Legal provisions of COM(2013)495 - Innovative Medicines Initiative 2 Joint Undertaking

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dossier COM(2013)495 - Innovative Medicines Initiative 2 Joint Undertaking.
document COM(2013)495 EN
date May  6, 2014

Contents

Article 1 - Establishment

1. For the implementation of the Joint Technology Initiative on Innovative Medicines, a joint undertaking within the meaning of Article 187 of the Treaty on the Functioning of the European Union (‘IMI2 Joint Undertaking’), is established for a period until 31 December 2024. In order to take into account the duration of Horizon 2020, calls for proposals by the IMI2 Joint Undertaking shall be launched at the latest by 31 December 2020. In duly justified cases calls for proposals may be launched by 31 December 2021.

2. The IMI2 Joint Undertaking shall replace and succeed the IMI Joint Undertaking, established by Regulation (EC) No 73/2008.

3. The IMI2 Joint Undertaking shall be a body entrusted with the implementation of a public-private partnership referred to in Article 209 of Regulation (EU, Euratom) No 966/2012.

4. The IMI2 Joint Undertaking shall have legal personality. In each of the Member States, it shall have the most extensive legal capacity accorded to legal persons under the laws of those Member States. It may, in particular, acquire or dispose of movable and immovable property and may be party to legal proceedings.

5. The seat of the IMI2 Joint Undertaking shall be located in Brussels, Belgium.

6. The Statutes of the IMI2 Joint Undertaking are set out in the Annex.

Article 2 - Objectives

The IMI2 Joint Undertaking shall have the following objectives:

(a)to support, in accordance with Article 25 of Regulation (EU) No 1291/2013, the development and implementation of pre-competitive research and of innovation activities of strategic importance to the Union’s competitiveness and industrial leadership or to address specific societal challenges in particular as described in parts II and III of Annex I to Decision 2013/743/EU, and in particular the challenge to improve European citizens’ health and well-being;

(b)to contribute to the objectives of the Joint Technology Initiative on Innovative Medicines, in particular to:

(i)increase the success rate in clinical trials of priority medicines identified by the World Health Organisation;

(ii)where possible, reduce the time to reach clinical proof of concept in medicine development, such as for cancer, immunological, respiratory, neurological and neurodegenerative diseases;

(iii)develop new therapies for diseases for which there is a high unmet need, such as Alzheimer’s disease and limited market incentives, such as antimicrobial resistance;

(iv)develop diagnostic and treatment biomarkers for diseases clearly linked to clinical relevance and approved by regulators;

(v)reduce the failure rate of vaccine candidates in phase III clinical trials through new biomarkers for initial efficacy and safety checks;

(vi)improve the current drug development process by providing support for the development of tools, standards and approaches to assess efficacy, safety and quality of regulated health products.

Article 3 - Union financial contribution

1. The Union financial contribution to the IMI2 Joint Undertaking, including EFTA appropriations, to cover administrative costs and operational costs shall be up to EUR 1 638 000 000 and shall consist of the following:

(a)up to EUR 1 425 000 000 to match the contribution of European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), or its constituent entities or their affiliated entities;

(b)up to EUR 213 000 000 to match additional contributions from other Members, Associated Partners, or from their constituent entities or their affiliated entities.

The contribution of the Union shall be paid from the appropriations in the general budget of the Union allocated to Horizon 2020 Specific Programme implementing Horizon 2020 in accordance with point (c)(iv) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 for bodies referred to in Article 209 of that Regulation.

2. The arrangements for the Union financial contribution shall be set out in a delegation agreement and annual transfer of funds agreements to be concluded between the Commission, on behalf of the Union, and the IMI2 Joint Undertaking.

3. The delegation agreement referred to in paragraph 2 of this Article shall address the elements set out in Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and in Article 40 of the Delegated Regulation (EU) No 1268/2012 as well as, inter alia, the following:

(a)the requirements for the IMI2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU;

(b)the requirements for the IMI2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU;

(c)the specific performance indicators related to the functioning of the IMI2 Joint Undertaking;

(d)the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(e)provisions for the publication of calls for proposals of the IMI2 Joint Undertaking also on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

(f)the use of and changes to human resources, in particular the recruitment by function group, grade and category, the reclassification exercise and any changes to the number of staff members.

Article 4 - Contributions of Members other than the Union and of Associated Partners

1. EFPIA shall make or arrange for its constituent entities or their affiliated entities to make contributions of at least EUR 1 425 000 000. Other Members other than the Union and Associated Partners shall make, or arrange for their constituent entities or their affiliated entities to make, the contributions corresponding to the amounts they have committed when becoming a Member or an Associated Partner.

