Proposal for a COUNCIL REGULATION on the Innovative Medicines Initiative 2 Joint Undertaking
Date: 2013-07-10
Institutions: European Commission
Subjects: EU programme, European Joint Undertaking, innovation, pharmaceutical industry, public-private partnership

EUROPEAN 
COMMISSION 

Brussels, 10.7.2013  
COM(2013) 495 final 

2013/0240 (NLE) 

Proposal for a 

COUNCIL REGULATION 

on the Innovative Medicines Initiative 2 Joint Undertaking 

(Text with EEA relevance) 

{SWD(2013) 245 final} 
{SWD(2013) 246 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context 

In  the  context  of  the  economic  and  financial  crisis  Europe  is  taking  steps  to  find  a  path  to 
sustainable  growth.  At  the  same  time,  Europe  is  faced  with  a  series  of  important  major 
challenges, such as climate change, finding sources of clean energy and improving the health 
and wellbeing of its citizens while containing the costs of healthcare. 

One of the aims of Horizon 2020, Europe's flagship programme for research and innovation, 
is to strengthen European industry by taking action to support research and innovation across 
a  range  of  industrial  sectors.  In  particular,  Horizon  2020  encourages  public-private 
partnerships  in  research  and  innovation  to  help  tackle  some  of  the  key  challenges  Europe 
faces, including in the public health sector. 

The  proposal  for  a  public-private  partnership  builds  on  the  Innovative  Medicines  Initiative 
Joint  Undertaking  (IMI  JU)  established  under  the  7th  Research  Framework  Programme 
(‘FP7’)  by  Regulation  (EC)  No  73/2008  of  the  Council  of  20  December  2007.  IMI  JU  is  a 
public-private  partnership  between  the  European  Commission  and  the  biopharmaceutical 
industry,  and  its  objective  is  to  improve  the  drug  development  process  by  supporting  more 
efficient  research  and  development  cooperation  among  academia,  small  and  medium 
enterprises (‘SMEs’) and the biopharmaceutical industry, in order to deliver better and safer 
medicines for patients.  

This proposal is in line with the Commission Communication Public-private partnerships, in 
Horizon 2020: a powerful tool to deliver on innovation and growth in Europe '1. 

Reasons for and objectives of the proposed Innovative Medicines Joint Undertaking  

A Joint Undertaking in the area of innovative medicines is needed: 

- Because the challenges it will tackle are vital for public health in Europe and for its citizens: 
improving  their  health  and  wellbeing  by  providing  new  and  more  effective  diagnostics  and 
treatments, while helping safeguard the future international competitiveness of the European 
biopharmaceutical  and  life-science  industries  such  as  diagnostics,  vaccines,  biomedical 
imaging and medical information technologies;  

- Because it will help tackle a series of obstacles to effective research and innovation in this 
area:  high  risks  of  engaging  in  expensive  and  complex  development  of  diagnostics  and 
treatments,  decreasing  productivity  of  the  drug  and  vaccine  development  processes  and  the 
lack  of  economic  incentives  to  develop  such  interventions;  high  risks  of  supporting  shared 
databases and networks that could speed up treatment development and help achieve lifelong 
health and wellbeing for all, particulary important in the context of an ageing population and 
the associated increase in chronic and degenerative diseases; the emergence and potential re-
emergence of infectious diseases (including the increase in anti-microbial resistance); limited 
knowledge spill-overs due to a lack of open-innovation eco-systems among the various actors 
from academia, SMEs and industry; and the threat posed by zoonoses. 

-  Because  industry  on  its  own  will  not  invest  due  to  these  obstacles,  and  because  public 
support  from  the  Member  States  acting  alone  is  too  fragmented  and  cannot  achieve  the 
coordinated, long-term, large-scale, transnational, cross-sectorial effort required. 

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COM(2013) […] 

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- Because a JU at EU level can help the life-science industries to set a long-term research and 
innovation  strategic  agenda  in  a  pan-European  structure,  create  the  necessary  critical  mass, 
leverage private investment, provide stable funding, facilitate knowledge sharing and reduce 
risk at lower costs. A JU will help create networks for open innovation, which bring together 
the main stakeholders along the entire drug development value chain. 

- Because a JU can contribute to the EU's goal in other policy areas such as the Commission 
Communication on Combatting Antimicrobial Resistance, where the current IMI is one of the 
key implementation measures, the European contribution to the Global One Health Initiative, 
the European Innovation Partnership on Active and Healthy Ageing, the European Partnership 
for Action Against Cancer, as well as the European Pact for Mental Health and action related 
to the Commission Communication on Alzheimer's disease and other dementias. 

Therefore,  the  new  proposal  aims  to  address  bottlenecks  in  areas  of  public  health  interest, 
which are limiting the efficiency, effectiveness and quality of the drug development activities 
needed to bring innovative medicines to the market. 

Building on past experience 

The proposed JU builds upon the achievements of the previous IMI JU set up under FP7.  

IMI  JU  has  mobilised  resources  by  bringing  together  partners  from  the  pharmaceutical 
industry,  academia,  SMEs,  patient  organisations  and  regulators  in  focused  projects;  it  has 
stepped  up  cooperation  between  stakeholders  in  the  health  research  and  innovation  field  by 
opening access to other partners’ expertise and it has increase the collaboration between the 
pharmaceutical  industry  and  other  stakeholders  in  Europe.  It  has  also  fostered  the 
development of comprehensive research agendas, and horizontal policy coordination.  

The interim evaluation of the IMI Joint Undertaking has underlined that IMI enables mutual 
learning  and  has  built  understanding  of  rationales  and  approaches  among  the  different 
stakeholders. This has benefit to all parties and has significantly contributed to the transition 
from a closed to an open innovation model in biopharmaceutical research, supported by a fair 
intellectual  property  regime.  No  other  European  programme  has  enabled  cross-company 
collaboration within the pharmaceutical sector on the scale that has been achieved in IMI. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

Consultation of interested parties and use of expertise  

Extensive  consultations  with  stakeholders  have  been  organised,  including  Member  States, 
SMEs in the life sciences, medical imaging and information technology industries conducted 
through a series of dedicated meetings (Impact Assessment, Annex 1). The impact assessment 
report  also  draws  on  the  results  of  the  current  JTI  evaluation  and  the  work  of  a  group  of 
experts.  A  public  consultation  was  held  from  11  July  to  4  October  20122.  In  addition,  an 
online consultation for participants of on-going IMI projects was conducted3. 

Impact assessment 

The  proposed  Regulation  has  been  subject  to  a  Commission  impact  assessment,  which  is 
attached to the proposal. 

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3 

http://ec.europa.eu/research/consultations/life_science_h2020/report_public_consultation.pdf 
ftp://ftp.cordis.europa.eu/pub/fp7/health/docs/outcome-imi-participants_en.pdf 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

The  proposal  consists  of  a  Council  Regulation  on  the  Innovative  Medicines  2  Joint 
Undertaking.  The  IMI  Joint  Undertaking  was  initially  established  by  Regulation  (EC)  No 
73/2008 of the Council of 20 December 2007, which is to be repealed.  

Legal basis  

The proposal is based on Article 187 of the Treaty on the Functioning of the European Union. 

The Rules for  Participation and Dissemination of Horizon 2020 will apply. However, given 
specific  operational  needs  of  this  initiative,  derogations  from  these  Rules  are  necessary. 
Nevertheless, these specific derogations are not included in the present proposal at this stage, 
in  order  not  to  prejudice  the  inter-institutional  discussions  concerning  the  appropriate  legal 
basis/procedural  modalities  for  their  adoption,  which  are  still  pending  in  the  context  of  the 
legislative  works  concerning  the  Commission  proposal  for  a  Regulation  of  the  European 
Parliament and of the Council laying down the Rules for Participation and  dissemination in 
Horizon  2020  (COM(2011)  0810  -  2011/0399  (COD).  The  specific  derogations  will  be 
introduced at a later stage in view of the outcome of the abovementioned discussions. 

A  first  derogation  will  allow  to  limit  the  eligibility  for  funding  to  entities  such  as  SMEs, 
secondary  and  higher  education  establishments,  non-profit  organizations,  and  companies 
encountering  difficulties  to  access  finance,  such  as  mid-caps  or  medium-sized  companies. 
Secondly, in order to facilitate and speed up the delivery of innovative medicines to patients 
and  to  improve  the  drug  research  and  development  in  Europe,  IMI2  Joint  Undertaking 
requires  derogations  from  the  intellectual  property  rules  which  concern  relevant  definitions, 
ownership, protection, exploitation, dissemination, transfer and licensing of results and access 
rights. 

Subsidiarity and proportionality 

The proposal is designed to maximise EU added value and impact, focusing on objectives and 
activities that cannot be sufficiently achieved by Member States acting alone. The industrial 
challenge  of  bringing  biomedical  research  and  innovation  to  new  products  and  thereby 
impacting the health of EU citizens is so large and complex that Member States acting alone 
do  not  have  the  necessary  framework  to  set  up  transnational  collaborative  platforms  for 
strategic industrial research.  

to  facilitate 

Public intervention at EU level is necessary as only the EU is able to provide sustained, large-
scale  public  sponsorship  able 
the  kind  of  cross-border,  cross-sector, 
interdisciplinary  research  and  innovation  consensus-building  and  implementation  required. 
Intervening at EU level by supporting transnational cooperation between firms on long-term 
strategic research agendas produces the following added value over and above what Member 
States acting alone can achieve. Joint undertakings are the best set up to achieve the critical 
mass, in particular by implementation of joint agenda setting, mobilising of additional funding 
and having a larger leverage effect on industrial R&D investment. 

In accordance with the principle of proportionality, the provisions of this regulation do not go 
beyond what is necessary to achieve its objectives. 

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4. 

BUDGETARY IMPLICATION  

The  Legislative  Financial  Statement  presented  with  this  regulation  sets  out  the  indicative 
budgetary implications. The Union contribution shall be up to EUR 1 725 million4 including 
EFTA contribution. The envelope is in current prices. The Union contribution shall be made 
from the ‘Health, demographic change and wellbeing’ challenge, DG Research & Innovation 
envelope,  as  part  of  the  implementation  of  Horizon  2020  –  The  Framework  Programme  for 
Research  and  Innovation.  The  maximum  amount  of  Union  contribution  for  administrative 
costs shall be EUR 44,85 million.  

4 

The amount is indicative and will depend on the final amount for the DG Research & Innovation under 
the above-mentioned challenge.  

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2013/0240 (NLE) 

Proposal for a 

COUNCIL REGULATION 

on the Innovative Medicines Initiative 2 Joint Undertaking 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 187 and the first paragraph of Article 188 thereof, 

Having regard to the proposal from the European Commission, 
Having regard to the opinion of the European Parliament5, 
Having regard to the opinion of the Economic and Social Committee6,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

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Public-private  partnerships  in  the  form  of  Joint  Technology  Initiatives  (JTIs)  were 
initially provided for in Decision No 1982/2006/EC of the European Parliament and of 
the Council of 18 December 2006 concerning the Seventh Framework programme of 
the European Community for research, technological development and demonstration 
activities (2007-2013)7.  

