Innovative Medicines Initiative

What is IMI?

IMI is the world’s largest public-private partnership in health with a total budget of €5 billion – half from the European Union and half from the pharmaceutical industry, through EFPIA. It sets out to address complex societal demands, unmet medical needs, and challenges in medicines development and problems arising from Europe’s current health systems, in an innovative way, thereby contributing to public health and citizens’ quality of life.

Its success stems from a unique collaborative model for delivering outstanding research results that allows it to pool expertise from a variety of contributing stakeholders. It also provides a framework in which pharmaceutical companies can work together to share data and risk, with the aim of delivering new medicines and treatments.

This approach has seen IMI projects deliver exciting results that are helping to advance the development of urgently needed new treatments in diverse areas.

Why is EFPIA involved in IMI?

Challenges to European health systems have intensified in the 21st century, with unprecedented pressures linked to ageing populations and rising costs. Against this backdrop, leading figures in the pharmaceutical industry, particularly within EFPIA, understood that a fresh evaluation of the situation was essential if Europe wants to improve health by speeding up the development of, and patient access to, innovative medicines – especially in areas where there an unmet medical or social need remains. 

A realisation also emerged that, while all companies are natural competitors, joining forces would be essential to resolving some of the critical challenges that industry and society faces. These are some of the thoughts that sowed the seeds for Europe’s largest public-private partnership in the life sciences area: the Innovative Medicines Initiative.

EFPIA’s input on research topics is balanced by input from the European Commission as well as the scientific community and Member States.

Idea Generation 

The strategic direction and overall objectives for IMI2 are outlined in the Strategic Research Agenda (SRA), which was developed as a result of multiple public consultations between June 2012 and October 2013. The focus of the SRA, which covers the period 2014-2024, is on delivering ‘the right prevention and treatment for the right patient at the right time’. With the launch of the 2014 research agenda for IMI 2, an explicit link was made with the WHO’s 2013 report on Priority Medicines for Europe and the World.

The final version of the SRA incorporates input from EFPIA, European Biopharmaceutical Enterprises (EBE) and Vaccines Europe members, as well as over eighty other stakeholder organisations, including academia, small- and medium-sized enterprises, large companies from various healthcare sectors, research organisations, learned societies, patient groups, and regulatory agencies. Third party suggestions for scientific proposals meeting the needs and scope of the SRA are also welcome.

The SRA focuses on tools to reduce failures of the research and development process, to get safer medicines, diagnostics and vaccines to patients faster and to obtain better health outcomes.  For achieving this, four key axis of research are addressed: target validation and biomarker research (efficacy and safety); adoption of innovative clinical trial paradigms; innovative medicines; and patient-tailored adherence programmes.

Projects (call topics) are identified by the industry, which does not receive public funding but invests people and other resources into projects jointly implemented with public partners.

EFPIA will channel the initial development of projects via the EFPIA InnoMedS, which then are subject to consultation with the IMI Scientific Committee and State Representative Group. The aim of InnoMedS is to shape and support and drive collaborative medicines development for increased R&D productivity and quality across Europe. InnoMedS also promotes the evolution of regulatory and medical practice/healthcare delivery. 

Public funding is allocated to public partners (academia, SMEs, NGOs and governmental agencies, hospitals, etc.) through an open competitive call process, including an independent expert review. 

In 2016, InnoMedS seeks to optimise the IMI framework, while also aiming to improve the perception of IMI and public/private partnerships in general as a tool for accelerating progress.

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How IMI activities are linked to other EFPIA strategic areas 

EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe. IMI is the perfect open innovation vehicle through which the pharmaceutical industry can deliver on these goals.

IMI projects see the pharmaceutical industry working together with universities, hospitals, small and medium-sized enterprises (SMEs), patient organisations and public authorities, including regulatory bodies. Current projects cover a wide spectrum of challenges, including early to late stages of medicines development; from biomarkers for vaccine safety to understanding chronic pain and developing anti-tuberculosis drug combinations.

As they are a reflection of the challenges currently facing European healthcare systems, IMI projects necessarily address many problems to which EFPIA and its member companies are seeking to find solutions. These already include: the creation of flexible development and access pathways that balance early patient access, public health and societal benefits (Medicines Adaptive Pathways to Patients/MAPPs); reducing the risk of entering into clinical trials, through development of new and better drug safety and efficacy biomarkers (example projects include: IMIDIA; MARCAR; and Onco Track); and the perpetual overall driver of increasing access to medicines, based on the SRA, which advocates delivering ‘the right prevention and treatment for the right patient at the right time’.

How is IMI funded? 

IMI is funded jointly by the European Commission and EFPIA. 

The total budget of the IMI 1 programme (2008-2013) was €2 billion, each party contributing €1 billion.

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IMI2, which runs from 2014-2024, saw an increase in funding, with €1,680 billion allocated by the EU for grants for public partners, from Horizon 2020, the EU research and innovation framework programme. This includes a contribution of up to €213 million from other Life Science industries, should they decide to join IMI 2 as members or as partners in individual projects. Public funding is not accessible by industry, but is allocated solely to public partners.

EFPIA member companies have committed €1,425 billion the form of in-kind contributions to the IMI2 programme. These contributions are mostly in the form of: personnel; other direct costs (consumables, equipment depreciation, samples, compounds etc.); subcontracting (e.g. for clinical trials); or financial contributions – a transfer of funds from an EFPIA company to an academic institution within the same project/consortium, where appropriate. 

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