### given the high level of unpredictability of fishing activities , exceptional circumstances may cause significant economic losses to fishers . in order to mitigate those consequences , it should be possible for the emff to support a compensation for the extraordinary cessation of fishing activities caused by the implementation of certain conservation measures , i . e . multiannual plans , targets for the conservation and sustainable exploitation of stocks , measures to adapt the fishing capacity of fishing vessels to available fishing opportunities and technical measures , by the implementation of emergency measures , by the interruption , due to reasons of force majeure , of the application of a sustainable fisheries partnership agreement , by a natural disaster or by an environmental incident . support should be granted only if the impact on fishers of such circumstances is significant , i . e . if the commercial activities of the vessel concerned are stopped during at least 90 consecutive days and if the economic losses resulting from the cessation amount to more than 30% of the average annual turnover of the business concerned during a specified period of time . the specificities of eel fisheries should be taken into account in the conditions for granting such support . ### given the high level of unpredictability of fishing activities , exceptional circumstances may cause significant economic losses to fishers . in order to mitigate those consequences , it should be possible for the emff to support a compensation for the extraordinary cessation of fishing activities caused by the implementation of certain conservation measures , i . e . multiannual plans , targets for the conservation and sustainable exploitation of stocks , measures to adapt the fishing capacity of fishing vessels to available fishing opportunities and technical measures , by the implementation of emergency measures , by the interruption , due to reasons of force majeure , of the application of a sustainable fisheries partnership agreement , by a natural disaster or by an environmental incident . support should be granted only if the economic impact on fishers of such circumstances is significant , i . e . if the commercial activities of the vessel concerned are stopped during at least 90 consecutive days and if the economic losses resulting from the cessation amount to more than 30% of the average annual turnover of the business concerned during a specified period of time . the specificities of eel fisheries should be taken into account in the conditions for granting such support .


### job creation in coastal regions relies on a locally driven development of a sustainable blue economy that revives the social fabric of those regions . ocean industries and services are likely to outperform the growth of the global economy and make an important contribution to employment and growth by 2030 . to be sustainable , blue growth depends on innovation and investment in new maritime businesses and in the bio - economy , including sustainable tourism models , ocean - based renewable energy , innovative high - end shipbuilding and new port service , which can create jobs and at the same time enhance local development . whilst public investment in the sustainable blue economy should be mainstreamed throughout the union budget , the emff should specifically concentrate on enabling conditions for the development of the sustainable blue economy and on removing bottlenecks to facilitate investment and the development of new markets and technologies or services . support for the development of the sustainable blue economy should be delivered through shared , direct and indirect management . ### job creation in coastal regions , and in particular on islands , relies on a locally driven development of a sustainable blue economy that revives the social fabric of those regions . sea and ocean industries and services are likely to outperform the growth of the global economy and make an important contribution to employment and growth by 2030 . to be sustainable , blue growth depends on innovation and investment in new maritime businesses and in the bio - economy , including sustainable tourism models , ocean - based renewable energy , innovative high - end shipbuilding and new port service , which can create jobs and at the same time enhance local development . whilst public investment in the sustainable blue economy should be mainstreamed throughout the union budget , the emff should specifically concentrate on enabling conditions for the development of the sustainable blue economy and on removing bottlenecks to facilitate investment and the development of new markets and technologies or services . support for the development of the sustainable blue economy should be delivered through shared , direct and indirect management .


### under direct and indirect management , the emff should focus on the enabling conditions for a sustainable blue economy through the promotion of an integrated governance and management of the maritime policy , the enhancement of the transfer and uptake of research , innovation and technology in the sustainable blue economy , the improvement of maritime skills , ocean literacy and sharing of socio - economic data on the sustainable blue economy , the promotion of a low - carbon and climate resilient sustainable blue economy and the development of project pipelines and innovative financing instruments . due consideration to the outermost regions ' specific situation should be given in relation to the above mentioned fields . ### under direct and indirect management , the emff should focus on the enabling conditions for a sustainable blue economy through the promotion of an integrated governance and management of the maritime policy , the enhancement of the transfer and uptake of research , innovation and technology in the sustainable blue economy , the improvement of maritime skills , sea and ocean literacy and sharing of socio - economic data on the sustainable blue economy , the promotion of a low - carbon and climate resilient sustainable blue economy and the development of project pipelines and innovative financing instruments . due consideration to the outermost regions ' specific situation should be given in relation to the above mentioned fields .


### in order to enhance transparency regarding the use of union funds and their sound financial management , in particular reinforcing public control of the money used , certain information on the operations funded under the emff should be published on a website of member state in accordance with regulation no [ regulation laying down common provisions ] . when a member state publishes information on operations funded under emff , the rules on the protection of personal data set out in regulation no 2016 / 679 of the european parliament and of the council24are to be complied with . _________________ 24 regulation no 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . ### in order to enhance transparency regarding the use of union funds and their sound financial management , in particular reinforcing public control of the money used , information on the operations funded under the emff should be published on a website of member state in accordance with regulation no [ regulation laying down common provisions ] . when a member state publishes information on operations funded under emff , the rules on the protection of personal data set out in regulation no 2016 / 679 of the european parliament and of the council24 are to be complied with . _________________ 24 regulation no 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### the commission shall develop an analysis for each sea basin indicating the common strengths and weaknesses of the sea basin with regard to the achievement of the objectives of the cfp , as referred to in article 2 of regulation no 1380 / 2013 . where applicable , this analysis shall take into account the existing sea basin and macro - regional strategies . ### the commission shall develop an analysis for each sea basin indicating the common strengths and weaknesses of the sea basin with regard to the achievement of the objectives of the cfp , as referred to in article 2 of regulation no 1380 / 2013 . this analysis shall take into account the existing sea basin and macro - regional strategies .


### the promotion of an integrated governance and management of the maritime policy , including through maritime spatial planning , sea basin strategies and maritime regional cooperation ; ### the promotion of an integrated governance and management of the maritime policy , including through maritime spatial planning , sea basin strategies , maritime regional cooperation , eu macro - regional strategies and cross - border cooperation ;


### this regulation should apply to online content services which are provided against payment of money . providers of such services are in a position to verify the member state of residence of their subscribers . the right to use an online content service should be regarded as acquired against payment of money whether such payment is made directly to the provider of the online content service , or to another party such as a provider offering a package combining a telecommunications service and an online content service operated by another provider . ### this regulation should apply to online content services which are provided against payment of money including the payment of a mandatory fee such as a broadcasting fee . providers of such services are in a position to verify the member state of residence of their subscribers . the right to use an online content service should be regarded as acquired against payment of money whether such payment is made directly or indirectly to the provider of the online content service , or to another party such as a provider offering a package combining a telecommunications service and an online content service operated by another provider .