Council  Decision  No  2006/971/EC  of  19  December  2006  concerning  the  Specific 
Programme  ‘Cooperation’  implementing  the  Seventh  Framework  programme  of  the 
European  Community  for  research,  technological  development  and  demonstration 
activities (2007-2013)8 identified specific public-private partnerships to be supported, 
including  a  public-private  partnership  on  Innovative  Medicines  Joint  Technology 
Initiative  between  the  Union  and  the  European  Federation  of  Pharmaceutical 
Industries and Associations (hereinafter "EFPIA"). 
Europe  2020  Strategy9  underscores  the  need  to  develop  favourable  conditions  for 
investment  in  knowledge  and  innovation  so  as  to  achieve  smart,  sustainable  and 
inclusive  growth  in  the  Union.  Both  the  European  Parliament  and  the  Council  have 
endorsed this strategy. 

Regulation  (EU)  No  …/2013  of  the  European  Parliament  and  of  the  Council  of  … 
2013  establishing  Horizon  2020  -  The  Framework  Programme  for  Research  and 
Innovation (2014-2020)10 aims to achieve a greater impact on research and innovation 
by  combining  Horizon  2020  Framework  Programme  and  private  sector  funds  in 
public-private partnerships in key areas where research and innovation can contribute 

OJ C […], […], p. […] 
OJ C […], […], p. […] 
OJ L 412 30.12.2006, p. 1 
OJ L 400 30.12.2006, p. 86 
COM(2010)2020 final 
OJ … [H2020 FP] 

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(5) 

(6) 

(7) 

(8) 

(9) 

to the Union's wider competitiveness goals and help tackle societal challenges. Union 
involvement  in  those  partnerships  could  take  the  form  of  financial  contributions  to 
joint undertakings established on the basis of Article 187 of the Treaty under Decision 
No 1982/2006/EC. 

In accordance with Decision (EU) No …/2013 of the Council of … 2013 establishing 
the  Specific  Programme  implementing  Horizon  2020  (2014-2020)11  further  support 
should be provided to joint undertakings established under Decision No 1982/2006/EC 
under the conditions specified in Decision (EU) No […]/2013..  

The  Innovative  Medicines  Initiative  (hereinafter  ''IMI'')  Joint  Undertaking  set  up  by 
Regulation (EC) No 73/2008 of the Council of 20 December 2007 setting up the IMI 
Joint  Undertaking12  has  demonstrated  the  effective  mobilisation  of  resources  by 
bringing together several partners from the pharmaceutical industry, academia, small 
and  medium-sized  enterprises  (hereinafter 
''SMEs''),  patient  organisations  and 
regulators.  

It  has  also  stepped  up  cooperation  between  stakeholders  in  the  health  research  and 
innovation  field  by  allowing  access  to  other  partners’  expertise  and  increasing  the 
collaboration between the pharmaceutical industry and other stakeholders in the Union 
by developing comprehensive research agendas and horizontal policy coordination. No 
other  European  or  national  programme  has  enabled  cross-company  collaboration 
within  the  pharmaceutical  sector  on  the  scale  that  has  been  achieved  by  IMI.  The 
interim  evaluation  of  the  IMI  Joint  Undertaking13  underlined  that  it  enables  mutual 
learning and provides the opportunity to improve the reciprocal understanding of the 
stakeholders,  which  benefits  all  parties  and  has  significantly  contributed  to  the 
transition towards an open innovation model in biopharmaceutical research. 

Research  related  to  the  future  of  medicine  shall  be  undertaken  in  areas  where 
combination of societal, public health and biomedical industry competitiveness goals 
requires  pooling  of  resources  and  fostering  collaboration  between  the  public  and 
private sectors, with the involvement of SMEs. The scope of the initiative should be 
expanded to all areas of  life science  research and innovation. The areas  would be of 
public health interest, as identified by the World Health Organisation report on priority 
medicines for Europe and the World, which is currently being updated with the new 
version  expected  to  be  released  in  2013.  The  initiative  should  consequently  seek  to 
involve  a  broader  range  of  partners,  including  mid-caps,  from  different  sectors  (e.g. 
biomedical imaging, medical information technology, diagnostic and/or animal health 
industries).  A  wider  participation  would  help  to  advance  the  development  of  new 
approaches  and  technologies  for  the  prevention,  diagnosis  and  treatment  of  diseases 
with high impact on public health. 

The  continuation  of  this  initiative  should  also  take  into  account  the  experience 
acquired from the operations of the IMI Joint Undertaking including the results of its 
interim  evaluation  and  stakeholders'  recommendations14  and  be  implemented  using  a 
more  fit-for-purpose  structure  and  rules  in  order  to  enhance  efficiency  and  ensure 
simplification at operational level. To this effect, the Innovative Medicines Initiative 2 
(hereinafter  ''IMI2'')  Joint  Undertaking  should  adopt  financial  rules  specific  to  its 
needs in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 of the 

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OJ … [H2020 SP] 
OJ L 30 of 4.2.2008 [FP7 JTI JU Regulation] 
SEC(2011) 1072 final 
http://ec.europa.eu/research/consultations/life_science_h2020/consultation_en.htm 

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European  Parliament  and  the  Council  of  25  October  2012  on  the  financial  rules 
applicable to the general budget of the Union15. 

(10)  The  private  Members  to  the  IMI2  Joint  Undertaking  have  expressed  in  writing  their 
agreement to pursue the research activities in the area of the IMI2 Joint Undertaking 
within  a  structure  better  adapted  to  the  nature  of  a  public-private  partnership.  It  is 
appropriate that the private-sector Members to the IMI2 Joint Undertaking accept the 
Statutes contained in the Annex by means of a letter of endorsement. 

(11)  As  a  means  to  further  develop  IMI2  Joint  Undertaking's  objectives,  membership 
should be open to other legal entities. Moreover, legal entities interested in supporting 
IMI2  Joint  Undertaking’s  objectives  in  their  specific  areas  of  research  should  be 
offered the possibility to become Associated Partners in the IMI2 Joint Undertaking. 

(12) 

In order to achieve its objectives, the IMI2 Joint Undertaking should provide financial 
support  to  participants  mainly  in  the  form  of  grants  following  open  and  competitive 
calls for proposals. 

(13)  Contributions  from  the  private  Members  should  relate  to  the  administrative  costs  of 
the  IMI2  Joint  Undertaking  and,  together  with  the  Associated  Partners  for  their 
specific  area  of  research,  to  the  co-financing  required  to  carry  out  research  and 
innovation actions supported by the IMI2 Joint Undertaking. 

(14)  Participation in indirect actions funded by the IMI2 Joint Undertaking should comply 
with Regulation (EU) No … /2013 of the European Parliament and of the Council of 
…  2013  laying  down  the  rules  for  the  participation  and  dissemination  in  "Horizon 
2020 - the Framework Programme for Research and Innovation (2014-2020)"16.  

(15)  The Union financial contribution should be managed in accordance with the principle 
of sound financial management and with the relevant rules on indirect management set 
out in Regulation (EU, Euratom) No 966/2012 and Commission delegated Regulation 
(EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, 
Euratom) No 966/201217. 

(16)  Audits of recipients of Union funds under this Regulation should be carried out in such 
a  manner  that  the  administrative  burden  is  reduced,  in  compliance  with  Regulation 
(EU) No […]/2013 [Horizon 2020 Framework Programme]. 

(17)  The  financial  interests  of  the  Union  and  of  the  other  Members  of  the  IMI2  Joint 
Undertaking  should  be  protected  through  proportionate  measures  throughout  the 
expenditure  cycle, 
investigation  of 
irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where 
appropriate, administrative and financial penalties in accordance with Regulation (EU, 
Euratom) No 966/2012. 

the  prevention,  detection  and 

including 

(18)  The  Commission's  internal  auditor  should  exercise  the  same  powers  over  the  IMI2 

Joint Undertaking as those exercised in respect of the Commission. 

(19) 

In  accordance  with  Article  287(1)  of  the  Treaty  on  the  Functioning  of  the  European 
Union,  the  constituent  instrument  of  bodies,  offices  or  agencies  set  up  by  the  Union 
may preclude the examination of the accounts of all revenue and expenditure of those 
bodies, offices or agencies by the Court of Auditors. In accordance with Article 60(5) 
of  Regulation  (EU,  Euratom)  No  966/2012,  the  accounts  of  the  bodies  under  Article 

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OJ L 298 26.10.2012, p. 1. 
OJ … [H2020 RfP] 
OJ L 362 31.12.2012, p. 1 

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(20) 

209  Regulation  (EU,  Euratom)  No  966/2012  are  to  be  examined  by  an  independent 
audit body which is to give an opinion inter alia on the reliability of the accounts and 
the legality and regularity of the underlying transactions. Avoidance of duplication of 
the  examination  of  the  accounts  justifies  that  the  accounts  of  the  IMI2  Joint 
Undertaking should not be subject to examination by the Court of Auditors. 

In  accordance  with  the  principles  of  subsidiarity  and  proportionality  as  set  out  in 
Article  5  of  the  Treaty  on  European  Union,  the  objectives  of  the  IMI2  Joint 
Undertaking  in  strengthening  industrial  research  and  innovation  across  the  Union 
cannot be sufficiently achieved by the Member States and can therefore, by reason of 
avoiding duplication, retaining critical mass and ensuring that public financing is used 
in an optimal way, be better achieved by the Union. This Regulation confines itself to 
the  minimum  required  in  order  to  achieve  those  objectives  and  does  not  go  beyond 
what is necessary for that purpose. 

(21)  The IMI Joint Undertaking was set up for a period up to 31 December 2017. The IMI2 
Joint  Undertaking  should  provide  continued  support  to  the  Innovative  Medicines 
research  programme  by  enlarging  the  scope  of  the  activities  under  a  modified  set  of 
rules.  The  transition  from  the  IMI  Joint  Undertaking  to  the  IMI2  Joint  Undertaking 
should be aligned and synchronized with the transition from the Seventh Framework 
programme to the Horizon 2020 Framework Programme to ensure optimal use of the 
funding  available  for  research.  In  the  interest  of  legal  certainty  and  clarity,  Council 
Regulation (EC) No 73/2008 should therefore be repealed and transitional provisions 
should be set out. 

HAS ADOPTED THIS REGULATION: 

Article 1 

Establishment 

1. 

2. 

3. 

4. 

5. 

6. 

For the implementation of the Joint Technology Initiative on Innovative Medicines, a 
joint undertaking within the meaning of Article 187 of the Treaty (hereinafter ''IMI2 
Joint  Undertaking''),  is  established  for  a  period  from  1  January  2014  until  31 
December 2024. 

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

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

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. 

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

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

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Article 2 

Objectives 

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The IMI 2 Joint Undertaking shall have the following objectives: 

(a) 

(b) 

to  contribute  to  the  implementation  of  Regulation  (EU)  No  […]/2013/EU  [the 
Horizon  2020  Framework  Programme],  in  particular  part  …  of  Decision  (EU)  No 
[…]/2013/EU [the Specific Programme implementing the Horizon 2020 Framework 
Programme], and in particular to improving European citizens' health and wellbeing. 

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

i) 

ii) 

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

reduce  the  time  to  reach  clinical  proof  of  concept  in  medicine  development, 
such  as  for  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) 

v) 

vi) 

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

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

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 contribution 

1. 

