### in line with the objectives of horizon 2020 framework programme , any member state and any country associated to the horizon 2020 framework programme should be entitled to participate in the edctp2 programme . ### in line with the objectives of horizon 2020 framework programme , any member state and any country associated to the horizon 2020 framework programme should be entitled to participate in the edctp2 programme . it should be ensured that projects receiving money via the horizon 2020 framework programme are not in breach of international human rights law .


### 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 .


### 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 .


### 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 .


### the maximum union financial contribution , including efta appropriations , to the edctp2 programme shall be eur 683 million , as follows : ### the maximum union financial contribution , including efta appropriations , to the edctp2 programme shall be eur 597 . 625 million , as follows :


### 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 . ### eur 77 . 875 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 .


### activities may include national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is . ### activities may include activities undertaken by public or private not - for - profit research organisations included in the national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is .


### by 31 december 2017 the commission shall conduct an interim evaluation of the edctp2 programme . the commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the commission . the commission shall send that report to the european parliament and to the council by 30 june 2018 . ### by 31 december 2017 the commission shall conduct an interim evaluation of the edctp2 programme . the commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the commission . the commission shall send that report to the european parliament and to the council by 30 june 2018 . the interim evaluation of edctp2 shall form part of and be compiled with the interim evaluation of horizon 2020 .


### by 31 december 2017 the commission shall conduct an interim evaluation of the edctp2 programme . the commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the commission . the commission shall send that report to the european parliament and to the council by 30 june 2018 . ### by 30 june 2018 , the commission shall conduct an interim evaluation of the edctp2 programme . the commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the commission . the commission shall send that report to the european parliament and to the council by 31 december 2018 .


### general objective 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 . ### general objective edctp 2 shall 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 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 , in partnership with these countries in sub - saharan africa .


### establish cooperation and launch joint actions with union , national and international development assistance initiatives in order to ensure complementarity and increase the impact of the results of edctp - funded activities . ### establish cooperation and launch joint actions with union , national and international development assistance initiatives in order to ensure complementarity and increase the impact of the results of edctp2 - funded activities .


### 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 .


### promoting networking , coordination , alignment , cooperation and integration of national research programmes and activities on poverty - related infectious diseases at scientific , management and financial level ; ### promoting networking , coordination , alignment , open collaboration , cooperation and integration of national research programmes and activities on poverty - related and neglected diseases at scientific , management and financial level ;


### assuring awareness , endorsement and acknowledgment of the edctp2 programme and its activities through advocacy and communication . ### assuring awareness , endorsement and acknowledgment of the edctp2 programme and its activities through advocacy and communication not only at european union level and in developing countries , in particular in sub - saharan africa , but also at global level .


### promoting networking , coordination , alignment , cooperation and integration of national research programmes and activities on poverty - related infectious diseases at scientific , management and financial level ; ### promoting networking , coordination , alignment , collaboration and cooperation and integration of national research programmes and activities on poverty - related diseases at scientific , management and financial level ;


### 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 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 or regional level ;


### the edctp2 programme shall be implemented by the edctp2 - is on the basis of an annual work plan and a multiannual strategic work plan prepared by the edctp2 - is and adopted by the general assembly of the edctp2 - is following international peer - review and subject to the prior approval by the commission . ### the edctp2 programme shall be implemented by the edctp2 - is on the basis of an annual work plan and a multiannual strategic work plan prepared by the edctp2 - is , with the consultation of the relevant stakeholders , and adopted by the general assembly of the edctp2 - is following international peer - review and subject to the prior approval by the commission . the annual work plan shall identify topics and activities to be implemented , in coordination with national programmes , including calls for proposals to be launched by edctp - is to select and fund indirect actions , as well as the budgets and edctp2 funding for those topics and activities edctp2 should seek scientific coordination and exchange of information with relevant public or private initiatives , including those under horizon 2020 , such as the innovative medicines initiative and the strategic panel for health .


### the annual work plan shall identify topics and activities to be implemented , including calls for proposals to be launched by edctp - is to select and fund indirect actions , as well as the budgets and edctp2 funding for those topics and activities . ### the annual work plan shall identify topics and activities to be implemented , in coordination , where appropriate , with national programmes , including calls for proposals to be launched by edctp - is to select and fund indirect actions , as well as the budgets and edctp2 funding for those topics and activities . edctp2 should seek scientific coordination and , where relevant , exchange of information with relevant public or private initiatives including those under horizon 2020 such as the innovative medicines initiative and the strategic panel for health .


### the ga shall decide by consensus . failing consensus , the ga shall take its decisions by a majority of at least 75 % of the votes . ### the ga shall take its decisions by a majority of at least 75 % of the votes .


### 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 that shall supervise the secretariat of the edctp2 - is established by the ga as the executive body of the edctp2 programme . sec shall have at least the following tasks :


### a scientific advisory committee shall advise the ga on the strategic priorities of the edctp2 programme . ### a strategic advisory committee shall provide strategic and scientific advice to the ga , the board and the sec .


### review and advise the ga on the content , scope and dimension of the edctp2 draft annual work plan , including diseases covered and approaches to be adopted , from a scientific and technical standpoint ### advise the ga on the content , scope and dimension of the edctp2 draft annual work plan , including diseases covered and approaches to be adopted , from a scientific and technical standpoint


### a framework for delivering macro - financial assistance to third countries with which the union has important political , economic and commercial ties should make the assistance more effective . in particular , it should be possible to provide macro - financial assistance to third countries to encourage them to adopt economic policy measures likely to solve a balance of payments crisis . ### a framework for delivering macro - financial assistance to candidate , potential candidate and neighbourhood countries should make the assistance more effective . in particular , it should be possible to provide macro - financial assistance to these countries to encourage them to adopt economic policy measures likely to solve a balance of payments crisis .


### the commission should ensure that macro - financial assistance is in line with the key principles , objectives and measures taken within the different areas of external action and other relevant union policies . ### the commission , in close cooperation with the eeas , should ensure that macro - financial assistance is in line with the key principles , objectives and measures taken within the different areas of external action and other relevant union policies .


### 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 .


### 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 .


### the commission shall inform the european parliament and the council of developments in country - specific assistance and provide them with the relevant documents . ### the commission and the eeas shall inform regularly and / or upon request the european parliament and the council of developments in country - specific assistance and shall ensure a simultaneous and timely transmission of the relevant documents .


### macro - financial assistance shall be disbursed to the central bank of the beneficiary country . ### macro - financial assistance shall be disbursed only to the central bank of the beneficiary country .


### beneficiary countries shall regularly check that financing provided from the budget of the union has been properly used , take appropriate measures to prevent irregularities and fraud , and , if necessary , take legal action to recover any funds provided under this regulation that have been misappropriated . ### beneficiary countries shall ensure that financing provided from the budget of the union has been properly used , take appropriate measures to prevent irregularities and fraud , and , if necessary , take legal action to recover any funds provided under this regulation that have been misappropriated .


### the commission shall examine the progress made on implementing the measures taken under this regulation and shall submit annually a report on the implementation of macro - financial assistance to the european parliament and the council . ### the commission , in close cooperation with the eeas , shall examine the progress made on implementing the measures taken under this regulation and shall submit annually a report on the implementation of macro - financial assistance to the european parliament and the council .


### committee the commission shall be assisted by a committee . ### committee the commission shall be assisted by a committee . the eeas shall be invited to its meetings and entitled to participate to its work .


### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union and shall expire on 31 december 2013 . ### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union .


### a high level of health protection should be ensured in the definition and implementation of all union policies and activities , in accordance with article 168 of the treaty . the union shall complement and support national health policies , encourage the cooperation between member states and promote the coordination between their programmes , in full respect of the responsibilities of the national authorities for shaping their health policies and organising and delivering health services and medical care . ### a high level of health protection should be ensured in the definition and implementation of all union policies and activities , in accordance with article 168 of the treaty and article 35 of the charter of fundamental rights of the european union . the union shall complement and support national health policies , encourage the cooperation between member states and promote the coordination between their programmes , in full respect of the responsibilities of the national authorities for shaping their health policies and organising and delivering health services and medical care .


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


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good 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 . support for and recognition of innovation in health help 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 line with the objectives of the europe 2020 strategy , the programme should focus on a set of well defined objectives and actions with clear , proven eu added value , and concentrate support on a smaller number of activities in priority areas . the emphasis will be placed in accordance with the principle of subsidiarity , on areas where member states cannot act in isolation in a cost - effective manner , where there are clear cross - border or internal market issues at stake , or where there are significant advantages and efficiency gains from collaboration at eu level . ### in line with the objectives of the europe 2020 strategy , the programme should focus on a set of well defined objectives and actions with clear , proven eu added value , and concentrate support on a smaller number of activities in priority areas . the emphasis will be placed in accordance with the principle of subsidiarity , on areas where member states cannot act in isolation in a cost - effective manner , where there are clear cross - border or internal market issues at stake , or where there are significant advantages and efficiency gains from collaboration at eu level . this applies in particular to the area of rare diseases and the area of serious childhood diseases , where the number of cases in the individual member states is very low and european collaboration offers significant advantages .


