### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex . ### in line with article 23 of the charter of fundamental rights of the european union and where applicable related case - law , member states should ensure transparency in their recruitment , selection and appointment procedures while respecting private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is at least equally qualified as the candidate of the other . member states should ensure that companies that have not achieved the directive ' s key objective disclose additional information on their recruitment , selection and appointment policies , and in particular deliver concrete plans to improve gender balance on their boards .


### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and accessible manner on their website . ### member states shall require listed companies to provide information to the competent national authorities in their annual reports once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the progress made and the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and where applicable , about the gender of all appointed directors during the reference period , and to publish that information in an appropriate and publicly accessible manner on their website .


### in order to attain the objective laid down in paragraph 1 , member states shall ensure that , in the selection of non - executive directors , priority shall be given to the candidate of the under - represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability , competence and professional performance , unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex . ### in order to attain the objective laid down in paragraph 1 , and in accordance with article 23 of the charter of fundamental rights of the european union , member states shall ensure that , in the recruitment , selection and appointment of directors , priority shall be given to the candidate of the under - represented sex , unless an objective assessment taking account of all criteria tilts the balance in favour of the candidate of the other sex . in the case of a competence - based selection procedure , priority shall be given to the candidate of the under - represented sex in cases where that candidate is at least equally qualified as a candidate of the other sex in terms of suitability , competence or professional performance .


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


### since listed companies should aim to increase the proportion of the under - represented sex in all decision - making positions , member states may provide that the objective laid down in this directive should be considered to be met where listed companies can show that members of the under - represented sex hold at least one third of all director positions , irrespective of whether they are executive or non - executive . ### since the percentage of women among executive directors is even lower , an additional incentive should be created to increase the number of female executive directors . member states may provide that the objective laid down in this directive should be considered to be met where listed companies can show that directors of the underrepresented sex hold at least one third of all director positions under the condition that at least one of the executive directors is of the under - represented sex .


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


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


### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the non - executive director positions make the appointments to those positions on the basis of a comparative analysis of the qualifications of each candidate , by applying pre - established , clear , neutrally formulated and unambiguous criteria , in order to attain the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states shall ensure that listed companies in whose boards members of the under - represented sex hold less than 40 per cent of the director positions adjust their recruitment , including pre - selection , selection , or appointment procedures for all director positions , in such a way that they effectively contribute to the attainment of the said percentage at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . member states shall ensure that listed companies make the adjustments at the appropriate stages of the recruitment , pre - selection , selection or appointment process . in particular , member states shall ensure that companies select candidates for a board position from a gender balanced selection pool . to the extent that the selection procedure takes place on the basis of a comparative analysis of the qualifications of each candidate , member states shall ensure that such adjustments include the application of pre - established , clear , neutrally formulated and unambiguous criteria .


### in order to attain the objective laid down in paragraph 1 , member states shall ensure that , in the selection of non - executive directors , priority shall be given to the candidate of the under - represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability , competence and professional performance , unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex . ### in order to attain the objective laid down in paragraph 1 , and in accordance with article 23 of the charter of fundamental rights of the european union , member states shall ensure that , in the recruitment , selection and appointment of directors , priority shall be given to the competent candidate of the under - represented sex , unless an objective assessment taking account of all criteria tilts the balance in favour of the candidate of the other sex . in the case of a competence - based selection procedure , priority shall be given to the candidate of the under - represented sex in cases where that candidate is at least equally qualified as a candidate of the other sex in terms of suitability , competence or professional performance .


### objectives with regard to non - executive directors ### objectives with regard to directors


### the efficient use of human capital is the most important determinant of an economy ' s competitiveness and is key to addressing the eu ' s demographic challenges , to competing successfully in a globalised economy and to ensuring a comparative advantage vis - à - vis third countries . the pool of highly trained and qualified women is constantly growing as evidenced by the fact that 60 per cent of university graduates are female . a continued failure to draw on this pool in appointments to economic decision - making positions would amount to a failure to fully exploit skilled human capital . ### the efficient use of human capital is the most important determinant of an economy ' s competitiveness , to competing successfully in a globalised economy . there is a pool of highly trained and qualified women as evidenced among others by the fact that 60 per cent of university graduates are female . a continued failure to draw on this pool in appointments to economic decision - making positions would amount to a failure to fully exploit skilled human capital .