The maximum Union contribution, including EFTA appropriations, to the IMI2 Joint 
Undertaking to cover administrative costs and operational costs shall be EUR 1 725 
million which shall consist of the following: 

(a)  up to EUR 1 500 million to match the contribution of EFPIA, or its constituent 

entities or their affiliated entities; 

(b)  up to EUR 225 million to match additional contributions from other Members 
Associated Partners, or from their constituent or their affiliated entities. 

the  Union  allocated 

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

to 

2. 

3. 

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. 

The  delegation  agreement  referred  to  in  paragraph  2  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  Commission  delegated  Regulation  (EU)  No 
1268/2012 as well as inter alia the following: 

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(a) 

(b) 

(c) 

(d) 

(e) 

the  requirements  for  the  IMI2  Joint  Undertaking's  contribution  regarding  the 
relevant performance indicators referred to in Annex II to Decision (EU) No … 
[the  Specific  Programme 
the  Horizon  2020  Framework 
Programme]; 

implementing 

the  requirements  for the IMI2  Joint  Undertaking's contribution in view of the 
monitoring  referred  to  in  Annex  III  to  Decision  (EU)  No  …  [the  Specific 
Programme implementing the Horizon 2020 Framework Programme]; 

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

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

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 

EFPIA shall make or arrange for its constituent entities or their affiliated entities to 
make  contributions  of  at  least  EUR  1  500  million.  Other  Members  other  than  the 
Union or 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. 

The contribution referred to in paragraph 1 shall consist of contributions to the IMI2 
Joint Undertaking as laid down in Clause 13(2), Clause 13(3)(b) and Clause 13(3)(c) 
of the Statutes contained in the Annex. 

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. 

For  the  purpose  of  valuing  the  contributions  referred  to  in  Clause  13(3)(b)  of  the 
Statutes contained in the Annex, the costs shall be determined according to the usual 
cost  accounting  practices  of  the  entities  concerned,  to  the  applicable  accounting 
standards  of  the  country  where  each  entity  is  established,  and  to  the  applicable 
International Accounting Standards/International Financial Reporting Standards. The 
costs  shall  be  certified  by  an  independent  external  auditor  appointed  by  the  entity 
concerned.  The  valuation  of  the  contributions  shall  be  verified  by  the  IMI2  Joint 
Undertaking. In case of remaining uncertainties, it may be audited by the IMI2 Joint 
Undertaking. 

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 Clause 21(2) of the Statutes contained in the Annex 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. 

1. 

2. 

3. 

4. 

5. 

EN 

11 

   EN 

Article 5 

Financial rules 

The IMI2 Joint Undertaking shall adopt its specific Financial rules in accordance with Article 
209  of  Regulation  (EU,  Euratom)  No  966/2012  and  Regulation  (EU)  No  …  [Delegated 
Regulation on the model Financial Regulation for PPPs]. 

Article 6 

Staff 

1. 

2. 

3. 

4. 

5. 

6. 

The Staff Regulations of Officials of the Union and the Conditions of Employment 
of Other Servants of the European Union as laid down by Council Regulation (EEC, 
Euratom,  ECSC)  No  259/6818  and  the  rules  adopted  by  agreement  between  the 
institutions  of  the  Union  for  giving  effect  to  those  Staff  Regulations  and  those 
Conditions of Employment of Other Servants shall apply to the staff employed by the 
IMI2 Joint Undertaking. 

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  by  the  Conditions  of  Employment  on  the  Authority  Empowered  to 
Conclude Contract of Employment (hereinafter "the appointing authority powers"). 

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

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

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. 

The staff resources shall be determined by 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. 

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

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

18 

OJ 56, 4.3.1968, p. 1. 

EN 

12 

   EN 

                                                 
Article 7 

Seconded national experts and trainees 

1. 

2. 

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

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  on  the  Privileges  and  Immunities  of  the  Union  shall  apply  to  the  IMI2  Joint 
Undertaking and its staff. 

Article 9 

Liability of the IMI2 Joint Undertaking 

1. 

2. 

3. 

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. 

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. 

Any payment by the IMI2 Joint Undertaking in respect of the liability referred to in 
paragraphs 1 and 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 
the resources of the IMI2 Joint Undertaking. 

4. 

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

Article 10 

Jurisdiction of the Court of Justice and applicable law 

1. 

The  Court  of  Justice  shall  have  jurisdiction  under  the  conditions  laid  down  in  the 
Treaty as well as in the following cases: 

(a) 

in any dispute between the Members of IMI2 Joint Undertaking which relates 
to the subject matter of this Regulation;  

(b)  pursuant  to  any  arbitration  clause  contained  in  agreements,  decisions  or 

contracts concluded by the IMI2 Joint Undertaking; 

(c) 

(d) 

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

in any dispute between the IMI2 Joint Undertaking and its servants within the 
limits and under the conditions laid down in the Staff Regulations of Officials 
and the Conditions of Employment of Other Servants of the European Union. 

EN 

13 

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2. 

1. 

2. 

3. 

1. 

2. 

1. 

2. 

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

Article 11 

Evaluation  

By  31  December  2017  the  Commission  shall  conduct  an  interim  evaluation  of  the 
IMI2  Joint  Undertaking.  The  Commission  shall  communicate  the  conclusions 
thereof,  accompanied  by  its  observations,  to  the  European  Parliament  and  to  the 
Council by 30 June 2018. 

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

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 Clause 
21  of  the  Statutes  contained  in  the  Annex,  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 

The discharge of the budget implementation with regard to the Union contribution to 
the  IMI2  Joint  Undertaking  shall  be  part  of  the  discharge  given  by  the  European 
Parliament, upon recommendation of the Council, to the Commission in accordance 
with the procedure provided for in Article 319 of the Treaty. 

The IMI2 Joint Undertaking shall fully cooperate with the institutions involved in the 
discharge  procedure  and  provide,  as  appropriate,  any  necessary  additional 
information. In this context, it may be requested to be represented in meetings with 
the  relevant  institutions  or  bodies  and  assist  the  Commission  authorising  officer  by 
delegation. 

Article 13 

Ex-post audits 

Ex-post  audits  of  expenditure  on  indirect  actions  shall  be  carried  out  by  the  IMI2 
Joint  Undertaking  in  accordance  with  Article  23  of  Regulation  (EU)  No  …  [the 
Horizon  2020  Framework  Programme]  as  part  of  the  Horizon  2020  Framework 
Programme indirect actions. 

To ensure coherence, the Commission may decide to carry out the audits referred to 
in  paragraph  1  on  those  participants  which  have  received  funding  from  the  IMI2 
Joint Undertaking. 

EN 

14 

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1. 

2. 

3. 

4. 

5. 

Article 14 

Protection of the financial interests of the Members 

Without prejudice to Clause 17(4), of the Statutes contained in the Annex, the IMI2 
Joint Undertaking 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. 

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 (EC) No 1073/1999 of the European Parliament and of the 
Council of 25 May 1999 concerning investigations conducted by the European Anti-
Fraud  Office  (OLAF)19  and  Council  Regulation  (Euratom,  EC)  No  2185/96  of  11 
November  1996  concerning  on-the-spot  checks  and  inspections  carried  out  by  the 
Commission  in  order  to  protect  the  European  Communities'  financial  interests 
against fraud and other irregularities20 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  or  decision  or  a  contract  funded  under 
this Regulation. 

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

(a) 

(b) 

the  IMI2  Joint  Undertaking  and  OLAF  to  conduct  such  audits  and 
investigations, according to their respective competences. 

the  Commission  and  the  Court  of  Auditors  to  conduct  such  audits  on  the 
recipients  of  funding  from  the  IMI2  Joint  Undertaking  according  to  their 
respective competences.  

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. 

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  OLAF21.  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  whose  disclosure  could  damage  the  interests  of  its  Members  or  of 
participants in the activities of the IMI2 Joint Undertaking. 

19 
20 
21 

OJ L 136, 31.05.1999 
OJ L 292, 15.11.1996, p. 2-5 
OJ L 136 from 31.5.1999, p. 1 

EN 

15 

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Article 16 

Transparency 

1. 

2. 

3. 

Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 
May 2001 regarding public access to European Parliament, Council and Commission 
documents22, shall apply to documents held by the IMI2 Joint Undertaking. 

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

Without  prejudice  to  Article  10,  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. 

Article 17 

Rules for participation and dissemination 

Regulation  (EU)  No  …  [Rules  for  participation  and  dissemination  in  Horizon  2020]  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 Clause 1 of the Statutes contained in 
the Annex. 

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 this State to the IMI2 Joint Undertaking. 

Article 19 

Repeal and transitional provisions 

1. 

2. 

Regulation (EC) No 73/2008 is repealed with effect from 1 January 2014. 

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 …/2008 shall  also  be  regarded as actions 
initiated under that Regulation. 

The interim evaluation referred to in Article 11(1) shall include a final evaluation of 
the IMI Joint Undertaking operations 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. 

22 

OJ L 145 from 31.05.2001 

EN 

16 

   EN 

                                                 
The Executive Director appointed on the basis of Regulation 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  1  January  2014.  The 
other conditions of contract shall remain unchanged. 

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  that 
Regulation are transferred to the Members of the IMI2 Joint Undertaking pursuant to 
this Regulation. 

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

4. 

5. 

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. 

Done at Brussels,  

For the Council 
The President 

EN 

17 

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ANNEX 

STATUTES OF THE IMI2 JOINT UNDERTAKING 

The IMI2 Joint Undertaking shall carry out the following tasks: 

1 - Tasks 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

to mobilise the public and private sector resources needed to achieve the objectives 
of IMI2 Joint Undertaking; 

to  regularly  review  and  make  any  necessary  adjustments  to  the  Strategic  Research 
Agenda of the IMI2 Joint Undertaking in light of scientific developments occurring 
during its implementation; 

to establish and develop close and long-term cooperation between the Union, other 
Members,  Associated  Partners,  and  the  other  stakeholders  such  as  other  industries, 
regulatory  bodies,  patient  organisations,  academia  and  clinical  centres,  as  well  as 
cooperation between industry and academia; 

to facilitate  coordination with European, national and  international activities in this 
area,  and  to  communicate  and  interact  with  the  Member  States  and  the  countries 
associated with Horizon 2020 Framework Programme; 

to effectively support research and innovation in life sciences mainly through grants; 

to define and carry out the IMI2 Joint Undertaking annual work plan mainly through 
calls for proposals; 

to  initiate  calls  for  proposals  and  any  other  necessary  procedure  for  funding,  to 
evaluate  proposals,  to  award  funding  to  projects  according  to  the  applicable  rules, 
within the limits of available funds; 

information,  communication,  exploitation  and  dissemination  activities  by  applying 
mutatis mutandis the provisions of Article 22 of the Regulation (EU) No […]/2013 
[the Horizon 2020 Framework Programme]; 

to organise a meeting at least annually with interest groups to ensure openness and 
transparency  of  the  research  activities  of  the  IMI2  Joint  Undertaking  with  its 
stakeholders; 

any  other  task  needed  to  achieve  the  objectives  referred  to  in  Article  2  of  this 
Regulation. 

1. 