### service providers should ensure that their subscribers are properly informed about the conditions of enjoyment of online content services in member states other than the member state of residence of the subscribers . the regulation enables right holders to require that the service provider make use of effective means in order to verify that the online content service is provided in conformity with this regulation . it is necessary , however , to ensure that the required means are reasonable and do not go beyond what is necessary in order to achieve this purpose . examples of the necessary technical and organisational measures may include sampling of ip address instead of constant monitoring of location , transparent information to the individuals about the methods used for the verification and its purposes , and appropriate security measures . considering that for purposes of the verification what matters is not the location , but rather , in which member state the subscriber is accessing the service , precise location data should not be collected and processed for this purpose . similarly , where authentication of a subscriber is sufficient in order to deliver the service provided , identification of the subscriber should not be required . ### service providers should ensure that their subscribers are properly informed about the conditions of enjoyment of online content services in member states other than the member state of residence of the subscribers . the regulation requires that the service provider make use of effective means in order to verify that the online content service is provided in conformity with this regulation . it is necessary , however , to ensure that the required means leave room for service providers to innovate with the online means of authentication they provide to consumers to subscribe and access online content , are reasonable and do not go beyond what is necessary in order to achieve this purpose . technical and organisational measures should be based on electronic means of identification at the time of subscription instead of constant monitoring of location , on transparent information to the individuals about the methods used for the verification and its purposes , and appropriate security measures . considering that for purposes of the verification what matters is not the location , but rather , in which member state the subscriber is accessing the service , precise location data should not be collected and processed for this purpose . similarly , where authentication of a subscriber is sufficient in order to deliver the service provided , identification of the subscriber should not be required . the subscriber should be able to access the information on the member state of residence verified and registered at the time of subscription .


### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders’ interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies’ assets or transactions which can have a significant impact on profits or turnover should be submitted to a vote by the shareholders in a general meeting . where the related party transaction involves a shareholder , this shareholder should be excluded from that vote . the company should not be allowed to conclude the transaction before the shareholders’ approval of the transaction . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether the transaction is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . member states should be allowed to exclude transactions entered into between the company and its wholly owned subsidiaries . member states should also be able to allow companies to request the advance approval by shareholders for certain clearly defined types of recurrent transactions above 5 percent of the assets , and to request from shareholders an advance exemption from the obligation to produce an independent third party report for recurrent transactions above 1 percent of the assets , under certain conditions , in order to facilitate the conclusion of such transactions by companies . ### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders ' interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies ' assets or transactions should be submitted either to a vote by the shareholders in a general meeting or to the approval of an administrative body of the company such as independent directors assessing whether the transaction is fair and reasonable from the perspective of the company and consequently its shareholders . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction . transactions entered into in the ordinary course of business or concluded on market terms or market equivalent terms should be excluded . transactions entered into between the company and its wholly or partly owned subsidiaries or joint ventures should also be excluded . member states should also be able to allow companies to request the advance approval by shareholders or an independent administrative body for certain clearly defined types of recurrent transactions above 5 percent of the assets .


### member states shall ensure that an intermediary that reports the name and contact details of a shareholder is not considered in breach of any restriction on disclosure of information imposed by contract or by any legislative , regulatory or administrative provision . ### member states shall ensure that an intermediary that imparts to the company information regarding shareholders referred to in paragraph 2 is not considered in breach of any restriction on disclosure of information imposed by contract or by any legislative , regulatory or administrative provision .


### member states shall ensure that if a company chooses not to directly communicate with its shareholders , the information related to their shares shall be transmitted to them or , in accordance with the instructions given by the shareholder , to a third party , by the intermediary without undue delay in all of the following cases : ### member states shall ensure that if a company chooses not to directly communicate with its shareholders , the information related to their shares shall be available online and transmitted to them or , in accordance with the instructions given by the shareholder , to a third party , by the intermediary without undue delay in all of the following cases :


### the relative change of the remuneration of directors over the last three financial years , its relation to the development of the value of the company and to change in the average remuneration of full time employees of the company other than directors ; ### the relative changes in the remuneration both of executive directors and of non - executive directors over the last three financial years , their relation to the development of the general performance of the company and to change in the average remuneration of employees in the same period ;


### information on how the remuneration of directors was established , including on the role of the remuneration committee . ### information on how the remuneration of directors was established , including , where appropriate , on the role of the remuneration committee .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies publicly announce transactions with related parties that represent more than 1% of their assets&#160 ; immediately following the approval of the transaction . the announcement shall at least&#160 ; contain information on the nature of the related party relationship , the name of the related party , the value of the transaction and any other information necessary to assess the financial impartiality of the transaction .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of significant transactions with related parties , publicly announce such transactions at the time of the conclusion of the transaction . member states may stipulate that this announcement is accompanied by a report from an independent third party which provides the information needed to assess the significance of the transaction for the company . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other material information necessary to assess the financial impartiality of the&#160 ; transaction .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction .


### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients . ### hta can assist member states in creating and maintaining sustainable and comprehensive healthcare systems while stimulating innovation and increasing sector competitiveness , which will ultimately deliver better outcomes for patients .


### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology , and in particular , to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology . the outcome of such assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . ### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology . in this connection , the joint clinical assessment provided for by this regulation constitutes a scientific analysis of the relative effects of health technology on clinical outcomes , evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of patients , taking into account the hta core model criteria . this will include consideration of the degree of certainty on the relative outcomes , based on the available evidence . the outcome of such joint clinical assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . the assessment conducted by each member state as part of its national appraisal should therefore fall outside the scope of this proposal .


### in order that the harmonised procedures fulfil their internal market objective , member states should be required to take full account of the results of joint clinical assessments and not repeat those assessments . compliance with this obligation does not prevent member states from carrying out non - clinical assessments on the same health technology , or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement . ### in order that the harmonised procedures fulfil their internal market objectives , increase the efficiency of clinical evaluations , contribute to the sustainability of healthcare systems and maximise innovation , member states should be required to take full account of the joint clinical assessment results . compliance with this obligation does not prevent member states from carrying out additional clinical analyses to the extent that they are missing from the joint clinical assessment and are deemed necessary within the national health technology assessment context . member states remain free to carry out non - clinical assessments on the same health technology , or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement .


### in order to ensure the inclusiveness and transparency of the joint work , the coordination group should engage and consult widely with interested parties and stakeholders . however , in order to preserve the integrity of the joint work , rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest . ### in order to ensure the inclusiveness and transparency of the joint work , the coordination group should engage and consult widely with interested parties and stakeholders . however , in order to preserve the integrity of the joint work , rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest . furthermore , these rules and all consultations should be made public .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the coordination group together with the commission should establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission and the coordination group should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to establish procedures for joint clinical assessments and procedures for joint scientific consultations . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 the procedural and methodological framework are updated at the frequency deemed necessary by the commission and the coordination group to ensure that they should be adapted to the evolution of science . in developing the methodological framework , the commission and in collaboration with the coordination group should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorization . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission and the coordination group should therefore ensure that the methodology provides for a sufficient level of clinical evidence to enable an adequate assessment of such health technologies . such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world evidence , as well as the acceptance of indirect treatment comparators . __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### in order to facilitate the joint work and the exchange of information between member states on hta , provision should be made for the establishment of an it platform that contains appropriate databases and secure channels for communication . the commission should also ensure a link between the it platform and other data infrastructures relevant for the purposes of hta such as registries of real world data . ### in order to facilitate the joint work and the exchange of information between member states on hta , provision should be made for the establishment of an it platform that contains appropriate databases and secure channels for communication . the commission should also ensure a link between the it platform and other data infrastructures relevant for the purposes of hta such as registries of real world data . the it platform should ensure the publication and transparency for both the joint scientific consultations and the joint technology assessment with regards to the final reports with a summary of all observations . given the sensitive nature of health information , the confidential handling of data should be safeguarded when commercially or personally sensible .


### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement on better law - making of 13 april 2016 , that evaluation should be based on the five criteria of efficiency , effectiveness , relevance , coherence and eu added value and should be supported by a monitoring programme . ### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement on better law - making of 13 april 2016 , that evaluation should be based on the five criteria of efficiency , effectiveness , relevance , coherence and eu added value and should be supported by a monitoring programme . the results should also be communicated to the european parliament and council .


### members of the coordination group , and their appointed representatives shall respect the principles of independence , impartiality , and confidentiality . ### members of the coordination group , and their appointed representatives shall respect the principles of transparency , independence , impartiality , and confidentiality of specific information .


### the commission shall publish a list of the designated members of the coordination group and its sub - groups on the it platform referred to in article 27 . ### the commission shall publish a list of the designated members of the coordination group and its sub - groups on the it platform referred to in article 27 . the commission shall regularly update the coordination group about any changes to this list or related information .


### medical devices classified as class iib and iii pursuant to article 51 of regulation 2017 / 745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation ; ### medical devices classified as class iib and iii pursuant to article 51 of regulation 2017 / 745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation that are considered to be a major innovation and with potential significant impact on national health care systems ;


### in vitro diagnostic medical devices classified as class d pursuant to article 47 of regulation 2017 / 74617 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to article 48 of that regulation . __________________ 17 regulation 2017 / 746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic medical devices and repealing directive 98 / 79 / ec and commission decision 2010 / 227 / eu . ### in vitro diagnostic medical devices classified as class d pursuant to article 47 of regulation 2017 / 74617 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to article 48 of that regulation that are considered to be a major innovation and with potential significant impact on national health care systems . __________________ 17 regulation 2017 / 746 of the european parliament and of the council of 5 april 2017 on in vitro diagnostic medical devices and repealing directive 98 / 79 / ec and commission decision 2010 / 227 / eu .


### the designated sub - group shall request relevant health technology developers to submit documentation containing the information , data and evidence necessary for the joint clinical assessment . ### the designated sub - group shall meet relevant health technology developers to agree on the scope of the assessment and submit documentation from relevant sources including clinical trials but also inter alia patient registries , databases or european reference networks , containing the information , data and evidence necessary for the joint clinical assessment .


### the designated sub - group shall ensure that stakeholders , including patients and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that stakeholders , experts , including experts from patient organisations and consumer organisations , where relevant , and clinical assessors , who are identified by the stakeholder network or by the coordination group are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments .


### the coordination group shall approve the final joint clinical assessment report and summary report , wherever possible by consensus or , where necessary , by a simple majority of member states . ### the coordination group shall approve the final joint clinical assessment report and summary report , wherever possible by consensus or , where necessary , by a 2 / 3 majority of member states . diverging views shall be outlined in the report .


### the assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report . ### the assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report . the assessor shall consult the developer on the report before its publication . the developer shall have a period of 7 working days to point out which information , if any , it considers confidential and to justify the commercially sensitive nature of that information .


### the rules for determining the stakeholders to be consulted for the purpose of this section . ### the rules for determining the stakeholders to be consulted for the purpose of this section . declarations on conflicts of interests of stakeholders shall be publicly available . experts with conflict of interests shall not participate in the process .


### the commission shall adopt implementing acts concerning : ### the commission shall adopt delegated acts in accordance with article 31 concerning :


### the consultation of patients , clinical experts , and other stakeholders in clinical assessments . ### the consultation of patients , experts from consumer organisations when relevant , clinical experts , and other stakeholders in clinical assessments . the declarations of conflicts of interest of consulted stakeholders shall be publicly available .


### methodologies used to formulate the contents and design of clinical assessments . ### methodologies used to formulate the contents and design of clinical assessments , based on the common tools and methodologies for cooperation developed after many years of cooperation through eunethta joint actions , beneluxa and valletta . they shall be developed after consultations with all stakeholders , in a transparent manner , regularly updated to reflect the evolution of science and publicly available . for medicinal products referred to in article 5 and article 32 the commission shall , when adopting delegated acts , take into account the distinctive characteristics of the medicinal product and medical device sectors . the methodology shall provide for a sufficient level of flexibility , on the condition that it will maintain the highest level possible in clinical evidence , allowing an adequate management of evidential uncertainty in specific cases , including but not limited to : orphan medicinal products where limited patient populations may affect the feasibility of a randomized clinical trial or the statistical relevance of the data ; b ) medicinal products which the european medicines agency has granted a conditional marketing authorization pursuant to article 14 of regulation no . 726 / 2004 or which benefit from a prime designation granted by the agency ; c ) medicinal products authorized based on clinical evidence from clinical trials with specific designs to account for the nature of the health technology or other considerations . the methodology shall also : provide for a suitable mechanism to identify the patient - relevant health outcome , taking due account of the roles and preferences of relevant stakeholders , including patients , physicians , regulators , hta bodies and health technology developers ; b ) take into account potential changes relating to the relevant comparator at national level due to the rapidly evolving standards of care .


### on the request of the coordination group , the commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the coordination group as observers . ### on the request of the coordination group , the commission shall invite patient , clinical and other experts nominated by the stakeholder network to attend meetings of the coordination group as observers .


### the definition of ‘ recreational fisheries’ should include all non - commercial fisheries , irrespective of their specific purpose , in order to cover all forms of fisheries that may affect fish stocks . ### the definition of ‘ recreational fisheries’ should include all non - commercial fisheries , irrespective of their specific purpose , in order to cover all forms of fisheries ; it is essential , therefore , that harmonised data drawn up in accordance with proper , standardised statistical principles should be available so that the impact on ecosystems and fish stocks can be assessed and taken into account in the context of regional management .


