The European Commission, DG Enterprise and Industry, Pharmaceuticals Unit commissioned the Fraunhofer Institute for Systems and Innovation Research together with the Coordination Centre for Clinical Studies at the University Hospital of Tübingen (KKS-UKT) with the project “Assessment of the European Community System of Pharmacovigilance” (EU Contract-No. FIF.20040739).
The "MetaForum Innovation for more Health" started as a project at Fraunhofer ISI under the leadership of Bernhard Bührlen, including a series of three conferences 2007-2009. It is now a private non-profit association for the promotion of innovation in healthcare, developing concepts and carrying out discussion events to foster interaction between all relevant stakeholders with a focus on policy-makers.
As a funding agency for innovation, the Swiss Commission for Technology and Innovation (KTI/CTI) supports joint projects of enterprises and research institutions. Based on a study by Fraunhofer ISI from 1996, the KTI Initiative MedTech started its project funding in 1998. Flanking that, communication activities, support of SMEs in quality assurance, coaching of start-ups, identification of new problem areas and challenges as well as of existing competencies, agency of contacts and of market information about medical technology were offered as accompanying measures.
Potential chances and risks of tissue-engineering
Clinical research is of paramount relevance for the development of new pharmaceuticals and other medical treatments as well as for securing and optimisation of their application in routine practice. All clinical studies are regulated by the German pharmaceuticals law (Arzneimittelgesetz, AMG), insofar as they assess the efficacy, safety or metabolisation of pharmaceuticals with the aim to test their safety of efficacy. This type of clinical studies is called "clinical trial" ("klinische Prüfung").
German policy-making has undertaken important steps to strengthen clinical research in Germany. However, the industry continues to complain about disadvantages in the competition with other countries. Although the number of clinical studies has been rising during the last years, this increase has been significantly bigger in some competing countries. In the long run this could impact on employment and supply of patients with innovative pharmaceuticals, as new products are introduced preferredly in those countries in which the clinical trials had taken place.
Evaluation of a EU research funding line
Innovations in healthcare are discussed controversially, with high uncertainty about costs and outcomes. In part because of methodological constraints, health technology assessment (HTA) to date mainly restricts itself to treatments that are already marketed. Regarding emerging healthcare technologies, the assessment criteria commonly used do not support the many decisions that need to be made in earlier phases of the development process by the different stakeholder groups (e.g. researchers, industry, healthcare professionals, patients, health insurers, policy-makers). Therefore, advances in treatments or technologies are often not sufficiently utilized.