The European Parliament has given its approval to the Innovative Medicines Initiative (IMI), the joint programme for public-private research partnerships initiated by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
A report on the Commission’s proposal for a Council regulation setting up the IMI as a Joint Undertaking was published by the European Parliament’s Committee on Industry, Research and Energy (rapporteur: Françoise Grossetête) on 28 November. It was subsequently adopted by Parliament on a show of hands on 11 December.
The IMI was one of four Joint Technology Initiatives (JTIs) voted through by Parliament after the EU’s Competiveness Council agreed a “general approach” to the proposals at its meeting on 22-23 November. The JTIs are a new model for 10-year public-private partnerships combining industry, member state and Commission resources under the EU’s 7th Research Framework Programme.
The parliamentary vote and the nod from the Competitiveness Council clear the way for a swift transition to final approval by the EU’s Council of Ministers, which means the Joint Technology Initiatives should be able to get started in early 2008. The initiatives will be implemented by giving them the legal status of Joint Undertakings, as suggested by the Commission when it tabled the first two JTI proposals (the Innovative Medicines Initiative and Embedded Computing Systems) in May.
The short- and long-term objectives of the Innovative Medicines Initiative are to eliminate bottlenecks in drug development; come up with new and improved tools/methodologies to predict the safety and efficacy of medicines; reinvigorate the European biopharmaceutical sector to the benefit of patients; and establish Europe as a prime location for research and development.
The initiative will be jointly funded by the 7th Framework Research Programme and the EFPIA plus its member companies, to the tune of €1 billion apiece over a seven-year period. Research conducted by the pharmaceutical industry under the IMI will be financed out of its own resources, while the EU funding will support research by the public sector (e.g., academia, patient organizations) and small- and medium-sized enterprises (SMEs).
Research activities will take the form of collaborative projects between public and private entities, selected through open calls for proposals and a peer review process. The research must involve two EFPIA independent legal entities and two non-EFPIA independent legal entities per project, and must be carried out in Europe or a country associated with the 7th Framework programme.
Fresh avenues
The types of research envisaged under the Innovative Medicines Initiative include applying genomics and other new technologies to open up fresh avenues in drug discovery and development; or using advances in predictive toxicology (toxicogenomics, toxicoproteomics, metabonomics) and improved understanding of disease mechanisms through approaches such as systems biology to establish an investigational compound’s safety and efficacy profile as early as possible in the drug development process.
Also key to the initiative is knowledge management, so that the potential of technologies such as genomics and proteomics can be optimised through integrated analysis of the huge volume of information they generate. The programme will also include education and training projects designed to identify and address specific gaps in European biomedical expertise.
The first call for proposals under the Innovative Medicines Initiative is now expected to be published next February, when there will be an official launch of the IMI Joint Undertaking. The deadline for Expressions of Interest will then be May 2008, with invitations to submit full project proposals going out in July. The agreed research projects should kick off in November 2008, with a second IMI call scheduled for publication in January 2009.
A total of 18 research projects have already been proposed for next year’s funding round, five of them in the field of safety prediction, one on pharmacovigilance, two on diabetes, three on brain disorders, two on respiratory diseases and five on education and training.
