### a risk assessment plan to identify risks and assess the impacts of potential incidents ; ### a risk management framework to establish a methodology for the identification , prioritisation , evaluation and treatment of risks , the assessment of the impacts of potential incidents , prevention and control options , and to define criteria for the choice of possible countermeasures ;


### as most network and information systems are privately operated , cooperation between the public and private sector is essential . market operators should be encouraged to pursue their own informal cooperation mechanisms to ensure nis . they should also cooperate with the public sector and share information and best practices in exchange of operational support in case of incidents . ### as most network and information systems are privately operated , cooperation between the public and private sector is essential . market operators should be encouraged to pursue their own informal cooperation mechanisms to ensure nis . they should also cooperate with the public sector and mutually share information and best practices as well as reciprocal operational support as needed in case of incidents .


### ‘ incident’ means any circumstance or event having an actual adverse effect on security ; ### ‘ incident’ means any event having an actual adverse effect on security ;


### a cooperation mechanism should be established at union level to allow for information exchange and coordinated detection and response regarding network and information security . for that mechanism to be effective and inclusive , it is essential that all member states have minimum capabilities and a strategy ensuring a high level of nis in their territory . minimum security requirements should also apply to public administrations and operators of critical information infrastructure to promote a culture of risk management and ensure that the most serious incidents are reported . ### a cooperation mechanism should be established at union level to allow for information exchange and coordinated detection and response regarding network and information security . for that mechanism to be effective and inclusive , it is essential that all member states have minimum capabilities and a strategy ensuring a high level of nis in their territory . minimum security requirements should also apply to operators of information infrastructure to promote a culture of risk management and ensure that the most serious incidents are reported .


### member states shall ensure that public administrations and market operators take appropriate technical and organisational measures to manage the risks posed to the security of the networks and information systems which they control and use in their operations . having regard to the state of the art , these measures shall guarantee a level of security appropriate to the risk presented . in particular , measures shall be taken to prevent and minimise the impact of incidents affecting their network and information system on the core services they provide and thus ensure the continuity of the services underpinned by those networks and information systems . ### member states shall ensure that market operators listed in annex ii take appropriate and proportionate technical and organisational measures to manage the risks posed to the security of the networks and information systems which they control and use in their operations . having regard to the state of the art , those measures shall guarantee a level of security appropriate to the risk presented . in particular , measures shall be taken to prevent and minimise the impact of incidents affecting their network and information system on the core services they provide and thus ensure the continuity of the services underpinned by those networks and information systems .


### those obligations should be extended beyond the electronic communications sector to key providers of information society services , as defined in directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services27 , which underpin downstream information society services or on - line activities , such as e - commerce platforms , internet payment gateways , social networks , search engines , cloud computing services , application stores . disruption of these enabling information society services prevents the provision of other information society services which rely on them as key inputs . software developers and hardware manufacturers are not providers of information society services and are therefore excluded . those obligations should also be extended to public administrations , and operators of critical infrastructure which rely heavily on information and communications technology and are essential to the maintenance of vital economical or societal functions such as electricity and gas , transport , credit institutions , stock exchange and health . disruption of those network and information systems would affect the internal market . __________________ 27 oj l 204 , 21 . 7 . 1998 , p . 37 . ### those obligations should be extended beyond the electronic communications sector to operators of infrastructure which rely heavily on information and communications technology and are essential to the maintenance of vital economical or societal functions such as electricity and gas , transport , credit institutions , financial market infrastructures and health . disruption of those network and information systems would affect the internal market . while the obligations set out in this directive do not extend to key providers of information society services , as defined in directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services27 , which underpin downstream information society services or on - line activities , such as e - commerce platforms , internet payment gateways , social networks , search engines , cloud computing services in general or application stores , these may , on a voluntary basis , inform the competent authority or single point of contact of those network security incidents they deem appropriate , and the competent authority or the single point of contact should , if reasonably possible , present the market operators that informed of the incident with strategically analysed information that will help overcome the security threat . __________________ 27 oj l 204 , 21 . 7 . 1998 , p . 37 .


### national competent authority on the security of network and information systems ### national competent authorities and single points of contact on the security of network and information systems


### responding effectively to the challenges of the security of network and information systems therefore requires a global approach at union level covering common minimum capacity building and planning requirements , exchange of information and coordination of actions , and common minimum security requirements for all market operators concerned and public administrations . ### responding effectively to the challenges of the security of network and information systems therefore requires a global approach at union level covering common minimum capacity building and planning requirements , developing sufficient cybersecurity skills , exchange of information and coordination of actions , and common minimum security requirements . minimal common standards should be applied in accordance with appropriate recommendations by the cyber security co - ordination groups .


### subject to any delegated act adopted under paragraph 5 , the competent authorities may adopt guidelines and , where necessary , issue instructions concerning the circumstances in which public administrations and market operators are required to notify incidents . ### the competent authorities or the single points of contact may adopt guidelines concerning the circumstances in which market operators are required to notify incidents .


### undergo a security audit carried out by a qualified independent body or national authority and make the results thereof available to the competent authority . ### provide evidence of effective implementation of security policies , such as results of a security audit carried out by internal auditors , a qualified independent body or national authority , and make the evidence available to the competent authority or to the single point of contact . where necessary , the competent authority or the single point of contact may require additional evidence or carry out an additional audit .


### each member state shall designate a national competent authority on the security of network and information systems . ### each member state shall designate one or more civilian national competent authorities on the security of network and information systems .


