Brussels, 09 May 2005
Responding to the Commission's proposal on the Seventh Framework Programme (FP7) unveiled on 6 April, Eucomed, the European Medical Technology Industry Association, has published ten key recommendations 'to boost medical technology innovation in the European Union'.
The recommendations are designed to help the Commission reach its goal of improving European citizens' health. As Eucomed explains, healthcare in an ageing Europe is currently a major societal challenge. The EU must, therefore, innovate in order to meet patients' needs, and to use the available resources more efficiently. More effective treatments lead to reduced hospital stays, a better prognosis for the patient and a faster return to a normal contribution to society.
'Innovation is critical for the health of citizens, the economy, employment and, indeed, the overall well-being of society. However, the European Union is still being surpassed by the US and Japan in terms of investment in medical technology R&D [research and development] and in terms of patient access to new treatments and technologies,' says Maurice Wagner, Director General of Eucomed.
The recommendations, which, according to Eucomed, should be considered as a 'package', include establishing an autonomous network of 'Medical Technology Innovation Centres' in Member States, coordinated centrally. These centres would facilitate the dissemination of 'innovation skills' and facilitate the networking between the European medical technology industry, research establishments, universities and other key European stakeholders. The approach of these centres would be centred on bringing new medical technologies as quickly as possible to the patient.
The second recommendation is the development of innovation (and patient) friendly regulations. 'Given that medical innovation is continuing rapidly and that there is an increasing trend towards convergence of technologies such as advanced materials science, cell and tissue biology, IT [information technology] and nanotechnology, Eucomed wishes to strongly emphasise the importance of ensuring that any future Directives/Regulations are as flexible as possible regarding innovation and promoting a variety of technical solutions whilst remaining robust enough to guarantee patient safety and effective performance of medical technology products,' states the association.
In view of the fact that Healthcare Technology Assessment (HTA) schemes are currently neither uniform nor reflecting new technologies adequately, the third recommendation advocates coherent and well-designed HTA schemes. This is especially important as HTAs vary considerably in their design and application in the different Member States.
Fourthly, Europe must be made more attractive to the best researchers and innovators.
The fifth recommendation calls for a European governance that takes into account the specific needs of medical technology. This include: the need to give European patients access to new medical technology and better quality of life; the need to take account of frequently underestimated or neglected benefits of medical innovation such as earlier disease detection, better treatments and prognosis and more efficient healthcare procedures, reduced hospital stays, faster recovery and return to a contributive role in society for patients; the need to balance risks, benefits and costs; the EU´s social responsibility of the well-being of the patients, and the need to take account of the medical consequences of the demographic changes in society.
The structuring of EU framework programmes to better support SMEs is the sixth recommendation. SMEs are responsible for some of the most active areas of medical technology innovation, and for some of the most exciting new treatments for patients. Yet they do not necessarily have the means or expertise to access EU R&D programmes. Eucomed therefore recommends that the administration of, and access to, EU R&D research programmes should be greatly simplified in FP7. Furthermore, 'Eucomed puts emphasis behind highlighting the low priority of medical innovation in comparison with some other subjects, e.g. agriculture, in the Structural Funds, and suggests, given the demographically important impact and improved healthcare provision in the future, that a better complementarity can be found between the Structural Funds and EU research to support medical innovation and new technology in the future,' states the position paper.
Closely related to this recommendation, the seventh suggests improving access to framework programme projects. According to Eucomed, there should be a much-increased focus on medical technology innovation in FP7 since health is a primary concern of citizens and a cornerstone of EU policymaking.
'In addition to their scientific excellence, Eucomed recommends that weighting medical innovation and technology could be given to projects based on their medical contribution to improving society and the quality of life of lots of individual patients,' it urges.
The eighth recommendation deals with improving intellectual property right (IPR) protection. For Eucomed, IPR is an absolute prerequisite to technological progress, and it considers therefore that the Commission should pay particular attention to: reaching the objective of creating a community patent, possibly in addition to national patents; deepening contacts with the European Patent Office (EPO) and developing and implementing simplified procedures; establishing and maintaining contacts with OECD and other stakeholders.
Turning to Community patents, Eucomed deplores the fact that in Europe there is an obligation to pay fees in all countries compared to one fee only, for example, in the US.
'Eucomed is, therefore, strongly in favour of a simplification of the existing patent procedures and proposes that the European Commission take steps, in conjunction with the EPO, to simplify patent systems.'
Emphasising the need for solid patents for frictionless research and innovation, Eucomed draws attention to the counterfeiting of valuable medical technology from the Far East. 'The European Commission should take measures to prevent access to the European market of counterfeited innovative technology products and, furthermore, should work with its regulatory counterparts internationally in order to seek a global solution to this increasing problem,' it urges.
The ninth recommendation deals with a better definition of the educational needs, and the tenth with the financing and improvement of capital conditions for innovations, especially for SMEs. For Eucomed, the EU should provide substantial funding for innovation in the medical sector, not only in the interests of the patient and society, but also in order to retain the competitiveness of the industry and the creation of employment in Europe.
'It is Eucomed´s view that far better financial support mechanisms are required to support the interests of innovators and entrepreneurs in the innovation process, and the EU should encourage such support amongst its Member States,' reads the paper.
'There are a number of facets to the capital conditions for innovations in the medical technology sector, including elements outside the immediate influence of the European Commission, such as the level of investment by venture capital organizations and cultural differences between the US, Japan and EU in approaching 'business risk'. A study of such differences between the United States, Japan and Europe is urgently required to take the necessary EU actions to establish a balance between US, Japan and EU innovation economy,' concludes the Eucomed position paper.
To read the position paper in full, please visit:
http:///www.eucomed.org/?x=13&y=29& am p;z=58&id=614