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


### the methods of recruiting and appointing directors differ from one member state to another and from one company to another . they may involve the pre - selection of candidates to be presented to the shareholders ' assembly , for example by a nomination committee , the direct appointment of directors by individual shareholders or a vote in the shareholders ' assembly on individual candidates or lists of candidates . the requirements concerning the selection of candidates should be met at the appropriate stage of the selection process in accordance with national law and the articles of association of the listed companies concerned . in this respect , this directive only establishes a minimum harmonisation of selection procedures , making it possible to apply the conditions provided for by the case - law of the court of justice with a view to attaining the objective of a more balanced gender representation in the boards of listed companies . ### the methods of recruiting and appointing directors differ from one member state to another and from one company to another . they may involve the pre - selection of candidates to be presented to the shareholders ' assembly , for example by a nomination committee , the direct appointment of directors by individual shareholders or a vote in the shareholders ' assembly on individual candidates or lists of candidates . this legislative instrument therefore respects the diversity of selection procedure while insisting that the aim of increasing women ' s participation on boards is attained . the requirements concerning the selection of candidates should be met at the appropriate stage of the selection process in accordance with national law and the articles of association of the listed companies concerned . in this respect , this directive allows for a diversity of selection procedure with a view to attaining the objective of a more balanced gender representation in the boards of listed companies .


### member states shall require listed companies to provide information to the competent national authorities , once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and to publish that information in an appropriate and accessible manner on their website . ### 2 . member states shall require listed companies to provide information to the competent national authorities and in their annual reports once a year as from [ two years after adoption ] , about the gender representation on their boards , distinguishing between non - executive and executive directors and about the progress made and the measures taken in view of the objectives laid down in article 4 and in paragraph 1 of this article , and where applicable , about the gender of all appointed directors during the reference period , and to publish that information in an appropriate and publicly accessible manner on their website .


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


### this directive aims to improve the gender balance among directors of companies listed on stock exchanges and thus to contribute to the realisation of the principle of equal treatment between men and women , recognised as a fundamental right of the union . listed companies should therefore be required to disclose , upon the request of an unsuccessful candidate , not only the qualification criteria upon which the selection was based , but also the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate who is not of the under - represented sex . these limitations to the right to respect for private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter , and the obligation for listed companies to supply that information , upon request , to the unsuccessful candidate , are necessary and , in conformity with the principle of proportionality , genuinely meet recognised objectives of general interest . they are therefore in line with the requirements for such limitations laid down in article 52 of the charter and with the relevant case - law of the court of justice . ### this directive aims to improve the gender balance among directors of companies listed on stock exchanges and thus to contribute to the realisation of the principle of equal treatment between men and women , recognised as a fundamental right of the union . listed companies should therefore be required to disclose to an unsuccessful candidate , not only the qualification criteria upon which the selection was based , but also the objective comparative assessment of those criteria and , where relevant , the considerations tilting the balance in favour of a candidate who is not of the under - represented sex . these limitations to the right to respect for private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter , and the obligation for listed companies to supply that information to the unsuccessful candidate , are necessary and , in conformity with the principle of proportionality , genuinely meet recognised objectives of general interest . they are therefore in line with the requirements for such limitations laid down in article 52 of the charter and with the relevant case - law of the court of justice .


### the methods of recruiting and appointing directors differ from one member state to another and from one company to another . they may involve the pre - selection of candidates to be presented to the shareholders ' assembly , for example by a nomination committee , the direct appointment of directors by individual shareholders or a vote in the shareholders ' assembly on individual candidates or lists of candidates . the requirements concerning the selection of candidates should be met at the appropriate stage of the selection process in accordance with national law and the articles of association of the listed companies concerned . in this respect , this directive only establishes a minimum harmonisation of selection procedures , making it possible to apply the conditions provided for by the case - law of the court of justice with a view to attaining the objective of a more balanced gender representation in the boards of listed companies . ### the methods of recruiting and appointing directors differ from one member state to another and from one company to another . they may involve the pre - selection of candidates to be presented to the shareholders ' assembly , for example by a nomination committee , the direct appointment of directors by individual shareholders or a vote in the shareholders ' assembly on individual candidates or lists of candidates . this legislative instrument therefore respects the diversity of selection procedures while insisting that adjustments to these procedures are made in order to attain the aim of increasing women ' s participation on boards is attained . the requirements concerning the selection of candidates should be met at the appropriate stage of the selection process in accordance with national law and the articles of association of the listed companies concerned . in this respect , this directive allows for a diversity of selection procedure with a view to attaining the objective of a more balanced gender representation in the boards of listed companies .


### in line with that case - law , member states should ensure that the selection of the best qualified candidates for non - executive directors is based on a comparative analysis of the qualifications of each candidate on the basis of pre - established , clear , neutrally formulated and unambiguous criteria . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is equally qualified as the candidate of the other sex in terms of suitability , competence and professional performance , and if an objective assessment taking account of all criteria specific to the individual candidates does not tilt the balance in favour of a candidate of the other sex . ### in line with article 23 of the charter of fundamental rights of the european union and where applicable related case - law , member states should ensure transparency in their recruitment , selection and appointment procedures while respecting private life with regard to the processing of personal data , recognised by the articles 7 and 8 of the charter . examples of types of selection criteria that companies could apply include professional experience in managerial and / or supervisory tasks , knowledge in specific relevant areas such as finance , controlling or human resources management , leadership and communication skills and networking abilities . priority should be given to the candidate of the under - represented sex if that candidate is at least equally qualified as the candidate of the other . member states should ensure that companies that have not achieved the directive ' s key objective disclose additional information on their recruitment , selection and appointment policies , and in particular deliver concrete plans to improve gender balance on their boards .


