Europe publishes Innovative Medicines Initiative regulation
The regulation on the Innovative Medicines Initiative (IMI), a public-private partnership aimed at speeding up the development of new treatments, has been published in the Official Journal of the European Union.
The regulation on the Innovative Medicines Initiative (IMI), a public-private partnership aimed at speeding up the development of new treatments, has been published in the Official Journal of the European Union.
The regulation provides for the creation of a joint undertaking between the EU and the pharmaceutical industry. Up to the end of 2017, the IMI Joint Undertaking will award grants following competitive calls for proposals.
The EU will contribute a maximum of Euro 1bn, taken from the Seventh Framework Programme for research and development. The pharmaceutical sector will make the same value contribution in kind, such as staff, lab space and equipment.
A range of organisations will be eligible for funding from the IMI, including micro, small and medium-sized enterprises, not-for-profit public bodies, intergovernmental organisations, secondary and higher education establishments and patient groups. But participating pharmaceutical companies that are members of the European Federation of Pharmaceutical Industries Associations (EFPIA) will not be able to benefit from financial support from the IMI Joint Undertaking for their activities.
All legal entities exercising activities linked with the objectives of the IMI Joint Undertaking in an EU member state or country associated with the Seventh Framework Programme can participate in the project, while all other entities may participate if the governing board so decides.
The scheme allows participants to retain intellectual property they enter the project with, or generate during the projects, except when they agree otherwise.
The IMI Joint Undertaking will be able to carry out its own internal audit, while the European Commission, assisted by independent experts, will carry out interim evaluations. The Commission will present an annual report to the European Parliament and the Council on the IMI's progress.
The founding members of the IMI are the European Commission and EFPIA, but under certain conditions, any legal entity supporting r&d in a Member State or a country associated with the Seventh Framework Programme can ask to become a member of the IMI Joint Undertaking.
Each member of the Joint Undertaking may have a maximum of five representatives on the governing board. The board makes decisions by a three-quarters majority, with each founding member having five votes.
It will meet at least twice annually, will appoint the executive director for three years and also has the power of dismissal.
The governing board can consult a 15-member scientific committee, composed of experts from universities, patient organisations, industry and regulatory bodies it chooses from states participating in the programme. The committee will offer its opinion on the relevance of the r&d programme and on the scientific priorities.