing those substances shall be supplied only in re-closable containers or high pressure cylinders smaller than three cubic decimetres or in 10 cubic centimetres or smaller glass ampoules , marked clearly as substances that deplete the ozone layer , restricted to laboratory and analytical uses and specifying that used or surplus substances are to be collected and recycled , if practical. the material shall be destroyed if recycling is not practical.


### any stocks; ### any stocks held at the beginning and the end of the reporting period;


### any quantities released for free circulation in the union , separately identifying imports for feedstock and process agent uses , for essential laboratory and analytical uses and for destruction. importers which imported controlled substances for destruction shall also communicate the actual final destination or destinations of each of the substances , providing separately for each destination the quantity of each of the substances and the name and address of destruction facility where the substance was delivered; ### any quantities released for free circulation in the union , separately identifying imports for feedstock and process agent uses , for essential laboratory and analytical uses and for destruction. importers which imported ozone depleting substances listed in annex i for destruction shall also communicate the actual final destination or destinations of each of the substances , providing separately for each destination the quantity of each of the substances and the name and address of destruction facility where the substance was delivered;


### any stocks waiting to be destroyed , including quantities contained in products or equipment; ### any stocks , held at the beginning and the end of the reporting period , waiting to be destroyed , including quantities contained in products or equipment;


### in the case of imports of controlled substances or products and equipment for destruction , the name(s) and address(es) of the facility(ies) where they will be destroyed; ### in the case of imports of ozone depleting substances listed in annex i or of products and equipment containing those substances for destruction , the name(s) and address(es) of the facility(ies) where they will be destroyed;


### — having regard to the european council conclusions of … , ### deleted


### — having regard to the council conclusions of … , ### deleted


### — having regard to its resolution of resolution of 28 november 2019 on the 2019 un climate change conference in madrid , spain (cop 25)1 , ### deleted


### 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 member states’ national health policies; whereas safe , effective and affordable medicines are needed to combat all diseases; whereas public interest and patient safety and well-being 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 a number of problems that already existed in the eu , such as shortages of essential medicines and the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;


### b. whereas covid-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience of our national health systems to cross-border threats , more european integration is necessary; whereas a european health union , which contributes to an increasingly social union , is key in this process; ### b. whereas covid-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the eu’s strengths and weaknesses; whereas in order to strengthen the resilience and integrity of our national health systems to cross-border health threats , more european cooperation is necessary; whereas a european health union plays an important role 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 universal , equitable access to medicines is a fundamental right;


### 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 realization of which can be achieved through policy ecosystem that fosters 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 , consumption and disposal , the digital transformation and climate neutrality;


### 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 value chain of medicines , and to develop the prospective european health emergency response authority (hera); recognises the importance of involving all stakeholders in the development and activities of hera , building on the positive experiences of public-private partnerships throughout the covid-19 pandemic;


### 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 so far not resulted in developing successful therapies for patients with rare diseases , chronic diseases including cancer and paediatric cancers , and neurodegenerative diseases , or in means to deal with the growing threat of antimicrobial resistance (amr) , concerning all amr pathogens , or to prevent infectious diseases outbreaks; calls for the introduction of new targeted measures 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. considers that research and scientific progress have not yet been sufficient for the underserved areas of rare diseases , paediatric cancers and neurodegenerative diseases , to deal with antimicrobial resistance (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. 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); calls for unmet needs and the concept of additional therapeutic value too be more closely defined.


### 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; stresses that intellectual property rights enhance the accessibility , innovation and competitiveness of the sector and improve the safety of medicines and of patients; calls for the role of the member states to be enhanced by improving communication and cooperation between the european institutions , national authorities , health professionals , industry representatives and stakeholders;


### 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 , and exist in the interest of patients and society at large , including by ensuring that europe continues to be an attractive location for r&;d investment and industrial development;


### 2. calls on the commission to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; ### 2. calls on the commission to maintain simple public access to patenting and licensing conditions , information on clinical and pre-clinical trials and public and private contributions;


### 2. calls on the commission to keep the results of union-funded r&d in the public domain; points out that the protection of patents must not run counter to the right to health; ### 2. calls on the commission to ensure that the results of public funded r&d (either on union or member state-level) shall benefit the public health;


### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be introduced and that communication campaigns on amr be coordinated through a single calendar at eu level; ### 3. considers it imperative that a common eu therapeutic guide for antimicrobials be drafted in close cooperation with all relevant authorities; recommends that this guidance document be introduced and that communication campaigns on amr be coordinated more closely at eu level;