### personal data are in many cases compromised as a result of incidents . in this context , competent authorities and data protection authorities should cooperate and exchange information on all relevant matters to tackle the personal data breaches resulting from incidents . member states shall implement the obligation to notify security incidents in a way that minimises the administrative burden in case the security incident is also a personal data breach in line with the regulation of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data . liaising with the competent authorities and the data protection authorities , enisa could assist by developing information exchange mechanisms and templates avoiding the need for two notification templates . this single notification template would facilitate the reporting of incidents compromising personal data thereby easing the administrative burden on businesses and public administrations . ### personal data are in many cases compromised as a result of incidents . in this context , competent authorities , single points of contact and data protection authorities should cooperate and exchange information on all relevant matters to tackle the personal data breaches resulting from incidents . the obligation to notify security incidents should be carried out in a way that minimises the administrative burden in case the security incident is also a personal data breach that requires to be notified in accordance with regulation 2013 / xx / eu of the european parliament and of the council1 . enisa should assist by developing information exchange mechanisms and a single notification template that would facilitate the reporting of incidents compromising personal data thereby easing the administrative burden on businesses and public administrations . __________________ 1 regulation xxx of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data .


### information that is considered confidential by a competent authority , in accordance with union and national rules on business confidentiality , should be exchanged with the commission and other competent authorities only where such exchange is strictly necessary for the application of this directive . the information exchanged should be limited to that which is relevant and proportionate to the purpose of such exchange . ### information that is considered confidential by a competent authority or a single point of contact , in accordance with union and national rules on business confidentiality , should be exchanged with the commission and other single points of contact only where such exchange is strictly necessary for the application of this directive . the information exchanged should be limited to that which is relevant , necessary and proportionate to the purpose of such exchange .


### notification of an early warning within the network should be required only where the scale and severity of the incident or risk concerned are or may become so significant that information or coordination of the response at union level is necessary . early warnings should therefore be limited to actual or potential incidents or risks that grow rapidly , exceed national response capacity or affect more than one member state . to allow for a proper evaluation , all information relevant for the assessment of the risk or incident should be communicated to the cooperation network . ### notification of an early warning within the network should be required only where the scale and severity of the incident or risk concerned are or may become so significant that information or coordination of the response at union level is necessary . early warnings should therefore be limited to incidents or risks that grow rapidly , exceed national response capacity or affect more than one member state . to allow for a proper evaluation , all information relevant for the assessment of the risk or incident should be communicated to the cooperation network .


### the competent authority may inform the public , or require the public administrations and market operators to do so , where it determines that disclosure of the incident is in the public interest . once a year , the competent authority shall submit a summary report to the cooperation network on the notifications received and the action taken in accordance with this paragraph . ### after consultation with the competent authority and the market operator concerned , the single point of contact may inform the public about individual incidents , where public awareness is necessary to prevent an incident or deal with an ongoing incident , or where the market operator , subject to an incident , has refused to address a serious structural vulnerability related to that incident without undue delay . once a year , the single point of contact shall submit a summary report to the cooperation network on the notifications received and the action taken in accordance with this paragraph .


### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between competent authorities and the commission within the cooperation network , the access to the secure information - sharing infrastructure , the union nis cooperation plan , the formats and procedures applicable to informing the public about incidents , and the standards and / or technical specifications relevant to nis . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . ### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between single points of contact and the commission within the cooperation network , without prejudice to existing cooperation mechanisms at national level , the access to the secure information - sharing infrastructure , the union nis cooperation plan , and the formats and procedures applicable to informing the public about incidents . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers .


### in order to allow for the proper functioning of the cooperation network , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the definition of the criteria to be fulfilled for a member state to be authorized to participate to the secure information - sharing system , of the further specification of the triggering events for early warning , and of the definition of the circumstances in which market operators and public administrations are required to notify incidents . ### in order to allow for the proper functioning of the cooperation network , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the further specification of the triggering events for early warning .


### – a definition of the format and procedures for the collection and sharing of compatible and comparable information on risks and incidents by the competent authorities , ### – a definition of the format and procedures for the collection and sharing of compatible and comparable information on risks and incidents by the single points of contact ,


### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between competent authorities and the commission within the cooperation network , the access to the secure information - sharing infrastructure , the union nis cooperation plan , the formats and procedures applicable to informing the public about incidents , and the standards and / or technical specifications relevant to nis . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers30 . __________________ 30 oj l 55 , 28 . 2 . 2011 , p . 13 . ### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between single points of contact and the commission within the cooperation network , without prejudice to existing cooperation mechanisms at national level , the common set of interconnection and security standards for the secure information - sharing infrastructure , the union nis cooperation plan and the formats and procedures applicable to notifying significant incidents . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers30 . __________________ 30 oj l 55 , 28 . 2 . 2011 , p . 13 .


### each member state shall notify to the commission without delay the designation of the competent authority , its tasks , and any subsequent change thereto . each member state shall make public its designation of the competent authority . ### each member state shall notify to the commission without delay the designation of the competent authorities and the single point of contact , its tasks , and any subsequent change thereto . each member state shall make public its designation of the competent authorities .


### competent authorities should have the necessary means to perform their duties , including powers to obtain sufficient information from market operators and public administrations in order to assess the level of security of network and information systems as well as reliable and comprehensive data about actual incidents that have had an impact on the operation of network and information systems . ### ( 29 public authorities , single points of contact and enisa should have the necessary means to perform their duties , including powers to obtain sufficient information from market operators and public administrations in order to assess the level of security of network and information systems as well as reliable and comprehensive data about actual incidents that have had an impact on the operation of network and information systems .