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


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


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


### in order to attain the objective laid down in paragraph 1 , member states shall ensure that , in the selection of non - executive directors , priority shall be given to the candidate of the under - represented sex if that candidate is equally qualified as a candidate of the other sex in terms of suitability , competence and professional performance , unless an objective assessment taking account of all criteria specific to the individual candidates tilts the balance in favour of the candidate of the other sex . ### in order to attain the objective laid down in paragraph 1 , and in accordance with article 23 of the charter of fundamental rights of the european union , member states shall ensure that , in the recruitment , selection and appointment of directors , priority shall be given to the candidate of the under - represented sex , unless an objective assessment taking account of all criteria tilts the balance in favour of the candidate of the other sex . in the case of a competence - based selection procedure , priority shall be given to the candidate of the under - represented sex in cases where that candidate is at least equally qualified as a candidate of the other sex in terms of suitability , competence or professional performance .


### member states may have already taken measures providing for means to ensure a more balanced representation of women and men in company boards before the entry into force of this directive . such member states should have an opportunity to apply those measures in place of the procedural requirements relating to appointments where they can demonstrate that the measures taken are of equivalent efficacy in order to attain the objective of a presence of the under - represented sex of at least 40 per cent among non - executive directors of listed companies at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . ### member states may have already taken measures providing for means to ensure a more balanced representation of women and men in company boards before the entry into force of this directive . such member states should have an opportunity to apply those measures in place of the procedural requirements relating to appointments where they can demonstrate that the measures taken are of equivalent efficacy in order to attain the objective of a presence of the under - represented sex of at least 40 per cent among non - executive directors of listed companies at the latest by 1 january 2020 or at the latest by 1 january 2018 in case of listed companies which are public undertakings . the commission should evaluate whether enough progress has been made towards the objectives of this directive . if progress is insufficient in a certain member state , the provisions of this directive will automatically come into force for that member state ;


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


### all board systems distinguish between executive directors , who are involved in the daily management of the company , and non - executive directors who are not involved in the daily management , but do perform a supervisory function . the quantitative objectives provided for in this directive should apply only to the non - executive directors in order to strike the right balance between the need to increase the gender diversity of boards and the need to minimise interference with the day - to - day management of a company . as the non - executive directors perform supervisory tasks , it is also easier to recruit qualified candidates from outside the company and to a large extent also from outside the specific sector in which a company operates – a consideration which is of importance for areas of the economy where members of a particular sex are especially under - represented in the workforce . ### all board systems distinguish between executive directors , who are involved in the daily management of the company , and non - executive directors who are not involved in the daily management , but do perform a supervisory function . the quantitative objectives provided for in this directive should apply to all directors .


### to support joined up policy - making and to promote the sustainable use of the marine and coastal resources and sustainable economic growth , innovation and employment in maritime sectors and coastal regions , in coherence with sectoral policy priorities and actions ; ### to promote protection of marine biodiversity , sustainable development , innovation and employment in maritime sectors and coastal regions , in coherence with sectoral policy priorities and actions ;


### to further define the boundaries of sustainability of human activities that have an impact on the marine environment , in the framework of the marine strategy framework directive ; ### to promote the protection of marine biodiversity and further define the boundaries of sustainability of human activities that have an impact on the marine environment ;


### to support joined up policy - making and to promote the sustainable use of the marine and coastal resources and sustainable economic growth , innovation and employment in maritime sectors and coastal regions , in coherence with sectoral policy priorities and actions ; ### to promote sustainable development , innovation and employment in maritime sectors and coastal regions , in coherence with sectoral policy priorities and actions ;


### to further define the boundaries of sustainability of human activities that have an impact on the marine environment , in the framework of the marine strategy framework directive ; ### to promote the protection and sustainable use of marine and coastal resources and further define the boundaries of sustainability of human activities that have an impact on the marine environment ;


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


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


### 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 in developing countries , in particular in sub - saharan africa , by accelerating the clinical development of effective , safe , accessible , appropriate and affordable medical interventions for poverty - related diseases , in partnership with sub - saharan africa .


### 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 of communicable and non - communicable diseases : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication , education and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , unhealthy eating and a sedentary lifestyle as part of addressing obesity , illegal drugs , improper use of pharmaceuticals , and risky sexual behaviour , with a focus on the cross - border dimension and on member states with no or little action on these issues .


### 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 , unhealthy diet , a sedentary lifestyle and obesity , illegal drugs , improper use of pharmaceuticals , risky sexual behaviour , as well as social and environmental factors , with a focus on the cross border dimension , in order to prevent diseases and promote good physical and mental health .