### the need to avoid duplication of data collection , ### the need for simplification and to avoid duplication of data collection ,


### coordinate the preparation of the annual report referred to in article 10 ; ### with a view to improving transparency , coordinate the preparation of the annual report referred to in article&#160 ; 10 , working closely with the relevant regional authorities ;


### ensure the transmission of information within the member state ; and ### ensure the transmission of information within the member state to the relevant authorities ; and


### member states shall on an annual basis submit to the commission a report on the carrying out of their&#160 ; work plans . the commission may adopt implementing acts laying down rules on procedures , format and&#160 ; timetables for the submission and approval of annual reports . those implementing acts shall be&#160 ; adopted in accordance with the&#160 ; examination procedure referred to in article&#160 ; 24 . ### member states shall on an annual basis submit to the commission a report on the carrying out of their work plans . the report shall be submitted at the latest by 31&#160 ; may in the year following the reference year . the commission may adopt implementing acts laying down rules on procedures , format and various timetables for the submission and approval of annual reports . those implementing acts shall be adopted in accordance with the examination procedure referred to in article&#160 ; 24 .


### the conditions under which masters of union fishing vessels are obliged to accept on board scientific observers , as referred to in paragraph 2 and alternative data collection methods , and rules for member states to monitor and report on those conditions and methods . ### the conditions under which masters of union fishing vessels are obliged to accept on board scientific observers as referred to in paragraph 2 , and alternative data collection methods in cases in which , for duly justified reasons , it is not possible for on board observers to be present , and rules for member states to monitor and report on those conditions and methods .


### for the purpose of the verification of the socio - economic data collected in accordance with article 6 , member states shall ensure that the commission has access to the national computerised databases referred to in article 12 . ### for the purpose of the verification of the socio - economic data collected in accordance with article 6 , member states shall take all the requisite steps to ensure that the commission has access to the national computerised databases referred to in article 12 .


### compatible data storage and exchange systems ### compatible systems for harmonising data storage and exchange


### in view of reducing costs and facilitating access to data for end - users and other interested parties , member states , the commission , scientific advisory bodies and any relevant end - users shall cooperate to develop compatible data storage and exchange systems , taking into account the provisions of directive 2007 / 2 / ec . those systems shall also facilitate dissemination of information to other interested parties . regional work plans referred to in article&#160 ; 8 may serve as a basis for agreement on such systems . ### in view of reducing costs and facilitating access to data for end - users and other interested parties , member states , the commission , scientific advisory bodies and any relevant end - users shall cooperate to develop compatible systems to harmonise data storage and exchange , taking into account the provisions of directive 2007 / 2 / ec . those systems shall also facilitate dissemination of information to other interested parties . regional work plans referred to in article 8 may serve as a basis for agreement on such systems .


### member states and the commission shall coordinate their efforts and cooperate in order to further improve the quality , timeliness and coverage of data enabling further improvement of the reliability of scientific advice , the quality of the work programmes and the working methods of the regional fisheries management organisations to which the union is contracting party or observer and international scientific bodies . ### member states , alongside regions with relevant powers and the commission shall coordinate their efforts and cooperate in order to further improve the quality , timeliness and coverage of data enabling further improvement of the reliability of scientific advice , the quality of the work programmes and the working methods of the regional fisheries management organisations to which the union is contracting party or observer and international scientific bodies .


### the provisions for recognition of professional qualifications in accordance with directive 2005 / 36 / ec of the european parliament and of the council15 are not applicable with regard to the recognition of certificates of seafarers under directive 2008 / 106 / ec . directive 2005 / 45 / ec of the european parliament and of the council16 regulated the mutual recognition of seafarers ' certificates issued by the member states . however , the definitions of seafarers ' certificates referred in directive 2005 / 45 / ec have become obsolete following the 2010 amendments to the stcw convention . therefore the mutual recognition scheme of seafarers ' certificates issued by member states should be amended in order to reflect the international amendments and the new definitions of seafarers certificates included in directive 2008 / 106 / ec . in addition , the seafarers ' medical certificates issued under the authority of member states should also be included in the mutual recognition scheme . in order to remove ambiguity and the risk of inconsistencies between directive 2005 / 45 / ec and directive 2008 / 106 / ec , the mutual recognition of seafarers ' certificates should be regulated by directive 2008 / 106 / ec . __________________ 15 directive 2005 / 36 / ec of the european parliament and of the council on the recognition of professional qualifications . 16 directive 2005 / 45 / ec of the european parliament and of the council on the mutual recognition of seafarers ' certificates issued by the member states and amending directive 2001 / 25 / ec . ### the provisions for recognition of professional qualifications in accordance with directive 2005 / 36 / ec of the european parliament and of the council15 are not applicable with regard to the recognition of certificates of seafarers under directive 2008 / 106 / ec . directive 2005 / 45 / ec of the european parliament and of the council16 regulated the mutual recognition of seafarers ' certificates issued by the member states . however , the definitions of seafarers ' certificates referred in directive 2005 / 45 / ec have become obsolete following the 2010 amendments to the stcw convention . therefore the mutual recognition scheme of seafarers ' certificates issued by member states should be amended in order to reflect the international amendments and the new definitions of seafarers certificates included in directive 2008 / 106 / ec . in addition , the seafarers ' medical certificates issued under the authority of member states should also be included in the mutual recognition scheme . in order to remove ambiguity and the risk of inconsistencies between directive 2005 / 45 / ec and directive 2008 / 106 / ec , the mutual recognition of seafarers ' certificates should be regulated by directive 2008 / 106 / ec . furthermore , in order to reduce the administrative burden on the member states and facilitate the management of ships , an electronic system for the presentation of seafarers’ qualifications needs to be introduced with a view to the qualifications and certificates system being completely paperless by 2027 . __________________ 15 directive 2005 / 36 / ec of the european parliament and of the council on the recognition of professional qualifications . 16 directive 2005 / 45 / ec of the european parliament and of the council on the mutual recognition of seafarers ' certificates issued by the member states and amending directive 2001 / 25 / ec .


### subject to article 19 any certificate required by this directive shall be kept available in its original form on board the ship on which the holder is serving . ### in article 5 , paragraph 10 is replaced by the following : ‘ 10 . subject to article 19 any certificate required by this directive shall be kept available in its original form on board the ship on which the holder is serving , on paper or in electronic format , the authenticity and validity of which shall be guaranteed by the issuing state , and which may be verified under the procedure laid down in point of paragraph 12 and paragraph 13 of this article . ’


### as of 1 january 2017 , the information required to be available in accordance with point of paragraph 12 shall be made available by electronic means . ### in article 5 , paragraph 13 is replaced by the following : ‘ 13 . as of 1 january 2017 , the information required to be available in accordance with point of paragraph 12 shall be made available by electronic means . as of 1 january 2027 , all certificates and endorsements shall , in accordance with point of paragraph 12 , be made available by electronic means . ’


### for the purposes of paragraph 8 of article 20 , paragraph 2 of article 21 and for use by the member states and the commission in policy - making , member states shall submit to the commission , on a yearly basis , the information referred to in annex v to this directive on certificates of competency and endorsements attesting the recognition of certificates of competency . they may also provide , on a voluntary basis , the information on certificates of proficiency issued to ratings in accordance with chapters ii , iii and vii of the annex to the stcw convention . ### for the purposes of paragraph 8 of article 20 and paragraph 2 of article 21 , as well as to facilitate the implementation of article 8 , the commission shall create , manage and update a database to which all the member states shall be connected , and which shall contain all the information referred to in annex v to this directive on certificates of competency and endorsements attesting the recognition of certificates of proficiency issued in accordance with regulations v / 1 - 1 and v / 1 - 2 of the stcw convention .


