### within the limits of this regulation , member states may adopt by law specific rules regulating the processing of employees ' personal data in the employment context , in particular for the purposes of the recruitment , the performance of the contract of employment , including discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship . ### member states may , in accordance with national law and practices , adopt specific rules regulating the processing of employees ' personal data on the labour market , in particular but not limited to for the purposes of the recruitment , the performance of the contract of employment , including discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship .


### within the limits of this regulation , member states may adopt by law specific rules regulating the processing of employees ' personal data in the employment context , in particular for the purposes of the recruitment , the performance of the contract of employment , including discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship . ### member states shall adopt by law and practice specific rules regulating the processing of employees ' personal data in the employment context , in particular but not limited to the purposes of the recruitment or the performance of the contract of employment . this will include measures to outlaw the blacklisting of workers , the discharge of obligations laid down by law or by collective agreements , management , planning and organisation of work , health and safety at work , and for the purposes of the exercise and enjoyment , on an individual or collective basis , of rights and benefits related to employment , and for the purpose of the termination of the employment relationship .


### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . therefore , in order to regulate the processing of employees ‘ personal data in the employment context , member states should be able , within the limits of this regulation , to adopt by law specific rules for the processing of personal data in the employment sector . ### the general principles on the protection of individuals with regard to the processing of personal data should also be applicable to the employment context . member states should be able to regulate the processing of employees ' personal data in the employment context by law or by collective agreement in accordance with national practices of regulating personal data in the employment context between employer - and workers ' representatives . such collective agreements can also regulate the processing of personal data and be the primary legal instrument for the parties to the agreement . the regulation should not impose restrictions on collective agreements . where a statutory basis exists in the member state in question for the regulation of employment matters by agreement between employee representatives and the management of the undertaking or the controlling undertaking of a group of undertakings or under directive 2009 / 38 / ec of the european parliament and of the council of 6 may 2009 on the establishment of a european works council or a procedure in community - scale undertakings and community - scale groups of undertakings for the purposes of informing and consulting employees it should also be possible to regulate the processing of personal data in an employment context by such an agreement .


### for the purposes of paragraph 1 , the eib shall provide the commission with yearly reports on eib financing operations carried out under this decision at project , sector , country and regional level and on the fulfilment of the external policy and strategic objectives of the eu , including cooperation with the commission , other international financial institutions and bilateral institutions . ### for the purposes of paragraph 1 , the eib shall provide the commission with yearly reports on eib financing operations carried out under this decision at project , sector , country and regional level , on the accessibility , transparency and effectiveness of the loans , and on the fulfilment of the external policy and strategic objectives of the eu , including cooperation with the commission , other international financial institutions and bilateral institutions . the memoranda of understanding between the eib and other ifis or bilateral institutions relating to carrying out financial operations under this decision shall be made public .


### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level as well as the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . ### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level , evaluations of the accessibility , transparency and efficiency of the loans , as well as an assessment of the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing .


### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level as well as the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing . ### the commission shall report annually to the european parliament and the council on eib financing operations carried out under this decision . the report shall include an assessment of eib financing operations at project , sector , country and regional level , evaluations of the accessibility , transparency and effectiveness of the loans , as well as an assessment of the contribution of the eib financing operations to the fulfilment of the external policy and strategic objectives of the eu . the report shall in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines referred to in article 5 , and shall include sections on added value for the achievement of eu policy objectives as well as on cooperation with the commission and other international financial institutions and bilateral institutions , including co - financing .


### the reporting and transmission of information by the eib to the commission should be strengthened in order to allow the commission to enhance its annual report to the european parliament and the council on the eib financing operations carried out under this decision . the report should in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines , and include sections on added value in line with eu policies and sections on cooperation with the commission , other ifis and bilateral donors , including co - financing . where necessary , the report should include references to significant changes in circumstances that would justify further amendments to the mandate before the end of the period . ### the reporting and transmission of information by the eib to the commission should be strengthened in order to allow the commission to enhance its annual report to the european parliament and the council on the eib financing operations carried out under this decision . the report should in particular assess the compliance of eib financing operations with this decision , taking into account the operational guidelines , and include sections on added value in line with eu policies and sections on cooperation with the commission , other ifis and bilateral donors , including co - financing , as well as evaluations of the accessibility , transparency and efficiency of the loans . where necessary , the report should include references to significant changes in circumstances that would justify further amendments to the mandate before the end of the period .


