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Funded by the
European Union

under FP6

 

 

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Fraunhofer ISI  
 
 

Last update
11-Nov-2009

 

 

 

Project information

 

Project data - Background - Aims - Literature - Work Programme

Project data

Specific targeted research or innovation project in the 6th Framework Programme,
Priority FP6-2005-SSP-5A

‘Integrating and strengthening the European Research Area’ -
Impact of new technologies and techniques on healthcare systems

Funded by the European Union under Contract Nr. SP5A-CT-2007-044390

Duration: 24 months (01. Jan. 2007 – 31. Dec. 2008)

Summary of the project and its results 

 Project description at the Scientific Support to Policies programme under FP6

 

Background

High expectations are related to innovations in the healthcare sector with respect to improving the treatment of diseases, saving healthcare expenditures and generating economic benefits such as employment. Particularly the large chronic diseases (as e.g. obesity), in which classical prevention comes to its limits, need target-group specific, innovative interventions, both technology-based and others. The Commission has identified Health Technology Assessment as an important measure to improve the European cooperation to enable better use of resources[1].

A number of European projects to foster HTA has been or is being carried out, e.g. the “European Collaboration for Health Technology Assessment – Assessment of Health Intervention” (ECHTA/ECAHI)[2]. The High Level Group on Health Services and Medical Care[3] has recognised the usefulness of establishing a sustainable European health technology assessment network which should address methods for developing common core information packages, methods to support transferability of assessments, methods for identifying and prioritising topics and commissioning reports, tailoring common core information to national health policy processes and sharing methodologies, expertise and practice issues. As a result, the EUNetHTA[4] project has started to work in 2006.
However, the benefits of health technology assessment (HTA) to improve the evidence-base for medical treatment are generally accepted. However, the potentials of HTA are not fully exploited yet. In classical HTA, which is currently mainly focussed on the health outcomes and economic performance of therapeutic measures, the innovation component is nearly totally missing. Thus, advances in medical technologies especially in their early developmental states are not sufficiently identified and utilized. According to the OECD Health Project relating to new and emerging health related technologies (NEHRT[5]), gaps caused by the lack of good evidence exist in the evidence-base of policy-making related to emerging health technologies.

Secondly, classical HTA very frequently only regards costs and efficacy as endpoints of a treatment and restricts its evidence base on randomised controlled clinical trials (RCTs), thus neglecting the often large amount of other evidence that exists on many aspects of the treatment method under question.

Another critical issue is the aim of classical HTA, which is nearly exclusively used by policy-makers for decisions of marketing authorisation or reimbursement decisions. Other highly important questions as e.g. the need for public funding to support the development of promising technologies or the decision of a producer to stop or continue the development of a technology are not analysed by classical HTA in depth and thus cannot be answered yet systematically[6].
As far as pharmaceutical innovations are concerned, the G10[7] medicines report tries to find a balance between health expenditures and the needs of the pharmaceutical industry. It fosters the development of health technology assessment (HTA) including clinical and cost effectiveness, in the Member States and the EU, while recognising that relative evaluation should remain a responsibility of Member States[8].

However, cost-benefit analyses as one approach to describe the public health impacts of pharmaceuticals are critically seen as a “fourth hurdle” to market access by the drug developers[9]. Recommendations to use primarily medicaments for which the long-term effectiveness has been proven by studies would discriminate against innovative therapies, because new medicaments often lack these studies[10]. The European Federation of Pharmaceutical Industries and Associations (EFPIA) claims that the cumulative benefits of incremental innovation might be overlooked by economic evaluations, which should not be applied arbitrarily to just some interventions (i.e.: pharmaceuticals) and not to others[11].

These shortcomings of classical HTA are based to a large extent on the methodological question of how to evaluate comprehensively the benefits of a healthcare innovation in its early developmental state, at which highest-level evidence for the risks and benefits of the technology is still missing.

Recently, a scientific discussion has started about how classical HTA could be improved in order to better account for the specific necessities of emerging healthcare technologies. Symposia were held to discuss the integration of the innovation aspect into HTA, among others

  • A plenary session on “Innovation, technology and government: role of HTA” and workshops “Emerging technologies”, “Early HTA” and “Early warning and horizon scanning activities” at the conference of HTA International, Rome, June 2005;
  • Conference “HTA: Focus biomedicine”, November 2005, Cologne (chairwoman: C. Wild from partner LBI@HTA)
  • Workshop “The  way of health innovations into statutory health insurance” of the German Network on Evidence-based Medicine, Bochum, March 2006 (speaker: H. Raspe from partner UL-IfSM)

Here, innovation research can contribute a new perspective. Health innovations can be distinguished into technological innovations (novel technologies and treatment methods) on the one side and systemic or organisational restructuring on the other (as e.g. by integrated healthcare models such as disease management programs). The present project will consider technological innovations including pharmaceuticals, novel medical innovations and medical technologies.

To adequately represent the complex process of innovation and distribution of drugs with its implications on the attainment of public health goals, an innovation systems approach is chosen for the present study. Innovation is understood as the whole process from the invention of a new product to the use by the consumers and its effects on the users and on the market. Innovations are developed along the value chain from basic research to broad diffusion within the market through a complex network of stakeholders, the so-called innovation system.