### the member states shall communicate the information referred to in annex v to the commission for the purposes of paragraph 8 of article 20 , paragraph 2 of article 21 and for use by the member states and the commission in policy - making . ### the member states shall ensure that the information listed in annex&#160 ; v is transferred to the database established pursuant to article&#160 ; 5a as soon as the relevant certificate or endorsement has been issued . the member states shall ensure that the information transferred to the database referred to in article 5a is validated for publication purposes within 72 hours . the member states shall have access to all the information recorded in the database established pursuant to article 5a for the purposes of implementing article 8 .


### when applying this regulation the ‘ best interests of the child’ should be a primary consideration , in line with the 1989 united nations convention on the rights of the child . in assessing the best interests of the child , member states ' authorities should in particular take due account of the principle of family unity , the minor’s well - being and social development , safety and security considerations and the views of the minor in accordance with his or her age and maturity . ### when applying this regulation the ‘ best interests of the child’ should be a primary consideration , in line with the 1989 united nations convention on the rights of the child . in assessing the best interests of the child , member states ' authorities should in particular take due account of the principle of family unity , the minor’s well - being and social development , safety and security considerations and the views of the minor in accordance with his or her age and maturity . children applicants then turning 18 before a decision on their application is taken would thus still benefit from family unity .


### when applying this regulation the ‘ best interests of the child’ should be a primary consideration , in line with the 1989 united nations convention on the rights of the child . in assessing the best interests of the child , member states ' authorities should in particular take due account of the principle of family unity , the minor’s well - being and social development , safety and security considerations and the views of the minor in accordance with his or her age and maturity . ### when applying this regulation the ‘ best interests of the child’ should be a primary consideration , in line with the 1989 united nations convention on the rights of the child . in assessing the best interests of the child , member states ' authorities should in particular take due account of the principle of family unity , the minor’s well - being and social development , the minor ' s cultural origin and linguistic skills , safety and security considerations and the views of the minor in accordance with his or her age and maturity .


### ‘ minor’ means a third - country national or stateless person below the age of 18 years ; ### ‘ minor’ means a third - country national or stateless person below the age of 18 years at the time his / her application for international protection is submitted .


### where aspects of the applicant’s statements are not supported by documentary or other evidence , no additional evidence shall be required in respect of those aspects where the following conditions are met : ### where aspects of the applicant’s statements are not supported by documentary or other evidence , no additional evidence shall be required and the applicant shall be given the benefit of the doubt in respect of those aspects where the following conditions are met :


### where union level country of origin information and common analysis of country of origin information as referred in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] indicate a significant change in the country of origin which is relevant for the protection needs of the applicant ; ### where union - level country of origin information and common analysis of country of origin information as referred in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] indicate a significant change in the country of origin which is relevant for the protection needs of the beneficiary of international protection ;


### where union level country of origin information and common analysis of country of origin information as referred in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] indicate a significant change in the country of origin which is relevant for the protection needs of the applicant , ### where union - level country of origin information and common analysis of country of origin information as referred in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] indicate a significant change in the country of origin which is relevant for the protection needs of the beneficiary of international protection ,


### in order to facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection shall have access to integration measures provided by the member states , in particular language courses , civic orientation and integration programs and vocational training which take into account their specific needs . ### in order to promote and facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection shall have free and effective access to integration measures provided by the member states , in particular language courses , civic orientation and integration programs and vocational training which take into account their specific needs .


### following the paris agreement adopted under the united nations framework convention on climate change4 , the eib should aim to sustain the current high level of climate relevant spending under the elm , contributing to increasing its climate - related investment in developing countries from 25 % to 35 % by 2020 . _________________ 4 council decision 2016 / 590 of 11 april 2016 on the conclusion , on behalf of the european union , of the paris agreement adopted under the united nations framework convention on climate change . ### following the paris agreement adopted under the united nations framework convention on climate change4 , the eib should aim to sustain the current high level of climate relevant spending under the elm , contributing to increasing its climate - related investment in developing countries from 25 % to 35 % by 2020 . in addition , the eib should work to phase out the financing of projects that do not contribute to the union ' s climate objectives and the transition to a low - carbon economy . _________________ 4 council decision 2016 / 590 of 11 april 2016 on the conclusion , on behalf of the european union , of the paris agreement adopted under the united nations framework convention on climate change .


### in point , the following sentence is added : ### point , is amended as follows :


### this directive should facilitate the practical application of the right to be presumed innocent and all its different aspects and also of the right to be present at one ' s trial , with a view to safeguarding the right to a fair trial . ### this directive should facilitate the practical application of the right to be presumed innocent and all its different aspects and also of the right to be present at one ' s trial , with a view to safeguarding the right to a fair trial , with due regard for the adversarial principle and balance between the rights of the parties .


### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . end - users increasingly substitute traditional voice telephony , text messages and electronic mail conveyance services by functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services . in order to ensure that end - users are effectively and equally protected when using functionally equivalent services , a future - oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach . the scope of necessary regulation should be appropriate to achieve its public interest objectives . while ' conveyance of signals ' remains an important parameter for determining the services falling into the scope of this directive , the definition should cover also other services that enable communication . from an end - user ' s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service . the amended definition of electronic communications services should therefore contain three types of services which may partly overlap , that is to say internet access services according to the definition in article 2 of regulation 2015 / 2120 , interpersonal communications services as defined in this directive , and services consisting wholly or mainly in the conveyance of signals . the definition of electronic communications service should eliminate ambiguities observed in the implementation of the previous definition and allow a calibrated provision - by - provision application of the specific rights and obligations contained in the framework to the different types of services . the processing of personal data by electronic communications services , whether as remuneration or otherwise , must be in compliance with directive 95 / 46 / ec which will be replaced by regulation 2016 / 679 on 25 may 201823 . __________________ 23 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec ; oj l 119 , 4 . 5 . 2016 , p . 1 ### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . end - users increasingly substitute traditional voice telephony , text messages and electronic mail conveyance services by functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services , although they still do not consider them as substitutes to traditional voice services , due to a perception of different levels of quality , security and interoperability . in order to ensure that end - users are effectively and equally protected when using functionally equivalent services , a future - oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach to the extent possible . the existing differences between services should however be acknowledged , online services such as voice over ip being provided in most cases without having substantial control over the network used for enabling the communication but on the other hand allowing end - user to switch from service to service in an easier manner than from traditional communication services . the scope of necessary regulation should be appropriate to achieve its public interest objectives . while ' conveyance of signals ' remains an important parameter for determining the services falling into the scope of this directive , the definition should cover also other services that enable communication in a proportionate manner to deliver the best outcomes for end users . from an end - user ' s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service , therefore these services should not be defined on the basis of the technology used , but on the legitimate expectations end - users have for the service provided depending for instance on the price paid or the ease of terminating the contract . the amended definition of electronic communications services should therefore contain three types of services which may partly overlap , that is to say internet access services according to the definition in article 2 of regulation 2015 / 2120 , interpersonal communications services as defined in this directive , and services consisting wholly or mainly in the conveyance of signals . this last category should not include services where connectivity is provided as an input product into connected devices or ' smart goods ' or where the provision of connectivity with such products is subject to a contract with the end - user , as they would be considered as embedded digital content or services according to the directive concerning contracts for the supply of digital content . the definition of electronic communications service should eliminate ambiguities observed in the implementation of the previous definition and allow a calibrated provision - by - provision application of the specific rights and obligations contained in the framework to the different types of services . the processing of personal data by electronic communications services , whether as remuneration or otherwise , must be in compliance with directive 95 / 46 / ec which will be replaced by regulation 2016 / 679 on 25 may 201823 . __________________ 23 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec ; oj l 119 , 4 . 5 . 2016 , p . 1


### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . end - users increasingly substitute traditional voice telephony , text messages and electronic mail conveyance services by functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services . in order to ensure that end - users are effectively and equally protected when using functionally equivalent services , a future - oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach . the scope of necessary regulation should be appropriate to achieve its public interest objectives . while ' conveyance of signals ' remains an important parameter for determining the services falling into the scope of this directive , the definition should cover also other services that enable communication . from an end - user ' s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service . the amended definition of electronic communications services should therefore contain three types of services which may partly overlap , that is to say internet access services according to the definition in article 2 of regulation 2015 / 2120 , interpersonal communications services as defined in this directive , and services consisting wholly or mainly in the conveyance of signals . the definition of electronic communications service should eliminate ambiguities observed in the implementation of the previous definition and allow a calibrated provision - by - provision application of the specific rights and obligations contained in the framework to the different types of services . the processing of personal data by electronic communications services , whether as remuneration or otherwise , must be in compliance with directive 95 / 46 / ec which will be replaced by regulation 2016 / 679 on 25 may 201823 . __________________ 23 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec ; oj l 119 , 4 . 5 . 2016 , p . 1 ### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . end - users increasingly substitute traditional voice telephony , text messages and electronic mail conveyance services by functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services . in order to ensure that end - users are effectively and equally protected when using functionally equivalent services , a future - oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach . the scope of necessary regulation should be appropriate to achieve its public interest objectives . while ' conveyance of signals ' remains an important parameter for determining the services falling into the scope of this directive , the definition should cover also other services that enable communication . from an end - user ' s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service . the amended definition of electronic communications services should therefore contain three types of services which may partly overlap , that is to say internet access services according to the definition in article 2 of regulation 2015 / 2120 , interpersonal communications services as defined in this directive , and services consisting wholly or mainly in the conveyance of signals . as said types of services may partly overlap , it is likely that services which only meet the criteria of the conveyance of signals category would be limited to transmission services used for the provision of machine - to - machine services and broadcasting . similarly to the case of broadcasting , where the transmitted content does not fall within the definition of an electronic communications service , a distinction between a machine - to - machine service and its underlying transmission should be made . only the transmission should be considered as conveyance of signals , whereas the application part of a machine - to - machine service should not . the definition of electronic communications service should eliminate ambiguities observed in the implementation of the previous definition and allow a calibrated provision - by - provision application of the specific rights and obligations contained in the framework to the different types of services . the processing of personal data by electronic communications services , whether as remuneration or otherwise , must be in compliance with directive 95 / 46 / ec which will be replaced by regulation 2016 / 679 on 25 may 201823 . __________________ 23 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec ; oj l 119 , 4 . 5 . 2016 , p . 1


### in order to fall within the scope of the definition of electronic communications service , a service needs to be provided normally in exchange for remuneration . in the digital economy , market participants increasingly consider information about users as having a monetary value . electronic communications services are often supplied against counter - performance other than money , for instance by giving access to personal data or other data . the concept of remuneration should therefore encompass situations where the provider of a service requests and the end - user actively provides personal data , such as name or email address , or other data directly or indirectly to the provider . it should also encompass situations where the provider collects information without the end - user actively supplying it , such as personal data , including the ip address , or other automatically generated information , such as information collected and transmitted by a cookie ) . in line with the jurisprudence of the court of justice of the european union on article 57 tfeu24 , remuneration exists within the meaning of the treaty also if the service provider is paid by a third party and not by the service recipient . the concept of remuneration should therefore also encompass situations where the end - user is exposed to advertisements as a condition for gaining access to the service , or situations where the service provider monetises personal data it has collected . __________________ 24 case c - 352 / 85 bond van adverteerders and others vs the netherlands state , eu : c : 1988 : 196 . ### in order to fall within the scope of the definition of electronic communications service , a service needs to be provided normally in exchange for remuneration . in the digital economy , market participants increasingly consider information about users as having a monetary value . electronic communications services are in some cases supplied against personal data where such data is used beyond what is essential for the performance of the contract . the concept of remuneration should therefore encompass situations where the provider of a service requests and the end - user provides personal data , directly or indirectly , that is used for a purpose which is not necessary for the performance of the contract . in line with the jurisprudence of the court of justice of the european union on article 57 tfeu24 , remuneration exists within the meaning of the treaty also if the service provider is paid by a third party and not by the service recipient . the concept of remuneration should therefore also encompass situations where the end - user is exposed to advertisements as a condition for gaining access to the service , or situations where the service provider monetises personal data it has collected . __________________ 24 case c - 352 / 85 bond van adverteerders and others vs the netherlands state , eu : c : 1988 : 196 .