### 3. stresses the importance of supporting research in the eu , not least in order to increase the number of patents filed in the member states; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention , in that connection , to the key role played by ai and its potential as a driver of research and development in the health and pharmaceutical sector; ### 3. stresses the importance of supporting research in the eu , 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 , such as orphan drugs , paediatric cancer therapies and antimicrobial resistance (amr) drugs; calls for unmet needs and the concept of additional therapeutic value to be more closely defined; 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 , in areas where the development of products would otherwise not be sustainable for companies , such as transferable market exclusivities to stimulate the development of new antimicrobials , based on decoupling mechanisms;


### 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 medicines for underserved therapeutic and prophylactic areas , where the development of products would otherwise not be sustainable for companies , prioritising projects combating rare diseases , paediatric cancers , 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 , together with the member states , to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs , prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry to combat rare diseases , cancer , including 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 actively promote awareness and provide for guidance and support with the implementation of national plans to fight these diseases;


### 4. stresses the importance of launching the unitary patent without delay , in order to create a one-stop shop for patent protection and enforcement across the eu and to do away with the fragmentation of the patent market and the obstacle that may pose to research and innovation; ### deleted


### 4. calls on the commission to develop a mandatory european licence in order to be able to respond rapidly to health crises; ### 4. takes the view that , in health emergencies involving shortages of medicines or vaccines , suspending patents is not a short-term solution to the problem; calls on the commission to look into the development of exceptional mechanisms to make it possible to respond rapidly to health crises based on an impact analysis; takes the view that , in such crises , the commission should work within a long-term framework and draw up a plan for the production of medicines or vaccines and , alternatively , identify solutions such as voluntary licensing by pharmaceutical companies to companies with production capacity , ensuring at all times that safety requirements are met;


### 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 initiatives to strengthen european capacities to be able to react quickly to health 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 high-level dialogue with the member states and stakeholders , including patient and industry representatives , to assess how national pricing can incentivise r&d investment in the eu , including considerations such as high environmental manufacturing standards , capacity of supply and investment in innovation , and to promote novel pricing and payment models to foster sustainability in european health systems , strong patient outcomes , and rewards for innovation , and drive a harmonised transformation to an outcomes-focused approach considering the value of the therapeutic and prophylactic 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 the dialogue with member states and stakeholders to include procurement criteria in national tenders , such as 'resilient and robust supply chain management ,’ investments in manufacturing , investments made by the eu to support research , or also adaptation to the value of the therapeutic benefit of the medicine , and the primary and broad 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 actively promote dialogue with the member states and stakeholders to provide for more guidance with existing and potentially new criteria for national prices , such as whether a product ‘made in europe’ represents a more effective and affordable treatment alternative , whether the eu has invested in the product to support research , or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine , and the primary and broader needs of the population;


### 6. calls on the commission to review the incentive system , increase price transparency , highlight the causes limiting affordability and patient access to medicinal products , and propose sustainable solutions that also promote competition; ### 6. calls on the commission to work with member states and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines , and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the commission to enhance affordability , based on the fundamental pricing principle of solidarity across member states , adequately rewarding the value of medicines across eu member states and supporting the research-based industry as eu strategic , competitive and globally leading sector;


### 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 for maximum transparency in the use of public research and development funding and for easy public access to information regarding patenting/licensing conditions , the findings of clinical trials and public/private contributions.


### 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 to review the incentive system , increase price transparency when it comes to the costs calculated in the prices , highlight the causes for 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; ### deleted


### 6. calls on the commission to support pricing models based on real production costs; ### 6. calls on the commission to support novel pricing models based on real value to patients and wider society;


### 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 competition after loss of patent and exclusivity leads to price decreases , greater affordability and contributes greatly to the budgetary sustainability of healthcare systems; calls on the commission to harmonise at eu level the interpretation of the so-called bolar provision with the broader scope of the bolar exemption in force in the patent laws of most member states; further calls on the commission to 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 , in respect of individual patient needs and clinicians’ freedom to prescribe the best treatment choice for each patient;


### 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 broadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by generating cost savings while maintaining equal quality of care , as well as freeing up resources for the development of new treatments; calls on the commission to introduce the necessary and appropriate measures to support a greater market presence of these medicines and to harmonise and enlarge 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 common european guidelines for the implementation of physician-led switching of biologic medicine , including biosimilar medicines as defined by ema; underlines that for the purposes of these guidelines , “physician” must signify exclusively medical doctors authorised to prescribe medical products;


### 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 patent 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 harmonised european member state guidelines for the implementation of physician-led switching of biological 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 changes to the legislation and a simplified approval procedure to support a greater market presence of these medicines in specific cases; calls to harmonise at eu level the interpretation of the so-called bolar provision concerning possible exemptions from the legal framework for the unitary patent system for generic drug manufacturers; calls for the revision of the bolar provision to bring legal certainty to the sector and encourage investment in key areas; calls , furthermore , on the commission and the member states to design rules that are conducive to the promotion of research , development and the production of generic and biosimilar medicines in the eu and to propose eu protocols for the interchangeability of biosimilar medicines;