2. The contributions referred to in paragraph 1 of this Article shall consist of contributions to the IMI2 Joint Undertaking as set out in Article 13(2), point (b) of Article 13(3) and point (c) of Article 13(3) of the Statutes. In-kind contributions consisting of costs incurred in third countries other than countries associated to Horizon 2020 shall be justified and relevant to the objectives set out in Article 2 of this Regulation, and shall not exceed 30 % of the eligible costs at the level of the IMI2 programme, incurred by the Members other than the Union and by the Associated Partners.

3. The Members other than the Union and Associated Partners shall report each year by 31 January to the Governing Board of the IMI2 Joint Undertaking on the value of the contributions referred to in paragraph 2 made in each of the previous financial years. The States Representatives Group shall also be informed thereof in a timely manner.

4. For the purpose of valuing the contributions referred to in point (b) of Article 13(3) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where the entity is established, and to the applicable International Accounting Standards and International Financial Reporting Standards. The costs shall be certified by an independent external auditor appointed by the entity concerned. The valuation method may be verified by the IMI2 Joint Undertaking should there be any uncertainty arising from the certification. In case of remaining uncertainties, it may be audited by the IMI2 Joint Undertaking.

5. The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the IMI2 Joint Undertaking or trigger the winding up procedure referred to in Article 21(2) of the Statutes if those Members and Associated Partners, their constituent entities or their affiliated entities do not contribute, contribute only partially or contribute late with regard to the contributions referred to in paragraph 2 of this Article.

Article 5 - Financial rules

Without prejudice to Article 12 of this Regulation, the IMI2 Joint Undertaking shall adopt its specific financial rules in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 110/2014 (9).

Article 6 - Staff

1. The Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (10) (hereinafter ‘Staff Regulations’ and ‘Conditions of Employment’) and the rules adopted jointly by the institutions of the Union for the purpose of applying Staff Regulations and Conditions of Employment shall apply to the staff of the IMI2 Joint Undertaking.

2. The Governing Board shall exercise, with respect to the staff of the IMI2 Joint Undertaking, the powers conferred by the Staff Regulations on the Appointing Authority and the powers conferred by the Conditions of Employment on the authority empowered to conclude contract (hereinafter ‘the appointing authority powers’).

The Governing Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation may be suspended. The Executive Director shall be authorised to sub-delegate those powers.

Where exceptional circumstances so require, the Governing Board may by decision temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subsequent sub-delegation of those powers by the latter. In such cases the Governing Board shall exercise the appointing authority powers itself or shall delegate them to one of its members or to a staff member of the IMI2 Joint Undertaking other than the Executive Director.

3. The Governing Board shall adopt appropriate implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations.

4. The staff resources shall be determined in the staff establishment plan of the IMI2 Joint Undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents, in line with its annual budget.

5. The staff of the IMI2 Joint Undertaking shall consist of temporary staff and contract staff.

6. All costs related to the staff shall be borne by the IMI2 Joint Undertaking.

Article 7 - Seconded national experts and trainees

1. The IMI2 Joint Undertaking may make use of seconded national experts and trainees not employed by the IMI2 Joint Undertaking. The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff as referred to in Article 6(4) in line with the annual budget.

2. The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the IMI2 Joint Undertaking and on the use of trainees.

Article 8 - Privileges and Immunities

The Protocol No 7 on the privileges and immunities of the European Union, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, shall apply to the IMI2 Joint Undertaking and its staff.

Article 9 - Liability of the IMI2 Joint Undertaking

1. The contractual liability of the IMI2 Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question.

2. In the case of non-contractual liability, the IMI2 Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties.

3. Any payment by the IMI2 Joint Undertaking in respect of the liability referred to in paragraphs 1 or 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the IMI2 Joint Undertaking and shall be covered by its resources.

4. The IMI2 Joint Undertaking shall be solely responsible for meeting its obligations.

Article 10 - Jurisdiction of the Court of Justice of the European Union and applicable law

1. The Court of Justice of the European Union shall have jurisdiction:

(a)pursuant to any arbitration clause contained in agreements or contracts concluded by the IMI2 Joint Undertaking or in its decisions;

(b)in disputes relating to compensation for damage caused by the staff of the IMI2 Joint Undertaking in the performance of their duties;

(c)in any dispute between the IMI2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment.

2. Regarding any matter not covered by this Regulation or by other Union legal acts, the law of the State where the seat of the IMI2 Joint Undertaking is located shall apply.

Article 11 - Evaluation

1. By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the IMI2 Joint Undertaking. 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 results of the interim evaluation of the IMI2 Joint Undertaking shall be taken into account in the in-depth assessment and in the interim evaluation referred to in Article 32 of Regulation (EU) No 1291/2013.

2. On the basis of the conclusions of the interim evaluation referred to in paragraph 1 of this Article the Commission may act in accordance with Article 4(5) or take any other appropriate action.

