Article 1 Establishment of the Programme
This Regulation establishes the third multi-annual programme for Union action in the field of health for the period from 1 January 2014 to 31 December 2020 ("the Programme").
Article 2 General objectives
The general objectives of the Programme shall be to complement, support and add value to the policies of the Member States to improve the health of Union citizens and reduce health inequalities by promoting health, encouraging innovation in health, increasing the sustainability of health systems and protecting Union citizens from serious cross-border health threats.
Article 3 Specific objectives and indicators
The general objectives referred to in Article 2 shall be pursued through the following specific objectives: (1) In order to promote health, prevent diseases, and foster supportive environments for healthy lifestyles: identify, disseminate and promote the uptake of evidence-based and good practices for cost-effective health promotion and disease prevention measures by addressing in particular the key lifestyle related risk factors with a focus on the Union added value. This objective shall be measured, in particular, through the increase in the number of Member States involved in health promotion and disease prevention, using evidence-based and good practices through measures and actions taken at the appropriate level in Member States. (2) In order to protect Union citizens from serious cross-border health threats: identify and develop coherent approaches and promote their implementation for better preparedness and coordination in health emergencies. This objective shall be measured, in particular, through the increase in the number of Member States integrating coherent approaches in the design of their preparedness plans. (3) In order to support public health capacity-building and contribute to innovative, efficient and sustainable health systems: identify and develop tools and mechanisms at Union level to address shortages of resources, both human and financial, and to facilitate the voluntary uptake of innovations in public health intervention and prevention strategies. This objective shall be measured, in particular, through the increase in the advice produced and the number of Member States using the tools and mechanisms identified in order to contribute to effective results in their health systems. (4) In order to facilitate access to better and safer healthcare for Union citizens: increase access to medical expertise and information for specific conditions beyond national borders, facilitate the application of the results of research and develop tools for the improvement of healthcare quality and patient safety through, inter alia , actions contributing to the improvement of health literacy. This objective shall be measured, in particular, through the increase in the number of European reference networks established in accordance with Directive 2011/24/EU of the European Parliament and of the Council ( 22 ) ("European reference networks"), the increase in the number of healthcare providers and centres of expertise joining European reference networks, and the increase in the number of Member States using the tools developed.
Article 4 Eligible actions
The specific objectives of the Programme shall be achieved through actions in line with the thematic priorities listed in Annex I and implemented via the annual work programmes referred to in Article 11.
Article 5 Funding
The financial envelope for the implementation of the Programme for the period from 1 January 2014 to 31 December 2020 shall be EUR 449 394 000 in current prices. The annual appropriations shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework.
Article 6 Participation of third countries
The Programme shall be open, on a cost basis, to the participation of third countries, in particular: (a) acceding countries, candidate countries and potential candidates benefiting from a pre-accession strategy, in accordance with the general principles and general terms and conditions for their participation in Union programmes established in the respective Framework Agreements, Association Council Decisions or similar agreements; (b) EFTA/EEA countries in accordance with the conditions established in the EEA Agreement; (c) neighbouring countries and the countries to which, in accordance with the conditions laid down by a relevant bilateral or multilateral agreement, the ENP applies; (d) other countries in accordance with the conditions laid down by a relevant bilateral or multilateral agreement.
Article 7 Types of intervention
1. In accordance with Regulation (EU, Euratom) No 966/2012, financial contributions by the Union shall take the form of grants, public procurement or any other form of intervention necessary for achieving the objectives of the Programme. 2. Grants may be awarded to fund: (a) actions having a clear Union added value co-financed by the competent authorities that are responsible for health in the Member States or in the third countries participating in the Programme pursuant to Article 6, or by public sector bodies and non-governmental bodies, as referred to in Article 8(1), acting individually or as a network, mandated by those competent authorities; (b) actions having a clear Union added value explicitly provided for and duly justified in the annual work programmes co-financed by other public, non-governmental or private bodies, as referred to in Article 8(1), including international organisations active in the area of health and, in the latter case, where appropriate, without a previous call for proposals; (c) the functioning of non-governmental bodies as referred to in Article 8(2), where financial support is necessary for the pursuit of one or more of the specific objectives of the Programme. 3. Grants paid by the Union shall not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs. For the actions referred to in point (a) of paragraph 2, exceptional utility is achieved, inter alia , where: (a) at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average; and (b) bodies from at least 14 participating countries participate in the action, out of which at least four are countries whose GNI per inhabitant is less than 90 % of the Union average. 4. By way of derogation from Article 130(2) of Regulation (EU, Euratom) No 966/2012 and in duly justified cases, the Commission may, in the annual work programme for 2014, consider the costs directly linked to the implementation of supported actions to be eligible for financing from 1 January 2014, even if they were incurred by the beneficiary before the grant application was submitted.
Article 8 Beneficiaries eligible for grants
1. The grants for actions referred to under Article 7(2)(a) and (b) may be awarded to legally established organisations, public authorities, public sector bodies, in particular research and health institutions, universities and higher education establishments. 2. The grants for the functioning of bodies referred to under Article 7(2)(c) may be awarded to bodies which fulfil all the following criteria: (a) they are non-governmental, non-profit-making and independent of industry, commercial and business or other conflicting interests; (b) they work in the public health area, play an effective role in civil dialogue processes at Union level and pursue at least one of the specific objectives of the Programme; (c) they are active at Union level and in at least half of the Member States, and have a balanced geographical coverage of the Union.