The Members of the IMI2 Joint Undertaking shall be the following: 

2 - Members and Associated Partners  

(a) 

the Union, represented by the Commission; 

(b)  upon  acceptance  of  these  Statutes  by  means  of  a  letter  of  endorsement,  the 
Industries  and  Associations 

European  Federation  of  Pharmaceutical 
(hereinafter ''EFPIA''). 

2. 

Provided that it contributes to the funding referred to in Clause 13 of these Statutes to 
achieve  the  objectives  of  the  IMI2  Joint  Undertaking  set  out  in  Article  2  of  this 
Regulation  and  accepts  these  Statutes,  any  legal  entity  that  directly  or  indirectly 
supports research and innovation in a Member State or in a country associated with 

EN 

18 

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3. 

the  Horizon  2020  Framework  Programme  may  apply  to  become  a  Member  of  the 
IMI2 Joint Undertaking.  

Upon  acceptance  of  these  Statutes  by  means  of  a  letter  of  endorsement,  any  legal 
entity  other  than  a  Member  or  a  constituent  entity  of  a  Member  or  any  affiliated 
entity  of  either,  supporting  the  objectives  of  the  IMI2  Joint  Undertaking  in  its 
specific  area  of  research,  in  a  Member  State  or  in  a  country  associated  with  the 
Horizon  2020  Framework  Programme,  may  apply  to  join  IMI2  as  an  Associated 
Partner. The letter of endorsement shall detail the scope of the association in terms of 
content, of activities and duration.  

4. 

Associated Partners shall contribute like Members other than the Union to the IMI2 
Joint Undertaking's operational costs, in accordance with Clause 13 of these Statutes. 

The letter of endorsement shall detail the Associated Partners’ contribution to IMI2 
Joint Undertaking and that the Union will match, in accordance with Articles 3 and 4 
of this Regulation.  

1. 

2. 

3. 

4. 

5. 

3 - Changes to membership and to association  

Any application for becoming a Member or an Associated Partner to the IMI2 Joint 
Undertaking shall be addressed to the Governing Board, accompanied in the case of 
application  for  becoming  a  Member  by  a  proposal  to  adapt  the  composition  of  the 
Governing Board set out in Clause 5. 

The Governing Board shall assess the application taking into account the relevance 
and the potential added value of the applicant for the achievement of the objectives 
of the IMI2 Joint Undertaking. It shall then decide on the application. 

Any Member or Associated Partner may terminate its membership or association to 
the IMI2 Joint Undertaking. The termination shall become effective and irrevocable 
six  months  after  notification  to  the  other  Members  and  Associated  Partners.  As  of 
then,  the  former  Member  or  Associated  Partner  shall  be  discharged  from  any 
obligations  other  than  those  approved  or  incurred  by  the  IMI2  Joint  Undertaking 
prior to terminating the membership or participation. 

Membership of or association to the IMI2 Joint Undertaking may not be transferred 
to a third party without prior agreement of the Governing Board. 

The  Commission  shall  publish  on  its  website  immediately  upon  any  change  to 
membership  or  association  pursuant  to  this  Clause  an  updated  list  of  Members  and 
Associated Partners of the IMI2 Joint Undertaking together with the date when such 
change takes effect. 

4 – Organization of the IMI2 Joint Undertaking 

1. 

The bodies of the IMI2 Joint Undertaking shall be: 

(a) 

(b) 

(c) 

(d) 

(e) 

the Governing Board; 

the Executive Director; 

the Scientific Committee; 

the States Representatives Group; 

the Stakeholder Forum. 

2. 

The  Scientific  Committee,  the  States  Representatives  Group  and  the  Stakeholder 
Forum shall be advisory bodies to the IMI2 Joint Undertaking. 

EN 

19 

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The Governing Board shall be composed of 5 representatives per Member. 

5 – Composition of the Governing Board 

6 – Functioning of the Governing Board 

1. 

Without prejudice to paragraph 2, each Member shall have a percentage out of 100 
voting  rights  corresponding  to  the  percentage  of  its  contribution  to  the  IMI2  Joint 
Undertaking. 

The  Commission  shall  hold  50%  of  the  voting  rights.  The  vote  of  the  Commission 
shall  be  indivisible.  Each  Member  may  allocate  its  voting  rights  among  its 
representatives in the Governing Board. The Members shall use their best efforts to 
achieve  consensus.  Failing  consensus,  the  Governing  Board  shall  take  its  decisions 
by a majority of at least 75% of all votes including the votes of those who are not in 
attendance.  

The chairperson of the Governing Board shall be appointed on a rotating annual basis 
by each the Union and the other Members, in turn. 

2. 

The Governing Board shall hold its ordinary meetings at least twice a year. It may 
hold  extraordinary  meetings  at  the  request  of  any  Member  or  at  the  request  of  the 
chairperson.  The  meetings  of  the  Governing  Board  shall  be  convened  by  its 
chairperson and shall normally take place at the seat of the IMI2 Joint Undertaking. 

The Executive Director shall take part in the deliberations, but shall have no voting 
rights.  

The  Governing  Board  shall  invite  any  Associated  Partner  to  take  part  in  its 
deliberations for those points on the agenda that concern its association. Associated 
Partners shall have no voting rights. 

The  chairperson  of  the  States  Representatives  Group  shall  attend  meetings  of  the 
Governing Board as an observer.  

The Governing Board may invite, on a case-by-case basis, other persons to attend its 
meetings  as  observers,  in  particular  representatives  of  regional  authorities  of  the 
Union. 

The  representatives  of  the  Members  shall  not  be  personally  liable  for  actions  they 
have undertaken in their capacity as representatives on the Governing Board. 

The Governing Board shall adopt its own rules of procedure. 

7 – Tasks of the Governing Board 

1. 

The  Governing  Board  shall  have  overall  responsibility  for  the  strategic  orientation 
and  the  operations  of  the  IMI2  Joint  Undertaking  and  shall  supervise  the 
implementation of its activities.  

2. 

The Governing Board shall in particular carry out the following tasks: 

(a) 

assess,  accept  or  reject  applications  for  new  membership  or  association  in 
accordance with Clause 3; 

(b)  decide on the termination  of the  membership  or  association in the  IMI2 Joint 
Undertaking  of  any  Member  or  Associated  Partner  that  does  not  fulfil  its 
obligations; 

(c) 

adopt  the  Financial  rules  of  the  IMI2  Joint  Undertaking  in  accordance  with 
Article 5 of this Regulation; 

EN 

20 

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(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

adopt  the  annual  budget  of  the  IMI2  Joint  Undertaking,  including  the  staff 
establishment plan indicating the number of temporary posts by function group 
and  by  grade  as  well  as  the  number  of  contract  staff  and  seconded  national 
experts expressed in full-time equivalents; 

exercise  the  appointing  authority  powers  with  respect  to  the  staff,  in 
accordance with Article 6(2); 

appoint, dismiss, extend the term of office of, provide guidance to and monitor 
the performance of the Executive Director; 

approve  the  organisational  structure  of  the  Programme  Office  referred  to  in 
Clause 9(5) upon recommendation by the Executive Director; 

adopt  the  annual  work  plan  and  the  corresponding  expenditure  estimates, 
proposed by the Executive Director in close cooperation with advisory groups 
referred to in Clause 7(2)(q), after having consulted the Scientific Committee 
and the States Representatives Group; 

approve the annual accounts; 

approve the annual activity report, including the corresponding expenditure; 

arrange, as appropriate, for the establishment of an internal audit capability of 
the IMI2 Joint Undertaking; 

approve the calls for proposals as well as, where appropriate, the related rules 
for submission, evaluation, selection, award and evaluation review procedures, 
proposed by the Executive Director in close cooperation with advisory groups 
referred to in Clause 7(2)(q);  

(m)  approve the list of proposals selected for funding; 

(n) 

establish 
recommendation of the Executive Director; 

the 

IMI2  Joint  Undertaking's  communications  policy  upon 

(o)  where appropriate, establish implementing rules in line with Article 6(3); 

(p)  where appropriate, establish rules on the secondment of national experts to the 
IMI2 Joint Undertaking and on the use of trainees in line with Article 7; 

(q)  where appropriate, set up advisory groups in addition to the bodies to the IMI2 

Joint Undertaking;  

(r)  where  appropriate,  submit  to  the  Commission  any  request  to  amend  this 

Regulation proposed by any Member of the IMI2 Joint Undertaking; 

(s) 

be  responsible  for  any  task  which  is  not  specifically  allocated  to  one  of  the 
bodies of the IMI2 Joint Undertaking; it may assign such tasks to one of those 
bodies. 

8 – Appointment, dismissal or extension of the term of office of the Executive Director 

1. 

The  Executive  Director  shall  be  appointed  by  the  Governing  Board  from  a  list  of 
candidates proposed by the Commission, following an open and transparent selection 
procedure.  The  Commission  shall  associate  the  representation  from  the  other 
members of the IMI2 Joint Undertaking in the selection procedure as appropriate.  

In particular, an appropriate representation from the other members of the IMI2 Joint 
Undertaking  shall  be  ensured  at  the  pre-selection  stage  of  the  selection  procedure. 

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2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

4. 

For  that  purpose,  the  private  members  shall  appoint  by  common  accord  a 
representative as well as an observer on behalf of the Governing Board.  

The  Executive  Director  is  a  member  of  staff  and  shall  be  engaged  as  a  temporary 
agent of the IMI2 Joint Undertaking under point (a) of Article 2 of the Conditions of 
Employment of Other Servants of the Union. 

For the purpose of concluding the contract of the Executive Director, the IMI2 Joint 
Undertaking shall be represented by the chairperson of the Governing Board. 

The term of office of the Executive Director shall be three years. By the end of that 
period,  the  Commission  associating  the  private  members  as  appropriate  shall 
undertake an assessment of the performance of the Executive Director and the IMI2 
Joint Undertaking's future tasks and challenges. 

The Governing Board, acting on a proposal from the Commission  which takes into 
account the assessment referred to in paragraph 3, may extend the term of office of 
the Executive Director once, for no more than four years. 

An Executive Director whose term of office has been extended may not participate in 
another selection procedure for the same post at the end of the overall period. 

The  Executive  Director  may  be  dismissed  only  upon  a  decision  of  the  Governing 
Board acting on a proposal from the Commission associating the private members as 
appropriate. 

9 - Tasks of the Executive Director 

The  Executive  Director  shall  be  the  chief  executive  responsible  for  the  day-to-day 
management of the IMI2 Joint Undertaking in accordance with the decisions of the 
Governing Board. 

The  Executive  Director  shall  be  the  legal  representative  of  the  IMI2  Joint 
Undertaking. He/she shall be accountable to the Governing Board. 

The Executive Director shall implement the budget of the IMI2 Joint Undertaking. 