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


### to minimise the public health consequences of cross - border health threats which could range from mass contamination caused by chemical incidents to pandemics , like those unleashed recently by e coli , influenza strain h1n1 or sars , the programme should contribute to the creation and maintenance of robust mechanisms and tools to detect , assess and manage major cross - border health threats . due to the nature of these threats , the programme should support coordinated public health measures at eu level to address different aspects , building on preparedness and response planning , robust and reliable risk assessment and a strong risk and crisis management framework . in this context , it is important that the programme should benefit from complementarity with the work programme of the european centre for disease prevention and control in the fight against communicable diseases and the activities supported under the unions programmes for research and innovation . special efforts should be undertaken to ensure coherence and synergies between the programme and global health work carried out under other community programmes and instruments that address in particular the areas of influenza , hiv / aids , tuberculosis and other cross - border health threats in third countries . action under the programme may also cover cross - border threats to health caused by biological and chemical incidents , environment and climate change . as stated in the commission ' s communication ‘ a budget for europe 2020’ , the commission has committed to mainstreaming climate change into overall union spending programmes and to direct at least 20% of the union budget to climate - related objectives . spending in the health for growth programme under objective 4 will contribute in a general manner to this objective by addressing health threats associated to climate change . the commission will provide information on climate change expenditure within the health for growth programme . ### to minimise the public health consequences of cross - border health threats which could range from mass contamination caused by chemical incidents to pandemics , like those unleashed recently by e coli , influenza strain h1n1 or sars , the programme should contribute to the creation and maintenance of robust mechanisms and tools to detect , assess and manage major cross - border health threats . due to the nature of these threats , the programme should support coordinated public health measures at eu level to address different aspects , building on preparedness and response planning , robust and reliable risk assessment and a strong risk and crisis management framework . in this context , it is important that the programme should benefit from complementarity with the work programme of the european centre for disease prevention and control in the fight against communicable diseases and the activities supported under the unions programmes for research and innovation . special efforts should be undertaken to ensure coherence and synergies between the programme and global health work carried out under other community programmes and instruments that address in particular the areas of influenza , hiv / aids , tuberculosis and other cross - border health threats in third countries . action under the programme should also cover cross - border threats to health caused by biological and chemical incidents , environment and climate change . as stated in the commission ' s communication ‘ a budget for europe 2020’ , the commission has committed to mainstreaming climate change into overall union spending programmes and to direct at least 20% of the union budget to climate - related objectives . spending in the programme under objective 4 will contribute in a general manner to this objective by addressing health threats associated to climate change . the commission will provide information on climate change expenditure within the programme .


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol , an unhealthy diet , a sedentary lifestyle , and obesity , illegal drugs , improper use of pharmaceuticals , risky sexual behaviour , as well as social and environmental factors , the programme will contribute to preventing diseases , particularly those causing deterioration or loss of physical or mental function , and promote good health .


### 2 . chronic diseases : support european cooperation and networking on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice and developing joint activities on prevention . cancer : follow - up work already undertaken ; set up a european cancer information system with comparable data ; support cancer screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist . ### 2 . chronic diseases : support european cooperation and networking on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice , promoting education and developing joint activities on prevention , including with regard to environmental risk factors . building on work already undertaken : set up a european chronic disease information system with comparable data ; support chronic disease screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist ; address the health effects of wider environmental determinants , including indoor air quality , exposure to toxic chemicals where not addressed by other union initiatives , and socio - economic determinants


### 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 . ### independent non - governmental bodies and health stakeholders , in particular independent 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 .


### 4 . safety : improve the prudent use of antimicrobial agents in medicinal products and reduce the practices that increase antimicrobial resistance ; reduce the burden of resistant infections and healthcare - associated infections and secure the availability of effective antimicrobials . ### 4 . safety : improve the prudent use of antimicrobial agents in medicinal products and reduce the practices that increase antimicrobial resistance , including in the veterinary sector ; reduce the burden of resistant infections and healthcare - associated infections and secure the availability of effective antimicrobials .


### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health ### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol , unhealthy diet , a sedentary lifestyle and obesity , illegal drugs , improper use of pharmaceuticals , risky sexual behaviour , as well as social and environmental factors , with a focus on the cross border dimension , in order to prevent diseases and promote good physical and mental health


### 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 member states , patient organisations and stakeholders by coordinated action at union level in order to effectively help patients affected by rare diseases as well as emerging rare diseases . this includes creation of centres of expertise , reference networks , information and registries for rare diseases based on the common criteria of accreditation .


### 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 . keeping people healthy , both physically and mentally , and active for longer will be of major benefit to people individually as well as to society as a whole , 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 the fundamental value of ‘ equality’ as laid down in article 2 of the treaty on european union . it is appropriate in this context to establish the third programme of eu action on health .