### member states may introduce or maintain provisions which are more favourable than those laid down in this directive to ensure a more balanced representation of men and women in respect of companies incorporated in their national territory , provided those provisions do not create unjustified discrimination , nor hinder the proper functioning of the internal market . ### member states may introduce or maintain provisions which are more favourable than those laid down in this directive to ensure a more balanced representation of men and women in respect of companies incorporated in their national territory .


### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements . ### this directive lays down measures to ensure a more balanced representation of men and women among the directors of listed companies by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements .


### while this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , the introduction of certain minimum standards as regards the requirement for listed companies without balanced gender representation to take appointment decisions for non - executive directors on the basis of an objective comparative assessment of the qualifications of candidates in terms of suitability , competence and professional performance is necessary in order to attain gender balance among non - executives directors . only an eu - level measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life . ### this directive does not aim to harmonise national laws on the selection procedures and qualification criteria for board positions in detail , but requires listed companies without balanced gender representation to adjust their recruitment , selection and appointment procedures , amongst others by taking appointment decisions for directors so as to attain gender balance among directors . only an eu - level measure can effectively help to ensure a competitive level - playing field throughout the union and avoid practical complications in business life .


### in several member states , a certain proportion of the non - executive directors can or must be appointed or elected by the company ' s workforce and / or organisations of workers pursuant to national law or practice . the quantitative objectives provided for in this directive should apply to all non - executive directors including employee representatives . however , the practical procedures for ensuring that those objectives are attained , taking into account the fact that some non - executive directors are employee representatives , should be defined by the member states concerned . ### in several member states , a certain proportion of the non - executive directors can or must be appointed or elected by the company ' s workforce and / or organisations of workers pursuant to national law or practice . the quantitative objectives provided for in this directive should apply to all non - executive directors including employee representatives . however , the practical procedures for ensuring that those objectives are attained , taking into account the fact that some non - executive directors are employee representatives , should be defined by the member states concerned on the basis of careful and extensive consultations with social partners at the national level .


### in addition to the measures relating to non - executive directors , and with a view also to improving the gender balance among directors involved in daily management tasks , listed companies should be required to make individual commitments regarding the representation of both sexes among executive directors , to be achieved at the latest by 1 january 2020 . these commitments should aim to achieve tangible progress from the individual company ' s current position towards better gender balance . ### in addition to the incentives relating to executive directors , and with a view to further improving the gender balance among directors involved in daily management tasks , listed companies should be required to make individual commitments regarding the representation of both sexes among executive directors , to be achieved at the latest by 1 january 2020 , and by 1 january 2018 in case of public undertakings . these commitments should aim to achieve tangible progress from the individual company ' s current position towards better gender balance .


### the sanctions must be effective , proportionate and dissuasive and may include the following measures : ### the sanctions must be effective , proportionate , progressive and dissuasive and shall include the following measures :


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies and public undertakings in whose boards members of the under - represented sex hold less than 40 per cent of director positions should adjust their recruitment , selection and appointment procedures to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders .


### without prejudice to article 4 and , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the non - executive directors of listed companies may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and , provided that it can be shown that those measures enable members of the under - represented sex to hold at least 40 per cent of the non - executive director positions of listed companies by at the latest 1 january 2020 , or at the latest 1 january 2018 for listed companies which are public undertakings . ### without prejudice to article 4 and , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the directors of listed companies and public undertakings may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and , provided that it can be shown that those measures enable members of the under - represented sex to hold at least 40 per cent of the director positions of listed companies by at the latest 1 january 2020 , or at the latest 1 january 2018 for public undertakings .


### the number of non - executive director positions necessary to meet the objective laid down in paragraph 1 shall be the number closest to the proportion of 40 per cent , but not exceeding 49 per cent . ### the number of director positions necessary to meet the objective laid down in paragraph 1 shall be the number closest to the proportion of 40 per cent , but not exceeding 49 per cent .


### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published and , where the company in question has not met the objective , it should include a description of the measures that it has taken so far and intends to take in the future in order to meet the objective . ### member states should require listed companies to provide information on the gender composition of their boards as well as information on how they managed to meet the objectives laid down in this directive , on a yearly basis to the competent national authorities in order to enable them to assess the progress of each listed company towards gender balance among directors . such information should be published in an appropriate and easily accessible manner in the annual report and on the website and , where the company in question has not met the objective , it should include a comprehensive description of the measures that it has taken so far and intends to take in the future in order to meet the objective .