### the position of the patient should be strengthened to achieve better and safer health outcomes . patients need to be empowered to manage their health and their healthcare more pro - actively . the transparency of healthcare activities and systems and the availability of information to patients should be optimised . healthcare practices should be informed by feedback from and communication with patients . support for member states , patient organisations and stakeholders is essential and should be coordinated at eu level in order to effectively help patients and in particular those affected by rare diseases to benefit from cross border healthcare . ### the position of the patient should be strengthened by enhancing health literacy to achieve better and safer health outcomes . citizens need to be empowered to manage their health , prevent poor health , cooperate with healthcare more pro - actively and to make informed choices , inter alia by enhancing their health literacy . the transparency and patient - centredness of healthcare activities and systems , and the availability of reliable , independent and user - friendly information to patients should be optimised . healthcare practices should be informed by feedback from and communication with patients . support for member states , patient organisations and stakeholders is essential and should be coordinated at eu level in order to effectively help patients and in particular those affected by rare diseases to benefit from cross border healthcare .


### non - governmental bodies and health stakeholders , in particular patients ' organisations and health professionals ' associations , play an important role in providing the commission the information and advice necessary to implement the programme . in playing this role , they may require contributions from the programme to enable them to function . that is why the programme shall be accessible to representative ngos and patient organisations working in the public health area , which play an effective role in civil dialogue processes at eu level , such as for example participation in consultative groups , and in that way contribute to pursuing the programme ' s specific objectives . ### patients ' organizations and health professionals ' associations , non - governmental bodies as well as churches and religious associations or communities working in the public health area and health stakeholders in general , play an important role in providing the commission the information and advice necessary to implement the programme . in playing this role , they may require contributions from the programme to enable them to function . that is why the programme shall be accessible to all entities , thereby strengthening their capacity to contribute to pursuing the programme ' s specific objectives .


### 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 , increase the sustainability of health systems and promote cooperation between them , to improve the health of the eu citizens and protect them from cross - border health threats .


### 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 voluntary up - take of innovation in healthcare in order to contribute to innovative , efficient and sustainable health systems .


### developing common tools and mechanisms at eu level to address shortages of resources , both human and financial and facilitating up - take of innovation in healthcare in order to contribute to innovative and sustainable health systems ### developing common tools and mechanisms at eu level to address shortages of resources , both human and financial , and facilitating voluntary up - take of innovation in healthcare in order to contribute to innovative , efficient , and sustainable health systems


### this objective will be measured in particular through the increase of number of member states using the developed tools and mechanisms and pieces of advice . ### this objective will be measured in particular through the results obtained by member states’ health systems .


### 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 and to develop shared solutions and guidelines to improve health literacy , patient empowerment , 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 , 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 .


### this objective will be measured in particular through the increase of number of health professionals using the expertise gathered through the european reference networks in the context of directive 2011 / 24 / eu on the application of patients ' rights in cross - border healthcare ; the increase of number of patients using these networks ; and the increase of number of member states using the developed guidelines . ### this objective will be measured in particular through the increase of number of health professionals using the expertise and information gathered through the european reference networks in the context of directive 2011 / 24 / eu on the application of patients ' rights in cross - border healthcare ; the increase of number of patients using these networks ; and the increase of number of member states using the developed guidelines .


### 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 and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health , and to empower eu citizens and patients to play an active role in managing their health and healthcare , inter alia by enhancing their health literacy skills .


### 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 , an unhealthy diet , a sedentary lifestyle and obesity , with a focus on the cross border dimension , in order to prevent diseases and promote good health .


### 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 .


### 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 .


### the commission shall implement the programme by establishing annual work programmes setting out the elements provided in the financial regulation and in particular : the priorities and the actions to be undertaken , including the allocation of financial resources ; detailed eligibility criteria for the beneficiaries in compliance with article 8 ; the criteria for the percentage of the financial contribution of the union , including criteria for assessing whether or not exceptional utility applies , and the applicable rate of the co - financing ; the essential selection and award criteria to be used to select the proposals receiving financial contributions ; the time schedule of the planned calls for the tenders and calls for proposals ; where appropriate , the authorisation to use lump sums , standard scales of unit costs or flat - rate financing in line with the financial regulation ; the actions co - financed by international organisations active in the area of health without previous call for proposal duly justified . 2 . the working programme referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in article 16 . 3 . in implementing the programme , the commission , together with the member states , shall ensure compliance with all relevant legal provisions regarding personal data protection and , where appropriate , the introduction of mechanisms to ensure the confidentiality and safety of such data . ### the commission shall be empowered to adopt delegated acts in accordance with article 16a in the form of annual work programmes setting out the elements provided in the financial regulation and in particular : the annual priorities and the actions to be undertaken , including the allocation of financial resources ; detailed eligibility criteria for the beneficiaries in compliance with article 8 ; the criteria for the percentage of the financial contribution of the union , including criteria for assessing whether or not exceptional utility applies , and the applicable rate of the co - financing ; the essential selection and award criteria to be used to select the proposals receiving financial contributions ; the actions co - financed by international organisations active in the area of health without previous call for proposal duly justified . 2 . the commission shall implement the annual work programmes by setting out : the time schedule of the planned calls for tenders and calls for proposals ; where appropriate , the authorisation to use lump sums , standard scales of unit costs or flat - rate financing in line with the financial regulation ; 2a . the measures referred to in paragraph 2 shall be adopted in accordance with the examination procedure referred to in article 16 . 3 . in implementing the programme , the commission , together with the member states , shall ensure compliance with all relevant legal provisions regarding personal data protection and , where appropriate , the introduction of mechanisms to ensure the confidentiality and safety of such data .


### 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 .


### 3 . health workforce : develop effective health workforce forecasting and planning in terms of numbers , scope of practice and skills , monitor mobility and migration of health professionals , establish efficient recruitment and retention strategies and capacity development . ### 3 . health workforce : develop effective health workforce forecasting and planning in terms of numbers , scope of practice and the extent to which training matches the requisite skills , monitor mobility and migration of health professionals , establish efficient recruitment and retention strategies and capacity development , taking due account of issues of dependency and population aging and conducting periodic assessments of these new requirements .


### 4 . decision making on health systems reforms : set up a mechanism for pooling expertise at union level , to provide sound and evidence - based advice on effective and efficient investment in public health and health systems . facilitate the uptake of the results streaming from research projects supported under the 7th framework programme and the in the longer term the activities which will be undertaken in the forthcoming research and innovation programme 2014 - 2020 . ### 4 . decision making on health systems reforms : set up a mechanism for pooling expertise at union level , to provide sound and evidence - based advice on effective and efficient investment in public health and health systems , whilst fostering the competitiveness of stakeholders . facilitate the uptake of the results streaming from research projects supported under the 7th framework programme and the in the longer term the activities which will be undertaken in the forthcoming research and innovation programme 2014 - 2020 .


### 5 . support for the european innovation partnership on active and healthy ageing in its three themes : innovation in awareness , prevention and early diagnosis ; innovation in cure and care and innovation for active ageing and independent living . ### 5 . support for the european innovation partnership on active and healthy ageing in its three themes : innovation in awareness , prevention and early diagnosis ; innovation in cure and care , particularly concerning the treatment of neurodegenerative diseases , and innovation for active ageing and independent living .


### 2 rare diseases : support member states , patient organisations and stakeholders by coordinated action at union level in order to effectively help patients affected by rare diseases . this includes creation of reference networks , information and registries for rare diseases based on the common criteria of accreditation . ### 2 rare diseases : support european cooperation , networking and information in the field of rare diseases , including support to member states , patient organisations and other relevant stakeholders . this includes creation of reference networks , information and registries for rare diseases based on the common criteria of accreditation .


### 2 . rare diseases : support member states , patient organisations and stakeholders by coordinated action at union level in order to effectively help patients affected by rare diseases . this includes creation of reference networks , information and registries for rare diseases based on the common criteria of accreditation . ### 2 . rare diseases and childhood diseases , including prematurity : support member states , patient organisations and stakeholders by coordinated action at union level in order to effectively help patients affected by rare diseases and children affected by serious diseases . this includes creation of reference networks , information and registries for rare diseases based on the common criteria of accreditation .


### 3 . quality and safety : strengthen collaboration on patient safety and quality of healthcare , through , inter alia , implementing the council recommendation on patient safety and the prevention and control of healthcare - associated infections ; exchange best practice on quality assurance systems ; develop guidelines and tools to promote patient safety and quality ; increase the availability of information to patients on safety and quality , improve feedback and interaction between health providers and patients ; support action to exchange knowledge and best practice on chronic diseases care , the response of health systems and research including development of european guidelines . ### 3 . quality and safety : strengthen collaboration on patient safety and quality of healthcare , through , inter alia , implementing the council recommendation on patient safety and the prevention and control of healthcare - associated infections ; exchange best practice on quality assurance systems ; develop guidelines and tools to promote patient safety and quality ; develop health education for eu citizens ; increase the availability of information to patients on safety and quality , improve feedback and interaction between health providers and patients ; support action to exchange knowledge and best practice on chronic diseases care , the response of health systems and research including development of european guidelines .