### where the consultations referred to in paragraph 2 fail to resolve the matter , the commission shall withdraw the authorisation for the agreement concerned . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 . it shall include a requirement that the member state takes appropriate action , and where necessary terminate the relevant agreement . ### where the consultations referred to in paragraph 2 fail to resolve the matter or the member state fails to take the necessary steps within the period agreed in the consultation , the commission shall withdraw the authorisation provided for in article 3 for the agreement concerned . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 .


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


### 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 four 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 .


### 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 agreements within a certain timeframe 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 which are addressed in this regulation .


### the existing exemption for that use should continue to apply until 31 december 2015 in order to enable industry to further adapt the relevant technologies . ### the existing exemption for that use should no longer apply after 30 june 2014 .


### at the end of paragraph 4 , the following wording is added : ‘ the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ’ ### paragraph 4 is replaced by the following : ‘ 4 . any negative decision shall contain a reference to the means of redress in case the applicant wishes to appeal the decision . the means of redress shall include a reference to the possibility of review by an authority in the member states . ’


### at the end of paragraph 4 , the following wording is added : ' the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ' ### paragraph 4 is replaced by the following : ' 4 . any decision on re - use shall contain a reference to the means of redress in case the applicant wishes to appeal the decision . the means of redress shall include the possibility of review by an impartial review body , such as the national competition authority , the national access to documents authority or the national judicial authority , that has the authority to investigate complaints regarding the re - use of public sector documents and whose decisions must be considered binding by the public sector body concerned . '


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


### member states , in cooperation with the commission , shall designate the imi coordinators and competent authorities and the internal market areas in which they have competence . ### member states shall designate the imi coordinators and competent authorities and the internal market areas in which they have competence . the commission may play a consultative role in this process .


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


### in case of disembarkation in a third country , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances to the extent possible before disembarkation . they shall inform the intercepted or rescued persons of the place of disembarkation in an appropriate way and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement . ### if disembarkation in a third country is considered , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances , including their medical conditions and other circumstances that might make them vulnerable or subject to international protection needs , before a decision is made . they shall inform the intercepted or rescued persons of the place of disembarkation and of the procedure to be followed to avoid being disembarked in the third country , in a language which those persons understand or may reasonably be presumed to understand . the participating units shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement . intercepted and rescued persons shall be granted effective access to legal assistance , to interpretation and to an effective remedy before disembarkation in a third country .


### in the territorial sea of the host member state or a participating member state , the participating units shall take one or more of the following measures when there are reasonable grounds to suspect that a ship is carrying persons intending to circumvent checks at border crossing points or is engaged in the smuggling of migrants by sea : ### in the territorial sea of the host member state or a participating member state , the participating units shall take one or more of the following measures in the following order , without prejudice to directive 2013 / 32 / eu on common procedures for granting and withdrawing international protection and the schengen border code and in accordance with article 4 of this regulation , when there are reasonable grounds to suspect that a ship is carrying persons intending to circumvent checks at border crossing points or is engaged in the smuggling of migrants by sea and / or trafficking of migrants by sea in accordance with directive 2011 / 36 / eu of the european parliament and of the council1 on preventing and combating trafficking in human beings and protecting its victims : directive 2011 / 36 / eu of the european parliament and of the council of 5 april 2011 on preventing and combating trafficking in human beings and protecting its victims .


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


### in case of disembarkation in a third country , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances to the extent possible before disembarkation . they shall inform the intercepted or rescued persons of the place of disembarkation in an appropriate way and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement . ### if disembarkation in a third country is considered , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances , including their medical conditions and other circumstances that might make them vulnerable , before a decision is made . they shall inform the intercepted or rescued persons of the place of disembarkation in a language which those persons understand or may reasonably be presumed to understand and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement .


### in the case of search and rescue situations as laid down in article 9 , the participating units shall cooperate with the responsible rescue coordination centre to provide a suitable port or place of safety for the rescued persons and to ensure their rapid and effective disembarkation . ### subject to the application of article 4 , in the case of search and rescue situations as laid down in article 9 , the participating units shall cooperate with the responsible rescue coordination centre to provide a suitable port or place of safety for the rescued persons and to ensure their rapid and effective disembarkation .


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


### the modalities for the disembarkation of the persons intercepted or rescued in a sea operation shall be set out in the operational plan . those modalities for disembarkation shall not have the effect of imposing obligations on member states not participating in the sea operation unless they expressly provide authorisation for measures to be taken in their territorial sea or contiguous zone in accordance with article 6 or article 8 . ### the modalities for the disembarkation of the persons intercepted or rescued in a sea operation shall be set out in the operational plan in accordance with article 4 . those modalities for disembarkation shall not have the effect of imposing obligations on member states not participating in the sea operation unless they expressly provide authorisation for measures to be taken in their territorial sea or contiguous zone in accordance with article 6 or article 8 . modalities for disembarkation may specify that disembarkation does not necessarily imply sole responsibility for the state on whose territory persons rescued at sea are disembarked .


