Health in Europe: A Strategic Approach. Consultation Statement from the Secretariat of the Public Health Genomics European Network (PHGEN)

Transcription

1 Health in Europe: A Strategic Approach Consultation Statement from the Secretariat of the Public Health Genomics European Network (PHGEN) The Public Health Genomics European Network (PHGEN) welcomes the drafting process for a new health strategy which has been initiated by the DG SANCO. PHGEN has expressed its vision for a health strategy which embraces the upcoming genome-based knowledge in various public statements and consultation processes. The new consultation process which intends to set the scene for a coherent health strategy in Europe continues the efforts of the European Commission which entered a new action level with the implementation of the Lisbon strategy in The dynamics of the Lisbon strategy for more growth and the implementation of innovations need to be extended to the health sector. As the secretariat of the PHGEN- Network we would like to contribute to this process by sharing our ideas and concerns about the current state of EC policies on health protection and prevention. Europe needs a wide and conceptual understanding of health and the determinants which influence the health of the European population. The understanding must be evidence-based and innovation friendly in order to have a maximum impact on health, the health care infrastructure, health technologies and economic growth in the health sector. Therefore we strongly support the desire of the DG SANCO for a "new overarching, strategic framework" which guides the future work on health in Europe. Such a framework would fall short from the tasks of the European Commission, as e.g. determined by Art 152 of the EC Treaty, if it was intended to be reduced to the sheer economic impact of health determinants. The EC needs to transfer its "health in all policies" strategy to real life. Thus, a focus on industry applications and short term economic effects is too narrow. A framework which includes the upcoming genome-based knowledge and combines the understanding of health determinants with strategies like health technology assessment would turn Europe into a more innovative and healthier place to live. Earlier and better targeted primary prevention which is based on reliable health information could substantially contribute to the subsidence of costs deriving from secondary and tertiary prevention. A concerted strategy of the DG SANCO potentially enfolds the economic and health outcomes and improves the well being of the European population. 1

2 Within its Discussion Document the DG SANCO highlights some "New developments on health threats" which illustrate the need for a European strategy that adds a particular value to the national programs in the health sector. We are concerned about the fact that a long term strategy, which needs to bridge change from a morphological to a molecular and genotype orientation in medicine, could be based on these exemplars which are either snapshots of current hot topics or / and which do not represent the long term needs of European populations. We would expect the European Commission to draft a strategy which supports the underlying changes in medicine and health service provision; from our perspective the EC could have more impact if it explored the interfaces and obstacles of health strategies with a special focus on genomic and other health determinants. The genomic determinants of common complex diseases represent an overwhelming quantity of the disease burden in Europe. The burden of disease, e.g. deriving from cardiovascular diseases, can not be lowered by developing a one size fits all strategy for a very small sector, e.g. a program for more physical activity of minors. In contrast it is necessary to understand influences of genomic, lifestyle, food, work place and other social determinants in order to develop risk adjusted actions. Therefore already now new strategies for using also genetic and genomic information for the improvement of the health in the population are becoming available i but further development is needed. The success of the new health strategy and the health in all policies plan depends on the outcome effects. Due to the revolution in medicine and the need for better outcome data the EC has to strive for a better understanding of the utility and effectiveness of novel technologies. The emerging technologies which are based on upcoming genome-based knowledge can only be transferred to practice if the EC supports translational research which includes the ethical and legal aspects. For the field of Public Health Genomics this vision has been summarised in the Bellagio Statement that defines Public Health Genomics as: "The responsible and effective translation of genome-based knowledge and technologies for the benefit of population health". We would be pleased to see a similar conceptual strategy for Europe as the words responsible and effective include the societal responsibility of health policy making in a changing world of medicine. During the last years the amount of gene tests for identifying diseases or disease risks rises (Figure 1). ii So far novel technologies such as gene tests suffer from a lack of quality data regarding the overall utility including clinical utility and the EC should support the work of projects and networks which address this issue. 2

3 Figure 1: Number of international available gene tests from Different from other regions many useful and positively evaluated inventions are not applied and marketed in Europe because national health care systems do not cover these inventions. This means a severe threat both to health care / prevention and economic growth. The structure of health systems in the EC affects the economic performance in the field of genomics and biotechnology. The integration of health information, health determinants and new health technologies would have a positive effect on both the quality of care and the European economy as health is promoted and new technologies are used to lower the burden of disease deriving from common complex diseases. Examples of technologies being under evaluation for application are shown in table 1, where the research topics of the Centers for Disease Control and Prevention project EGAPP (Evaluation of Genomic Applications in Practice and Prevention) are listed. Table 1: Research topics 2007 of the CDC project " Evaluation of Genomic Applications in Practice and Prevention (EGAPP), Source: Muin Khoury, PHGEN network meeting February 2 nd EGAPP topics Proteomic tests for ovarian cancer detection and management - Hereditary nonpolyposis colorectal cancer (HNPCC) screening - Cyp450 Polymorphisms testing in adults with depression - UGT1A1 testing in colorectal cancer patients treated with Irinotecan - Impact of gene expression profiles on breast cancer outcomes - Use of genomic profiling to assess cardiovascular risk and identify individualized prevention strategies - Cyp450 testing to predict response to pain Management with codeine 3

4 In the 2002 "Life Sciences and Biotechnology A Strategy for Europe" communication (2002/C55/03) the European Commission has paved the way for a coherent strategy in Europe. In the section on the "Potential of Life Sciences and Biotechnology" the Commission has highlighted the goal of a personalised and preventive medicine that includes gene testing and other genome-based approaches. The paradigm shift which goes along with these tasks requires a broad understanding of health and concrete transferral of health into all policies. The SANCO should therefore develop a health strategy which is in principal open to genome-based approaches and answers the needs of Europe in the 21 st century, both in the fields of health and economy. With a contiguous health strategy for Europe which endorses the interdisciplinary endeavour for an outcome oriented health policy the DG SANCO could emphasise the leading role of the EC as a European health policy pacemaker. So far, the current discussion document falls short from this ambitious goal. For further information please contact: Project leader / Project coordinator Dr Helmut Brand M.Sc. / Dr Peter Schröder Institute of Public Health NRW Westerfeldstr. 35/37 D Bielefeld Germany Tel.: / 261 Fax: phgen@loegd.nrw.de Project Speaker / Senior Researcher Prof. Dr. Angela Brand MPH / Tobias Schulte in den Bäumen German Center for Public Health Genomics (DZPHG), c/o University of Applied Sciences Kurt-Schumacher-Str. 6 D Bielefeld Germany Tel.: or 7865 angela.brand@fh-bielefeld.de tsidb@fh-bielefeld.de i Already existing new strategies are getting available in the pharmacogenomical sector, where for example tests which give information about adverse drug reactions are applicable [Roses AD. Pharmacogenetics and drug development: the path to safer and more effective drugs. Nat Rev Genet 2004;5: ]. Furthermore the family history approach is applicable for getting combined information about inherited and life style risk factors [Yoon PW, Scheuner MT, Peterson-Oehlke KL et al. Can Family History Be Used as a Tool for Public Health and Preventive Medicine? Genetics in Medicine 2002; 4(4): ]. ii Within the Public Health Genomic European Network it is decided in the current stage to differentiate genetic testing and gene testing. They are defined as followed: Genetic Testing = refers to any test/diagnosis that delivers genetic information; including conventional testing. Gene Testing = is a subgroup of genetic testing. Gene testing is the analysis of DNA or RNA. 4

5 This paper represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumer Protection DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof.