Generally speaking, basic parameters must be shaped in such a way that they ensure the neces- sary foundation for the provision of health care services and impede as little as possible the use of
A lighthouse project – The electronic health data card
An interconnected health care system not only improves the quality of health care, it also operates more efficiently and saves costs. Such a system requires all participants in the health care system to be interconnected with the help of information technology – as is being targeted with the electronic health data card and its telematics infrastructure. The electronic health data card provides a foundation for and thus opens the door to other important telematics applications such as the electronic patient file.
Germany's Health Care Modernisation Act which went into effect on January 1, 2004 pro- vides the legal foundation for incrementally converting the current health insurance card into an electronic health data card. The trial phase involving lab tests began in late 2005 and will lay the groundwork for testing the electronic health data card in eight of Germany's 16 Länder. Besides demonstrating that the technical solutions being deployed are suitable for practical use, these tests also aim to prove that the electronic health data card meets Ger- many's stringent data protection requirements which are designed to protect patient privacy.
34 Full steam ahead – The individual innovation strategiesHIGH-TECH STRATEGY FOR GERMANY
new products in the health care field. This will be taken into account in the German government's overhaul of the health care sector. The high quality of medical treatment must be maintained. At the same time, treatment must be cost-efficient in both clinical and economic terms. In addition, speedy and safe approval procedures for diagnostic agents, medical equipment and new con- cepts for health care and medical treatment are of fundamental importance – as is launching innovative medicines at an early point in time. Important improvements that are helping clinical trials include the restructuring of Germany's Federal Institute for Drugs and Medical Devices and the health insurance companies' coverage of the medical costs of hospital patients who are parti- cipating in a clinical study. Efforts are now underway to make it possible for health insurance companies to cover the medical costs of individuals participating in clinical trials being con- ducted in an ambulatory setting. Current discussions are examining whether health insurance companies have the right to commission research work such as clinical trials. European regula- tions in the medicine and medical devices field should be transposed into German law in such a way that they do not lead to any special impediments to research into or the development of new and innovative methods of treatment. The German government is also working to achieve recip- rocal international recognition of GxP certification (which currently does not exist with the USA).
In order to facilitate the introduction of new types of treatment, diagnostic agents and medical devices to the market, decisions on whether insurance companies will include them in their coverage must also take into consideration not only the improvements they bring to the quality of health care but also the macroeconomic benefits offered by their long-term savings potential.
Of the advanced biology-based technologies, biomedicine enjoys the greatest trust among the public. The high degree of transparency in the research field, flanking bioethics debates and information campaigns regarding the opportunities and risks of the underlying technologies will continue to strengthen this trust. Political strategies for developing biomedicine will also continue to include bioethical and social aspects.
Individual research and innovation policy initiatives 2006 – 2009
• A roadmap process conducted by the Health Research Council will identify future funding prior- ities in preparation of a new health research pro- gramme.
• Basic genetics research will be continued and will be boosted by translational approaches.
• Infection research, particularly on zoonoses, will be expanded.
• Priority will be given to clinical research.
• A funding priority for Molecular Diagnostics and a funding priority for the Development of Innovative Medicines will be established to improve Germany's attractiveness as a location for pharmaceutical research and production.
• An action plan will be developed for assisting and fostering medical technology.
BMBF, BMG
BMBF
BMBF, BMG, BMELV
BMBF, BMG, BMAS
BMBF
BMBF
2006/ 2007
2007
2006
2006
2006
2006
• The High-Tech for Health funding initiative targets the development of medical procedures that en- able early, accurate diagnoses and gentler treat- ments and make it possible to assess the effects of individual medicines at an early point in time.
• The funding provided for initially two Translational Research Clusters in the highly-innovative field of regenerative medicine will support prototypal implementation concepts in which insurance com- panies and regulatory authorities are also involved.
• Prevention and gerontological research will be strengthened and improved.
• Conditions for conducting clinical trials in Germany are to be improved through funding initiatives to establish clinical trial centres at university medical clinics, nationwide networks on major diseases, and integrated research and treatment centres.
• Provisions under which health insurance companies will cover the cost of medical care during clinical studies conducted on an ambulant basis will make Germany more innovation-friendly as a location for pharmaceutical research and production. In add- ition, the question of whether statutory health in- surance companies should be allowed in future to commission research work such as health care research or studies on issues of relevance to the provision of health care will examined.
• The introduction of the electronic health data card will push forward the nationwide use of ICT in the health care system and concomitantly open up untapped potential for greater efficiency.
• Funding initiatives for tapping neuroscience's innov- ation potential for applications in the health care field, information technologies and education.
BMBF
BMBF
BMBF
BMBF
BMG, BMBF
BMG
BMBF
Starting 2006
Starting 2006
Starting 2006
Starting 2007
Starting 2006
Starting 2006
Starting 2006
Please see page 107 for an explanation of the abbreviations used here.
36 Full steam ahead – The individual innovation strategiesHIGH-TECH STRATEGY FOR GERMANY