### administrative fines ; ### early warning followed by progressive administrative fines ;


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a vacancy announcement opening up for applications and a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders .


### member states shall ensure that listed companies are obliged to disclose , on the request of an unsuccessful candidate , the qualification criteria upon which the selection was based , the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate of the other sex . ### member states shall ensure that listed companies and public undertakings are obliged to disclose , on the request of an unsuccessful candidate , the qualification criteria upon which the recruitment , selection or appointment was based , the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate of the other sex .


### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the non - executive director positions make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the director positions adjust their recruitment , selection or appointment procedures , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . these procedures may include among others selecting on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria . whatever the procedure chosen , the adjustment shall aim at attaining the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings .


### proposal for a directive of the european parliament and of the council on improving the gender balance among non - executive directors of companies listed on stock exchanges and related measures ### proposal for a directive of the european parliament and of the council on improving the gender balance among non - executive directors of companies listed on stock exchanges and of small and medium - sized enterprises and related measures


### the number of non - executive director positions necessary to meet the objective laid down in paragraph 1 shall be the number closest to the proportion of 40 per cent , but not exceeding 49 per cent . ### the number of non - executive director positions necessary to meet the objective laid down in paragraph 1 shall be at least 40 per cent .


### determining the number of non - executive director positions necessary to meet the objective requires further specification since for most board sizes it is mathematically possible only to go beyond or remain below the exact share of 40 per cent . therefore , the number of board positions necessary to meet the objective should be the number closest to 40 per cent . at the same time , in order to avoid discrimination of the initially over - represented sex , listed companies should not be obliged to appoint members of the under - represented sex to half or more of the non - executive board positions . thus , for example , members of the under - represented sex should hold at least one position on boards with three or four non - executive directors , at least two positions on boards with five or six non - executive directors , and at least three positions on boards with seven or eight non - executive directors . ### determining the number of non - executive director positions necessary to meet the objective requires further specification since for most board sizes it is mathematically possible only to go beyond or remain below the exact share of 40 per cent . therefore , the number of board positions necessary to meet the objective should be the number closest to 40 per cent . at the same time , in order to avoid discrimination of the initially over - represented sex , listed companies should not be obliged to appoint members of the under - represented sex to more than half of the non - executive board positions . thus , for example , members of the under - represented sex should hold at least one position on boards with three non - executive directors , at least two positions on boards with four , five or six non - executive directors , and at least three positions on boards with seven or eight non - executive directors .


### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of non - executive director positions should make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders . ### listed companies in the union should be imposed obligations of means providing for appropriate procedures with a view of meeting specific objectives regarding the gender composition of their boards . those listed companies in whose boards members of the under - represented sex hold less than 40 per cent of director positions should adjust their recruitment , selection and appointment procedures in order to attain the said percentage at the latest by 1 january 2020 . therefore , the directive establishes the objective of at least 40 per cent of non - executive directors of the under - represented sex by that date . this objective in principle only concerns the overall gender diversity among the executive and non - executive directors and does not interfere with the concrete choice of individual directors from a wide pool of male and female candidates in each individual case . in particular , it does not exclude any particular candidates for director positions , nor does it impose any individual directors on companies or shareholders . the decision on the appropriate board members thus remains with the companies and shareholders .


### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements . ### this directive lays down measures to ensure a more balanced representation of men and women among the non - executive directors of listed companies and of small and medium - sized enterprises by establishing measures aimed at accelerated progress towards gender balance while allowing companies sufficient time to make the necessary arrangements .


### without prejudice to article 4 and , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the non - executive directors of listed companies may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and , provided that it can be shown that those measures enable members of the under - represented sex to hold at least 40 per cent of the non - executive director positions of listed companies by at the latest 1 january 2020 , or at the latest 1 january 2018 for listed companies which are public undertakings . ### without prejudice to article 4 and , member states which before the entry into force of this directive have already taken measures to ensure a more balanced representation of women and men among the non - executive directors of listed companies may suspend the application of the procedural requirements relating to appointments contained in article 4 , , and , provided that it can be shown that those measures enable members of the under - represented sex to hold at least 40 per cent of the director / board member positions of listed companies by at the latest 1 january 2020 , or at the latest 1 january 2018 for listed companies which are public undertakings .


