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IMI Big Data and Health Outcomes Programme – Streamlined after Consultation – Calls to be published in September


There is an overall consensus amongst healthcare professionals, pharmaceutical manufacturers, payers and other stakeholders that the use of big data will lead to better patient outcomes and thereby relieve pressure on health budgets. The increasing availability of large health and population data sets, combined with growing analytic capabilities will undoubtedly drive improvement in the value of healthcare delivered.

It is against this backdrop that plans for an Innovative Medicines Initiative programme focused on maximising the potential of big data in healthcare are gathering pace. The aim has been to catalyse and support the evolution towards outcomes-focused and sustainable healthcare systems in Europe. The latest contribution to this project is a set of results to the IMI Consultation Paper, “Big Data for Better Outcomes – concept for an IMI2 programme”, which was launched in May this year.

It is the first time that IMI has published a concept well ahead of a call for expressions of interest. This means a process that was formerly internal to industry alone, simultaneously has been opened up to scrutiny and for input. It is the input element that will inform ongoing project generation and may inspire additional projects in the future.

The results of the consultation come in the form of answers to four crucial questions that were posed to stakeholders and were designed to move the project forward on a basis of consensus. The actual response has been encouraging, with some 100 people attending the Stakeholder Forum session (viewable on IMI’s YouTube Channel) and 24 written responses received by e-mail.

The foundation is solid: responders considered the scope and objectives of our public health-driven programme to be relevant and clear. In fact, the clarity of the message has prompted more organisations to show interest in joining current or future proposals within the programme.

Consultation contributors’ suggestions also left the programme positively swimming in the number of therapeutic areas that might benefit from its approach. These included: cardiovascular diseases; oncology; respiratory diseases; rare diseases; multiple sclerosis; dementias and age-related cognitive disorders; as well as human infertility; medication during pregnancy; chronic disease in the elderly, with consideration for personalised care, including upcoming innovative treatments.

In fact, the good news is that diseases with high economic burden are already being addressed, such as Alzheimer’s disease, cardiovascular diseases and cancer.

The projects will also address a number of questions raised in the consultation about the sustainability of the programme results (outcomes definitions and data) as well as data privacy and quality, access to various information sources and interoperability. We have already reached out to – and continue to reach out to – data companies, encouraging them to collaborate with EFPIA members as part of the industry consortium on the projects.

The programme also acknowledges the valuable commodity of active involvement by patients. This includes a commitment to following a patient-centric approach, including holistic and personalised management of patient health, analysis of patient pathways, the use of wearables and digital health to improve care, among other things. Patient participation will be made explicit in any future call text for projects.

We have additionally given concrete backing to responders’ calls for multiple partners, beyond patients and patient organisations, to be involved in the programme for it to be successful. This includes, but is not limited to: healthcare providers; physicians; regulatory bodies; health technology assessment associations; payers; academia; scientific groups; registries; organisations with access to long-term follow-up data in real-life situations; experts in managing governance and patient rights; data and bioinformatics ethicists; experts in data analysis (clinical, epidemiological, health economic); key opinion leaders and data collection software companies.

It is important to stress here that the programme will be open to all interested stakeholders.

An equally vital message that needs to be underscored, though, is that it is only within the framework of a multi-stakeholder effort, such as IMI, that a cross-sectoral, integrated approach to finding new solutions to pan-European health care issues can be found effectively. IMI is the world’s largest public/private partnership in life sciences, funded equally by the European Union and EFPIA. Moreover, EFPIA member companies contribute voluntarily and do not receive any funding from IMI or other contributors.

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EFPIA Science Policy Director

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