The  Executive  Director  shall  in  particular  carry  out  the  following  tasks  in  an 
independent manner: 

(a)  prepare  and  submit  for  adoption  to  the  Governing  Board  the  draft  annual 
budget,  including  the  corresponding  staff  establishment  plan  indicating  the 
number of temporary posts in each grade and function group and the number of 
contract staff and seconded national experts expressed in full-time equivalents; 

(b)  prepare in close cooperation with advisory bodies referred to in Clause 7(2)(q) 
and submit for adoption to the Governing Board the annual work plan and the 
corresponding expenditure estimates; 

(c) 

submit for approval to the Governing Board the annual accounts; 

(d)  prepare  and  submit  for  approval  to  the  Governing  Board  the  annual  activity 

report, including the corresponding expenditure; 

(e) 

submit  for  approval  to  the  Governing  Board  the  list  of  proposals  selected  for 
funding; 

(f) 

sign individual grant agreements or decisions; 

(g) 

sign procurement contracts; 

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(h) 

(i) 

(j) 

(k) 

(l) 

implement the IMI2 Joint Undertaking's communications policy; 
organise,  direct  and  supervise  the  operations  and  the  staff  of  the  IMI2  Joint 
Undertaking within the constraints of the delegation by the Governing Board as 
provided for in Article 6(2) of this Regulation; 

establish  and  ensure  the  functioning  of  an  effective  and  efficient  internal 
control system and report any significant change to it to the Governing Board; 

ensure that risk assessment and risk management are performed; 

take  any  other  measures  needed  for  assessing  the  progress  of  the  IMI2  Joint 
Undertaking towards achieving its objectives; 

(m)  perform any other tasks entrusted or delegated to the Executive Director by the 

Governing Board. 

5. 

The  Executive  Director  shall  set  up  a  Programme  Office  for  the  execution,  under 
his/her  responsibility,  of  all  support  tasks  arising  from  this  Regulation.  The 
Programme Office shall be composed of the staff of the IMI2 Joint Undertaking and 
shall in particular carry out the following tasks: 

(a)  provide  support  in  establishing  and  managing  an  appropriate  accounting 

system in accordance with the Financial rules of the IMI2 Joint Undertaking; 

(b)  manage  the  calls  for  proposals  as  provided  for  in  the  annual  work  plan  and 
administer the grant agreements or decisions, including their coordination; 

(c)  provide to the Members and to the other bodies of the IMI2 Joint Undertaking 
all relevant information and support necessary for them to perform their duties 
as well as responding to their specific requests; 

(d) 

act as the secretariat of the bodies of the Joint Undertaking and provide support 
to any advisory group set up by the Governing Board. 

10 - Scientific Committee 

The Scientific Committee shall consist of no more than 7 members appointed for a 
renewable period of one year. It shall elect a chairperson from amongst its members 
for one year. 

Additional  experts  may  be  appointed  if  necessary  for  specific  ad-hoc  tasks  and 
limited duration. 

The members of the Scientific Committee shall reflect a balanced representation of 
world-wide  recognized  experts  from  academia,  industry  and  regulatory  bodies. 
Collectively,  the  Scientific  Committee  members  shall  have  the  necessary  scientific 
competencies and expertise covering the technical domain needed to make strategic 
science-based recommendations to the IMI2 Joint Undertaking. 

The Governing Board shall establish the specific criteria and selection process for the 
composition  of  the  Scientific  Committee  and  shall  appoint  its  members.  The 
Governing Board shall take into consideration the potential candidates proposed by 
the IMI2 States Representatives Group. 

1. 

2. 

3. 

4. 

The Scientific Committee shall carry out the following tasks: 

(a) 

(b) 

advise on the scientific priorities to be addressed in the annual work plans; 

advise on the scientific achievements described in the annual activity report. 

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5. 

6. 

7. 

1. 

2. 

The  Scientific  Committee  shall  meet  at  least  once  a  year.  The  meetings  shall  be 
convened by its chairperson. 

The  Scientific  Committee  may,  with  the  agreement  of  the  chairperson,  invite  other 
persons to attend its meetings. 

The Scientific Committee shall adopt its own rules of procedure. 

11- States Representatives Group 

The  IMI2  States  Representatives  Group  shall  consist  of  one  representative  of  each 
Member  State  and  of  each  country  associated  to  the  Horizon  2020  Framework 
Programme. It shall elect a chairperson from amongst its members. 

The States Representatives Group shall meet at least once a year. The meetings shall 
be  convened  by  its  chairperson.  The  chairperson  of  the  Governing  Board  and  the 
Executive Director or their representatives shall attend the meetings. 

The  chairperson  of  the  States  Representatives  Group  may  invite  other  persons  to 
attend its meetings as observers, in particular representatives of regional authorities 
of the Union and representatives of SME associations. 

3. 

The States Representatives Group shall in particular review information and provide 
advice on the following matters: 

(a)  programme  progress  in  the  IMI2  Joint  Undertaking  and  achievement  of  its 

targets; 

(b)  updating of strategic orientation; 

(c) 

(d) 

(e) 

links to the Horizon 2020 Framework Programme; 

annual work plans; 

involvement of SMEs. 

4. 

The  States  Representatives  Group  shall  also  provide  information  to  and  act  as  an 
interface with the IMI2 Joint Undertaking on the following matters: 

(a) 

(b) 

the status of relevant national or regional research and innovation programmes 
and identification of potential areas of cooperation, including deployment; 

specific  measures  taken  at  national  level  or  regional  level  with  regard  to 
dissemination  events,  dedicated  technical  workshops  and  communication 
activities. 

The States Representatives Group may issue, on its own initiative, recommendations 
to  the  IMI2  Joint  Undertaking  on  technical,  managerial  and  financial  matters,  in 
particular when those matters affect national or regional interests. 

The  IMI2  Joint  Undertaking  shall  inform  the  States  Representatives  Group  of  the 
follow up it has given to such recommendations. 

The States Representatives Group shall adopt its own rules of procedure. 

12 - Stakeholder Forum 

The  Stakeholder  Forum  shall  be  open  to  all  public  and  private  stakeholders, 
international  interest  groups  from  Member  States,  associated  countries  as  well  as 
from other countries. 

5. 

6. 

1. 

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24 

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2. 

3. 

1. 

2. 

3. 

The  Stakeholder  Forum  shall  be  informed  of  the  activities  of  the  IMI2  Joint 
Undertaking and shall be invited to provide comments. 

The meetings of the Stakeholder Forum shall be convened by the Executive Director. 

13 - Sources of financing  

The IMI2 Joint Undertaking shall be jointly funded by the Union, the Members other 
than  the  Union  and  the  Associated  Partners,  or  their  constituent  entities  or  their 
affiliated  entities, 
instalments  and 
through  financial  contributions  paid 
contributions  consisting  of  the  costs  incurred  by  them  in  implementing  indirect 
actions and that are not reimbursed by the IMI2 Joint Undertaking. 

in 

The  administrative  costs  of  the  IMI2  Joint  Undertaking  shall  not  exceed  EUR  89,7 
million  and  shall  be  covered  through  financial  contributions  divided  equally  on  an 
annual basis between the Union and the Members other than the Union. If part of the 
contribution for administrative costs is not used, it may be made available to cover 
the operational costs of the IMI2 Joint Undertaking.  

The  operational  costs  of  the  IMI2  Joint  Undertaking  shall  be  covered  through  the 
following contributions:  

(a) 

(b) 

a financial contribution by the Union; 

in kind contributions by the Members other than the Union and the Associated 
Partners, or their constituent entities or their affiliated entities, consisting of the 
costs  incurred  by  them  in  implementing  indirect  actions,  and  in  relation  to 
advisory  bodies  referred  to  in  Clause  7(2)(q)  if  foreseen  in  the  annual  work 
plan, less the contribution of the IMI2 Joint Undertaking and any other Union 
contribution to those costs; 

(c) 

a  financial  contribution  by  the  Members  other  than  the  Union  and  the 
Associated  Partners,  or  their  constituent  entities  or  their  affiliated  entities, 
which may be made in addition to, or instead of point (b). 

4. 

The resources of the IMI2 Joint Undertaking entered to its budget shall be composed 
of the following contributions: 

(a)  Members' financial contributions to the administrative costs; 

(b)  Members'  and  Associated  Partners’  financial  contributions  to  the  operational 

costs; 

(c) 

any revenue generated by the IMI2 Joint Undertaking; 

(d)  other financial contributions, resources and revenues. 

5. 

6. 

7. 

Any interest yielded by the contributions paid to the IMI2 Joint Undertaking by its 
Members and Associated Partners shall be considered to be its revenue. 

All resources of the IMI2 Joint Undertaking and its activities shall be devoted to the 
objectives set out in Article 2 of this Regulation. 

The IMI2 Joint Undertaking shall own all assets generated by it or transferred to it 
for the achievement of its objectives provided for in Article 2 of this Regulation. 
Except  when  the  IMI2  Joint  Undertaking  is  wound  up  pursuant  to  Clause  21,  any 
excess revenue over expenditure shall not be paid to the Members of the IMI2 Joint 
Undertaking.  

14 – Financial commitments 

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Financial  commitments  of  the  IMI2  Joint  Undertaking  shall  not  exceed  the  amount  of 
financial  resources  available  or  committed  to  its  budget  by  its  Members  and  Associated 
Partners. 

The financial year shall run from 1 January to 31 December. 

16 – Operational and financial planning 

15 - Financial year 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

The  Executive  Director  shall  submit  for  adoption  to  the  Governing  Board  a  draft 
annual work plan, which shall include a detailed plan of the research and innovation 
activities,  the  administrative  activities  and  the  corresponding  expenditure  estimates 
for the coming year. The draft work plan shall also include the estimated value of the 
contributions to be made in accordance with clause 13(3)(b). 

The  annual  work  plan  for  a  particular  year  shall  be  adopted  by  the  end  of  the 
previous year. The annual work plan shall be made publicly available. 

The Executive Director shall prepare the draft annual budget for the following year 
and submit it to the Governing Board for adoption. 

The annual budget for a particular year shall be adopted by the Governing Board by 
the end of the previous year. 

The annual budget shall be adapted in order to take into account the amount of the 
Union contribution as set out in the Union budget. 

17 – Operational and financial reporting 

The  Executive  Director  shall  report  annually  to  the  Governing  Board  on  the 
performance  of  his  duties  in  accordance  with  the  Financial  rules  of  the  IMI2  Joint 
Undertaking. 

By  15  February  each  year  the  Executive  Director  shall  submit  to  the  Governing 
Board for approval an annual activity report on the progress made by the IMI2 Joint 
Undertaking in the previous calendar year, in particular in relation to the annual work 
plan for that year. That report shall include, inter alia, information on the following 
matters: 

(a) 

research,  innovation  and  other  actions  carried  out  and  the  corresponding 
expenditure; 

(b)  proposals  submitted,  including  a  breakdown  by  participant  type,  including 

SMEs, and by country; 

(c) 

the  actions  selected  for  funding,  including  a  breakdown  by  participant  type, 
including  SMEs,  and  by  country  and  indicating  the  contribution  of  the  IMI2 
Joint Undertaking to the individual participants and actions. 

Once  approved  by  the  Governing  Board,  the  annual  activity  report  shall  be  made 
publicly available. 

The IMI2 Joint Undertaking shall report annually to the Commission in accordance 
with Article 60(5) of Regulation (EU, Euratom) No 966/2012. 

The  accounts  of  the  IMI2  Joint  Undertaking  shall  be  examined  by  an  independent 
audit body as laid down in Article 60(5) of Regulation (EU, Euratom) No 966/2012. 

The accounts of the IMI2 Joint Undertaking shall not be subject to examination by 
the Court of Auditors. 

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The  Commission's  internal  auditor  shall  exercise  the  same  powers  over  the  IMI2  Joint 
Undertaking as those exercised in respect of the Commission. 

