Innovative Medicines Initiative (IMI) Guide

The Innovative Medicines Initiative (IMI) was established as Europe’s flagship public-private partnership between the European Union and the research-based pharmaceutical industry to accelerate the discovery and development of safer, more effective treatments. Operating under the European Seventh Framework Programme (FP7) as IMI1 and Horizon 2020 as IMI2, the programme pooled public research funding with private industry resources to address major bottlenecks in pharmacology research and drug development. In 2021, the initiative transitioned under Horizon Europe into the Innovative Health Initiative (IHI), broadening its mandate across biopharmaceuticals, digital health, and medical technologies.

What it is and who runs it

The Innovative Medicines Initiative operates as an institutionalised European partnership established under Article 187 of the Treaty on the Functioning of the European Union (TFEU). First created in December 2007 by Council Regulation (EC) 73/2008, IMI brought together the European Community (represented by the European Commission) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The initiative was designed to support pre-competitive biomedical research, open innovation platforms, and regulatory science across Europe.

Operationally, IMI progressed through two major funding cycles before its current institutional form:

IMI1 (2008–2013): Funded under FP7 with a total budget of €2 billion, supporting 59 collaborative consortia focused on drug safety, knowledge management, neurodegenerative diseases, diabetes, and antimicrobial resistance.
IMI2 (2014–2020): Funded under Horizon 2020 with a total budget of €3.276 billion across 123 projects, introducing Associated Partner mechanisms that allowed global foundations and non-EFPIA entities to contribute matched funding.
Innovative Health Initiative (IHI, 2021–2027): Governed by Council Regulation (EU) 2021/2085 under Horizon Europe with a €2.4 billion budget, expanding the partnership beyond EFPIA to include MedTech Europe, EuropaBio, and COCIR.

Administrative and operational management is directed by the dedicated IHI Programme Office based in Brussels, overseen by an Executive Director and a Governing Board with equal representation between European Commission officials and industry association delegates. The Programme Office oversees ongoing legacy IMI2 projects alongside active IHI actions.

Eligibility

Eligibility for participation and financial reimbursement follows Horizon Europe and Joint Undertaking legal rules as described on the official program pages. While any legal entity worldwide can participate in consortium activities, funding allocation distinguishes between non-profit academic entities and large commercial enterprises:

Eligible for direct EU funding: Higher education institutions, research organisations, public bodies, patient advocacy groups, regulatory authorities, and small-to-medium enterprises (SMEs) established in EU Member States or Associated Countries to Horizon Europe.
Industry participants and large enterprises: Under standard rules, commercial partners with an annual turnover exceeding €500 million participating through industry associations do not receive direct EU cash grants. Instead, they provide matched in-kind contributions.
International participants: Entities from non-associated third countries may join consortia, but receive direct funding only if their participation is formally deemed essential in the call text or covered by bilateral agreements.

To receive disbursements, each organisation must register in the EU Funding & Tenders Portal, obtain a validated Participant Identification Code (PIC), and demonstrate legal standing as an eligible Horizon Europe beneficiary.

What it funds or requires

IMI and IHI funding mechanisms address translational challenges that exceed the risk tolerance or capacity of single pharmaceutical companies. In contrast to clinical pharmacy practice, which focuses on medication administration and patient monitoring as detailed in the pharmacy vs. pharmacology comparison, IMI investments target pre-competitive infrastructure, predictive toxicology models, biomarker qualification, and shared clinical data repositories.

Key financial and operational requirements include:

Matched co-funding: Calls require industry and contributing partners to match public contributions. In single-stage calls, the contributing industry partners must account for at least 45% of the total project operational costs through eligible in-kind or financial contributions.
In-kind contributions: Industry commitments consist of in-kind contributions to operational activities (IKOP)—such as personnel time, proprietary compounds, and specialized assays—or in-kind contributions to additional activities (IKAA) linked to project objectives.
Reimbursement rates: Eligible academic, clinical, and SME partners receive up to 100% reimbursement of direct eligible costs plus a flat 25% indirect cost allocation for institutional overhead.
Open access and data stewardship: Consortia must adhere to FAIR (Findable, Accessible, Interoperable, and Reusable) data standards and ensure peer-reviewed publications are made openly available without embargo.