### competent authorities should pay due attention to preserving informal and trusted channels of information - sharing between market operators and between the public and the private sectors . publicity of incidents reported to the competent authorities should duly balance the interest of the public in being informed about threats with possible reputational and commercial damages for the public administrations and market operators reporting incidents . in the implementation of the notification obligations , competent authorities should pay particular attention to the need to maintain information about product vulnerabilities strictly confidential prior to the release of appropriate security fixes . ### competent authorities and single points of contact should pay due attention to preserving informal and trusted channels of information - sharing between market operators and between the public and the private sectors . publicity of incidents reported to the competent authorities and single points of contact should duly balance the interest of the public in being informed about threats with possible reputational and commercial damages for the market operators reporting incidents . in the implementation of the notification obligations , competent authorities and single points of contact should pay particular attention to the need to maintain information about product vulnerabilities strictly confidential prior to the release of appropriate security fixes . as a general rule , single points of contact should not disclose personal data of individuals involved in incidents . single points of contact should only disclose personal data where the disclosure of such data is necessary and proportionate in view of the objective pursued .


### the existing capabilities are not sufficient enough to ensure a high level of nis within the union . member states have very different levels of preparedness leading to fragmented approaches across the union . this leads to an unequal level of protection of consumers and businesses , and undermines the overall level of nis within the union . lack of common minimum requirements on public administrations and market operators in turn makes it impossible to set up a global and effective mechanism for cooperation at union level . ### the existing capabilities are not sufficient enough to ensure a high level of nis within the union . member states have very different levels of preparedness leading to fragmented approaches across the union . this leads to an unequal level of protection of consumers and businesses , and undermines the overall level of nis within the union . lack of common minimum requirements on market operators in turn makes it impossible to set up a global and effective mechanism for cooperation at union level .


### the definition of the roles and responsibilities of the various actors involved in the implementation of the plan ; ### the definition of the roles and responsibilities of the various authorities and other actors involved in the implementation of the framework ;


### as most network and information systems are privately operated , cooperation between the public and private sector is essential . market operators should be encouraged to pursue their own informal cooperation mechanisms to ensure nis . they should also cooperate with the public sector and share information and best practices in exchange of operational support in case of incidents . ### as most network and information systems are privately operated , cooperation between the public and private sector is essential . market operators should be encouraged to pursue their own informal cooperation mechanisms to ensure nis . they should also cooperate with the public sector and mutually share information and best practices including the reciprocal in exchange of relevant information and operational support and strategically analysed information , in case of incidents . to effectively encourage the sharing of information and of best practices , it is essential to ensure that market operators , who participate in such exchanges , are not disadvantaged as a result of their cooperation . adequate safeguards are needed to ensure that such cooperation will not expose these operators to higher compliance risk or new liabilities under , inter alia , competition , intellectual property , data protection or cybercrime law , nor expose them to increase operational or security risks .


### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between competent authorities and the commission within the cooperation network , the access to the secure information - sharing infrastructure , the union nis cooperation plan , the formats and procedures applicable to informing the public about incidents , and the standards and / or technical specifications relevant to nis . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . ### in order to ensure uniform conditions for the implementation of this directive , implementing powers should be conferred on the commission as regards the cooperation between single points of contact and the commission within the cooperation network , without prejudice to existing cooperation mechanisms at national level , the common set of interconnection and security standards for the secure information - sharing infrastructure , the union nis cooperation plan and the formats and procedures applicable to the notification of incidents having a significant impact . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers .


### the commission shall adopt , by means of implementing acts , decisions on the access of the member states to this secure infrastructure , pursuant to the criteria referred to in paragraph 2 and 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 19 . ### the commission shall adopt , by means of implementing acts , a common set of interconnections and security standards that single points of contact must meet in order to exchange information . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 19 .


### a cooperation mechanism should be established at union level to allow for information exchange and coordinated detection and response regarding network and information security . for that mechanism to be effective and inclusive , it is essential that all member states have minimum capabilities and a strategy ensuring a high level of nis in their territory . minimum security requirements should also apply to public administrations and operators of critical information infrastructure to promote a culture of risk management and ensure that the most serious incidents are reported . ### a cooperation mechanism should be established at union level to allow for information exchange and coordinated detection and response regarding network and information security . for that mechanism to be effective and inclusive , it is essential that all member states have minimum capabilities and a strategy ensuring a high level of nis in their territory . minimum security requirements should also apply to operators of information infrastructure to promote a culture of risk management and ensure that the most serious incidents are reported .


### member states shall ensure that the competent authorities have adequate technical , financial and human resources to carry out in an effective and efficient manner the tasks assigned to them and thereby to fulfil the objectives of this directive . member states shall ensure the effective , efficient and secure cooperation of the competent authorities via the network referred to in article 8 . ### member states shall ensure that the competent authorities and the single points of contact have adequate technical , financial and human resources to carry out in an effective and efficient manner the tasks assigned to them and thereby to fulfil the objectives of this directive . member states shall ensure the effective , efficient and secure cooperation of the single points of contact via the network referred to in article 8 .