### ‘ place of safety’ means a location where rescue operations are considered to terminate and where the survivors ' safety of life including as regards the protection of their fundamental rights is not threatened , where their basic human needs can be met and from which transportation arrangements can be made for the survivors ' next destination or final destination ; ### ‘ place of safety’ means a location where rescue operations are considered to terminate and where the survivors ' safety of life as well as the protection of their fundamental rights is not threatened , where their basic human needs can be met and from which transportation arrangements can be made for the survivors ' next destination or final destination , in compliance with the principle of non - refoulement ;


### ' place of safety ' means a location where rescue operations are considered to terminate and where the survivors ' safety of life including as regards the protection of their fundamental rights is not threatened , where their basic human needs can be met and from which transportation arrangements can be made for the survivors ' next destination or final destination ; ### ' place of safety ' means a location where rescue operations are considered to terminate and where the survivors ' safety of life as well as the protection of their fundamental rights are not threatened , where their basic human needs can be met and from which transportation arrangements can be made for the survivors ' next destination or final destination , in compliance with the principle of non - refoulement ;


### border guards participating in a sea operation shall be trained with regard to relevant provisions of fundamental rights , refugee law and the international legal regime of search and rescue . ### all border guards and other personnel of the member states shall receive , prior to their participation in a sea operation , training in relevant union and international law , including fundamental rights and access to international protection and guidelines for the purpose of identifying persons seeking protection and directing them towards the appropriate facilities , and the international legal regime of search and rescue . each participating unit shall include at least one person with advanced medical training and one person with expertise in refugee and asylum law .


### seizing the ship and apprehending persons on board ; ### if evidence is found that the vessel is engaged in the smuggling and / or trafficking of migrants , seizing the ship and apprehending persons suspected of smuggling and or trafficking on board ;


### in the zone contiguous to the territorial sea of a member state , which is a host member state or a participating member state , the measures laid down in article 6 shall be taken in accordance with article 6 . ### in the zone contiguous to the territorial sea of a member state , which is a host member state or a participating member state , the measures laid down in article 6 shall be taken in accordance with article 6 and article 4 .


### no person shall be disembarked in , or otherwise handed over to the authorities of a country where there is a serious risk that such person would be subjected to the death penalty , torture or other inhuman or degrading treatment or punishment or from which there is a serious risk of expulsion , removal or extradition to another country in contravention of the principle of non - refoulement . ### no person shall be disembarked in , otherwise handed over to the authorities of , or forced to enter , a country where there is a serious risk that such person would be subjected to the death penalty , torture or other inhuman or degrading treatment or punishment or from which there is a serious risk of expulsion , removal or extradition to another country in contravention of the principle of non - refoulement .


### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ; ### ' data subject ' means an identified natural person or a natural person who can be identified or singled out , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number or other unique identifier , location data , online identifier or to one or more factors specific to the gender , physical , physiological , genetic , mental , economic , cultural or social identity or sexual orientation of that person ;


### adequate , relevant , and not excessive in relation to the purposes for which they are processed ; ### adequate , relevant , and limited to the minimum necessary in relation to the purposes for which they are processed ; they shall only be processed if , and as long as , the purposes could not be fulfilled by processing information that does not involve personal data ; data held by private parties shall only be accessed to investigate or prosecute criminal offences in accordance with necessity and proportionality requirements to be defined by each member state in its national law , subject to the relevant provisions of european union law or public international law , and in particular the echr as interpreted by the european court of human rights .


### member states shall provide that each controller and processor maintains documentation of all processing systems and procedures under their responsibility . ### all competent authorities shall maintain detailed documentation of all processing systems and procedures under their responsibility . 1 a . transmissions of personal data are to be logged or documented for the purposes of verification of the lawfulness of the data processing , self - monitoring and ensuring proper data integrity and security . 1 b . the logs and documents so produced must be made available to the supervisory authority upon request . the supervisory authority shall use this information only for the purpose of checking the lawfulness of the data processing and ensuring proper data integrity and security .


### processed fairly and lawfully ; ### processed fairly and lawfully and in a transparent manner in relation to the data subject ;


### adequate , relevant , and not excessive in relation to the purposes for which they are processed ; ### adequate , relevant , and limited to the minimum necessary in relation to the purposes for which they are processed ; they shall only be processed where anonymous processing is not sufficient for the respective purpose ;


### member states shall ensure that , as far as possible , the different categories of personal data undergoing processing are distinguished in accordance with their degree of accuracy and reliability . ### the competent authorities shall ensure that , as far as possible , personal data are factually accurate , complete and , if necessary , up to date .


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent and for the period that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned , based on a concrete and individual examination of each specific case :


### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or marking of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . ### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or restriction of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### instead of erasure , the controller shall mark the personal data where : ### instead of erasure , the controller shall restrict the processing of the personal data where :


### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans . ### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans and thereby promoting animal health


### ‘ kept animals’ means animals which are kept by humans ; in the case of aquatic animals , aquaculture animals ; ### ‘ kept animals’ means living animals which are kept by humans ;


### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases , except where that is specifically authorised for scientific purposes , as appropriate for : ### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility , or from such kept animals and wild animals , of diseases , except where that is specifically authorised for scientific purposes , as appropriate for :


### the member states may take measures concerning the use of veterinary medicinal products for listed diseases , to ensure the most efficient disease prevention or control for those diseases , provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to article 47 . ### the member states shall take measures concerning the responsible use of veterinary medicinal products for transmissible diseases , to ensure the most efficient disease prevention or control for those diseases , provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to article 47 .


### member states shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific listed disease : ### member states shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific disease :


### specific conditions for the use veterinary medicinal products for a specific listed disease ; ### specific conditions for the use veterinary medicinal products for a specific disease ;


### risk mitigating measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals ; ### risk mitigating measures to prevent the spread of diseases through animals treated with the veterinary medicinal products or products from such animals ;


### surveillance following the use of vaccines and other veterinary medicinal products for specific listed diseases . ### surveillance following the use of vaccines and other veterinary medicinal products for specific diseases .


### approval of disease control aquatic food establishments ### approval of processing establishments and disease control aquatic food establishments


### operators of disease control aquatic food establishments shall ensure that their establishments are approved by the competent authority to slaughter aquatic animals for disease control purposes in accordance with article 61 , article 62 and articles 68 , 78 and and the rules adopted pursuant to article 63 and articles 70 , 71 and 78 . ### operators of processing establishments and disease control aquatic food establishments shall ensure that their establishments are approved by the competent authority to slaughter aquatic animals for disease control purposes in accordance with article 61 , article 62 and articles 68 , 78 and and the rules adopted pursuant to article 63 and articles 70 , 71 and 78 .


### register of the competent authority of aquaculture establishments and disease control aquatic food establishments ### register of the competent authority of aquaculture establishments , processing establishments and disease control aquatic food establishments


### register of aquaculture establishments and disease control aquatic food establishments ### register of aquaculture establishments , processing establishments and disease control aquatic food establishments


### all disease control aquatic food establishments approved in accordance with article 179 . ### all processing establishments and disease control aquatic food establishments approved in accordance with article 179 .


### record keeping obligation for disease control aquatic food establishments ### record keeping obligation for processing establishments and disease control aquatic food establishments


### operators of disease control aquatic food establishments subject to approval in accordance with article 177 shall keep up - to - date records of all movement of aquaculture animals and products of animal origin obtained from such animals into and out of such establishments . ### operators of processing establishments and disease control aquatic food establishments subject to approval in accordance with article 177 shall keep up - to - date records of all movement of aquaculture animals and products of animal origin obtained from such animals into and out of such establishments .


### operators of disease control aquatic food establishments shall : ### operators of processing establishments and disease control aquatic food establishments shall :


### transporters of aquaculture animals and wild aquatic animals intended for aquaculture shall keep up - to date records on : ### transporters of aquaculture animals and wild aquatic animals intended for aquaculture or release in natural waters shall keep up - to date records on :


### operators of establishments and food business establishments receiving aquaculture animals shall : ### operators of establishments and food business establishments receiving aquatic animals shall :


### the aquaculture animals received ; ### the aquatic animals received ;


### movement of aquaculture animals intended for member states , zones or compartments which have been declared disease free or which are subject to an eradication programme and delegated acts ### movement of kept aquatic animals intended for member states , zones or compartments which have been declared disease free or which are subject to an eradication programme and delegated acts


### movement of aquaculture animals intended for member states , zones or compartments which have been declared disease - free or which are subject to an eradication programme and delegated acts ### movement of kept aquatic animals intended for human consumption in member states , zones or compartments which have been declared disease - free or which are subject to an eradication programme and delegated acts


### operators shall only move aquaculture animals from an aquaculture establishment for the purposes referred to in point or of this article , if those aquaculture animals originate from a member state , or zone or compartment thereof , which has been declared disease - free in accordance with article 36 or 37 for listed diseases referred to in article 8 or when they are of listed species for those listed diseases and the aquaculture animals are : ### operators shall only move kept aquatic from an establishment for the purposes referred to in point and of this article , if those animals originate from a member state , or zone or compartment thereof , which has been declared disease - free in accordance with article 36 or 37 for listed diseases referred to in article 8 or when they are of listed species for those listed diseases and the kept aquatic animals are :