3. Within six months after the winding up of the IMI2 Joint Undertaking, but no later than two years after the triggering of the winding up procedure referred to in Article 21 of the Statutes, the Commission shall conduct a final evaluation of the IMI2 Joint Undertaking. The results of that final evaluation shall be presented to the European Parliament and to the Council.

Article 12 - Discharge

By way of derogation from Article 60(7) and Article 209 of Regulation (EU, Euratom) No 966/2012, the discharge for the implementation of the budget of the IMI2 Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council in accordance with the procedure provided for in the financial rules of the IMI2 Joint Undertaking.

Article 13 - Ex post audits

1. Ex post audits of expenditure on indirect actions shall be carried out by the IMI2 Joint Undertaking in accordance with Article 29 of Regulation (EU) No 1291/2013 as part of Horizon 2020 indirect actions.

2. The Commission may decide to carry out the audits referred to in paragraph 1 itself of those participants which have received funding from the IMI2 Joint Undertaking. 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 14 - Protection of the financial interests of the Members

1. The IMI2 Joint Undertaking shall grant Commission staff and other persons authorised by the IMI2 Joint Undertaking or the Commission, 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.

2. 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 an agreement, decision or contract funded under this Regulation.

3. Without prejudice to paragraphs 1 and 2 agreements, decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering:

(a)the IMI2 Joint Undertaking and OLAF to conduct audits and investigations, for the purposes described in paragraphs 1 and 2, in accordance with their respective competences; and

(b)the Commission and the Court of Auditors to conduct audits, for the purposes described in paragraphs 1 and 2, of the recipients of funding from the IMI2 Joint Undertaking, in accordance with their respective competences.

4. The IMI2 Joint Undertaking shall ensure that the financial interests of its Members are adequately protected by carrying out or commissioning appropriate internal and external controls.

5. The IMI2 Joint Undertaking shall accede to the Inter-institutional Agreement of 25 May 1999 between the European Parliament, the Council and the Commission concerning internal investigations by the European Anti-fraud Office (OLAF) (13). The IMI2 Joint Undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF.

Article 15 - Confidentiality

Without prejudice to Article 16, the IMI2 Joint Undertaking shall ensure the protection of sensitive information the disclosure of which could damage the interests of its Members or of participants in the activities of the IMI2 Joint Undertaking.

Article 16 - Transparency

1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (14) shall apply to documents held by the IMI2 Joint Undertaking.

2. The IMI2 Joint Undertaking Governing Board may adopt the practical arrangements for implementing Regulation (EC) No 1049/2001.

3. Without prejudice to Article 10 of this Regulation, decisions taken by the IMI2 Joint Undertaking pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman under the conditions laid down in Article 228 of the Treaty on the Functioning of the European Union.

Article 17 - Rules for participation and dissemination

Regulation (EU) No 1290/2013 shall apply to the actions funded by the IMI2 Joint Undertaking. In accordance with that Regulation, the IMI2 Joint Undertaking shall be considered as a funding body and shall provide financial support to indirect actions as set out in Article 1 of the Statutes.

Article 18 - Support from the host State

An administrative agreement may be concluded between the IMI2 Joint Undertaking and the State where its seat is located concerning privileges and immunities and other support to be provided by that State to the IMI2 Joint Undertaking.

Article 19 - Repeal and transitional provisions

1. Regulation (EC) No 73/2008 is repealed.

2. Without prejudice to paragraph 1, actions initiated under Regulation (EC) No 73/2008 and financial obligations related to those actions shall continue to be governed by that Regulation until their completion.

The actions arising from calls for proposals provided for in annual implementation plans adopted under Regulation (EC) No 73/2008 shall also be regarded as actions initiated under that Regulation.

The interim evaluation referred to in Article 11(1) of this Regulation shall include a final evaluation of the IMI Joint Undertaking under Regulation (EC) No 73/2008.

3. This Regulation shall not affect the rights and obligations of staff engaged under Regulation (EC) No 73/2008.

The employment contracts of staff referred to in the first subparagraph may be renewed under this Regulation in accordance with the Staff Regulations and Conditions of Employment.

The Executive Director appointed on the basis of Regulation (EC) No 73/2008 shall, for the remaining period of term of office, be assigned to the functions of the Executive Director as provided for in this Regulation with effect from 27 June 2014. The other conditions of contract shall remain unchanged.

4. Unless otherwise agreed between the Members of the IMI Joint Undertaking pursuant to Regulation (EC) No 73/2008, all rights and obligations including assets, debts or liabilities of the Members of the IMI Joint Undertaking pursuant to Regulation (EC) No 73/2008 shall be transferred to the Members of the IMI2 Joint Undertaking pursuant to this Regulation.

5. Any unused appropriations under Regulation (EC) No 73/2008 shall be transferred to the IMI2 Joint Undertaking.

Article 20 - Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.