### the sharing of information on risks and incidents within the cooperation network and compliance with the requirements to notify incidents to the national competent authorities may require the processing of personal data . such a processing of personal data is necessary to meet the objectives of public interest pursued by this directive and is thus legitimate under article 7 of directive 95 / 46 / ec . it does not constitute , in relation to these legitimate aims , a disproportionate and intolerable interference impairing the very substance of the right to the protection of personal data guaranteed by article 8 of the charter of fundamental rights . in the application of this directive , regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents should apply as appropriate . when data are processed by union institutions and bodies , such processing for the purpose of implementing this directive should comply with regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . ### the sharing of information on risks and incidents within the cooperation network and compliance with the requirements to notify incidents to the national competent authorities or single points of contact may require the processing of personal data . such a processing of personal data is necessary to meet the objectives of public interest pursued by this directive and is thus legitimate under article 7 of directive 95 / 46 / ec . it does not constitute , in relation to these legitimate aims , a disproportionate and intolerable interference impairing the very substance of the right to the protection of personal data guaranteed by article 8 of the charter of fundamental rights . in the application of this directive , regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents should apply as appropriate . when data are processed by union institutions and bodies , such processing for the purpose of implementing this directive should comply with regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data .


### list of market operators referred to in article 3a ) e - commerce platforms 2 . internet payment gateways 3 . social networks 4 . search engines 5 . cloud computing services 6 . application stores ### list of market operators referred to in article 3a ) e - commerce platforms 2 . internet payment gateways 3 . search engines 4 . cloud computing services that store critical infrastructure data of the european union


### subject to any delegated act adopted under paragraph 5 , the competent authorities may adopt guidelines and , where necessary , issue instructions concerning the circumstances in which public administrations and market operators are required to notify incidents . ### the competent authorities or the single points of contact may adopt guidelines concerning the circumstances in which market operators are required to notify incidents .


### each member state shall notify to the commission those provisions of its law which it adopts pursuant to paragraph 1 , by the date specified in article 91 at the latest and , without delay , any subsequent amendment affecting them . ### each member state shall notify to the commission those legal provisions which it adopts pursuant to paragraphs 1 and 1a , by the date specified in article 91 at the latest and , without delay , any subsequent amendment affecting them .


### 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 adopt by legal provisions specific rules regulating the processing of employees ' personal data in the employment context 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 , 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 level of protection afforded by this regulation may on no account be undercut , especially in the case of collective agreements . the right of member states to provide employees with more favourable protection provisions in respect of the processing of personal data in the employment context shall remain unaffected .


### the commission shall be empowered to adopt delegated acts in accordance with article 86 for the purpose of further specifying the criteria and requirements for the safeguards for the processing of personal data for the purposes referred to in paragraph 1 . ### the commission shall be empowered to adopt delegated acts in accordance with article 86 , exclusively for the purpose of further specifying the criteria and requirements which will warrant the latest technological and security related developments for the processing of personal data with respect to the purposes referred to in paragraph 1 .


### an enterprise or an organisation employing fewer than 250 persons is processing personal data only as an activity ancillary to its main activities . ### an enterprise or an organisation is processing personal data only as an activity ancillary to its main activities .


### each member state shall notify to the commission those provisions of its law which it adopts pursuant to paragraph 1 , by the date specified in article 91 at the latest and , without delay , any subsequent amendment affecting them . ### each member state shall notify the commission those provisions of its law which it adopts pursuant to paragraph 1 , and in conjunction with the subsidiarity principle , by the date specified in article 91 at the latest and , without delay , any subsequent amendment affecting them .


### 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 . ### in order to regulate the processing of employees ' personal data in the employment context . member states should be able to adopt by legal provisions specific rules for the processing of personal data in the employment sector . the processing of personal data in the employment context should qualify for exemption from the requirements of this regulation . therefore , when adopting by legal provisions specific rules for the processing of personal data in employment context . member states may adopt legal provisions which should lay down exemptions and derogations . it should be also possible for the member states to provide for that the matters referred to in article 82 can be defined also by collective agreements negotiated and concluded at national level by social partners .


### 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 .


### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ' personal data in the employment context . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject . ### consent should not provide a valid legal ground for the processing of personal data , where there is a clear imbalance between the data subject and the controller . this is especially the case where the data subject is in a situation of dependence from the controller , among others , where personal data are processed by the employer of employees ‘ personal data in the employment context , unless the processing is intended to have legally or financially advantageous consequences for the data subject . where the controller is a public authority , there would be an imbalance only in the specific data processing operations where the public authority can impose an obligation by virtue of its relevant public powers and the consent cannot be deemed as freely given , taking into account the interest of the data subject .


### 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 .


### member states should provide for effective , proportionate and dissuasive sanctions for breaches of this directive , which could include , inter alia , administrative fines and nullity or annulment declared by a judicial body of the appointment or of the election of non - executive directors made contrary to the national provisions adopted pursuant to article 4 . ### member states should provide for effective , proportionate and dissuasive sanctions for breaches of this directive , which may , however , not include nullity or annulment declared by a judicial body of the appointment or of the election of non - executive directors made contrary to the national provisions adopted pursuant to article 4 . a failure to reach the objective laid down in article 4 or 4 shall not constitute an infringement of the national provisions adopted pursuant to this directive and shall not be subject to sanctions .


### 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 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 , with the aim of 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 .


### 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 . ### 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 .


### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises , even if they are listed companies . ### this directive should not apply to micro , small and medium - sized enterprises , as defined by commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises , even if they are listed companies . furthermore , this directive should not apply to small - cap listed companies .


### vat shall not be considered an eligible cost for projects referred to in article 18 . ### vat shall be considered an eligible cost for projects referred to in article 18 , as shall expenditure on permanent staff .


### 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 , carbon capture and storage , renewable energy in urban , agricultural , mountainous or remote areas , waste recovery and biogas production , energy efficiency , public lighting , transport and fuels , in particular third - generation fuels , ozone layer protection and fluorinated gases .