### 5 . actions required by or contributing to the implementation of union legislation in the fields of tissues and cells , blood , organs , medicinal products use and patients’ rights in cross - border healthcare . such action may include activities aimed at ensuring the implementation , application , monitoring and review of that legislation . ### 5 . actions required by or contributing to the implementation of union legislation in the fields of tissues and cells , blood and organs , medicinal product use and patients’ rights in cross - border healthcare . such action may include activities aimed at ensuring the implementation , application , monitoring and review of that legislation .


### 6 . fostering a health knowledge system to contribute to evidence - based decision making including collecting and analysing health data and wide - dissemination of the results of the programme . ### 6 fostering a health knowledge system to contribute to evidence - based decision making including collecting and analysing health data and wide dissemination of the results of the programme , and supporting efforts to periodically update this data and make it more easily comparable from member state to member state .


### 4 fostering a health knowledge system to contribute to evidence - based decision making including collecting and analysing health data and wide - dissemination of the results of the programme . ### 4 . fostering a health knowledge system to contribute to evidence - based decision making including collecting and analysing health data and wide dissemination of the results of the programme , and support efforts to periodically update this data and make it more easily comparable from member state to member state .


### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity with a focus on the cross - border dimension and on member states with no or little action on these issues . ### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in improving health literacy through communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity and low physical activity with a focus on the cross - border dimension and on member states with no or little action on these issues .


### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity with a focus on the cross - border dimension and on member states with no or little action on these issues . ### 1 . cost - effective promotion and prevention measures : actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , internal and external air pollution and addressing obesity with a focus on the cross - border dimension and on member states with no or little action on these issues .


### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity with a focus on the cross - border dimension and on member states with no or little action on these issues . ### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging a wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , unhealthy eating and a sedentary lifestyle , as part of effects to address obesity with a focus on the cross - border dimension and on member states with no or little action on these issues .


### 3 . support capacity building against health threats in member states : develop preparedness and response planning , public health response coordination , common approaches on vaccination ; develop guidelines on protective measures in an emergency situation , guidelines on information and guides to good practice ; set up a new mechanism for joint procurement of medical countermeasures ; develop common communication strategies . ### 3 . support capacity building against health threats in member states : develop preparedness and response planning , public health response coordination , common approaches on vaccination , including the introduction of optimal vaccination cover to effectively combat the resurgence in infectious diseases ; develop guidelines on protective measures in an emergency situation , guidelines on information and guides to good practice ; set up a new mechanism for joint procurement of medical countermeasures ; develop common communication strategies .


### the rules governing interest generated by pre - financing should be simplified as they generate excessive administrative burden on both recipients of union funds and commission services and create misunderstandings between the commission services and operators and partners . for reasons of simplification , in particular in respect of grant beneficiaries , and in line with the principle of sound financial management , there should no longer be an obligation to generate interest on pre - financing and to recover such interest . however , it should be possible to include such obligation in a delegation agreement in order to allow the re - use of interests generated by prefinancing for the programmes managed by some delegates , or its recovery . ### the rules governing interest generated by pre - financing should be simplified as they generate excessive administrative burden on both recipients of union funds and commission services and create misunderstandings between the commission services and operators and partners . for reasons of simplification , in particular in respect of grant beneficiaries , and in line with the principle of sound financial management , the obligation to generate interest on pre - financing and to recover such interest on pre - financing should be lifted immediately . however , it should be possible to include such obligation in a delegation agreement in order to allow the re - use of interests generated by prefinancing for the programmes managed by some delegates , or its recovery .


### concerning provisions on proportionality , the notion of tolerable risk of error should be introduced as part of the risk assessment made by the authorising officer . the institutions should be able to move away from the general 2% materiality threshold used by the court of auditors to conclude on the legality and regularity of the underlying transactions . tolerable risk levels constitute more appropriate basis for the discharge authority to judge the quality of the management of risk by the commission . the european parliament and the council should therefore determine the level of tolerable risk of error per policy area , taking into account the costs and benefits of controls . ### concerning provisions on proportionality , the notion of tolerable risk of error , something that reduces both complexity and ex - post audits , ensuring a proper balance between sound financial management and appropriate controls , should be introduced as part of the risk assessment made by the authorising officer . the institutions should be able to move away from the general 2% materiality threshold used by the court of auditors to conclude on the legality and regularity of the underlying transactions . tolerable risk levels constitute more appropriate basis for the discharge authority to judge the quality of the management of risk by the commission . the european parliament and the council should therefore determine the level of tolerable risk of error per policy area , taking into account the costs and benefits of controls . it is crucial to ensure that the legally binding rules on the tre are interpreted and applied in a uniform manner , leading to a decrease in the tre rate .