### interpersonal communications services are services that enable interpersonal and interactive exchange of information , covering services like traditional voice calls between two individuals but also all types of emails , messaging services , or group chats . interpersonal communications services only cover communications between a finite , that is to say not potentially unlimited , number of natural persons which is determined by the sender of the communication . communications involving legal persons should be within the scope of the definition where natural persons act on behalf of those legal persons or are involved at least on one side of the communication . interactive communication entails that the service allows the recipient of the information to respond . services which do not meet those requirements , such as linear broadcasting , video on demand , websites , social networks , blogs , or exchange of information between machines , should not be considered as interpersonal communications services . under exceptional circumstances , a service should not be considered as an interpersonal communications service if the interpersonal and interactive communication facility is a purely ancillary feature to another service and for objective technical reasons cannot be used without that principal service , and its integration is not a means to circumvent the applicability of the rules governing electronic communications services . an example for such an exception could be , in principle , a communication channel in online games , depending on the features of the communication facility of the service . ### interpersonal communications services are services where the principal purpose of the service consists in enabling interpersonal and interactive exchange of information , covering services like traditional voice calls between two individuals but also messaging services , or group chats . interpersonal communications services only cover communications between a finite , that is to say not potentially unlimited , number of natural persons which is determined by the sender of the communication . communications involving legal persons should be within the scope of the definition where natural persons act on behalf of those legal persons or are involved at least on one side of the communication . interactive communication entails that the service allows the recipient of the information to respond . services which do not meet those requirements , such as linear broadcasting , video on demand , websites , social networks , blogs , or exchange of information between machines , should not be considered as interpersonal communications services . a service should not be considered as an interpersonal communications service if the interpersonal and interactive communication facility is not the main purpose of the service and for objective technical reasons cannot be used without that principal service , and its integration is not a means to circumvent the applicability of the rules governing electronic communications services , as the application of the provisions in this directive would not be proportionate to the level of connectivity provided with this service . an example for such an exception could be , in principle , a communication channel in online games , depending on the features of the communication facility of the service .


### the benefits of the single market to service providers and end - users can be best achieved by general authorisation of electronic communications networks and of electronic communications services other than number - independent interpersonal communications services , without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to a declaratory notification only . where member states require notification by providers of electronic communications networks or services when they start their activities , this notification should be submitted to berec which acts as a single contact point . such notification should not entail administrative cost for the providers and could be made available via an entry point at the website of the national regulatory authorities . berec should forward in good time the notifications to the national regulatory authority in all member states in which the providers of electronic communications networks or services intend to provide electronic communications networks or services . member states can also require proof that notification was made by means of any legally recognised postal or electronic acknowledgement of receipt of the notification to berec . such acknowledgement should in any case not consist of or require an administrative act by the national regulatory authority , or any other authority . ### the benefits of the single market to service providers and end - users can be best achieved by general authorisation of electronic communications networks and of electronic communications services other than number - independent interpersonal communications services , without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to a declaratory notification only . where member states require notification by providers of electronic communications networks or services when they start their activities , one single notification should be submitted to berec which acts as a single contact point . such notification should not entail administrative cost for the providers and should be made available via an entry point on the website of berec . berec should forward in good time the notifications to the national regulatory authority in all member states in which the providers of electronic communications networks or services intend to provide electronic communications networks or services . member states can also require proof that notification was made by means of any legally recognised postal or electronic acknowledgement of receipt of the notification to berec . such acknowledgement should in any case not consist of or require an administrative act by the national regulatory authority , or any other authority .


### it is desirable to enable consumers to achieve the fullest connectivity possible to digital television sets . interoperability is an evolving concept in dynamic markets . standards bodies should do their utmost to ensure that appropriate standards evolve along with the technologies concerned . it is likewise important to ensure that connectors are available on digital television sets that are capable of passing all the necessary elements of a digital signal , including the audio and video streams , conditional access information , service information , application program interface information and copy protection information . this directive should therefore ensure that the functionality associated to and / or implemented in connectors is not limited by network operators , service providers or equipment manufacturers and continue to evolve in line with technological developments . for display and presentation of connected television services , the realisation of a common standard through a market - driven mechanism is recognised as a consumer benefit . member states and the commission may take policy initiatives , consistent with the treaty , to encourage this development . ### it is desirable to enable consumers to achieve the fullest connectivity possible to digital radio and television sets . interoperability is an evolving concept in dynamic markets . standards bodies should do their utmost to ensure that appropriate standards evolve along with the technologies concerned . it is likewise important to ensure that connectors are available on digital television sets that are capable of passing all the necessary elements of a digital signal , including the audio and video streams , conditional access information , service information , application program interface information and copy protection information . this directive should therefore ensure that the functionality associated to and / or implemented in connectors is not limited by network operators , service providers or equipment manufacturers and continue to evolve in line with technological developments . for display and presentation of connected television services , the realisation of a common standard through a market - driven mechanism is recognised as a consumer benefit . member states and the commission may take policy initiatives , consistent with the treaty , to encourage this development . a radio set should be understood as a device whose primary functions include the receiving of radio broadcasts , even when combined with other functions . purely ancillary receivers should not be deemed as making a device , a radio set . for example , a vehicle headset unit combining a navigation system and radio receiver should be included within this understanding , while a mobile telephone with a fm receiver would not have radio reception as a primary function .


### ' interpersonal communications service’ means a service normally provided for remuneration that enables direct interpersonal and interactive exchange of information via electronic communications networks between a finite number of persons , whereby the persons initiating or participating in the communication determine its recipient ; it does not include services which enable interpersonal and interactive communication merely as a minor ancillary feature that is intrinsically linked to another service ; ### ' interpersonal communications service ' means a service normally provided for remuneration where the principal purpose of the service is devoted to enabling direct interpersonal and interactive exchange of information via electronic communications networks between a finite number of persons , whereby the persons initiating or participating in the communication determine its recipient ;


### ‘ emergency communication’ : communication by means of interpersonal communications services between an end - user and the psap with the goal to request and receive emergency relief from emergency services ; ### ' emergency communication ' : communication by means of voice communication services and relevant number - based interpersonal communications services between an end - user and the psap with the goal to request and receive emergency relief from emergency services ;


### without prejudice to information and reporting obligations under national legislation other than the general authorisation , national regulatory and other competent authorities may only require undertakings to provide information under the general authorisation , for rights of use or the specific obligations referred to in article 13 that is proportionate and objectively justified for : ### without prejudice to information and reporting obligations under national legislation other than the general authorisation , national regulatory and other competent authorities may only require undertakings to provide information under the general authorisation , in a common and standardised format , for rights of use or the specific obligations referred to in article 13 that is proportionate and objectively justified for :


### submit to a security audit carried out by a qualified independent body or a competent authority and make the results thereof available to the competent authority . the cost of the audit shall be paid by the undertaking . ### for undertakings providing electronic communications networks , submit to a security audit carried out by a qualified independent body or a competent authority and make the results thereof available to the competent authority . the cost of the audit shall be paid by the undertaking .


### porting of numbers and their subsequent activation shall be carried out within the shortest possible time . in any case , end - users who have concluded an agreement to port a number to a new undertaking shall have that number activated within one working day from the conclusion of such an agreement . ### porting of numbers and their subsequent activation shall be carried out within the shortest possible time . in any case , consumers who have concluded an agreement to port a number to a new undertaking shall have that number activated within one working day from the conclusion of such an agreement , unless the end - user expressly requests a different delay .