### in the concession documents , the contracting authority or contracting entity may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subconcessionaires . ### in the concession documents , the grantor may ask or may be required by a member state to ask the tenderer to indicate in its tender any share of the contract it may intend to subcontract to third parties and any proposed subconcessionaires . the selection of subcontractors shall be updated in the course of the concession contract , subject to replacements and changes .


### a ' public works concession ' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities and having as their object the execution of works , where the consideration for the the works to be carried out consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment . ### a ' works concession ' means a contract for pecuniary interest concluded in writing , under which one or more contracting authorities or bodies entrust the execution of the works for which they are responsible to one or more economic operators , where the consideration for this delegation consists either solely in the right to exploit the works that are the subject of the contract or in that right together with payment ; ‘ ’services concession’ means a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or bodies entrusts the operation of a service for which they are responsible to one or more economic operators , where the consideration for this delegation consists either solely in the right to exploit the services that are the subject of the contract or in that right together with payment . the right to exploit the works or services shall imply the transfer to the concessionaire of the substantial economic risk in exploiting these works or services , defined as the risk of exposure to the vagaries of the market . the concessionaire shall be deemed to assume the substantial operating risk where , under normal conditions of exploitation , it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject - matter of the concession .


### 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 certain agreements having as their object the right of an economic operator to exploit certain public domains or resources , such as contracts concerning rights in rem over immovable property , including public property , whereby the state or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services . .


### societal challenges , eur 35888 million . ### societal challenges , 36 , 4% .


### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of eur 3194 million as set out in annex ii . a first allocation of eur 1542 million shall be provided to the european institute of innovation and technology for activities under title xvii of the treaty on the functioning of the european union . a second allocation of up to eur 1652 million shall be provided , subject to the review set out in article 26 . this additional amount shall be provided on a pro - rata basis , as indicated in annex ii , from the amount for the specific objective ‘ leadership in enabling and industrial technologies’ within the priority on industrial leadership set out in paragraph 2 and from the amount for the priority on societal challenges set out in 2 . ### the european institute of innovation and technology shall be financed through a maximum contribution from horizon 2020 of 3 % of the total budget as set out in annex ii .


### draft legislative resolution ### considers that the reference amount indicated in the legislative proposal is compatible with the ceiling for subheading 1a of multiannual financial framework 2007 - 2013 , but the margin remaining in heading 1a for 2011 - 2013 is very limited ; stresses that the funding of new activities must not jeopardise the financing of other priorities under subheading 1a ; stresses its intention of using in the context of the mid - term review all the necessary means provided by the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management , including the revision of the financial framework in order to ensure the financing of this new agency without jeopardising the financing of its other priorities under this subheading and ensuring that a sufficient margin will remain in subheading 1a ;


### to contribute to the development of tools that cut across sea or coast - related sectoral policies ; ### to contribute to the development of cross - sectoral tools to support sea or coast - related policies , particularly in the field of economic development , employment , environmental protection , research , maritime safety and energy ;


### to contribute to the development of tools that cut across sea or coast - related sectoral policies ; ### to contribute to the development of cross - sectoral tools to support sea or coast - related policies , particularly in the field of environmental protection and development of green maritime technologies ;


### consumer organisations and small and medium sized enterprises shall be properly represented . ### consumer organisations , civil society and small and medium sized enterprises shall be equally represented , as well as data protection authorities .


### enhancing the knowledge on technical tools to prevent and combat counterfeiting and piracy , including tracking and tracing systems ; ### enhancing the knowledge on technical tools to prevent and combat counterfeiting and piracy , including tracking and tracing systems in compliance with the union acquis on e - commerce and data protection ;


### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 . ### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; training needs to be promoted and developing countries ' capacities stepped up ; the integration of european national programmes should be further improved ; cooperation with other major public and private partners , including the pharmaceutical industry , public - private partnerships such as product development partnerships , non - governmental organisations and foundations , and civil society needs to be strengthened and extended and respond to clear and transparent rules of governance ; synergies with european external policy actions should be developed , specifically with eu development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . ____________________ 8 van velzen et al . , independent external evaluation report , december 2009 .


### an increased impact due to effective cooperation with relevant european union initiatives , including its development assistance . ### better coordination , alignment and , where appropriate , integration with relevant european union initiatives , including its development assistance and other key initiatives to enhance research and development for poverty - related diseases , product development partnerships and other government - led programmes in order to better take advantage of synergies , create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of european public investments .


### better coordination , alignment and integration of relevant national programmes to increase the cost - effectiveness of european public investments ; ### better coordination , alignment and , where appropriate , integration of relevant national programmes to increase the cost - effectiveness of european public investments . moreover , the research priorities should be established in an objective - orientated manner in order to accelerate results and contribute to the eradication of poverty - related and neglected diseases .


### the ga shall appoint a management board that shall supervise the secretariat of the edctp2 - is established by the ga as the executive body of the edctp2 programme . sec shall have the following tasks : ### the ga shall appoint a management board . in doing so , the ga shall take due account of the contributions of the participating states and shall also ensure geographical balance in the membership of that board . at least one member of the board must come from a country in sub - saharan africa . the management board shall supervise the secretariat of the edctp2 - is established by the ga as the executive body of the edctp2 programme . sec shall have the following tasks :


### target : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in sub - sahara africa for at least one year after their fellowship . ### indicator : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 .


### an increased impact due to effective cooperation with relevant european union initiatives , including its development assistance . ### an increased impact due to effective cooperation with relevant european union initiatives , in particular its development assistance .


### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe and affordable medical interventions for poverty - related diseases , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary for that purpose . ### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty - related diseases and neglected infectious diseases in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe , straightforward and affordable medical interventions which are tailored to developing countries’ specific circumstances , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary in order to achieve those objectives .


### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe and affordable medical interventions for poverty - related diseases , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary for that purpose . ### since the objectives of this decision , namely to contribute to the reduction of the social and economic burden of poverty related diseases and neglected diseases prioritising those with the greatest socioeconomic impact on the most vulnerable groups , in particular the children , in developing countries and in particular in sub - saharan africa by accelerating the clinical development of effective , safe , suitable , accessible and affordable medical interventions which are tailored to the specific needs and circumstances of the developing countries , cannot be sufficiently achieved by the member states due to the lack of necessary critical mass to be achieved , both in human and financial terms , and can therefore , by reason of the scale of the action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary for that purpose .


### a ceiling should be established for the union ' s participation in edctp2 for the duration of horizon 2020 framework programme . within that ceiling , the union contribution should be equal to the initial contributions committed by the participating states in order to achieve a high leverage effect and ensure a stronger integration of participating states ' programmes . that ceiling should also provide for matching the contributions from any other member state or country associated to horizon 2020 framework programme joining the edctp2 programme during the horizon 2020 framework programme . ### a ceiling should be established for the union ' s participation in edctp2 for the duration of horizon 2020 framework programme . in that period , and within that ceiling , the union contribution should be equal to the contributions of the states referred to in article 1 of this decision in order to achieve a high leverage effect and ensure a stronger integration of those states ' programmes .


### edctp2 shall contribute to the reduction of the social and economic burden of poverty - related diseases in developing countries , in particular in sub - saharan africa , by accelerating the clinical development of effective , safe and affordable medical interventions for poverty - related diseases , in partnership with sub - saharan africa . ### edctp2 shall contribute to the reduction of the social and economic burden of poverty - related diseases and neglected infectious diseases , focussing on diseases that particularly affect women and children as the most vulnerable population groups . to that end , it shall target an acceleration of the clinical development of effective , safe , straightforward and affordable medical interventions which are tailored to developing countries’ specific circumstances , in partnership with developing countries and particularly those of sub - saharan africa . that clinical development may cover all the stages in the process from phase i to phase iv .


### an increased impact due to effective cooperation with relevant european union initiatives , including its development assistance . ### better coordination , alignment and , where appropriate , integration with relevant european union initiatives , including its development assistance in order to better take advantage of synergies , create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of european public investments ;


### the maximum union financial contribution , including efta appropriations , to the edctp2 programme shall be eur 683 million , as follows : eur 594 million to equal the contributions of participating states listed in article 1 . 1 ; eur 89 million to equal the contributions of any other member state or any other country associated to horizon 2020 framework programme participating in the edctp2 programme in accordance with article 1 . 2 . ### the maximum union financial contribution , including efta appropriations , to the edctp 2 programme shall be eur 683 million , to equal the contributions of participating states listed in article 1 .


### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with union development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 . ### in 2009 , independent experts adopted the report of the interim evaluation of edctp18 . the opinion of the expert panel was that edctp1 provided a unique platform for a genuine dialogue with african scientists and it has started to bridge the gap between north and south in building research capacities and in providing learning and working opportunities for young african researchers . following this report , there are fundamental issues to be taken into consideration for a second european and developing countries clinical trials partnership programme : the current scope of edctp1 needs to be changed and extended ; the capabilities in developing countries for sound conduct and management of clinical trials should , where necessary , be further developed and strengthened , in particular the role and development of ethical review committees and the corresponding regulatory environment , the coordination , collaboration and where appropriate integration of european national programmes should be further improved ; collaboration with other major public and private funders , including the pharmaceutical industry , needs to be strengthened and extended ; synergies with european external policy actions should be developed , in particular with union development assistance ; co - funding rules should be clarified and simplified ; monitoring tools need to be strengthened . __________________ 8 van velzen et al . , independent external evaluation report , december 2009 .


### better coordination , alignment and integration of relevant national programmes to increase the cost - effectiveness of european public investments ; ### better coordination , alignment and , where appropriate , integration of relevant national programmes to increase the cost - effectiveness of european public investments ;


### establish cooperation and launch joint actions with other public and private funders . ### establish cooperation and launch joint actions with other public and private partners and hence markedly increase the funding they contribute to the edctp - ii programme .


### fostering capacity development for clinical trials and related research in developing countries through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional level ; ### fostering capacity development for clinical trials and related research in developing countries , in particular in sub - saharan africa , through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional level ;


### extended international cooperation with other public and private funders ; ### extended international cooperation with other public and private partners - including ngo and foundations - and with other initiatives working to improve research into poverty related and neglected diseases , including for example product development partnerships , the world health organisation and its consultative expert working group , and other programmes .


### with regards to calls managed by edctp - is , the annual report shall moreover include information on the number of projects submitted and selected for funding , the detailed use of the union financial contribution , the distribution of national and other contributions , the types of participants , country statistics , brokerage events and dissemination activities . ### with regards to calls managed by edctp - is , the annual report shall moreover include information on the projects submitted and selected for funding , the detailed use of the union financial contribution , the distribution of national and other contributions , the types of participants , country statistics , brokerage events and dissemination activities .


### target : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in sub - sahara africa for at least one year after their fellowship . ### indicator : increase the number of fellowships to sub - saharan african researchers and msc / phd students to at least 600 compared to 400 under edctp1 , with at least 90 % of them continuing their research career in or matters relating to sub - sahara africa for at least one year after their fellowship .


### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20134 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states in accordance with article 185 of the treaty . __________________ 4 oj . . . [ horizon 2020 framework programme ] . ### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20134 aims at achieving a greater impact on research and innovation by developing closer synergies , increasing coordination and avoiding unnecessary duplication with international , national and regional research programmes . public - public partnerships , including union participation in programmes undertaken by several member states in accordance with article 185 of the treaty , should achieve those aims , meet the conditions specified in that regulation , in particular in articles 26 and be in full compliance with the general principles , in particular the conditions relating to the communication and dissemination of information and open access . __________________ 4 oj . . . [ horizon 2020 framework programme ] .


### establishing cooperation and launching joint actions with other public and private funders ; ### establishing cooperation and launching joint actions with other public and private funders , including industry and product development partnerships .


### extended international cooperation with other public and private funders ; ### extended international cooperation with other public and / or private funders to ensure that the impact of all research is maximised and that synergies can be taken into consideration .


### the disbursement of the assistance shall be conditional on a satisfactory track record of an imf programme . it shall also be conditional on the implementation , within a specific time frame , of a series of clearly defined economic policy measures focusing on structural reforms , to be agreed between the commission and the beneficiary country and to be laid down in a memorandum of understanding . ### the disbursement of the assistance shall be conditional on a satisfactory track record of an imf programme and of respect for the genval political and value - based principles . it shall also be conditional on the implementation , within a specific time frame , of a series of clearly defined economic policy measures focusing on structural reforms , to be agreed between the commission and the beneficiary country and to be laid down in a memorandum of understanding .


### the amount of the assistance shall be based on the residual external financing needs of the beneficiary country . these shall be established by the commission in cooperation with international financial institutions , based on a comprehensive and well documented quantitative assessment . in particular , the commission will draw on the latest balance of payments projections for the country in question produced by the imf and take into account the expected financial contributions from multilateral donors . ### the amount of the assistance shall be based on the residual external financing needs of the beneficiary country . these shall be established by the commission in cooperation with international financial institutions and the eeas , based on a comprehensive and well documented quantitative assessment . in particular , the commission will draw on the latest balance of payments projections for the country in question produced by the imf and take into account the expected financial contributions from multilateral donors .


### a pre - condition for granting macro - financial assistance shall be that the recipient country respects effective democratic mechanisms , including multi - party parliamentary systems , the rule of law and respect for human rights . ### a pre - condition for granting macro - financial assistance shall be that the recipient country demonstrates commitment to the establishment and / or promotion of effective democratic mechanisms , including multi - party parliamentary systems , the rule of law and respect for human rights . this assessment shall be entrusted to the eeas in cooperation with the european commission and shall take into consideration the latest resolutions and reports of the european parliament concerning&#160 ; beneficiary countries .


### in case the financing needs of the beneficiary country decline fundamentally during the period of disbursement of the macro - financial assistance , the commission , acting in accordance with article 14 , may decide to reduce the amount of funds made available in the context of the assistance , suspend or cancel the assistance . ### in case the financing needs of the beneficiary country decline significantly over the period of disbursement of the macro - financial assistance compared to the time when a decision for granting macro - financial assistance was taken , the commission shall re - assess the economic and financial situation in the beneficiary country and , based on that assessment and acting in accordance with article 14 , may decide to reduce the amount of funds made available in the context of the assistance , suspend or cancel the assistance .


### innovation in health in terms of products and services , and the organisation and provision of care , has the potential to enhance the quality of care to patients and respond to unmet needs , while also improving the cost - efficiency and sustainability of care . therefore , the programme should facilitate the uptake of innovation in healthcare . ### innovation in health in terms of products and services , and the organisation and provision of care , has the potential to enhance the quality of care to patients and respond to unmet needs , while also improving the cost - efficiency and sustainability of care . therefore , the programme should facilitate the uptake of innovation in healthcare and promote the introduction of an industrial policy supporting the healthcare sector in the eu .


### the objectives referred to in article 3 shall be achieved through the actions listed below and according to the priorities set out in the work programme referred to in article 11 of this regulation . contributing to innovative and sustainable health systems : 1 . 1 . develop eu cooperation on health technology assessment in the context of directive 2011 / 24 / eu on the application of patients ' rights in cross - border healthcare ; 1 . 2 . promote the uptake of health innovation and e - health by increasing the interoperability of e - health applications ; 1 . 3 . support the sustainability of eu health workforce by promoting effective forecasting and planning and efficient recruitment and retention strategies ; 1 . 4 . provide expertise to assist member states undertaking health systems reforms ; 1 . 5 support to the european innovation partnership on active and healthy ageing , a pilot project under europe 2020 flagship initiative innovation union ; 1 . 6 actions required by or contributing to the objectives of eu legislation in the fields of medical devices as well as e - health and health technology assessment provisions in legislation on cross border healthcare ; 1 . 7 foster a health knowledge system , including scientific committees , to contribute to evidence - based decision making . 2 ) increasing access to better and safer healthcare for citizens : 2 . 1 . set up accreditation and support european reference networks ; 2 . 2 . support action on rare diseases including creation of european reference networks , information and registries based on the common criteria for accreditation ; 2 . 3 . strengthen collaboration on patient safety and quality of healthcare , by increasing the availability of information to patients , exchange of best practices and development of guidelines ; support action on chronic diseases care and research including development of european guidelines ; 2 . 4 . develop guidelines to improve the prudent use of antimicrobials in human medicine and reduce the practices that increase antimicrobial resistance ; 2 . 5 . actions required by or contributing to the objectives of eu legislation in the fields of tissues and cells , blood , organs , patients ' rights in cross - border healthcare and medicinal products ; 2 . 6 . foster a health knowledge system to contribute to evidence - based decision making . 3 ) promoting good health and preventing diseases : 3 . 1 exchange best practices on key health issues such as smoking prevention , abuse of alcohol and obesity ; 3 . 2 . supporting the prevention of chronic diseases including cancer , by sharing knowledge and best practice and developing joint activities ; 3 . 3 . actions required by or contributing to the objectives of eu legislation in the fields of tobacco products and advertisement ; 3 . 4 . foster a health knowledge system , to contribute to evidence - based decision making . 4 ) protecting citizens from cross border health threats : 4 . 1 . strengthen preparedness and response for serious cross border health threats ; 4 . 2 . improve risk assessment capacity by providing additional capacities for scientific expertise and map existing assessments ; 4 . 3 . support capacity building against health threats in member states by inter alia developing preparedness and response planning and coordination , common approaches to vaccination , developing guidelines and mechanisms for joint procurement of medical countermeasures ; 4 . 4 . actions required by or contributing to the objectives of eu legislation in the fields of communicable diseases and other health threats ; 4 . 5 . foster a health knowledge system to contribute to evidence - based decision making . a more detailed description of the content those actions may have is included in annex i . an indicative list of the relevant legislation is provided in annex ii to this regulation . ### the objectives referred to in article 3 shall be achieved through the actions listed in annex i and according to the priorities set out in the work programme referred to in article 11 of this regulation . an indicative list of the relevant legislation is provided in annex ii to this regulation .


