Legal provisions of COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States

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dossier COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly ...
document COM(2013)498 EN
date May 15, 2014

Contents

Article 1 - Participation in the second European and Developing Countries Clinical Trials Partnership Programme

1. The Union shall participate in the second European and Developing Countries Clinical Trials Partnership Programme (the ‘EDCTP2 Programme’), jointly undertaken by Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom (the ‘Participating States’) in accordance with the conditions laid down in this Decision.

2. Any Member State other than those listed in paragraph 1 and any other country associated to Horizon 2020 may participate in the EDCTP2 Programme, provided it fulfils the condition set out in point (e) of Article 3(1) of this Decision. If it fulfils the condition set out in point (e) of Article 3(1), it shall be regarded as a Participating State for the purposes of this Decision.

Article 2 - Union’s financial contribution

1. The Union’s financial contribution, including EFTA appropriations, to the EDCTP2 Programme shall be up to EUR 683 000 000 to equal the contributions of Participating States.

2. The Union’s financial contribution shall be paid from the appropriations in the general budget of the Union allocated to the relevant parts of the Specific Programme implementing Horizon 2020, established by Decision 2013/743/EU, and in particular from the appropriations under the specific objective ‘Health, demographic change and wellbeing’ in accordance with point (c)(vi) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012.

3. Up to 6 % of the Union’s financial contribution referred to in paragraph 1 may be used by the implementing structure of EDCTP2 (the ‘EDCTP2-IS’) to cover its administrative costs.

Article 3 - Conditions for the Union’s financial contribution

1. The Union’s financial contribution shall be conditional upon the following:

(a)the demonstration by the Participating States that the EDCTP2 Programme is set up in accordance with Annexes I, II and III;

(b)the designation by the Participating States or organisations designated by the Participating States of the EDCTP2-IS, an entity with legal personality, as the structure responsible for implementing the EDCTP2 Programme and for receiving, allocating and monitoring the Participating States’ contribution, as well as the Union’s financial contribution;

(c)the demonstration by the EDCTP2-IS of its capacity to implement the EDCTP2 Programme, including receiving, allocating and monitoring the Union’s contribution in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012;

(d)the establishment of a governance model for the EDCTP2 Programme in accordance with Annex III; and

(e)the commitment by each Participating State to contribute to the financing of the EDCTP2 Programme.

2. During the implementation of the EDCTP2 Programme, the Union’s financial contribution shall be conditional upon the following:

(a)the implementation by the EDCTP2-IS of the objectives set out in Annex I, and activities set out in Annex II, to this Decision, in particular the activities and indirect actions that it funds, in compliance with Regulation (EU) No 1290/2013 as referred to in Article 6 of this Decision;

(b)the maintenance of an appropriate and efficient governance model for the EDCTP2 Programme in accordance with Annex III;

(c)the compliance by the EDCTP2-IS with the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012; and

(d)the fulfilment of the commitments referred to in point (e) of paragraph 1.

Article 4 - Activities of the EDCTP2 Programme

1. The activities of the EDCTP2 Programme shall meet the objectives described in Annex I and shall comply with Annex II.

Activities may include national programme activities of Participating States, including activities undertaken by public or private not-for-profit research organisations, and new activities, including calls for proposals managed by the EDCTP2-IS.

Activities shall be included in the work plan of the EDCTP2 Programme adopted annually by the EDCTP2-IS (‘the EDCTP2 annual work plan’), following the positive outcome of their external evaluation by international peer review with regard to the objectives of the EDCTP2 Programme.

2. The EDCTP2 annual work plan shall detail the budgeted value of each activity and shall provide for the allocation of the funding managed by the EDCTP2-IS, including the Union’s financial contribution.

The EDCTP2 annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues.

3. The EDCTP2-IS shall implement the EDCTP2 annual work plan.

The EDCTP2-IS shall monitor and report to the Commission on the implementation of all the activities included therein or selected following calls for proposals managed by the EDCTP2-IS.

4. Activities included in the EDCTP2 annual work plan that are not funded by the EDCTP2-IS shall be implemented in compliance with common principles to be agreed by the Participating States and the Commission, taking into account the principles set out in this Decision, in Title VI of Regulation (EU, Euratom) No 966/2012 and in Regulation (EU) No 1290/2013, in particular the principles of equal treatment, transparency, independent peer review evaluation and selection. The Participating States and the Commission shall also agree on the reporting requirements to the EDCTP2-IS, including with regard to indicators inserted into each of those activities.

Any activity funded by the EDCTP2-IS in accordance with the EDCTP2 annual work plan, or following calls for proposals managed by the EDCTP2-IS, shall be considered to be an indirect action within the meaning of Regulation (EU) No 1290/2013, and shall be implemented in accordance with Article 6 of this Decision.

5. Any communication or publication in the area of the activities of the EDCTP2 Programme, and performed in close collaboration with EDCTP2, whether undertaken by the EDCTP2-IS, a Participating State, or participants to an activity, shall be labelled or co-labelled as ‘[name of the activity] is part of the EDCTP2 programme supported by the European Union’.

Article 5 - Contributions from Participating States

1. Contributions from the Participating States shall consist of the following:

(a)financial contributions to the EDCTP2-IS;

(b)in-kind contributions consisting of the costs incurred by the Participating States in implementing activities included and clearly identified in the EDCTP2 annual work plan, or in relation to the administrative budget of the EDCTP2-IS.

