Public-private partnership in innovative medicines

 

SUMMARY OF:

Regulation (EU) No 557/2014 establishing the Innovative Medicines Initiative 2 Joint Undertaking

WHAT IS THE AIM OF THE REGULATION?

It establishes the second phase of the Innovative Medicines Initiative (IMI) Joint Undertaking (JU) for the period from 2014 to 2020.

The IMI 2 JU aims to develop new vaccines, medicines and treatments. This is done by means of joint research projects to address Europe’s health challenges and to ensure that Europe’s pharmaceutical industry remains competitive.

KEY POINTS

Aims

• a 30% better success rate in clinical trials of priority medicines identified by the World Health Organisation;
• clinical proof of concept (i.e. trial) in immunological, respiratory, neurological and neurodegenerative diseases in just 5 years;
• diagnostic and treatment markers (i.e. indicators of a pathological or physiological process or disease) for 4 diseases;
• at least 2 new medicines (for anti-microbial resistance or Alzheimer’s disease).

Strategic Research Agenda

IMI 2’s focus is on 4 areas of research:

• 1.

  target validation and biomarker* research (efficacy and safety);

• 2.

  adoption of innovative clinical trial paradigms;

• 3.

  innovative medicines;

• 4.

  patient-tailored adherence (the extent to which patients take the treatment that they are prescribed, as directed) programmes.

Health priorities to be addressed by IMI include:

• antimicrobial resistance;
• osteoarthritis;
• cardiovascular diseases;
• diabetes;
• neurodegenerative diseases;
• psychiatric diseases;
• respiratory diseases;
• immune-mediated diseases (resulting from the activity of the immune system, such as coeliac disease);
• ageing-associated diseases;
• cancer;
• rare/orphan diseases (diseases that affect a small percentage of the population);
• vaccines.

Management

• The IMI 2 JU is a legal entity set up for the purpose under Article 187 of the Treaty on the Functioning of the European Union. This article allows for public-private partnerships at European level in the field of industrial research.
• The JU sets its own strategic research agenda and funds projects selected following calls for proposals published on IMI 2 JU's website. As a general rule, the JU applies the Horizon 2020 rules for participation; the exceptions to this rule are detailed on Regulation (EU) No 622/2014. However, large European pharmaceutical companies are not eligible for funding.
• The JU is managed by an Executive Director, who is supported by the staff of the Executive Office. It has a Governing Board comprising an equal number of industry and European Commission representatives. It has overall responsibility for the operations of the JU and oversees the implementation of its activities.
• It is advised by a Scientific Committee on scientific priorities. There is also a States Representatives Group representing the countries involved, as well as a Stakeholder Forum.
• Decisions are taken in accordance with the voting rules established by the JU.
• Article 209 of the EU’s Financial Regulation (Regulation (EU, Euratom) No 966/2012) provides for new lighter rules customised for EU PPP bodies.

Budget

The EU’s contribution to IMI 2 is up to €1,638 billion for the period to 2024. This will be matched by €1,425 billion committed by the pharmaceutical industry (in-kind contributions). Additional funding comes from other life science industries or organisations that decide to contribute to IMI 2 as members or associated partners in individual projects. The JU also seeks to develop synergies with the European Structural and Investment Funds.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 27 June 2014.

BACKGROUND

For more information, see:

• Europe’s partnership for health (IMI — Innovative Medicines Initiative)
• History — the IMI story so far (IMI — Innovative Medicines Initiative)
• Strategic Research Agenda (IMI — Innovative Medicines Initiative).

KEY TERMS

MAIN DOCUMENT

Council Regulation (EU) No 557/2014 of 6 May 2014 establishing the Innovative Medicines Initiative 2 Joint Undertaking (OJ L 169, 7.6.2014, pp. 54-76)

RELATED DOCUMENTS

Commission Delegated Regulation (EU) No 622/2014 of 14 February 2014 establishing a derogation from Regulation (EU) No 1290/2013 of the European Parliament and of the Council laying down the rules for participation and dissemination in ‘Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)’ with regard to the Innovative Medicines Initiative 2 Joint Undertaking (OJ L 174, 13.6.2014, pp. 7-11)

Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in ‘Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)’ and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, pp. 81-103)

Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing ‘Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)’ and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, pp. 104-173)

Successive amendments to Regulation (EU) No 1291/2013 have been incorporated into the original document. This consolidated version is of documentary value only.

last update 21.08.2018