### proposal for a directive of the european parliament and of the council on improving the gender balance among non - executive directors of companies listed on stock exchanges and related measures ### proposal for a directive of the european parliament and of the council on improving the gender balance among directors of companies listed on stock exchanges and related measures


### determining the number of non - executive director positions necessary to meet the objective requires further specification since for most board sizes it is mathematically possible only to go beyond or remain below the exact share of 40 per cent . therefore , the number of board positions necessary to meet the objective should be the number closest to 40 per cent . at the same time , in order to avoid discrimination of the initially over - represented sex , listed companies should not be obliged to appoint members of the under - represented sex to half or more of the non - executive board positions . thus , for example , members of the under - represented sex should hold at least one position on boards with three or four non - executive directors , at least two positions on boards with five or six non - executive directors , and at least three positions on boards with seven or eight non - executive directors . ### determining the number of director positions necessary to meet the objective requires further specification since for most board sizes it is mathematically possible only to go beyond or remain below the exact share of 40 per cent . therefore , the number of board positions necessary to meet the objective should be the number closest to 40 per cent . at the same time , in order to avoid discrimination of the initially over - represented sex , listed companies and public undertakings should not be obliged to appoint members of the under - represented sex to more than half of the board positions . thus , for example , members of the under - represented sex should hold at least one position on boards with three directors , at least two positions on boards with four , five or six directors , and at least three positions on boards with seven or eight directors .


### member states exercise a dominant influence over listed companies which are public undertakings within the meaning of article 2 of commission directive 2006 / 111 / ec of 16 november 2006 on the transparency of financial relations between member states and public undertakings , as well as on financial transparency within certain undertakings . 32 due to that dominant influence , they have the instruments at their disposal to bring about the necessary change more rapidly . therefore , in such companies the objective of least 40 per cent of non - executive directors of the under - represented sex should be set at an earlier date . ### member states exercise a dominant influence over listed companies which are public undertakings within the meaning of article 2 of commission directive 2006 / 111 / ec of 16 november 2006 on the transparency of financial relations between member states and public undertakings , as well as on financial transparency within certain undertakings . 32 due to that dominant influence , they have the instruments at their disposal to bring about the necessary change more rapidly . therefore , in such companies the objective of least 40 per cent of directors of the under - represented sex should be set at an earlier date .


### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , carbon capture and storage , renewable energy , energy efficiency , transport and fuels , ozone layer protection and fluorinated gases . ### the priority area climate change mitigation should contribute to the development and implementation of union climate - related policy and legislation , in particular with regard to greenhouse gas monitoring and reporting , policies related to land use , land use change and forestry , emissions trading system , member states ' effort to reduce greenhouse gas emissions , climate measures in towns , renewable energy , energy efficiency , transport and fuels , ozone layer protection and fluorinated gases .


### concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists , normally , in the right to exploit the works or services that are the subject of the contract . the execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable . by contrast , certain state acts such as authorisations or licences whereby the state or a public authority establishes the conditions for the exercise of an economic activity , should not qualify as concessions . the same applies to certain agreements having as their object the right of an economic operator to exploit certain public domains or resources , such as land lease contracts whereby the state or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services . ### concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists , normally , in the right to exploit the works or services that are the subject of the contract . the execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable . by contrast , certain state acts such as authorisations or licences whereby the state or a public authority establishes the conditions for the exercise of an economic activity , should not qualify as concessions . the same applies to agreements whereby the state or contracting authority or entity grants an economic operator , for remuneration , the right to exploit certain public domains or resources and in which , as a rule , only general conditions for their use are established without the contracting authority becoming the recipient of specific services performed by the contract partner . the general conditions contained in both tenancy and land lease contracts are rules concerning the transfer of the rented property or land to the tenant , the use thereof , the respective obligations of the landlord and the tenant with regard to the maintenance of the rented property or land , the duration of the lease and repossession by the landlord of the rented property or land , the rent and other costs borne by the tenant .


### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the commission may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 10 % of the total initial allocation of each priority and up to 10 % of the initial indicative breakdown of each specific objective . this does not concern the amount set out for the direct actions of the joint research centre in paragraph 2 or the contribution to the european institute of innovation and technology set out in paragraph 3 . ### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the commission may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure and without prejudice to the prerogatives of the budgetary authority review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 10 % of the total initial allocation of each priority and up to 10 % of the initial indicative breakdown of each specific objective .


### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 27 million people in the union suffer from diabetes and the total cost of brain disorders has been estimated at eur 800 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these . ### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 120 million citizens suffer from rheumatic and musculoskeletal conditions in the union and 27 million people in the union suffer from diabetes while the total cost of brain disorders has been estimated at eur 800 billion and the total cost of rheumatic and musculoskeletal diseases at eur 240 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these .


### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness . ### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging public and private investment , creating new job opportunities , promoting economic , social and territorial cohesion and ensuring europe ' s long - term sustainable growth and competitiveness .


### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from research to market . horizon 2020 should support all stages in the innovation chain , especially activities closer to the market including innovative financial instruments , as well as non - technological and social innovation , and aims to satisfy the research needs of a broad spectrum of union policies by placing emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training . ### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from research to market . the union added value lies mainly in funding pre - competitive , transnational , collaborative research , which should attain in horizon 2020 at least the levels of the seventh framework programme . it is necessary to place as well emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation . thus , horizon 2020 should support all stages in the innovation chain , including innovative financial instruments , as well as non - technological and social innovation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training .


### in order to guarantee its full autonomy and independence , the authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the general budget of the european union . the community budgetary procedure should be applicable as far as the community contribution is concerned . the auditing of accounts should be undertaken by the court of auditors . ### in order to guarantee its full autonomy and independence , the authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the general budget of the european union . the community budgetary procedure should be applicable as far as the community contribution is concerned . the auditing of accounts should be undertaken by the court of auditors . the overall budget is subject to the discharge procedure .


### promote the establishing cross - sectoral cooperation platforms and networks , including interests from industry , research stakeholders , regions , public authorities and ngos ; ### promote the establishing cross - sectoral cooperation platforms and networks , including representatives of local and regional public authorities , industry , research stakeholders , the social partners and civil society , and ngos ;


### the eu declaration of conformity shall follow the model structure set out in annex iii to decision no 768 / 2008 / ec . it shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . ### the eu declaration of conformity shall follow the model structure set out in annex iii to decision no 768 / 2008 / ec . it shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated , where necessary .


### the wheel mark may be supplemented or replaced by an appropriate and reliable form of electronic tag . in such case , articles 9 and 10 shall apply , as appropriate , mutatis mutandi . ### manufacturers shall , as soon as possible , use an appropriate and reliable form of electronic tag instead of or in addition to the wheel mark . in such case , articles 9 and 10 shall apply , as appropriate , mutatis mutandis .


### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this directive . ### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for a period of five years from the date of entry into force of this directive . the commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the office shall invite to the meetings referred to in point of article 2 representatives from public administrations , bodies and organisations dealing with the protection of intellectual property rights and representatives from the private sector . ### the office shall invite to the meetings referred to in point of article 2 representatives from public administrations , bodies and organisations dealing with the protection of intellectual property rights and representatives from the private sector and civil society .


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ and contribute to the union ' s objective of ' well - being of its peoples ' set out in article 3 of the treaty . it is appropriate in this context to establish a ' health for all ' programme , the third programme of eu action on health .


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ' healthy life years ' and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social , environmental and congenital nature .


### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health . ### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measures addressing key risk factors such as smoking , abuse of alcohol , a sedentary lifestyle , obesity and an unhealthy diet , as well as hiv / aids , and by supporting awareness raising campaigns promoting healthy lifestyles , including the development of healthy lifestyle behaviours in young children , in order to prevent diseases and promote good health .


### the general objectives of the health for growth programme shall be to work with the member states to encourage innovation in healthcare and increase the sustainability of health systems , to improve the health of the eu citizens and protect them from cross - border health threats . ### the general objectives of the health for growth programme shall be to work with the member states and representative health stakeholder organizations to encourage innovation in healthcare in the widest sense and increase the sustainability of health systems , to improve the health of the eu citizens and protect them from cross - border health threats .


### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health ### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measures by addressing the key risk factors , namely smoking , alcohol consumption , unbalanced diets and obesity , physical inactivity , mental health , the environment and some communicable diseases , with a focus on the cross border dimension , in order to prevent diseases and promote good health


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , alcohol consumption , unbalanced diets and obesity , physical inactivity , mental health , the environment and some communicable diseases , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature .


### 60 % of eligible costs for the functioning of a non - governmental body . in cases of exceptional utility such bodies may benefit from a financial contribution up to a maximum of 80% of eligible costs ; ### 60 % of eligible costs for the functioning of a non - governmental body or its projects . in cases of exceptional utility such bodies may benefit from a financial contribution up to a maximum of 80% of eligible costs ;


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer and empowering them to take an active role in managing their health , inter alia by improving people ' s health literacy , will have positive overall effects on health , including reduction of health inequalities , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in all factors and measures having an impact on health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health .


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good mental and physical health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in mental and physical health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health .


### proposal for a regulation of the european parliament and of the council on establishing a health for growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020 ### proposal for a regulation of the european parliament and of the council on establishing an improved health for sustainable growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020


### actions having a clear eu added value co - financed by the competent authorities of the member states responsible for public health or the third countries participating pursuant to article 6 , or by non - governmental bodies mandated by these competent authorities ; ### actions having a clear eu added value co - financed by the competent authorities of the member states responsible for public health or the third countries participating pursuant to article 6 , or by non - governmental bodies and specialised networks mandated by these competent authorities ;


### the general objectives of the health for growth programme shall be to work with the member states to encourage innovation in healthcare and increase the sustainability of health systems , to improve the health of the eu citizens and protect them from cross - border health threats . ### the general objectives of the health for all programme shall be to work with the member states and representative non - governmental bodies and health stakeholders , in particular patients ' organisations and health professionals ' associations , to encourage innovation in healthcare and increase the sustainability of health systems , promote healthy lifestyles and reduce inequalities within and between member states to improve the health of all eu citizens , and protect them from cross - border health threats .


### 2 . chronic diseases : support european cooperation and networking on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice and developing joint activities on prevention . cancer : follow - up work already undertaken ; set up a european cancer information system with comparable data ; support cancer screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist . ### 2 . chronic diseases : support european cooperation and networking on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice and developing joint activities on prevention and enhancing health literacy . cancer : follow - up work already undertaken ; set up a european cancer information system with comparable data ; support cancer screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist .


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote physical and mental health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu , and are often accompanied by mental health problems . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature .


### draft legislative resolution proposal for a regulation of the european parliament and of the council establishing a health for growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020 ### proposal for a regulation of the european parliament and of the council establishing a better health for sustainable growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020


### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health . ### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measures by addressing the key risk factors , namely smoking , alcohol consumption , unbalanced diets and obesity , physical inactivity , mental health , the environment and some communicable diseases , with a focus on the cross border dimension , in order to prevent diseases and promote good health .


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ' healthy life years ' and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , operating within a gender - sensitive framework , also bearing in mind underlying factors of a social and environmental nature .


### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to investment . ### this regulation lays down a notification procedure in order to provide transparency on all bilateral agreements of the member states that are maintained in force . the notification may be withdrawn by a member state if the respective agreement is terminated .


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy , or to the implementation of the principles and objectives of the union ' s action on the international scene , as defined by article 21 of the treaty on european union .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation establishes the terms , conditions and the procedure under which member states shall cooperate with the commission when some of their already in force bilateral agreements with third countries relating to investment are incompatible with the laws or policies of the union .


### as the authorisation to maintain , amend or conclude agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as an exceptional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states . ### as this regulation concerns an area of exclusive union competence , it must be regarded as an exceptional measure . the arrangements under this regulation are without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states .


### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to investment , it shall notify the commission of its intentions in writing . ### where a member state intends to enter into negotiations in order to amend an existing agreement or to conclude a new agreement falling within the scope of this regulation , it shall notify the commission in writing of its intention at the earliest possible moment before the opening of formal negotiations is envisaged .


### in the interest of eu investors and their investments in third countries , and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force . ### in the interest of eu investors and their investments and third countries , member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force and remain binding on the parties under public international law unless replaced by new agreements that provide for at least the same level of investor protection . this will be applied not only to bits already in force but also to bits concluded and / or signed by the time of the entering in to force of this regulation .


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union’s policies relating to investment .