### 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 . follow up work already undertaken ; set up a european information system with comparable data ; support screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist .


### 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 to encourage innovation in healthcare and increase the sustainability of health systems , to address the health - related , social and economic challenges posed by population aging and the increase in chronic illnesses , to improve the health of the 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 . follow - up work already undertaken ; set up a european chronic disease information system with comparable data ; support chronic disease screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist .


### 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 measure by addressing the key risk factors , namely smoking , abuse of alcohol , a sedentary lifestyle , an unhealthy diet and obesity , 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 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 measure by addressing the key risk factors , namely smoking , abuse of alcohol , obesity and internal and external air pollution , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health .


### to increase access to medical expertise and information for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens . ### to increase access to medical expertise and information for specific conditions also beyond national borders , develop shared solutions and guidelines , promote research and comparisons between national health systems to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens .


### 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 , obesity and internal and external air pollution , 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 .


### 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 .


### 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 in health promotion , prevention , early diagnosis and management of diseases , including chronic diseases , can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older , while encouraging active and healthy ageing . 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 , sedentary lifestyle , an unhealthy diet and obesity , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature .


### to develop common tools and mechanisms at eu level to address shortages of resources , both human and financial , and to facilitate up - take of innovation in healthcare in order to contribute to innovative and sustainable health systems . ### to develop common tools and mechanisms at eu level to address shortages of resources , both human and financial , and to facilitate up - take of innovation in healthcare and primary healthcare in order to contribute to innovative and sustainable health systems , in primary healthcare , in particular through third - sector involvement .


### 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 .


### the commission shall , in cooperation with the member states , ensure overall consistency and complementarity between the programme and other policies , instruments and actions of the union . ### the commission shall , in cooperation with the member states , ensure overall consistency and complementarity between the programme and other policies , instruments and actions of the union and the activities of agencies whose remit is covered by the programme .


### 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 and neurodegenerative diseases , 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 . neurodegenerative diseases : improve prevention , diagnostic visualisation methods , early diagnosis methods , standardisation criteria and diagnostic measures , draw up treatment strategies and carry out clinical trials of new chemical and biological agents , vaccines and technologies .


### this objective will be measured in particular through the increase of number of member states involved in promoting good health and preventing diseases , using the validated best practices . ### this objective will be measured in particular through the increase in the number of legislative measures and actions taken by member states involved in promoting good health and preventing chronic diseases .


### actions having a clear eu added value co - financed by other public or private bodies , as referred to in article 8 , including international organisations active in the area of health and for the latter , where appropriate without previous call for proposal , duly justified in the annual work programmes ; ### actions having a clear eu added value co - financed by other public or private bodies , as referred to in article 8 , including international organisations active in the area of health and for the latter , where appropriate without previous call for proposal , duly justified in the annual work programmes , in accordance with the eu financial regulations and its implementing rules ;


### 4 . safety : improve the prudent use of antimicrobial agents in medicinal products and reduce the practices that increase antimicrobial resistance ; reduce the burden of resistant infections and healthcare - associated infections and secure the availability of effective antimicrobials . ### 4 . safety : improve the prudent use of antimicrobial agents in medicinal products and reduce the practices that increase antimicrobial resistance ; reduce the burden of resistant infections and healthcare - associated infections and secure the availability of effective antimicrobials ; promote the establishment of a european system of interoperable national registers of patients who , as a result of medical errors or vaccine therapies , have contracted serious diseases , chronic illnesses , or disabilities , one of its aims being to encourage member states to grant fair compensation to such patients and allow them to receive appropriate treatments free of charge .


### 2 . health innovation and e - health : increasing the interoperability of patient registers and other e - health solutions ; support european cooperation on e - health , notably on registries and uptake by health professionals . this will serve the european voluntary network on e - health set up by the directive 2011 / 24 / eu of the european parliament and of the council . ### 2 . health innovation and e - health : increasing the interoperability of patient registers and other e - health solutions , including voluntary use of a health card containing relevant patient information ; supporting european cooperation on e - health , notably on registries and uptake by health professionals . this will serve the european voluntary network on e - health set up by directive 2011 / 24 / eu of the european parliament and of the council .