### member states shall ensure that caller location information is available to the psap without delay after the emergency communication is set up . member states shall ensure that the establishment and the transmission of the caller location information are free of charge for the end - user and to the authority handling the emergency communication with regard to all emergency communications to the single european emergency number ‘ 112’ . member states may extend that obligation to cover emergency communications to national emergency numbers . competent regulatory authorities shall lay down criteria for the accuracy and reliability of the caller location information provided . ### member states shall ensure that caller location information is made available to the psap without delay after the emergency communication is set up . this shall include both network - based location information and , where technically feasible , handset - derived caller location information . member states shall ensure that the establishment and the transmission of the end - user location information are free of charge for the end - user and to the psap with regard to all emergency communications to the single european emergency number ' 112 ' . this shall not prevent competent regulatory authorities from laying down criteria for the accuracy and reliability of the caller location information provided .


### eurojust shall have direct access to the ecris - tcn system for the purpose of the implementation of article 14 , as well as for fulfilling its statutory tasks . ### authorised staff of eurojust shall have direct access to the ecris - tcn system for the purpose of the implementation of article 14 , as well as for fulfilling its statutory tasks .


### the member states shall notify eu - lisa of their central authorities which have access to enter , amend , delete consult or search data . eu - lisa shall regularly publish a list of these central authorities . ### the member states shall notify eu - lisa of their central authorities which have access to enter , amend , delete consult or search data . eu - lisa shall publish a list of these central authorities as soon as a change occurs .


### in compliance with its reporting requirement pursuant to article [ 38 ] of the financial regulation , the commission shall present to the european parliament and the council information on performance in accordance with annex ii . ### in compliance with its reporting requirement pursuant to article [ 38 ] of the financial regulation , the commission shall present to the european parliament and the council information on performance and results in accordance with annex ii by reporting on both progress and shortfalls and by ensuring a clear link between spending and performance .


### at least 6% of the erdf resources at national level under the investment for jobs and growth goal , other than for technical assistance , shall be allocated to sustainable urban development in the form of community - led local development , integrated territorial investments or another territorial tool under po5 . ### at least 6% of the erdf resources at national level under the investment for jobs and growth goal , other than for technical assistance , shall be allocated to sustainable urban development in the form of community - led local development , integrated territorial investments or another territorial tool under po5 incorporating relevant po1 to po4 .


### all decisions restricting an applicant ' s freedom of movement need to be based on the individual behaviour and particular situation of the person concerned , taking into account any special reception needs of applicants and the principle of proportionality . applicants must be duly informed of such decisions and of the consequences of non - compliance . ### any restriction on the applicant ' s freedom of movement should be based on a decision of judicial authorities , which takes into account the individual behaviour and particular situation of the person concerned , including any special reception needs of applicants and the principle of proportionality . applicants should be duly informed of such decisions and of the consequences of non - compliance . they should also be provided with the possibility of an appeal against such decisions .


### the detention of applicants should be applied in accordance with the underlying principle that a person should not be held in detention for the sole reason that he or she is seeking international protection , particularly in accordance with the international legal obligations of the member states and with article 31 of the geneva convention . applicants may be detained only under the very clearly defined exceptional circumstances laid down in this directive and subject to the principle of necessity and proportionality with regard to both the manner and the purpose of such detention . detention of applicants pursuant to this directive should only be ordered in writing by judicial or administrative authorities stating the reasons on which it is based , including in the cases where the person is already detained when making the application for international protection . where an applicant is held in detention he or she should have effective access to the necessary procedural guarantees , such as judicial remedy before a national judicial authority . ### the detention of applicants should be applied in accordance with the underlying principle that a person should not be held in detention for the sole reason that he or she is seeking international protection , particularly in accordance with the international legal obligations of the member states and with article 31 of the geneva convention . applicants may be detained only under the very clearly defined exceptional circumstances laid down in this directive and subject to the principle of necessity and proportionality with regard to both the manner and the purpose of such detention . detention of applicants pursuant to this directive should only be ordered in writing by judicial authorities stating the reasons on which it is based , including in the cases where the person is already detained when making the application for international protection . any decision imposing detention should contain a reference to the consideration of the available alternatives and the reasons why they could not be applied effectively . where an applicant is held in detention he or she should have effective access to the necessary procedural guarantees , such as judicial remedy .


### member states should ensure that applicants receive the necessary health care which should include , at least , emergency care and essential treatment of illnesses , including of serious mental disorders . to respond to public health concerns with regard to disease prevention and safeguard the health of individual applicants , applicants ' access to health care should also include preventive medical treatment , such as vaccinations . member states may require medical screening for applicants on public health grounds . the results of medical screening should not influence the assessment of applications for international protection , which should always be carried out objectively , impartially and on an individual basis in line with regulation no xxx / xxx [ procedures regulation ] . ### member states should ensure that applicants receive full access to necessary health care which should include , at least , emergency care , maternity care and essential treatment of illnesses , including of serious mental disorders , such as post - traumatic stress disorders . to respond to public health concerns with regard to disease prevention and safeguard the health and rights of individual applicants , applicants ' access to health care should also include sexual and reproductive health services and preventive medical treatment , such as vaccinations . member states may require medical screening for applicants on public health grounds , in accordance with guidelines to be established , jointly , by the european union agency for asylum and the european centre for disease prevention and control . the results of medical screening should not influence the assessment of applications for international protection , which should always be carried out objectively , impartially and on an individual basis in line with regulation no xxx / xxx [ procedures regulation ] .


### an applicant ' s entitlement to material reception conditions under this directive may be curtailed in certain circumstances such as where an applicant has absconded to another member state from the member state where he or she is required to be present . however , member states should in all circumstances ensure access to health care and a dignified standard of living for applicants in line with the charter of fundamental rights of the european union and the united nations convention on the rights of the child , in particular by providing for the applicant ' s subsistence and basic needs both in terms of physical safety and dignity and in terms of interpersonal relationships , with due regard to the inherent vulnerabilities of the person as applicant for international protection and that of his or her family or caretaker . due regard must also be given to applicants with special reception needs . the specific needs of children , in particular with regard to respect for the child ' s right to education and access to healthcare have to be taken into account . when a minor is in a member state other than the one in which he or she is required to be present , member states should provide the minor with access to suitable educational activities pending the transfer to the member state responsible . the specific needs of women applicants who have experienced gender - based harm should be taken into account , including via ensuring access , at different stages of the asylum procedure , to medical care , legal support , and to appropriate trauma counselling and psycho - social care . ### member states should in all circumstances ensure access to health care . the specific needs of children , in particular with regard to respect for the child ' s right to education and access to healthcare have to be taken into account . the specific needs of applicants , in particular women , who have experienced sexual or gender - based violence should be taken into account , including via ensuring access , at different stages of the asylum procedure , to medical care , legal support , and to appropriate trauma counselling and psycho - social care . such applicants should be considered to be persons with special reception needs .