### 7. calls on the commission to promote joint procurement and apply most economically advantageous tender (meat) criteria more stringently; ### 7. calls on the commission to explore joint procurement only in exceptional circumstances and for extraordinary public cross-border health threats , such as the covid-19 pandemic , if purchase of products cannot be ensured as efficiently by other means , and apply the most economically advantageous tender (meat) criteria more stringently; highlights that joint public procurement should have a clearly defined scope and be limited in time , and should not hinder patient access , medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the eu or third countries , and should not jeopardise product choice , or create market distortion or any concentration of demand;


### 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. notes 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; stresses the need for member states to work towards making centrally authorised medicines available to patients at the time of european medicines agency (ema)’s approval , 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 devote more resources at european level to combat unfair and abusive market practices with regard to medicines; stresses the need to reduce and speed up 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. 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 order to fund research and production of innovative medicines and medicine repurposing;


### 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 eu joint procurement should be used only in exceptional circumstances and for extraordinary public cross-border health threats , such as the covid-19 pandemic , if purchase of products cannot be ensured as efficiently by other means , to ensure patient access to emergency medicines; highlights that joint public procurement should have a clearly defined scope and be limited in time , and should not hinder patient access , medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the eu or third countries , and should not jeopardise product choice , or create market distortion or any concentration of demand;


### 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 medicines during health crises , as well as unmet therapeutic needs , while taking into account the need for a better balance between public and private interests , including clear rules on liability for manufacturers , as well as the need for sufficient flexibility for member states , as well as respect for the principle of subsidiarity , due to national specificities or divergent financial capacities across the eu;


### 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 and timely competition as a key enabler for resilience and efficiency , as well as to stabilize and balance the national drugs 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; welcomes the commission’s intention to review pharmaceutical legislation to promote robust competition in order to support member states in stabilising and balancing 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 , which at the same time sustains a robust and responsible framework of requirements , safeguarding the principle of prevention and the availably of safe , effective and quality medicines on the eu market; 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 research-based 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 the european research-based pharmaceutical industry can only 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;


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### 13. calls on the commission to address the fragmented implementation of supplementary protection certificates (spcs) across member states by introducing a unified spc grant mechanism and/or create a unitary spc title;


### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; ### 13. calls on the commission to revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the eu; stresses that this revision should be accompanied by an impact assessment and take account of horizontal regulation in the area of intellectual property.


### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector , facilitating talent retention and mobility at eu level; ### 14. stresses the importance of creating quality jobs in the eu along the entire pharmaceutical value chain , with the support of the nextgenerationeu instrument; calls on the commission to propose measures to promote employment in the pharmaceutical sector in all eu member states , facilitating geographical balance , talent retention and employment opportunities across the whole eu;


### 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; stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large , for example by enabling a shift from expensive chronic management and care to one-time treatment , thereby reducing costs for health systems , and strengthening their efficacy , sustainability and resilience; urges the commission to ensure sufficient regulatory expertise to support intensive dialogue with developers , and to develop appropriate regulatory frameworks , including for new vaccines and therapeutics for use in emergencies and those addressing other unmet medical needs , to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality , 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 , radionuclide therapy , nanotechnology , next-generation vaccines , e-health and the ‘million plus genomes’ initiative can bring significant benefits in relation to the prevention , diagnosis , treatment and post-treatment of all diseases; stresses the transformative potential of these novel therapies and technologies for patients as well as societies at large , for example by enabling a shift from expensive chronic management and care to one-time treatment , thereby reducing costs for health systems , and strengthening their efficacy , sustainability and resilience; urges the commission , in close cooperation with member states , to develop appropriate regulatory frameworks , to guide new business models without compromising the high level of safety , quality and effectiveness of medicines , 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 that gene and cell therapies , personalised medicine , nanotechnology , next generation vaccines , e-health , medicines repurposing and the 'million plus genomes' initiative can bring enormous benefits in 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 promote information campaigns to raise awareness and encourage the application of these innovations;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; calls on the commission to establish mechanisms for continuous dialogue between the ecdc , ema and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety;


### 16. calls on the commission to fully implement the clinical trials regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network; ### 16. calls on the commission to fully implement the clinical trials regulation; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products , scientific advances and technological transformation and re-examine the need for exemptions in light of these advances , while safeguarding the interest of public health and of patients for safe , effective and quality medicines on the eu market; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety , supported by an eu-wide clinical trials network;


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