One of the central outcomes of modern innovation research is the finding that innovations do not follow a linear path from basic research to applied research and further to industrial development and market introduction of new products and processes. Instead, innovation activities are characterised by complicated feedback mechanisms and interactive relations, involving different players which have a significant influence on the success of innovations. Innovation processes occur over time and are influenced by multiple factors. The entire innovation process starting from scientific basic research, followed by the commercialisation of research results and industrial development, market introduction of new products, processes or services up to market penetration has to be considered in the analysis.
Different from the concepts of national and technological innovation systems, the concept of sectoral innovation systems (SSIs) is able to describe the innovation process under inclusion of internationally acting firms or organisations. Based on the work of Malerba[12] and Breschi and Malerba[13], SSIs assume that different industries work under specific technological framework conditions, risks and chances, as well as different degrees of complexity of the necessary knowledge base.
The following elements characterise a sectoral innovation system[14] (see Figure 1):

  • Products
  • Actors
  • Knowledge and learning processes
  • Base technologies, means of production used, demand factors and the respective interrelations and complementarities
  • Mechanisms of interaction between companies and other actors
  • Selection processes and competition between the actors
  • Institutional framework conditions, e.g. standards, regulation, labour market

 

Figure 1. Sectoral innovation system

Generic innovation system
Source: Fraunhofer ISI, modified from Senker, J.; van Zwanenberg, P.; Enzing, C.; Kern, S.; Mangematin, V.; Martinsen, R.; Munoz, E.; Diaz, V.; O’Hara, S.; Burke, K.; Reiss, T.; Wörner, S. (2001): European Biotechnology Innovation System. Brussels: European Commission

The present study will include at all stages the points of view of the most important actors.
To be able to regard the whole innovation process for healthcare technologies, the most important aspects of the total healthcare innovation system have to be covered by methods and indicators more comprehensively than it is possible to date. Examples for innovation indicators in the healthcare sector are:
for the performance of the innovation system:

  • number of publications or patents granted with relation to a particular technology,
  • number and scope of clinical trials carried out for the technology,

for patient outcomes:

  • efficacy, effectiveness,
  • quality of life,

for healthcare system outcomes:

  • costs, cost-benefit-ratio etc.

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Aims

The present project aims at helping to close the gap between the development of new technologies on the one hand and their application within the healthcare system on the other hand. To meet this objective, a generic methodology for the evaluation of healthcare innovations is developed. The methodology expands the focus of HTA to a comprehensive assessment of innovations in the healthcare system. Considered is the technology as such, its scientific foundation, potentials, its implementation and effects on society as well as implications of adoption or non-adoption, to inform policy-making, economy, but also healthcare professionals, health service providers as well as health insurance institutions.

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Literature

[1] European Commission (2004). Communication from the Commission - Follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union. COM(2004) 301 final

[2] Jonsson, E., Banta, D., Henshall, C., & Samietro-Colom, L. The ECHTA/ECAHI Project. Stockholm: Swedish Council on Technology Assessment in Health Care

[4] EUNetHTA coordinates the efforts of 27 European countries including 24 Member States of the European Union in evaluating health technology in Europe (http://www.eunethta.net). The EUNetHTA project objectives are to provide a robust multi-faceted input to decision making; use limited resources to undertake a wider range of HTAs; gain a better understanding of the links between HTA and policy making in different Member States; and support counties with limited HTA experience. The project is co-financed by the European Commission DG Health and Consumer Protection.

[6] The project MATCH is a research collaboration between five leading UK universities in healthcare technology assessment, and a cohort of industrial partners. It aims at informing the manufacturers of medical technology about emerging technologies, whereas the main target groups of Inno-HTA are policy-making, healthcare professionals, and the public. Experts from this project will be invited to participate in the external expert panel of Inno-HTA.

[7] The High Level Group on Innovation and Provision of Medicines – The G10 Medicines Group – was set up by Commissioners Liikanen and Byrne in 2001. The objective of the group was to review the extent to which current pharmaceutical, health and enterprise policies can achieve the twin goals of both encouraging innovation and competitiveness and ensuring satisfactory delivery of public health and social imperatives. The final report was published in May 2002 (High Level Group on innovation and provision of medicines (2002): Recommendations for action, Brussels: European Commission.).

[8] High Level Group on innovation and provision of medicines 2002

[9] Scheuble (2002): Negative Prognose für den Pharmastandort Deutschland im Jahr 2003. In: Die Pharmazeutische Industrie, 64 (12), 228-231.

[10] Fink-Anthe (2002): Chronisch krank. In: Die Pharmazeutische Industrie, 64 (9), 164-166.

[11] EFPIA (2001): G10 Medicines High Level Group on innovation and provision of medicines consultation paper - EFPIA comments: EFPIA (Accessed: 03).

[12] Malerba (2002): Sectoral systems of innovation and production. In: Research Policy, 32, 247-264.

[13] Breschi, Malerba (1997): Sectoral innovation systems: Technological regimes, Schumpeterian dynamics, and spatial boundaries - Systems of Innovation: Technology, institutions and organisations, Edquist, C., London: Pinter.

[14] Jungmittag et al. (2000): Changing Innovation in the Pharmaceutical Industry. Globalization and New Ways of Drug Development, Berlin: Springer.

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