It is hard to define return on EU’s €3.3B Innovative Medicines Initiative, review says

Europe’s €3.3 billion Innovative Medicines Initiative drug research programme remains relevant and justified, but the wider benefits of the project are difficult to pin down, according to an independent review.

IMI was set up to revive drug development pipelines in Europe’s pharma companies, and in particular, in antibiotics and treatments for cancer, respiratory, neurological and neurodegenerative diseases.

A dense evaluation, published on Tuesday, assessed the progress of IMI2, from 2014 to 2016, the first half of the current Horizon 2020 research programme.

At the time of evaluation, most of the first generation of IMI projects, funded through Framework Programme 7 and dating from 2007-2013, were still running, with some due to continue until 2021. Meanwhile, the first projects of the second generation of IMI2, funded as part of Horizon 2020, only started two years ago.

However, the evaluation team reaches some stark conclusions on the contribution of IMI to drugs research in Europe to date.

“There are limited examples that IMI helped to shorten the time of development of new applications or that IMI brought new, safer and more effective therapies or products to patients,” the report says. However, it notes there are promising results emerging from the development of a new Ebola vaccine and clinical trials in Africa.

Despite this, there are “no guarantees” IMI funded projects will lead to the development of new drugs.

IMI director Pierre Meulien told Science|Business the report is balanced and that many of its recommendations had already been taken on board. 

The main success of the programme is that, for the first time, pharma companies in Europe are doing precompetitive research together, and setting the research agenda.

“Take an area like Alzheimer’s, where previously companies were going hammer and tongs. Having failed to develop a new drug, they decided to come together and share data, leverage funding, and create new ecosystems,” said Meulien.

“So, IMI may not be for everyone and everything, but there is a real sweet spot where it can have an effect,” he said.

Front edge of innovation

The review team says there is not sufficient quantitative data to demonstrate IMI will keep the European pharmaceutical industry at the front edge of innovation. There is however, an acknowledgement that since it got off the ground in 2008, IMI may have increased the resilience of the industry during the global financial crisis. As evidence of this, the review notes the number of clinical trials remained stable across Europe in this period.

In comparison to other EU public-private initiatives, IMI has mobilised significant private investment. However, the report notes, but this mainly has come in the form of in-kind contributions, such as access to research facilities or resources.

The evaluation also questions whether the European Federation of Pharmaceutical Industries and Associations, leader and coordinator of projects for the industry side of the project, was able to adequately tackle new challenges

One recommendation in the report is for IMI to increase collaboration with industry, which notes that participation of SMEs has decreased by almost 30 per cent compared to 2007-2013. Participation from pharma companies is also marginally down.

The EU has put €1.6 billion of Horizon 2020 money into IMI, matched by €1.4 billion of in-kind contributions from pharma companies.

Collaboration partners include universities, smaller firms, patient organisations, and drug regulators.

Of successful proposals made to IMI, a full 91.5 per cent were from researchers based in the richer EU-15 countries, and only 1.8 per cent from EU-13 countries.

Hard to gauge progress

Feedback from patient organisations interviewed for the report is positive. They say they appreciate the opportunity to participate in the design of IMI projects, something which is not possible in other Horizon 2020 projects.

Of the claim in the report that IMI is yet to demonstrate a return on investment, Meulien says, “I have to admit that it’s very challenging, on a broad scale, to measure the impact of investment on health systems and industry competitiveness, and be able to attribute any of this to IMI.”

With the programme running until 2024, this review is not the final word on IMI, which still has a lot of unrealised potential, Meulien said. “The real impact of the programme may not be discovered until after it finishes.”