Application or compliance steps

Securing IMI and IHI grants requires navigating rigorous multi-party evaluation procedures via the EU Funding & Tenders Opportunities Portal. Projects follow either single-stage or two-stage submission workflows:

Topic publication and analysis: Review the annual work programme and published call topics. Topics define specific medical needs, target outcomes, and required multi-disciplinary expertise.
Consortium building: Assemble an international consortium representing academic institutions, clinical trials centres, patient organisations, and SMEs. For single-stage calls, pre-identified industry partners must be integrated into the applicant team from the outset.
Stage 1 proposal submission (two-stage calls): Submit a short proposal (Part A administrative data and Part B technical outline) focusing on scientific excellence and methodology. Independent peer-review experts evaluate and rank the proposals.
Consortium merger (two-stage calls): The highest-ranked applicant consortium in Stage 1 is invited to merge with the pre-identified industry consortium to collaboratively draft the full Stage 2 proposal.
Full proposal submission: Finalize comprehensive work packages, deliverable schedules, milestone definitions, and detailed budget matrices in Part B and mandatory annexes.
Grant preparation: Execute the formalized Horizon Europe grant agreement with the Joint Undertaking Programme Office.
Internal consortium agreement: Prior to signature of the main grant, all consortium participants must sign a legally binding consortium agreement defining governance boards, decision-making quorums, IP access rights, and publication review mechanisms.

Typical timeline phases

A typical IMI or IHI project follows structured operational phases across a multi-year lifecycle:

Phase 1: Topic gestation and call launch: Call topics are drafted through advisory panel consultations and published with a 3-month submission window.
Phase 2: Evaluation and ranking: Peer review and consensus panels evaluate Stage 1 submissions over a 2-month interval, followed by notification of results.
Phase 3: Stage 2 co-development: The winning applicant group and industry partners co-develop the full proposal over a 3-month drafting period.
Phase 4: Grant finalisation: Formal validation of participant legal documents, ethics screening, and execution of the consortium agreement take place over 3 months prior to project launch.
Phase 5: Implementation and periodic reviews: Execution spans 4 to 6 years, structured by formal 12-month or 18-month reporting periods with deliverables, financial audits, and scientific milestone assessments.

Common mistakes

Consortia applying for IMI and IHI calls frequently encounter operational setbacks due to avoidable planning failures:

Ignoring industry call objectives: Drafting an open discovery research proposal rather than addressing the specific translational deliverables delineated in the call text.
Underestimating consortium agreement complexity: Delaying negotiations over pre-existing background intellectual property, data licensing, and commercialization terms until after scientific approval.
Unbalanced geographic or sector representation: Omitting clinical trial investigators, patient advocates, or regulatory specialists when the topic requires translational pathway validation.
Inaccurate financial planning for SMEs: Failing to verify official SME status under European Commission definitions prior to submission, leading to budget disqualification.
Neglecting clinical study annexes: Omitting required clinical trials protocols and ethics approvals documentation required in mandatory submission annexes.

Related programs

Public-private partnerships and European health funding mechanisms complement IMI and IHI initiatives across different stages of biomedical innovation:

Programme	Managing Body	Core Focus	Key Eligibility Requirement
Innovative Health Initiative (IHI)	IHI Joint Undertaking	Cross-sectoral health research (pharma, medtech, biotech, digital)	Collaborative consortia with matched industry co-funding
Horizon Europe Health Cluster	European Health and Digital Executive Agency (HaDEA)	General public health, disease prevention, and environmental health	Transnational consortia with minimum 3 independent legal entities
Global Health EDCTP3	EDCTP3 Joint Undertaking	Infectious diseases in sub-Saharan Africa	Consortia combining European and sub-Saharan African research partners
EIT Health	European Institute of Innovation and Technology	Healthcare business creation, incubation, and commercial acceleration	Membership within EIT Health co-location centres and innovation hubs

Frequently asked questions

What is the difference between IMI and IHI?

The Innovative Medicines Initiative (IMI) focused specifically on biopharmaceuticals and drug discovery in partnership with the pharmaceutical industry (EFPIA). The Innovative Health Initiative (IHI) succeeds IMI under Horizon Europe, expanding the partnership to include medical technologies, digital health, and biotechnology industry associations alongside pharma.

How do IMI grants handle intellectual property?

Each partner retains ownership of their pre-existing background intellectual property. Results generated during the project are owned by the beneficiary that created them, but project partners receive royalty-free access rights to background and results for implementation and internal research purposes.

Who is eligible to receive EU funding in IMI and IHI calls?

Universities, research organisations, patient groups, healthcare providers, and small-to-medium enterprises (SMEs) based in EU Member States or Associated Countries are eligible for direct funding. Large pharmaceutical and technology companies participate primarily through in-kind contributions.

Sources

Innovative Health Initiative Official Portal. History and Legal Basis: Council Regulation (EU) 2021/2085. https://www.ihi.europa.eu/about-ihi/history (2026-11-07).
Innovative Health Initiative Official Portal. Governance and Partnerships. https://www.ihi.europa.eu/about-ihi/who-we-are (2026-11-07).
Innovative Health Initiative Official Portal. Call Documents, Templates and Guidance for Applicants. https://www.ihi.europa.eu/apply-funding/call-documents (2026-11-07).
European Commission. European Partnerships in Horizon Europe: Health. https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/european-partnerships-horizon-europe/health_en (2026-11-07).