### notwithstanding the union ' s competences relating to investment and without prejudice to other obligations of member states under the law of the union , member states are authorised in accordance with article 2 of the treaty to maintain in force bilateral agreements relating to investment that have been notified in accordance with article 2 of this regulation . ### notwithstanding the union ' s competences relating to investment and without prejudice to other obligations of member states under the law of the union , bilateral agreements relating to investment that have been notified in accordance with article 2 of this regulation remain unchanged unless the review referred to in article 5 requires modification of those agreements .


### for all agreements falling within the scope of this regulation , the member state concerned shall inform the commission without undue delay of any representations made to it that a particular measure is inconsistent with the agreement . the member state shall also immediately inform the commission of any request for dispute settlement lodged under the auspices of the agreement as soon as the member state becomes aware of the request . the member state and the commission shall fully cooperate and take all necessary measures to ensure an effective defence which may include , where appropriate , that the commission participates in the procedure . ### for all agreements falling within the scope of this regulation , the member state concerned shall inform the commission without undue delay of any representations made to it that a particular measure is inconsistent with the agreement . the member state shall also immediately inform the commission of any request for dispute settlement lodged under the auspices of the agreement as soon as the member state becomes aware of the request . the member state and the commission shall fully cooperate and take all the necessary measures to ensure an effective defence . the commission shall participate in the procedure .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements to facilitate searches for documents available for re - use throughout the union , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists .


### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the independent authority referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article . ### in exceptional cases , public sector bodies , where psi revenues form a substantial part of their operational budget , may be expressly permitted by the independent authority to charge over and above the marginal cost for the costs of collection , production , reproduction and / or dissemination of documents . these exceptions should be granted by the independent authority on a case - by - case basis , provided this is in the public interest and according to objective , transparent and verifiable criteria , and without prejudice to paragraphs 3 and 4 of this article , and shall be reviewed every three years .


### for documents for which libraries , museums and archives have intellectual property rights , member states shall ensure that , where the re - use of documents is allowed , these documents shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv . ### for documents for which libraries , museums and archives have intellectual property rights , member states shall ensure that , where the re - use of documents is allowed , these documents shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv , provided that the documents concerned are of types classified as accessible under the rules which exist in the member states regarding access to public - sector information . where possible , these documents shall be disseminated in technology - neutral , machine - readable form .


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not contain an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member states or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### subject to paragraph member states shall ensure that documents referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv . ### subject to paragraph member states shall ensure that documents of public sector bodies referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv , provided that the documents concerned are of types classified as accessible under the rules which exist in the member states regarding access to public sector information . where possible , these documents shall be disseminated in technology - neutral , machine - readable form .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ' 1 . ' public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . '


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not justify an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . this shall not imply an obligation for public sector bodies to create or adapt documents in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation .


### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . as it constitutes a limitation to the intellectual property rights hold by the authors of the documents , the scope of such a link between the right of access and the right of use should be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights . ### directive 2003 / 98 / ec limits the intellectual property rights held by the authors of the documents . the scope of such a link between the right of access and the right of use should therefore be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights .


### ' machine - readable ' means that digital documents are sufficiently structured for software applications to identify reliably individual statements of fact and their internal structure . ’ ### ' machine - readable ' means that digital documents are structured so that software applications can , in a technology - neutral manner , extract individual data which are of interest . ’


### in article 7 , the words ‘ over and above the marginal costs or’ are inserted after ‘ calculation of charges’ . ### in article 7 , the third sentence is replaced by the following : ‘ the public sector body in question shall also indicate which factors will be taken into account in the calculation of charges as referred to in article 6 . ’


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ' ### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction , provision and dissemination . '


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ‘ 1 . public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . ’


### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] and the following paragraph is added : ### in article 13 the date of 1 july 2008 is replaced by [ 5 years after the date of entry into force ] and the following paragraph is added :


### ‘ public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ’ ### public sector bodies may allow re - use of documents without conditions or may impose conditions , where appropriate through a licence dealing with relevant issues . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require review by authorities competent on the re - use of public sector information . member states have a responsibility to make appropriate national authorities responsible for this review . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata , in a technologically - neutral way . ' .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction , provision and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . member states have a responsibility to make appropriate national authorities responsible for supervision . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . where implementation results in conflict , recourse can be made to national ombudsmen systems or the european ombudsman .


