Brussels, 18 th June 2009
State aid: Commission gives France the go-ahead to grant €33 million to Carmat's R&D programme for the development of an artificial heart
The European Commission has decided not to raise any objections under the EC Treaty state aid rules to the financial support of €33 million granted by France to Carmat's R&D programme. The lead company, Carmat S.A.S., backed up by four industrial partners and a large number of SMEs acting as subcontractors, will have the task of designing and developing an artificial heart that is fully implantable, together with the associated electrical supply and telediagnostic systems. After scrutiny, the Commission concluded that the programme was compatible with the R&D&I framework (see ). In particular, it remedies a market failure, and it will have a positive impact, especially in the public health sector, without significantly altering competition conditions.
Competition Commissioner Neelie Kroes said: "Thanks to this very innovative programme, within a few years Europe will have an implantable artificial heart which will significantly improve life expectancy and quality of life for thousands of patients. I am delighted to be able to approve aid to help develop a project like this, whose positive impact will far outweigh any distortions of competition to which the aid might give rise."
The Carmat programme focuses on patients suffering from advanced heart failure who cannot undergo transplants and who have exhausted all the available options as regards medicine use. Advanced heart failure is a major public health problem which affects several million people worldwide. It is a physiopathological condition in which a heart function anomaly reduces the capacity of the ventricles to contract. They then become incapable of maintaining a level of blood flow that meets the body's metabolic needs. In other words, the heart no longer functions as a pump. Apart from heart transplants, which cannot meet all existing needs, given the limited number of organs available and the fact that there are adverse side-effects for many patients, there is currently no medical treatment available for patients with advanced heart failure.
The Carmat R&D programme will extend over five years and involve a total of about €74 million of eligible expenditure. State aid of €33 million will primarily benefit Carmat S.A.S., the company leading the project (€31 million, of which €14.5 million in the form of refundable advances).
This aid is an instance of the application of scheme N121/2006, approved by the Commission on 19 July 2006 (see ). On 7 January 2009, France notified aid of €31 million to Carmat S.A.S., whilst the other partners were to receive smaller amounts of aid which did not, therefore, have to be notified for individual examination.
The Carmat programme will provide a major boost to public health. The cost of treating advanced heart failure with the Carmat heart should be significantly lower than that of a heart transplant. Moreover, the Carmat heart should improve the patient's quality of life, as it does not involve extensive immunosuppressive treatments, but nonetheless enhances patients' mobility and in some cases enables them to return to work. In addition to these benefits to society, the dissemination of knowledge will have a positive impact on applications other than those developed by Carmat SAS, such as the medical use of biosynthetic materials. The free play of market forces would never have provided the incentive for spontaneous investment in these extremely risky technologies, where the outcome is very uncertain .
Finally, any distortions in competition arising from state aid will remain limited, as the amount of aid is small in comparison with total R&D spending in the sector and the recipient envisages that the market share will be limited (7.3%). Moreover, complementary solutions exist and if this endeavour is successful Carmat will be helping to create a new market, so there is no doubt that competitors will continue to invest in the sector.
The non-confidential version of the decision will be made available under case number in the on the website once any confidentiality issues have been resolved. The electronic newsletter lists the most recent decisions on state aid published in the Official Journal and on the website.