18 - Internal audit  

1. 

2. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

19 - Liability of Members and insurance 

The  financial  liability  of  the  Members  for  the  debts  of  the  IMI2  Joint  Undertaking 
shall be limited to their contribution already made for the administrative costs. 

The IMI2 Joint Undertaking shall take out and maintain appropriate insurance. 

20 - Conflict of interest 

The IMI2 Joint Undertaking, its bodies and staff shall avoid conflict of interest in the 
implementation of their activities. 

The  IMI2  Joint  Undertaking  Governing  Board  may  adopt  rules  for  the  prevention 
and  management  of  conflicts  of  interest  in  respect  of  its  Members,  Associated 
Partners, bodies and staff. In those rules, provision shall be made to avoid conflict of 
interest for the representatives of the Members serving the Governing Board.  

21 - Winding up 

The IMI2 Joint Undertaking shall be wound up at the end of the period in Article 1 of 
this Regulation. 

The winding up procedure shall be automatically triggered if the Commission or all 
other Members withdraw from the IMI2 Joint Undertaking. 

For  the  purpose  of  conducting  the  proceedings  to  wind  up  the  IMI2  Joint 
Undertaking, the Governing Board shall appoint one or more liquidators, who shall 
comply with the decisions of the Governing Board. 

When the IMI2 Joint Undertaking is being wound up, its assets shall be used to cover 
its  liabilities  and  the  expenditure  relating  to  its  winding  up.  Any  surplus  shall  be 
distributed among the Members at the time of the winding up in proportion to their 
financial contribution to the IMI2 Joint Undertaking. Any such surplus distributed to 
the Union shall be returned to the Union budget. 

An  ad  hoc  procedure  shall  be  set  up  to  ensure  the  appropriate  management  of  any 
agreement concluded or decision adopted by the IMI2 Joint Undertaking as well as 
any procurement contract with a duration longer than its duration. 

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LEGISLATIVE FINANCIAL STATEMENT  

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

1.6. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

Title of the proposal/initiative  

Policy area(s) concerned in the ABM/ABB structure 

Nature of the proposal/initiative  

Objectives  

Grounds for the proposal/initiative  

Duration and financial impact  

1.7.  Management mode(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

3.2.2.  Estimated impact on Innovative Medicines Initiative Joint Undertaking's appropriations  

3.2.3.  Estimated impact on Innovative Medicines Initiative Joint Undertaking's human resources 

3.2.4.  Compatibility with the current multiannual financial framework 

3.2.5.  Third-party contributions  

3.3. 

Estimated impact on revenue 

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LEGISLATIVE FINANCIAL STATEMENT  

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  Council  Regulation  on  the  Innovative  Medicines  Initiative  2  Joint 
Undertaking  
Policy area(s) concerned in the ABM/ABB structure23  

1.2. 

Policy area: Smart and Inclusive Growth 

Activity:  Horizon  2020  –  The  Framework  Programme  for  Research  and  Innovation; 
‘Societal challenges’; in the challenge ‘Health, demographic change and wellbeing’ 

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  
(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action24  

X The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objective(s) 

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative  

The action is part of the Smart and Inclusive Growth strategic objective. 

The action is addressing two objectives of Horizon 2020 strategy: 

- Objective number 1. Innovation Union 
- Objective number 5. An industrial policy for the globalisation area 

The objectives of the IMI2 JU are to: 

i. 

ii. 

iii. 

iv. 

v. 

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

reduce  the  time  to  reach  clinical  proof  of  concept  in  immunological,  respiratory, 
neurological and neurodegenerative diseases; 

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; 

develop diagnostic markers for diseases clearly linked to clinical relevance approved 
by regulators; 

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

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

Specific objective Nbr 8 

Societal challenge to improve the lifelong health and wellbeing of all. 

ABM/ABB activity(ies) concerned 

23 
24 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 54(2)(a) or (b) of the Financial Regulation. 

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Societal challenges - JTI IMI2 

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

This issue is addressed in the Impact Assessment document attached to this proposal. 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

Scientific and technological progress 

Monitoring 

achievement of 
objectives of the JU 

Indicator 
Monitoring the achievement of 
specific objectives  

Target 
See section 3.2 of the Impact Assessment Report 

Number of open innovation 
networks established 

3 open innovation network between different industry 
sectors, and 2 clinical trial networks 

Number of strategic agenda setting 
beyond JU 
Number of partnerships 
established 

Strategic agenda setting in 3 research areas defined by the 
specific objectives in section 3.2;  
Partnerships in 16 research areas defined by the specific 
objectives in section 3.2 

Monitoring 
implementation of 
the strategic 
research agenda 

Number of data points analysed 
for reaching at unbiased molecular 
taxonomy of disease 
Number of diseases classified 
Number of trials analysed for 
learning from negative results 
Level of taking account of health 
and demographic change and 
wellbeing policy goals 

Monitoring JU operations 
Selection of projects 
and allocation of 
funding 

Time-to-grant  
Time-to-pay 
Level of adherence to time 
schedule 
Level of SME participation and 
benefits 

Efficiency of 
research programme 

Number of publications 
Impact factor of journals where 
articles are published 
Impact of publications 
Number of patents 

5 million data points 

4 diseases area 
125 trials 

Strategic research agenda needs to address points 1.1.2, 
1.2.2, parts of 1.2.3 and parts of 1.3.1 of partial general 
approach of Horizon 2020 

270 days 
30 days 
Budget committed and calls launched accordingly 

From the beginning 20% IMI2 funding going to SMEs, 
benefit to SMEs monitored as from 2nd year: at least 70% 
of SME respondents stating that they benefit from the 
expertise of industry and/or academic partners; 80% of 
SMEs stating that objectives could not have been met 
without IMI2 support. 
On average 20 publications per €10 million funding 
Average impact factor 10% above EU average 

Citations 20% above average for EU publications  
On average 2 patent applications per €10 million funding 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

IMI2 JU shall contribute to achieving smart, sustainable and inclusive growth. 

1.5.2.  Added value of EU involvement 

This issue is addressed in the Impact Assessment document attached to this proposal. 

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1.5.3.  Lessons learned from similar experiences in the past 

The  ongoing  Innovative  Medicines  Initiative  has  achieved  a  significant  mobilisation  of 
resources, bringing together a large number of partners from the pharmaceutical industry, 
academia,  SMEs,  patient  organisations  and  regulators  in  focused  projects  that  mobilise 
significant resources (average project size €32 million). The  large pharmaceutical industry 
participates strongly in IMI (50% of resources, 30% of staff – total commitment to projects 
by  large  industry  of  €715  million  until  end  2012),  whereas  its  participation  in  European 
research programmes outside IMI is very low (0.78% of participations in FP7 Health, total 
contribution to all of FP7 about €80 million, ¼ of which to FP7 Health). 

IMI  has  significantly  contributed  to  strengthening  the  links  between  the  different 
stakeholders  in  the  health  research  and  innovation  field  by  opening  access  to  other 
partner’s  expertise  and  increasing  collaboration  between  the  pharmaceutical  industry  and 
other stakeholders in Europe. 

IMI  also  achieves  focusing  and  developing  strategic  research  agendas  and  horizontal 
policy  coordination,  the  former  having  a  structuring  effect  on  European  life  science 
research, notably in neuropsychiatric diseases, in antimicrobial resistance, and other areas, 
the  latter  by  coordinating  the  involvement  of  patient  organisations  and  -  in  projects 
addressing  regulatory  sciences  -  of  regulatory  agencies,  which  was  considered  a  rare 
achievement in the interim evaluation. 

The  ongoing  Innovative  Medicines  Initiative  has  demonstrated  that  bringing  together 
relevant partners can lead to a new model of innovation and can address key bottlenecks in 
biomedical and pharmaceutical research. 

Areas for improvement concern especially the administrative set-up, where simplification 
is required and the opening of the partnership by the expanding the scope to all areas of life 
science research and innovation and consequently involving a broader range of partners. A 
particular  issue  that  needs  to  be  addressed  is  to  open  the  partnership  to  industrial 
participants who are neither EFPIA companies nor SMEs under the EU definition. 

1.5.4.  Compatibility and possible synergy with other appropriate instruments 

The  societal  challenge  of  the  ageing  population  is  so  large  that  the  PPP  under  Horizon 
2020  cannot  address  it  alone.  The  future  IMI  will  be  complementary  to  the  Ambient 
Assisted Living Article 185 initiative, which is focused on deploying technology solutions 
for  helping  elderly  citizens  live  independently.  The  European  Innovation  Partnership  on 
Active and Healthy Ageing (EIP on AHA) under the Innovation Union flagship initiative, 
aims at increasing by two the number of healthy life years of European citizens by 2020 
through the coordination of many different activities. Results from IMI2 will support this 
EIP  on  AHA.  Research  actions  conducted  under  IMI2  will  be  tightly  coordinated  with 
research funded from the ‘Health, demographic change and wellbeing challenge’. Finally, 
this initiative aligns with the proposed EU Regulation on Clinical Trials, which addresses 
current shortcomings in Europe resulting from too different national legislations hampering 
product development. 

1.6. 

Duration and financial impact  

X Proposal/initiative of limited duration  

X 

X 

X 

Proposal/initiative in effect from 01/01/2014 to 31/12/2024  

Financial impact from 01/01/2014 to 31/12/2020 for commitment appropriations 

Financial impact from 01/01/2014 to 31/12/2024 for payment appropriations 

(cid:133) Proposal/initiative of unlimited duration 

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–  Implementation with a start-up period from YYYY to YYYY, 

–  followed by full-scale operation. 
1.7.  Management mode(s) envisaged25  

(cid:133) Direct management by the Commission through: 

(cid:133) 

executive agencies  

(cid:133) Shared management with Member States: 

X Indirect management by entrusting budget implementation tasks to: 

(cid:133) 

(cid:133) 

X 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

international organisations and their agencies (please specify); 

the EIB and the European Investment Bank; 

bodies referred to in Article 209 FR; 

public law bodies; 

bodies governed by private law with a public service mission to the extent that they 
provide adequate financial guarantees; 

bodies  governed  by  the  private  law  of  a  Member  State  that  are  entrusted  with  the 
implementation  of  a  public-private  partnership  and  that  provide  adequate  financial 
guarantees; 

persons entrusted with the implementation of specific actions in the CFSP pursuant 
to Title V of the TEU and identified in the relevant basic act. 

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The  IMI  Joint  Undertaking  will  be  monitored  through  intermediary  contacts  and  as 
provided in Articles 6 and 16 of the Statutes. 

A set of quantitative and qualitative performance indicators will be established to monitor 
the implementation of IMI2. These performance indicators will measure the impact of the 
JU on EU competitiveness and on achieving the objectives of advancing health research to 
bring biomedical innovations to patients. 

The  top-level  monitoring  will  fall  upon  the  Governing  Board  of  the  JU,  in  which  the 
Commission will be represented according to its share of the overall budget. The Executive 
Management will monitor the operations of the JU internally.  

In  support  of  the  European  Research  Area  objective,  the  organisation  of  the  annual 
Stakeholder forum will continue, in order to report on the progress of IMI2 operations, to 
contribute to the exchange of information and to help coordinating activities between the 
JTI, other EU initiatives, and national, regional and private actions. 

