History

IHI’s origins lie in the European Technology Platform (ETP) on Innovative Medicines that was supported under the European Commission's Sixth Framework Programme for Research (FP6). Dubbed ‘INNOMED’, the ETP gathered together a range of stakeholders and was led by the pharmaceutical industry. The project ran from 2005 to 2009 and laid the foundations for IMI by developing a Strategic Research Agenda to boost drug development in Europe, and by delivering proof of the effectiveness of a collaborative approach in two key areas: Alzheimer’s disease and medicines safety.

In 2007, the European Commission released a proposal for the creation of the Innovative Medicines Initiative (IMI) Joint Undertaking, a public-private partnership (PPP) between the European Community, represented by the European Commission, and the European Federation of Pharmaceutical Industries and Associations, EFPIA. The proposal made use of an article in the EU treaties (now Article 187 of the Treaty on the Functioning of the European Union), which allows the EU to set up joint undertakings ‘for the efficient execution of Union research, technological development and demonstration programmes’. Following discussions in the European Parliament and among the Member States, the legislation creating IMI was approved in December 2007, and the first Call for proposals was launched in April 2008.

The overall goal of the IMI1 programme was to ‘significantly improving the efficiency and effectiveness of the drug development process with the long-term aim that the pharmaceutical sector produce more effective and safer innovative medicines’. IMI’s €2 billion budget for the period 2008-2013 made it the largest life sciences PPP in the world. Half of this budget came from the EU’s Seventh Framework Programme (FP7). The rest came in the form of in-kind contributions from EFPIA and its member companies. EFPIA companies do not receive any EU funding via IMI; the EU funding supports the participation of universities, research centres, small and medium-sized enterprises (SMEs) and mid-sized companies, patient groups, and regulators.

IMI1 resulted in 59 projects. Some focused on specific health issues such as neurological conditions (Alzheimer’s disease, schizophrenia, depression, chronic pain, and autism), diabetes, lung disease, oncology, inflammation & infection, tuberculosis, and obesity. Others focused on broader challenges in drug development like drug and vaccine safety, knowledge management, the sustainability of chemical drug production, the use of stem cells for drug discovery, drug behaviour in the body, the creation of a European platform to discover novel medicines, and antimicrobial resistance. In addition to research projects, IMI supported a number of education and training projects.

Most importantly, through its projects, IMI demonstrated the success of the PPP model. By bringing together experts from industry, academia, small and medium-sized enterprises (SMEs), patient groups, and regulators, IMI projects delivered scientific breakthroughs that would not have been possible without the public-private partnership model offered by IMI.

The success of IMI1 prompted the European Commission and EFPIA to continue IMI under Horizon 2020, the framework programme for research and innovation that ran from 2014 to 2020. The legislation creating IMI2 was approved in the first half of 2014, and the first Call for proposals was launched in July of the same year.

IMI2 ran until 2020 and had a total budget of up to €3.276 billion. Half came from the EU’s Horizon 2020 programme, and most of the rest came from EFPIA and its member companies.

The IMI2 programme built on the successes of IMI1. As set out in the Strategic Research Agenda, IMI2 kept the focus on the needs of patients and society, and on delivering tools and resources to speed up the development of urgently-needed treatments. In addition, IMI2 placed a greater emphasis on accelerating patient access to new treatments.

The legislation creating IMI2 also emphasised the need to bring partners from other sectors (e.g. diagnostics, animal health, IT, imaging, etc.) into the IMI community. The open nature of IMI2 was also reflected in the creation of the ‘Associated Partner’ status. This allowed organisations that are not EFPIA members to contribute to IMI and have that contribution matched by the EU. Over 30 organisations from around the world, including diabetes organisation JDRF, the Bill and Melinda Gates Foundation, the Children’s Tumor Foundation and the TB Alliance, decided to contribute to IMI2 as Associated Partners. In addition, many organisations outside the pharmaceutical sector contributed to IMI2 by becoming ‘EFPIA Partners in Research’.

IMI2 resulted in over 100 projects. As under IMI1, some focused on specific disease areas, including AMR, dementia, diabetes and cancer, as well as Ebola and related diseases and coronaviruses. IMI2 also saw the launch of a programme dedicated to ‘big data for better outcomes’ as well as growing numbers of projects focused on digital health and the use of artificial intelligence in health research.

IMI2 delivered a range of results, including an Ebola vaccine regimen that has received marketing authorisation from the European Commission; new insights into the use of digital and wearable devices as tools to monitor disease; a greater understanding of type 1 diabetes and novel clinical trials for new treatments; and advances in the use of existing data to drive new discoveries.

In February 2021, the European Commission released a proposal to create the Innovative Health Initiative (IHI), a new PPP in health. The proposal was adopted and came into force in November 2021.

While IMI was a partnership between the EU and the pharmaceutical industry, IHI is a truly cross-sectoral partnership, involving the pharmaceutical, medical technology, biotechnology, digital health and vaccine industries.

IHI is designed to build on what worked well in IMI, address the lessons learnt, and leverage the benefits of cross-sectoral collaboration in research and innovation to better respond to current and emerging health needs.

The cross-sectoral approach reflects the fact that health research and development increasingly spans different sectors, and future breakthroughs will likely involve diverse sectors, such as medical device / drug combinations or diagnostics based on artificial intelligence.