### ' however , such arrangements involving cultural establishments and university libraries shall be terminated at the end of the contract or in any case not later than 31 december 20xx [ 6 years after entry into force of the directive ] . ' ### ' however , such arrangements involving cultural establishments and university libraries shall be terminated at the end of the contract . '


### the agency may object to the information submitted or parts thereof on grounds related to non - compliance with the provisions of title viiia of directive 2001 / 83 / ec within 60 days after receipt of the notification . if the agency does not object within 60 days , the information shall be deemed accepted and may be published . ### the agency may object to the information submitted or parts thereof on grounds related to non - compliance with the provisions of title viiia of directive 2001 / 83 / ec , stating the grounds for its decision , within 120 days after receipt of the notification . if the agency does not object within 120 days , the information shall be deemed accepted and may be published .


### by way of derogation from article 100g of directive 2001 / 83 / ec , medicinal product - related information referred to in article 100b of that directive shall be subject to vetting by the agency prior to its dissemination . ### by way of derogation from article 100g of directive 2001 / 83 / ec , medicinal product - related information referred to in article 100b of that directive shall be subject to vetting by the agency prior to its dissemination , unless this information is given on an internet website where responsibility for monitoring the content disseminated rests with a member state in accordance with article 100h of directive 2001 / 83 / ec .


### external actors may use imi with the technical means provided for this purpose , where necessary to facilitate administrative cooperation between competent authorities in member states , or in order to exercise their rights as data subjects , or where otherwise provided for by a union act . ### external actors may use imi with the technical means provided for this purpose , where necessary to facilitate administrative cooperation between competent authorities in member states , or in order to exercise their rights as data subjects , or where otherwise provided for by a union act . the use by external actors of imi may not provide access to the personal data of citizens .


### personal data processed in imi shall be blocked at the latest eighteen months after the formal closure of an administrative cooperation procedure , unless blocking before that period is expressly requested by a competent authority , on a case - by - case basis . ### personal data processed in imi shall be blocked in the system&#160 ; after&#160 ; a period of&#160 ; no longer than eighteen months after the formal closure of an administrative cooperation procedure , &#160 ; and which is determined either&#160 ; on the request of&#160 ; a competent authority , on a case - by - case basis , or&#160 ; on the basis of the applicable union act .


### before deciding on disembarkation in a third country , the participating units shall take into account the general situation in that third country and intercepted or rescued persons shall not be disembarked in that third country when the host member state or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . ### before and during a sea operation , the host member state and the participating member states shall examine the general situation in the third countries where disembarkation could potentially take place . intercepted or rescued persons shall not be conducted towards or otherwise handed over to the authorities of , or forced to enter or be disembarked in a third country when the host member state or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . those member states shall provide that information to the participating units . for that purpose , they shall use information based on a range of sources , including in particular information from other member states , easo , unhcr , the council of europe and other relevant international and non - governmental organisations .


### the participating units shall communicate information about any ship suspected of being engaged in illegal activities at sea outside the scope of a sea operation to the international coordination centre , which shall convey this information to the national coordination centre of the member state or member states concerned . ### the participating units shall communicate information about any ship suspected of being engaged in illegal activities at sea , which are outside the scope of the sea operation , to the international coordination centre , which shall convey this information to the national coordination centre of the member state or member states concerned .


### before deciding on disembarkation in a third country , the participating units shall take into account the general situation in that third country and intercepted or rescued persons shall not be disembarked in that third country when the host member state or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . ### before and during a sea operation , the host member state and the participating member states shall examine the general situation in the neighbouring third countries . intercepted or rescued persons shall not be disembarked in a third country when the host member state , the agency or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . those member states shall provide that information to the participating units . for that purpose , they may use the information prepared by the european asylum support office , the agency and the united nations high commissioner for refugees .


### in case of disembarkation in a third country , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances to the extent possible before disembarkation . they shall inform the intercepted or rescued persons of the place of disembarkation in an appropriate way and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement . ### if disembarkation in a third country is considered , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances , including their medical condition and other circumstances that might make them vulnerable . before a decision is taken , they shall inform the intercepted or rescued persons of their rights , in particular the right to international protection , and of the place of disembarkation in an appropriate way , and in a language which those persons understand or may be presumed to understand , and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be unlawful . intercepted or rescued persons shall be granted legal assistance and access to effective remedy and translators , and it shall be made possible for them to produce evidence in support of their case .