Quantitative  indicators  will  be  measured  in  a  comparative  and  systematic  manner,  and 
qualitative analyses will be performed annually. 

An  interim  evaluation  will  be  carried  out  by  31.12.2017  and  a  final  evaluation  within  6 
months after the end of IMI2. 

25 

Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 

EN 

32 

   EN 

                                                 
2.2.  Management and control system  

2.2.1. 

Internal control framework  

The  Commission  (DG  RTD)  through  the  Authorising  Officer  by  Delegation  will  ensure 
that the rules applicable to the IMI JTI JU fully comply with the requirements of Article 60 
and 61 of the Financial Regulation. Monitoring arrangements, including membership of the 
Governing  Board,  of  the  IMI  JTI  JU  and  reporting  arrangements  will  ensure  that  the 
Commission services can meet the accountability requirements both to the College and to 
the Budgetary Authority. 

The internal control framework for the IMI JTI JU is built on: 

-the  implementation  of  the  Internal  Control  Standards  offering  at  least  equivalent 
guarantees to those of the Commission; 

-procedures  for  selecting  the  best  projects  through  independent  evaluation,  and  for 
translating them into legal instruments; 

- project and contract management throughout the lifetime of every project; 

-  ex-ante  checks  on  100%  of  claims,  including  receipt  of  audit  certificates  and  ex-ante 
certification of cost methodologies;  

- ex-post audits on a sample of claims as part of the Horizon 2020 ex-post audits; 

- and scientific evaluation of project results. 

Various measures have been established to mitigate the inherent risk of conflict of interest 
within  the  IMI  JTI  JU,  especially  equal  votes  for  the  Commission  and  for  industrial 
partners in the Governing Board, selection of the Director by the Governing Board based 
on  a  proposal  by  the  Commission,  independence  of  staff,  evaluations  by  independent 
experts  based  on  published  selection  criteria  together  with  appeal  mechanisms  and  full 
declarations of any interests. The establishment of ethical and organisational values will be 
one of the key roles of the JTI JU, and will be monitored by the Commission. 

2.2.2.  Costs and benefits of controls  

 The  Commission's  internal  auditor  shall  exercise  the  same  powers  over  the  Joint 
Undertaking  as  those  exercised  in  respect  of  the  Commission.  Moreover,  the  Governing 
Board may arrange, as appropriate, for the establishment of an internal audit capability of 
the Joint Undertaking. 

The  Executive  Director  of  the  IMI  JTI  JU,  as  Authorising  Officer,  will  be  required  to 
introduce  a  cost-effective  system  of  internal  control  and  management.  He/she  will  be 
required to report to the Commission on the internal control framework adopted. 

The Commission will monitor the risk of non-compliance through the reporting system that 
it will develop, as well as by following the results of ex-post audits on the recipients of EU 
funds from the IMI JTI, as part of ex-post audits covering the whole of the Horizon 2020.  

The control system established will need to take account of the strong feeling, amongst the 
recipients of EU funds as well as amongst the legislative authority, that the control burden 
required to attain an error limit of 2% has become too great. This runs the risk of lowering 
the attractiveness of the Union's Research programme, and so negatively affecting Union 
research and innovation. 

The  European  Council  of  February  4th  2011  concluded  that  ‘it  is  crucial  that  EU 
instruments aimed at fostering R&D&I be simplified in order to facilitate their take-up by 
the  best  scientists  and  the  most  innovative  companies,  in  particular  by  agreeing  between 

EN 

33 

   EN 

the relevant institutions a new balance between trust and control and between risk taking 
and risk avoidance’ (see EUCO 2/1/11 REV1, Brussels 8 March 2011). 

The European Parliament, in its Resolution of 11 November 2010 (P7_TA(2010)0401) on 
simplifying  the  implementation  of  the  Research  Framework  Programmes  explicitly 
supports  a  higher  risk  of  errors  for  research  funding  and  "expresses  its  concern  that  the 
current system and the practice of FP7 management are excessively control-oriented, thus 
leading to waste of resources, lower participation and less attractive research landscapes; 
notes with concern that the current management system of ‘zero risk tolerance’ seems to 
avoid, rather than to manage, risks".  

There is therefore an acceptance among stakeholders and Institutions that the whole range 
of  objectives  and  interests,  especially  the  success  of  the  Research  policy,  international 
competitiveness and scientific excellence, should be considered, along with the error rate. 
At the same time, there is a clear need to manage the budget in an efficient and effective 
manner, and to prevent fraud and waste.  

As  stated  above,  the  Commission  will  monitor  the  risk  of  non-compliance  through  the 
reporting system that it will establish, as well as by following the results of ex-post audits 
on the recipients of EU funds from the IMI JTI JU, as part of the ex-post audits covering 
the whole of the Horizon 2020.  

2.2.3.  Expected level of risk of non-compliance 

As  the  Commission  reported  in  the  Legislative  Financial  Statement  for  Horizon  2020,  it 
remains  the  ultimate  objective  to  achieve  a  residual  error  rate  of  less  than  2%  of  total 
expenditure over the lifetime of the programme, and to that end, it has introduced a number 
of simplification measures. However, the other objectives set out above as well as the costs 
of controls need to be considered. 

As the rules for participation of the IMI JTI JU are similar to those of Horizon 2020, and 
with a population of beneficiaries with a similar risk profile to those of the Commission, it 
can be expected that the level of error will be similar to that established by the Commission 
for Horizon 2020, i.e. to give reasonable assurance that the risk of error over the course of 
the multiannual expenditure period is, on an annual basis, within a range of 2-5 %, with the 
ultimate aim to achieve a residual level of error as close as possible to 2 % at the closure of 
the  multi-annual  programmes,  once  the  financial  impact  of  all  audits,  correction  and 
recovery measures have been taken into account. 

See the Legislative Financial Statement for Horizon 2020 for full details of the error rate 
expected with respect to participants. 

2.3.  Measures to prevent fraud and irregularities  

The  Commission  will  ensure  that  procedures  to  fight  against  fraud  at  all  stages  of  the 
management process are applied by the IMI2 JTI JU. The proposals for Horizon 2020 have 
been  subject  to  fraud  proofing  and  an  assessment  of  their  impact.  Overall  the  measures 
proposed  should  have  a  positive  impact  on  the  fight  against  fraud,  especially  the  greater 
emphasis on risk based audit and reinforced scientific evaluation and control. 

The  Commission  will  ensure  that  appropriate  measures  are  in  place  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 the 
recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate 
and deterrent penalties. 

EN 

34 

   EN 

The  current  IMI2  JTI  JU  already  cooperates  with  the  Commission  services  in  matters 
relating to fraud and irregularity, the Commission will ensure that this will continue and be 
strengthened.  

The  accounts  of  the  IMI2  Joint  Undertaking  shall  be  examined  by  an  independent  audit 
body  as  laid  down  in  Article  60(5)  of  Regulation  (EU,  Euratom)  No  966/2012.  The 
accounts of the IMI2 Joint Undertaking shall not be subject to examination by the Court of 
Auditors.  The  Court  of  Auditors  may  conduct  audits  on  those  participants  that  have 
received funding from the IMI2 Joint Undertaking.  

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 (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 
1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and 
Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-
spot  checks  and  inspections  carried  out  by  the  Commission  in  order  to  protect  the 
European  Communities'  financial  interests  against  fraud  and  other  irregularities  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 or decision 
or a contract funded under this Regulation. 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading of the multiannual financial framework and expenditure budget line affected 

•  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 

Budget line 

Type of 
expenditure

Contribution  

Number  
[H1a  Competitiveness  for  growth  and 
jobs] 

Diff./non-
diff. 

from 
EFTA 
countries

from 
candidate 
countries 

from 
third 
countries 

within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  

1a 

08.020731 
08.020301) 

(mother 

line 

[Diff] 

YES 

YES 

YES 

YES 

EN 

35 

   EN 

3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial  
Framework:  

H1a 

Competitiveness for growth and jobs 

EUR million (to three decimal places) 

 IMI 2 Joint Undertaking 

Title 1 Staff expenditure 

Title 2 Infrastructure and operating expenditure 

Title 3 operational expenditure 

TOTAL appropriations 
for [IMI 2 JU] 

Commitments 
Payments 
Commitments 
Payments 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 
(1a) 
(2a) 

(3a) 

(3b) 

=1+1a 
+3a 

=2+2a 

+3b 

Year 2014

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

0,239 

0,239 

0,496 
0,496 

0,378 

0,378 

0,672 
0,672 

0,555 

0,555 

0,706 
0,706 

0,648 

0,648 

0,717 
0,717 

2,534 

2,534 

3,243 
3,243 

2,585 

2,585 

3,192 
3,192 

12,999 

2,636 

15,886 
3,140 

Year 
2021-
2024  

0 

10,363 

0 
12,746 

TOTAL 

19,938 

19,938 

24,912 
24,912 

207,300 

211,000 

214,800 

190,850 

276,200 

293,000 

287,000 

0 

1.680,150 

16,600 

65,950 

105,000 

146,000 

191,000 

209,200 

245,000 

701,400 

1.680,150 

208,035 

212,050 

216,061 

192,215 

281,977 

298,777 

315,885 

0 

1.725,000 

17,335 

67,000 

106,261 

147,365 

196,777 

214,977 

250,776 

724,509 

1.725,000 

1 In addition EUR 15.8 million (including EFTA) has been frontloaded in 2013for the IMI running cost related to the completion of its activities under FP7.  

The  annual 

split  of 

these  appropriations  as  well  as 

the  corresponding 

industry  contribution  are  presented 

in 

the 

table  under  point  3.2.3.3.d.

EN 

36 

EN 

 
  
  
 
 
 
 
 
Heading of multiannual financial  
framework:  

1A 

Competitiveness for growth and jobs 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Year 
2021-
2024 

TOTAL 

EUR million (to three decimal places) 

DG: RTD 

(cid:121) Human resources  

(cid:121) Other administrative expenditure  

0,559 

0,570 

0,582 

0,593 

0,605 

0,617 

0,630 

0 

0 

0 

0 

0 

0 

0 

0 

TOTAL DG RTD 

Appropriations  

0,559 

0,570 

0,582 

0,593 

0,605 

0,617 

0,630 

4,156 

0 

4,156 

TOTAL appropriations 
under HEADING 1A 
of the multiannual financial framework  

(Total 
Total payments) 

commitments  = 

0,559 

0,570 

0,582 

0,593 

0,605 

0,617 

0,630 

4,156 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

Payments 

EUR million (to three decimal places) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Year 
2021-
2024 

TOTAL 

208,594 

212,620 

216,643 

192,808 

282,582 

299,394 

316,515 

1.729,156 

17,894 

67,570 

106,843 

147,958 

197,382 

215,594 

251,406 

724,509 

1.729,156 

EN 

37 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on IMI 2 JU's appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  X  The proposal/initiative requires the use of operational appropriations, as described below: 

Indicate 
objectives 
and 
outputs  

(cid:216) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 
OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

Type26 

Average 
cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

SPECIFIC OBJECTIVE NO 127 
supporting grants for collaborative 
projects led by EFPIA 
- Output 
~€17,5m 
Grants 
Subtotal for specific objective N°1 

10 

179,500 

10 

182,700 

11 

186,000 

10 

179,500 

10 

182.700 

11 

186,000 

r
e
b
m
u
N

9 

9 

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

Total 
number 

Total 
cost 

165,100 

14 

239,200 

15 

254,000 

14 

248,650 

165,100 

14 

239,200 

15 

254,000 

14 

248,650 

83 

83 

1.455,150 

1.455,150 

SPECIFIC OBJECTIVE No 2 
supporting grants for collaborative 
projects led by other industries 
- Output 
~€13,2m 
Subtotal for specific objective No 2 
- Output 

Grants 

Participation 
in  investment 
projects 

2 

2 

27,800 

27,800 

2 

2 

28,300 

28,300 

2 

2 

28,800 

28,800 

2 

2 

25,600 

25,600 

3 

3 

37,000 

37,000 

3 

3 

39,300 

39,300 

3 

3 

38,200 

38,200 

17 

17 

225,000 

225,000 

Subtotal for specific objective No 3 
TOTAL COST 

12 

207,300 

12 

211,000 

13 

214,800 

11 

190,700 

17 

276,200 

18 

293,300 

17 

286,850 

100 

1.680,150 

26 
27 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)’. 