### operators shall only move aquaculture animals from an aquaculture establishment for the purposes referred to in point or of this paragraph , if those aquaculture animals originate from a member state , or zone or compartment thereof , which has been declared disease - free in accordance with article 36 or 37 for listed diseases referred to in article 8 or when they are of listed species for those listed diseases and they are : ### operators shall only move kept aquatic animals intended for human consumption from an establishment for the purposes referred to in point or of this paragraph , if those animals originate from a member state , or zone or compartment thereof , which has been declared disease - free in accordance with article 36 or 37 for listed diseases referred to in article 8 or when they are of listed species for those listed diseases and they are :


### the species , categories , and life stage of the aquaculture animals ; ### the species , categories , and life stage of the kept aquatic animals ;


### the species , categories , and live stage of the aquaculture animals ; ### the species , categories , and live stage of the kept aquatic animals ;


### the intended use of the aquaculture animals ; ### the intended use of the kept aquatic animals ;


### the place of destination of the aquaculture animals ; ### the place of destination of the kept aquatic animals ;


### member states may require that aquaculture animals shall only be released into the wild if they originate from a member state , or zone or compartment declared disease - free in accordance with article 36 or article 37 as regards the listed diseases referred to in article 8 and for which the species of aquaculture animals to be moved is a listed species , regardless of the health status of the area where the aquaculture animals are to be released . ### member states may require that aquatic animals shall only be released into the wild if they originate from a member state , or zone or compartment declared disease - free in accordance with article 36 or article 37 as regards the listed diseases referred to in article 8 and for which the species of aquatic animals to be moved is a listed species , regardless of the health status of the area where the aquatic animals are to be released .


### articles 196 and 197 shall also apply to movements of wild aquatic animals intended for an aquaculture establishment or disease control aquatic food establishment subject to : ### articles 196 and 197 shall also apply to movements of wild aquatic animals intended for an aquaculture establishment , processing establishment or disease control aquatic food establishment subject to :


### by way of derogation from paragraph 1 of this article member states may authorise operators to introduce aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with article 30 or as regards the listed diseases referred to in article 8 and , from another zone or compartment for which such a programme has also been established as regards the same diseases within that member state , provided that such movement will not jeopardise the health status of the member state , or zone or compartment thereof . ### by way of derogation from paragraph 1 of this article member states may authorise operators to introduce kept aquatic animals into a zone or compartment for which an eradication programme has been established in accordance with article 30 or as regards the listed diseases referred to in article 8 and , from another zone or compartment for which such a programme has also been established as regards the same diseases within that member state , provided that such movement will not jeopardise the health status of the member state , or zone or compartment thereof .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the derogations from movement requirements provided for in paragraph 2 of this article for those movements of aquaculture animals which do not pose significant risk of spreading of diseases due to : ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the derogations from movement requirements provided for in paragraph 2 of this article for those movements of kept aquatic animals which do not pose significant risk of spreading of diseases due to :


### the methods of keeping the aquaculture animals and type of production in the aquaculture establishments of origin and of destination ; ### the methods of keeping the aquatic animals and type of production in the establishments of origin and of destination ;


### any specific conditions under which the aquaculture animals are kept ; ### any specific conditions under which the aquatic animals are kept ;


### specific movement patterns of the type of aquaculture establishment and concerned species or category of aquaculture animals ; ### specific movement patterns of the type of establishment and concerned species or category of aquatic animals ;


### self - declaration by operators for movements of aquaculture to other member states and delegated acts ### self - declaration by operators for movements of aquatic animals to other member states and delegated acts


### operators at the place of origin , shall issue a self - declaration document for movements of aquaculture animals from their place of origin in one member state to the place of destination in another member state and ensure that it accompanies such aquaculture animals , where they are not required to be accompanied by an animal health certificate provided for in articles 208 and 209 or rules adopted pursuant to that articles 211 and article 214 . ### operators at the place of origin , shall issue a self - declaration document for movements of aquatic animals from their place of origin in one member state to the place of destination in another member state and ensure that it accompanies such aquatic animals , where they are not required to be accompanied by an animal health certificate provided for in articles 208 and 209 or rules adopted pursuant to that articles 211 and article 214 .


### the self - declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquaculture animals : ### the self - declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquatic animals :


### a description of the aquaculture animals , the species , their quantity , weight or volume as relevant for the animals concerned ; ### a description of the aquatic animals , the species , their quantity , weight or volume as relevant for the animals concerned ;


### the information needed to demonstrate that the aquaculture animals comply with the movement requirements provided for in sections 1 to 5 . ### the information needed to demonstrate that the aquatic animals comply with the movement requirements provided for in sections 1 to 5 .


### detailed rules on the content of the self - declaration document provided for in paragraph 2 of this article for different species and categories of aquaculture animals ; ### detailed rules on the content of the self - declaration document provided for in paragraph 2 of this article for different species and categories of aquatic animals ;