Article 9 Administrative and technical assistance
The financial envelope for the Programme may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities required directly for the management of the Programme and the achievement of its objectives, in particular studies, meetings, information and communication actions, including corporate communication of the political priorities of the Union in so far as they are related to the general objectives of the Programme, expenses pertaining to IT networks focusing on information exchange, as well as all other technical and administrative assistance expenses incurred by the Commission for the management of the Programme.
Article 10 Methods of implementation
The Commission shall be responsible for the implementation of the Programme in compliance with the management modes set out in Regulation (EU, Euratom) No 966/2012.
Article 11 Annual work programmes
1. The Commission shall implement the Programme by establishing annual work programmes in accordance with Regulation (EU, Euratom) No 966/2012 and the criteria set out in Annex II to this Regulation. 2. The Commission shall adopt, by means of implementing acts, annual work programmes which shall set out, in particular, actions to be undertaken, including the indicative allocation of financial resources. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). 3. In implementing the Programme, the Commission, together with the Member States, shall ensure compliance with all relevant legal provisions regarding personal data protection and, where appropriate, the introduction of mechanisms to ensure the confidentiality and safety of such data.
Article 12 Consistency and complementarity with other policies
The Commission shall, in cooperation with the Member States, ensure overall consistency and complementarity between the Programme and other policies, instruments and actions of the Union, including those of the relevant Union agencies.
Article 13 Monitoring, evaluation and dissemination of results
1. The Commission shall, in close cooperation with the Member States, monitor the implementation of the actions under the Programme in the light of its objectives and indicators, including available information on the amount of climate-related expenditure. It shall report thereon to the committee referred to in Article 17(1), and shall keep the European Parliament and the Council informed. 2. At the request of the Commission, Member States shall submit available information on the implementation and impact of the Programme. Such requests for information shall be proportionate and shall avoid imposing any unnecessary increase in the administrative burden on Member States. 3. Half way through the duration of the Programme, but not later than 30 June 2017, the Commission shall draw up and present to the European Parliament and to the Council a mid-term evaluation report on the achievement of the objectives of the Programme, the state-of-play regarding the implementation of the thematic priorities set out in Annex I, and the efficiency of the use of resources and the Union added value of the Programme, in view of a decision on the renewal, modification or suspension of its thematic priorities. The mid-term evaluation report shall, additionally, address the scope for simplification, the internal and external coherence of the Programme, the continued relevance of all objectives, as well as the contribution of the actions to the achievement of the objectives set out in Article 168 TFEU. It shall take into account evaluation results on the long-term impact of the previous programme. In the mid-term evaluation report, the Commission shall, in particular, indicate the following: (a) if it is not possible to implement and achieve one or more of the thematic priorities listed in Annex I in line with the objectives of the Programme and within the remaining duration of the Programme; (b) whether the evaluation identified one or more specific, significant thematic priorities which are not listed in Annex I, but which have become necessary to achieve the general and specific objectives of the Programme; (c) the reasons for the conclusions referred to in points (a) and (b). The long-term impact and the sustainability of effects of the Programme shall be evaluated with a view to feeding into a decision on the possible renewal, modification or suspension of a subsequent programme. 4. The Commission shall make the results of actions undertaken pursuant to this Regulation publicly available and shall ensure that they are widely disseminated in order to contribute to improving health in the Union.
Article 14 Follow-up to the mid-term evaluation report
1. Where the mid-term evaluation report identifies that one or more thematic priorities cannot be implemented and achieved in line with the objectives of the Programme and within the duration of the Programme, the Commission shall be empowered to adopt, by 31 August 2017, delegated acts in accordance with Article 18 in order to remove the thematic priority or priorities concerned from Annex I. Only one delegated act removing one or more thematic priorities may enter into force pursuant to Article 18 throughout the duration of the Programme. 2. Where the mid-term evaluation report identifies one or more specific, significant thematic priorities which are not listed in Annex I, but which have become necessary to achieve the general and specific objectives of the Programme, the Commission shall be empowered to adopt, by 31 August 2017, delegated acts in accordance with Article 18 in order to add the thematic priority or priorities concerned to Annex I. A thematic priority shall be achievable within the duration of the Programme. Only one delegated act adding one or more thematic priorities may enter into force pursuant to Article 18 throughout the duration of the Programme. 3. Any such removal or addition of thematic priorities shall be in line with the general objectives and with the relevant specific objectives of the Programme.
Article 15 National Focal Points
Member States shall designate National Focal Points which shall assist the Commission in the promotion of the Programme and, as appropriate, the dissemination of the results of the Programme and the available information on the impact of the Programme as referred to in Article 13(2).
Article 16 Protection of the financial interests of the Union
1. The Commission shall take appropriate measures to ensure that, when actions financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by dissuasive administrative and financial penalties. 2. The Commission, or its representatives, and the Court of Auditors shall have the power of audit, on the basis of documents and on-the-spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council ( 23 ) and Council Regulation (Euratom, EC) No 2185/96 ( 24 ) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences.
Article 17 Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 18 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 14(1) and (2) shall be conferred on the Commission for the duration of the Programme. 3. The delegation of power referred to in Article 14(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 14(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 19 Transitional provisions
1. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted under Decision No 1350/2007/EC. 2. If necessary, appropriations may be entered in the budget beyond 2020 to cover the expenses provided for in Article 9, to enable the management of actions not completed by 31 December 2020.
Article 20 Repeal
Decision No 1350/2007/EC shall be repealed with effect from 1 January 2014.
Article 21 Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union . It shall apply from 1 January 2014.