EN 

38 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
3.2.3.  Estimated impact on IMI 2 JU's human resources  

3.2.3.1.  Summary  

–  X  The  proposal/initiative  does  not  require 

the  use  of  appropriations  of  an 

administrative nature  

–  (cid:133)  The  proposal/initiative  requires  the  use  of  appropriations  of  an  administrative 

nature, as described below: 

Staffing numbers (in headcounts / FTE)28 

Year 
201429 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

0 

0 

8 

0 

0 

9 

0 

0 

9 

33 

35 

38 

0 

0 

10 

39 

0 

0 

10 

39 

0 

0 

10 

39 

0 

0 

10 

39 

0 

0 

9 

0 

0 

9 

0 

0 

9 

0 

0 

8 

38 

37 

37 

35 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Officials (AD 
Grades) 

Officials 
(AST Grades) 

Contract 
agents 

Temporary 
agents (AD only) 
Seconded 
National 
Experts30 

TOTAL 

41 

44 

47 

49 

49 

49 

49 

47 

46 

46 

43 

EUR million (to three decimal places) 

Year 
201431 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0,376 

0,431 

0,440 

0,499 

0,509 

0,519 

0,529 

0,486 

0,496 

0,506 

0,458 

3,564 

3,856 

4,270 

4,470 

4,559 

4,650 

4,743 

4,714 

4,682 

4,776 

4,608 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Officials (AD 
Grades) 

Officials 
(AST Grades) 

Contract 
agents 

Temporary 
agents  

Seconded 
National Experts 

These amounts consider costs until 2024 including the phasing out costs. 

TOTAL 

3,940 

4,287 

4,710 

4,969 

5,068 

5,169 

5,273 

5,200 

5,178 

5,281 

5,066

28 
29 
30 

31 

In the case of EU PPP bodies under Article 209 FR, this table is included for information purposes. 
Year N is the year in which implementation of the proposal/initiative starts. 
In  accordance  with  Article  7  of  the  Council  Regulation,  the  IMI2  Joint  Undertaking  may  make  use  of 
seconded national experts and trainees not employed by the Joint Undertaking. Staff numbers for temporary 
agents will be reduced if IMI2 employs ENDs. 
Year N is the year in which implementation of the proposal/initiative starts. 

EN 

39 

   EN 

 
 
 
 
                                                 
3.2.3.2.  Estimated requirements of human resources for the parent DG 

–  (cid:133)  The proposal/initiative does not require the use of human resources.  

–  X  The proposal/initiative requires the use of human resources, as described below: 

Estimate to be expressed in full number 

Year 201432 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020* 

(cid:121) Establishment plan posts (officials and temporary staff) 

XX 01 01 01 (Headquarters 
and Commission’s 
Representation Offices) 

XX 01 01 02 (Delegations) 

08 01 05 01 (Indirect 
research) 

10 01 05 01 (Direct 
research) 

0 

0 

4 

0 

(cid:121) External staff (in Full Time Equivalent: FTE)33 

XX 01 02 01 (CA, SNE, INT 
from the ‘global envelope’) 

XX 01 02 02 (CA, LA, SNE, 
INT and JED in the 
delegations) 

0 

0 

XX 01 04 yy34 

- at 
Headquarters35 

- in delegations 

08 01 05 02 (CA, SNE, INT - 
Indirect research) 

10 01 05 02 (CA, SNE, INT- 
Direct research) 

Other budget lines (specify) 

TOTAL 

0.5 

0 

0 

4.5 

0 

0 

4 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0.5 

0.5 

0.5 

0.5 

0.5 

0.5 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

4.5 

4.5 

4.5 

4.5 

4.5 

4.5 

*Staff number for the period after 2020 will be decided at the later stage. 

32 
33 

34 
35 

Year N is the year in which implementation of the proposal/initiative starts. 
CA=  Contract  Agent;  LA  =  Local  Agent;  SNE  =  Seconded  National  Expert;  INT=  agency  staff 
(‘Intérimaire’).  
Sub-ceiling for external staff covered by operational appropriations (former "BA" lines). 
Mainly  for  the  Structural  Funds,  the  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and  the 
European Fisheries Fund (EFF). 

EN 

40 

   EN 

 
 
 
 
                                                 
The human resources required will be met by staff from the DG who are already assigned to management of 
the action and/or have been redeployed within the DG, together if necessary with any additional allocation 
which  may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of 
budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

The tasks of Commission staff in conjunction with the implementation of the IMI 
JU  are  to  assure  the  correct  budget  implementation  and  supervision  of  the 
operations of the IMI JU. Senior managers from Commission services will serve 
on the IMI2 JU Governing Board. 

Commission staff members will contribute to the work of the advisory groups of 
IMI2  that  may  be  established  by  the  Governing  Board.  It  is  estimated  that  4 
advisory  groups  will  be  established,  each  requiring  0.25  FTE  of  work  from 
Commission staff members for the entire period of establishment of IMI. 

External  staff  will  support  officials  and  temporary  staff  in  assuring  the  correct 
budget implementation and supervision of the operations of the IMI JU. 

Description of the calculation of cost for FTE equivalent should be included in the Annex, section 
3.  
3.2.3.3.  a. Estimated requirements of human resources for the IMI 2 JU36 

–  (cid:133)  The proposal/initiative does not require the use of human resources.  

–  X  The proposal/initiative requires the use of human resources, as described below:  

b.  Estimated  requirements  of  human  resources  to  be  financed  from  appropriations  under 

2014-2020 Multiannual Financial Framework 

Estimate to be expressed in full in numbers 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020* 

(cid:121) Establishment plan posts (officials and temporary staff) 

XX XX XX XX (PPP body) 

Temporary (AD grades) 
Temporary (AST grades) 

IMI JU (PPP body) 

TA 

CA 

SNE 

INT 

TOTAL 

0 

0 

4 

1 

0 

0 

5 

0 

0 

6 

2 

0 

0 

8 

0 

0 

9 

2 

0 

0 

11 

0 

0 

10 

3 

0 

0 

13 

0 

0 

39 

10 

0 

0 

49 

0 

0 

39 

10 

0 

0 

49 

0 

0 

39 

10 

0 

0 

49 

*for years 2021 to 2024 please refer to table 3.2.3.1 

Description of tasks to be carried out: 

Officials and temporary staff 

The tasks are described in Article 1 of the Statutes annexed to the Council Regulation. 
The tasks of the Executive Director of IMI2 are described in Article 6 of the Statutes. 

External staff 

External staff shall assist the temporary staff of the IMI JU in carrying out their tasks. 

36 

In the case of EU PPP bodies under Article 209 FR, this section is included for information purposes. 

EN 

41 

   EN 

 
 
 
 
                                                 
c. Human resources financed from appropriations under 2007-2013 Multiannual Financial 

Framework37  

Estimate to be expressed in full numbers (of FTE) 

Year 2014 

Year 2015 

Year 2016 

Year 2017 

(cid:121) Establishment plan posts (officials and temporary staff) 

IMI JU (PPP body) 

Temporary (AD grades) 

Temporary (AST grades) 

(cid:121) External staff (in Full Time Equivalent: FTE)38 

IMI JU (PPP body) 

TA 

CA 

SNE  

INT 

TOTAL 

0 

0 

29 

7 

0 

0 

36 

0 

0 

29 

7 

0 

0 

36 

0 

0 

29 

7 

0 

0 

36 

0 

0 

29 

7 

0 

0 

36 

d.  Contribution  to  the  running  costs  for  the  phasing  out  of  the  PPP  body  under  the 

Multiannual Financial Framework 2007-2013 

EUR million (to 3 decimal places)  

Contribution  in  cash  from  the 
EU  

Contribution in cash from third 
parties 

Year 
2014 

3,950 

Year 
2015 

3,950 

Year 
2016 

3,950 

Year 
2017 

Total39 

3,950 

15,800 

3,950 

3,950 

3,950 

3,950 

15,800 

TOTAL 

7,900 

7,900 

7,900 

7,900 

31,600 

3.2.4.  Compatibility with the current multiannual financial framework  

–  X  Proposal/initiative is compatible the current multiannual financial framework. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain  what  reprogramming  is  required,  specifying  the  budget  lines  concerned  and  the  corresponding 
amounts. [Not applicable] 

37 
38 

39 

In the case of EU PPP bodies under Article 209 FR, this table is included for information purposes. 
CA  =  Contract  Agent;  LA  =  Local  Agent;  SNE  =  Seconded  National  Expert;  INT  =  agency  staff 
(‘Intérimaire’).  
The  total  for  the  EU  cash  contribution  should  equal  the  amount  front-loaded  in  the  2013  budget  for  the 
completion of the 2007-2013 activities of the body. 

EN 

42 

   EN 

 
 
 
 
 
 
                                                 
–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision of the 

multiannual financial framework40. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 
[Not applicable] 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties.  

–  X The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to three decimal places) 

Year 
2014* 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 
and 
later 

TOTAL 

European  Federation  of 
Pharmaceutical  Industries 
– 
Associations 
and 
contribution  in  cash  to 
administrative costs 

partners, 
Associated 
and 
future  members 
the  co-
participants 
investment 
-
contribution  in  cash  to 
administrative costs 

to 
scheme 

contribution in cash to the 
operational 
- 
not 
amount 
specified;  is  expected  to 
be made 

costs 
currently 

TOTAL 
cofinanced by EFPIA 

appropriations 

Total 
appropriations 
cofinanced  by  associated 
future 
or 
partners 
members  of  the  PPP  or 
participations  in  the  co-
investment scheme 

0,735 

1,050 

1,260 

1,366 

5,777 

5,777 

28,885 

44,850 

0 

0 

0 

0 

0 

0 

0 

0 

0,735 

1,050 

1,260 

1,366 

5,777 

5,777 

28,885 

44,850 

The total contribution from members other than the Union are laid down by Article 4 of the Council 
Regulation of the IMI2 Joint Undertaking. 

Estimated impact on revenue  

–  X  Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

(cid:133) 

(cid:133) 

on own resources 

on miscellaneous revenue 

40 

See points 19 and 24 of the Inter-institutional Agreement. 

EN 

43 

   EN