2. For the purpose of evaluating the contributions referred to in point (b) of paragraph 1, the costs shall be determined in accordance with the usual accounting practices and accounting standards of the Participating State concerned and to the applicable International Accounting Standards/International Financial Reporting Standards.

Article 6 - Rules for participation and dissemination

1. Regulation (EU) No 1290/2013 shall apply to indirect actions selected and funded by the EDCTP2-IS on the basis of the EDCTP2 annual work plan or following calls for proposals managed by the EDCTP2-IS. In accordance with that Regulation, the EDCTP2-IS shall be considered to be a funding body and shall provide financial support to indirect actions in accordance with Annex II to this Decision.

2. By way of derogation from point (b) of Article 9(1) of Regulation (EU) No 1290/2013, the minimum number of participants shall be two legal entities established in two different Participating States and a third legal entity in a sub-Saharan African country listed in the EDCTP2 annual work plan.

3. By way of derogation from point (c) of Article 10(1) of Regulation (EU) No 1290/2013, any legal entity established in a sub-Saharan country listed in the EDCTP2 annual work plan shall be eligible for funding.

4. Where such an activity is included in the EDCTP2 annual work plan, the EDCTP2-IS may launch joint calls with third countries or their scientific and technological organisations and agencies, with international organisations or with other third parties, in particular non-governmental organisations, in accordance with the rules developed based on Article 12 of Regulation (EU) No 1290/2013.

Article 7 - Agreements between the Union and the EDCTP2-IS

1. Subject to a positive ex-ante assessment of the EDCTP2-IS in accordance with Article 61(1) of Regulation (EU, Euratom) No 966/2012, the Commission, on behalf of the Union, shall conclude a delegation agreement and annual transfer of funds agreements with the EDCTP2-IS.

2. The delegation agreement referred to in paragraph 1 shall be concluded in accordance with Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and Article 40 of Delegated Regulation (EU) No 1268/2012. It shall also set out, inter alia, the following:

(a)the requirements for the EDCTP2-IS contribution regarding the performance indicators set out in Annex II to Decision 2013/743/EU;

(b)the requirements for the EDCTP2-IS contribution in relation to the monitoring referred to in Annex III to Decision 2013/743/EU;

(c)the specific performance indicators related to the functioning of the EDCTP2-IS;

(d)the requirements for the EDCTP2-IS regarding the provision of information on administrative costs and on detailed figures concerning the implementation of the EDCTP2 Programme;

(e)the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations;

(f)the arrangements for the approval or rejection by the Commission of the draft EDCTP2 annual work plan, before it is adopted by the EDCTP2-IS; and

(g)provisions for the publication of calls for proposals by EDCTP2, in particular on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission.

Article 8 - Termination, reduction or suspension of the Union’s financial contribution

If the EDCTP2 Programme is not implemented or is implemented inadequately, partially or late, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution in line with the actual implementation of the EDCTP2 Programme.

If the Participating States do not contribute, contribute partially or late to the financing of the EDCTP2 Programme, the Commission may terminate, proportionately reduce or suspend the Union’s financial contribution, taking into account the amount of funding allocated by the Participating States to implement the EDCTP2 Programme.

Article 9 - Ex-post audits

1. Ex-post audits of expenditure on indirect actions shall be carried out by the EDCTP2-IS in accordance with Article 29 of Regulation (EU) No 1291/2013.

2. The Commission may decide to carry out itself the audits referred to in paragraph 1. In such cases, it shall do so in accordance with the applicable rules, in particular the provisions of Regulations (EU, Euratom) No 966/2012, (EU) No 1290/2013 and (EU) No 1291/2013.

Article 10 - Protection of the financial interests of the Union

1. The Commission shall take appropriate measures ensuring that, when actions financed under this Decision 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 the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties.

2. The EDCTP2-IS shall grant Commission staff and other persons authorised by it, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits.

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 Council Regulation (Euratom, EC) No 2185/96 (11) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12) 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 in accordance with this Decision.

4. Contracts, grant agreements and grant decisions resulting from the implementation of this Decision shall contain provisions expressly empowering the Commission, the EDCTP2-IS, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their competences.

5. In implementing the EDCTP2 Programme, the Participating States shall take the legislative, regulatory, administrative and other measures necessary to protect the Union’s financial interests, in particular, to ensure full recovery of any amounts due to the Union in accordance with Regulation (EU, Euratom) No 966/2012 and Delegated Regulation (EU) No 1268/2012.

Article 11 - Communication of information

1. On request, the EDCTP2-IS shall send any information necessary for preparation of the reports referred to in Article 12 to the Commission.

2. The Participating States shall submit to the Commission, through the EDCTP2-IS, any information that is requested by the European Parliament, the Council or the Court of Auditors concerning the financial management of the EDCTP2 Programme.

3. The Commission shall include the information referred to in paragraph 2 of this Article in the reports referred to in Article 12.

Article 12 - Evaluation

1. By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the EDCTP2 Programme. The Commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 31 December 2017. The result of the interim evaluation of EDCTP2 Programme shall be taken into account in the interim evaluation of Horizon 2020.

2. At the end of the Union participation in EDCTP2 but not later than 31 December 2023, the Commission shall conduct another interim evaluation of the EDCTP2 Programme. The Commission shall prepare a report on that evaluation which is to include the results of that evaluation. The Commission shall send that report to the European Parliament and to the Council.

3. The Commission shall conduct a final evaluation of the EDCTP2 Programme by 31 December 2026. The Commission shall send the results of that evaluation to the European Parliament and to the Council.

Article 13 - Entry into force

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 14 - Addressees

This Decision is addressed to the Member States.