A silver bullet for Europe’s health challenges: The birth of IMI (Guest blog)

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 understood that a fresh evaluation of the situation was essential if Europe wanted to improve health by speeding up the development of, and patient access to, innovative medicines – particularly in areas where there an unmet medical or social need remained.

There were a number of immediate points for consideration. The industry was faced with: scientific opportunities, but complex science; high attrition rates for safety reasons, because of an underperforming, predictive toolkit and a poor understanding of the pathophysiology of diseases; and a dramatically long duration from discovery to delivery to patients, which was further exacerbated by a siloed approach – that is companies doing the same things at the same time and failing.

These thoughts sowed the seeds for Europe’s largest public-private partnership in the life sciences area: the Innovative Medicines Initiative.

Despite numerous recent advances in research, we were conscious that massive gaps still existed in our understanding of the pathophysiology of many diseases and, as a result, it was becoming increasingly difficult to develop therapies for these unmet medical needs.

It was also vital to recognise that a company or institution would find it extremely difficult to address these knowledge gaps on their own, as this would entail the analysis of a large series of data that, in reality, was fragmented.

Tackling these issues clearly required a step-by-step approach. The group of Research Directors of EFPIA, therefore, made an initial attempt to set up a collaborative framework of research, involving a few companies within the EU Commission Framework Programme. This effort, which focused on toxicology, established a solid foundation on which to build on the concept of an expanded collaborative network, which would include not only companies but also a wide variety of other public stakeholders, in academia, for example.

With the groundwork for a “Private/Public alliance” already laid, we entered into discussions with the European Commission – which was itself arriving at the same conclusion on the value of intensifying industry participation in collaborative research initiatives – focusing on how we could transform from concept to reality in a revolutionary approach that was detached from the methodology that underpinned traditional Framework Programmes.

We eventually discovered how to do this through the concept of Joint Technology Initiatives (JTI). This represented a groundbreaking legislative platform on which we could establish independent public-private partnerships.

The road ahead was by no means smooth: it took long time to discuss with all EU institutions the most delicate principles around this JTI, including the rules on Intellectual Property and the way in which we would match the contributions that were coming from the European Union.

With regard to the latter, we decided that a vital element of this deal would be to have participating EFPIA companies to contribute, not with cash, but with “in-kind” support. The clear reasoning was that this would push companies to engage actively in these collaborative research programmes either with human resources, with data or with scientific knowledge.

Finally, we decided that the first programmes would be launched in pre-competitive areas. This was an essential element because it would foster collaboration among scientists of different companies and institutions.

These key principles continue to underpin the Innovative Medicines Initiative, which has kicked off more than 70 projects involving more than 7000 researchers from public and private sectors.

Carlo Incerti

Carlo Incerti is Senior Vice President; Head of Global Medical Affairs at Genzyme and serves on the governing board...
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