### a general statement of revenue and expenditure ; ### a general statement of revenue and expenditure making a distinction between operations and investment ;


### persons referred to in point of article 55 may satisfy these requirements progressively . they shall adopt their financial rules with the commission ' s prior consent . ### persons referred to in point of article 55 may satisfy these requirements progressively . they shall adopt their financial rules with the commission ' s prior consent . those financial rules shall comply with either european standards or national standards , where the latter have been certified by the competent national authorities . with a view to ensuring legal certainty , stricter participation rules may not be applied retroactively and recipients may not be asked to recalculate financial statements that have already been approved by the commission .


### the accounting officer shall recover amounts by offsetting them against equivalent claims that the union have on any debtor who himself has a claim on the union that is certain , of a fixed amount and due . ### the accounting officer shall recover amounts by offsetting them against equivalent claims that the union have on any debtor who himself has a claim on the union . such claims must be certain , of a fixed amount and due .


### for the purposes of this regulation , ‘ prizes’ shall mean financial contributions awarded following contests . ### prizes are financial contributions given as rewards following contests .


### entities and territorial authorities that are not recognised as states by at least one member state : taiwan . ### entities and territorial authorities that are not recognised as states by at least one member state : taiwan . the exemption from the visa requirement does not apply to holders of passports issued by taiwan which do not include an identity card number .


### the authorisation to amend or conclude agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation . ### the authorisation to amend or conclude foreign direct investment agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to foreign direct investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation .


### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning investment , or otherwise terminated , bilateral agreements concluded by member states with third countries remain binding on the parties under public international law . ### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning foreign direct investment , or otherwise terminated , bilateral foreign direct investment agreements concluded by member states with third countries remain binding on the parties under public international law . an indicative timeline should be set that contemplates when the transition from the existing bilateral investment treaties of member states to union international investment treaties might be completed .


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within 30 days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to fdi concluded before the entry into force of this regulation that will either remain in force or be permitted to enter into force under this chapter . the notification shall include a copy of those bilateral agreements .


### an agreement constitutes an obstacle to the development and the implementation of the union ' s policies relating to investment , including in particular the common commercial policy , or ### an agreement constitutes an obstacle to the conclusion of future investment agreements with that third country , or


### subject to the conditions laid down in articles 8 to 12 , a member state shall be authorised to enter into negotiations to amend an existing or to conclude a new agreement relating to investment with a third country . ### subject to the conditions laid down in articles 8 to 12 , a member state shall be authorised to enter into negotiations to amend an existing or to conclude a new agreement relating to fdi with a third country .


### decisions on the authorisation referred to in paragraph 1 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take its decision within 90 days of receipt of the notification referred to in article 8 . where additional information is needed to take a decision , the 90 days shall run from the date of receipt of the additional information . ### decisions on the authorisation referred to in paragraph 1 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take its decision within 35 days of receipt of the notification referred to in article 8 . where additional information is needed to take a decision , the 35 days shall run from the date of receipt of the additional information .


### the commission shall be kept informed of the progress and results throughout the different stages of negotiations and may request to participate in the negotiations between the member state and the third country concerning investment . ### the commission shall be kept informed of the progress and results throughout the different stages of negotiations and may request to participate in the negotiations between the member state and the third country concerning investment . the commission may participate as an observer in the negotiations between the member state and the third country as far as matters falling within the scope of this regulation are concerned .


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


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


### entry into force ### entry into force and consolidation


### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . a consolidated version of directive 2006 / 66 / ec shall be drawn up within three months of the date of entry into force of this directive .


### open data policies which encourage the wide availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned . ### open data policies which encourage the wide availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , and which promote the circulation of information not only for economic operators but also for members of the public and the free movement of persons within the union , with due regard for fundamental rights in every case , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned .


### open data policies which encourage the wide availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned . ### open data policies which encourage the wide availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information , stimulate economic growth and promote social engagement . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned .


### allowing re - use of documents held by a public sector body adds value for the re - users , for the end users and for the society in general and in many cases for the public body itself , by providing feedback from re - users and end users which allows the holder to improve the quality of the information collected . ### allowing re - use of data and documents held by a public sector body adds value for the re - users , for the end users , for the society in general and for the public body itself , by promoting transparency and providing feedback from re - users and end users which allows the holder to improve the quality of the information collected .


### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions . ### the scope of application of the directive is extended to libraries , museums and archives , encouraging the use of virtualisation of historical sites in order to simplify access to this type of information . the directive does not apply to research and education establishments or to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions .


### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions . ### the scope of application of the directive is extended to libraries , museums , public bodies managing archaeological and cultural sites and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions .


### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions . ### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions , or to public service broadcasting bodies .


### to facilitate re - use , public sector bodies should make documents available through machine readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community 23 ### to facilitate re - use , public sector bodies should make documents available through machine readable formats and together with their metadata where possible and appropriate , using open standards where possible , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community 23


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should be set according to objective , transparent and verifiable criteria that ensure equal treatment . they should in principle be limited to the marginal costs involved in reproducing documents and making them available . however , the fact that some public bodies may generate revenue to cover a substantial part of their costs relating to the performance of their public tasks from the exploitation of their intellectual property rights should notably be taken into consideration . those bodies and also libraries , museums and archives , should be able to levy charges that exceed the marginal costs involved in reproducing documents and making them available and provide a reasonable return on investment . the charges should be set according to objective , transparent and verifiable criteria that ensure equal treatment . the burden of proving that charges are cost oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies shall , where practicable , impose conditions on the re - user , such as acknowledgment of source . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences .


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


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


### since the objective of this directive , namely to facilitate the creation of union - wide information products and services based on public sector documents , to ensure the effective cross - border use of public sector documents by private companies for added - value information products and services , and to limit distortions of competition on the union market , cannot be sufficiently achieved by member states and can therefore , in view of the intrinsic pan - european scope of the proposed 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 functioning of the european union . in accordance with the principles of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives . ### since the objective of this directive , namely to facilitate the creation of union - wide information products and services based on public sector documents , to ensure the effective cross - border use of public sector documents on the one hand by private companies for added - value information products and services and on the other hand by citizens to facilitate the free circulation of information and communication , cannot be sufficiently achieved by member states and can therefore , in view of the intrinsic pan - european scope of the proposed 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 functioning of the european union . in accordance with the principles of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives .


### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### it is necessary to ensure that the member states report to the commission on the availability of public sector information for re - use , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the impartial body . to ensure consistency between approaches at union level , coordination between the impartial bodies should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### the commission should assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties . ### the commission may assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties .


### ‘ documents held by educational and research establishments , such as research facilities , including , where relevant , organisations established for the transfer of research results , schools and universities and ; ’ ### “ documents held by educational and research establishments , including organisations established for the transfer of research results , schools and universities and ; ”


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


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


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


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


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


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### ' 1 . public sector bodies may allow re - use without conditions for non - commercial use or may impose conditions , such as indication of source , where appropriate through a licence . when used for commercial purposes , a minimum condition of the indication of source shall be required . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . '


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


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


### directive 2001 / 83 / ec provides that certain types of information are subject to control by the member states ' national competent authorities prior to their dissemination . this concerns information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . in the case of medicinal products for human use authorised pursuant to title ii of regulation no 726 / 2004 , provision should also be made for certain types of information to be subject to prior vetting by the european medicines agency . ### directive 2001 / 83 / ec provides that certain types of information are subject to control by the member states ' national competent authorities prior to their dissemination . in the case of medicinal products for human use authorised pursuant to title ii of regulation no 726 / 2004 , provision should also be made for certain types of information to be subject to prior vetting by the european medicines agency , and for the agency to monitor the measures to be taken by the manufacturer following a report of adverse reactions , and the consequent updating of the literature .


### for the purposes of paragraph 1 , the marketing authorisation holder shall submit to the agency a mock - up of the information to be disseminated . ### for the purposes of paragraph 1 , the marketing authorisation holder shall submit to the agency a mock - up of the information to be made available .


### micro - entities are however often subject to the same reporting rules as larger companies . those rules put a burden on them which is not in proportion to their size and is therefore disproportionate for the smallest enterprises as compared to the larger enterprises . therefore it should be possible to exempt micro - entities from the obligation to draw up annual accounts , even if such accounts provide an input for statistical information . ### micro - entities are however often subject to the same reporting rules as larger companies . those rules put a burden on them which is not in proportion to their size and is therefore disproportionate for the smallest enterprises as compared to the larger enterprises . therefore it should be possible to exempt micro - entities from the obligation to draw up annual accounts , even if such accounts provide an input for statistical information . however , micro - entities must still be subject to the obligation of cash - based accounting as a minimum standard to which member states remain free to add further obligations .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive if and when they decide to make use of the option provided for in article 1a of directive 78 / 660 / eec . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive if and when they decide to make use of the option provided for in article 1a of directive 78 / 660 / eec , taking account in particular of the situation at national level regarding the number of businesses covered under the threshold values laid down in the directive . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive .


### imi actors shall ensure that requests of other imi actors for confidential treatment of information exchanged by means of imi are complied with by imi users working under their authority . ### imi actors shall ensure that requests of other imi actors for confidential treatment of information exchanged by means of imi are respected by imi users working under their authority .


### no later than 15 months after the date of the application pursuant to article 8 or by the date laid down in the delegated act taken in accordance with article 4 the member state shall present an interim report to the commission on the implementation of the financial contribution , including on the funding , timing and type of actions already carried out and on the rate of reintegration into employment or new activities achieved 12 months after the date of the application . ### no later than 15 months after the date of the application pursuant to article 8 or by the date laid down in the delegated act taken in accordance with article 4 the member state shall present an interim report to the commission on the implementation of the financial contribution , including on the funding , timing and type of actions already carried out and on the rate of reintegration into employment , with particular reference to the gender dimension , or new activities achieved 12 months after the date of the application .


### by 1 august of every second year , and for the first time in 2015 , the commission shall present to the european parliament and to the council a quantitative and qualitative report on the activities under this regulation and regulation 1927 / 2006 in the previous two years . the report shall focus mainly on the results achieved by the egf and shall in particular contain information relating to applications submitted , decisions adopted , actions funded , including their complementarity with actions funded by other union funds , notably the european social fund and the european agricultural fund for rural development , and the winding - up of financial contributions made . it should also document those applications that have been rejected or reduced owing to a lack of sufficient appropriations or to non - eligibility . ### by 1 august of every second year , and for the first time in 2015 , the commission shall present to the european parliament and to the council a quantitative and qualitative report on the activities under this regulation and regulation 1927 / 2006 in the previous two years . the report shall focus mainly on the results achieved by the egf and shall in particular contain information relating to applications submitted , decisions adopted , actions funded , including their complementarity with actions funded by other union funds , notably the european social fund and the european agricultural fund for rural development , information and statistics on the reintegration rate for workers with particular reference to the more vulnerable categories such as women and the elderly , and the winding - up of financial contributions made . it should also document those applications that have been rejected or reduced owing to a lack of sufficient appropriations or to non - eligibility .


### the establishment of the european border surveillance system established by regulation no [ … / … ] of the european parliament and of the council of [ … ] should strengthen the information exchange and operational cooperation between member states and with the agency . this ensures that the situational awareness and reaction capability of member states improves considerably , also with the support of the agency , for the purposes of detecting and preventing irregular migration , for combating cross - border crime and for contributing to protect and save the lives of migrants at their external borders . when coordinating border surveillance operations , the agency should provide member states with information and analysis concerning these operations . ### the establishment of the european border surveillance system established by regulation no [ … / … ] of the european parliament and of the council of [ … ] should strengthen the information exchange and operational cooperation between member states and with the agency . this ensures that the situational awareness and reaction capability of member states improves considerably , also with the support of the agency , for the purposes of detecting and preventing irregular migration , for combating human trafficking by cross - border criminal organisations and for contributing to protect and save the lives of migrants at their external borders . when coordinating border surveillance operations , the agency should provide member states with information and analysis concerning these operations .


### during border surveillance operations , member states and the agency should respect their obligations under the united nations convention on the law of the sea , the international convention for the safety of life at sea , the international convention on maritime search and rescue , the united nations convention against transnational organized crime and its protocol against the smuggling of migrants by land , sea and air , the convention relating to the status of refugees , the european convention for the protection of human rights and fundamental freedoms , the international covenant on civil and political rights , the united nations convention against torture and other cruel , inhuman or degrading treatment or punishment and other relevant international instruments . ### during border surveillance operations , member states and the agency should respect their obligations under the united nations convention on the law of the sea , the international convention for the safety of life at sea , the international convention on maritime search and rescue , the united nations convention against transnational organized crime and its protocol against the smuggling of migrants by land , sea and air , the convention relating to the status of refugees , the european convention for the protection of human rights and fundamental freedoms , the international covenant on civil and political rights , the united nations convention against torture and other cruel , inhuman or degrading treatment or punishment , the un convention on the right of the child and other relevant international instruments .