Annex I / Health

Objective

Improving the health of European citizens and increasing the competitiveness and boosting the innovative capacity of European health-related industries and businesses, while addressing global health issues including emerging epidemics. Emphasis will be put on translational research (translation of basic discoveries in clinical applications including scientific validation of experimental results), the development and validation of new therapies, methods for health promotion and prevention including promotion of healthy ageing, diagnostic tools and medical technologies, as well as sustainable and efficient healthcare systems.

Rationale

The sequencing of the human genome and the recent advances in post-genomics have revolutionised research into human health and diseases. Integrating the vast amounts of data and understanding underlying biological processes and developing key technologies for health-related bio-industries requires bringing together critical masses of various expertises and resources that are not available at a national level, with a view to developing knowledge and capacity for intervention.

Significant advances in translational health research, which is essential to ensure that biomedical research provides practical benefits and improves life quality, also requires multidisciplinary and pan-European approaches involving different stakeholders. Such approaches allow Europe to contribute more effectively to international efforts to combat diseases of global importance.

Clinical research on many diseases (e.g. cancer, cardiovascular and infectious diseases, mental and neurological diseases, in particular those linked with ageing, such as Alzheimer and Parkinson diseases) relies on international multi-centre trials to achieve the required number of patients in a short time-frame.

Epidemiological research requires a large diversity of populations and international networks to achieve significant conclusions. Developing new diagnostics and treatments for rare disorders as well as performing epidemiological research on those disorders also require multi-country approaches to increase the number of patients for each study. And performing health policy-driven research at the European level enables comparisons of the models, systems, data, and patient material held in national databases and biobanks.

A strong EU-based biomedical research will help strengthen the competitiveness of the European healthcare biotechnology, medical technology and pharmaceutical industries. EU collaboration with developing countries will allow those countries to develop research capacities. The EU also has to play an active role in creating an environment conducive to innovation in the public and pharmaceutical sector which address public health needs, in particular to maximise the success of clinical research. Research-based SMEs are the main economic drivers of the healthcare biotechnology and medical technology industries. Although Europe now has more Biotechnology companies than US, most of them are small and less mature than their competitors. Public-private research efforts at the EU level will facilitate their development. EU research will also contribute to the development of new norms and standards to set up an appropriate legislative framework for new medical technologies (e.g. regenerative medicine). Global leadership in European research and innovation in the field of alternative testing strategies, in particular non-animal methods, should be ensured

The activities that will be addressed, which include research essential to policy requirements, are set out below. The strategic issues, child health, health of the ageing population will receive specific attention across the activities. Long-term research agendas such as those established by European Technology Platforms, such as the one on innovative medicines, will be supported where relevant. To respond to new policy needs, additional actions may be supported for example in the areas of health policy issues and occupational health and safety.

Ethical, legal and socio-economic issues will be taken into account within each of the following activities.

Activities

• Biotechnology, generic tools and medical technologies for human health

– High-throughput research. To catalyse progress in fundamental genomics (genome and post?genome) and biomedical research by enhancing data generation, standardisation, acquisition and analysis.

– Detection, diagnosis and monitoring. With emphasis on non-invasive or minimally invasive approaches and technologies such as new preventive tools for regenerative medicine (e.g. through molecular imaging and diagnostics).

– Predicting suitability, safety and efficacy of therapies. To develop and validate biological markers, in vivo and in vitro methods and models, including simulation, pharmacogenomics, targeting and delivery approaches and alternatives to animal testing.

– Innovative therapeutic approaches and intervention. To research, consolidate and ensure further developments in advanced therapies and technologies with potential application in many diseases and disorders such as new therapeutic tools for regenerative medicine.

• Translating research for human health

– Integrating biological data and processes: large-scale data gathering, systems biology (including modelling of complex systems). To generate and analyse the vast amount of data needed to understand better the complex regulatory networks of thousands of genes and gene-products controlling important biological processes in all relevant organisms and at all levels of organisation.

– Research on the brain and related diseases, human development and ageing. To explore the process of healthy ageing and the way genes and environment interact with brain activity, under normal conditions as well as in brain diseases and relevant age?related illness (e.g. dementia).

– Translational research in infectious diseases. To address drug resistance, the global threats of HIV/AIDS, malaria and tuberculosis as well as Hepatitis C and potentially new and re-emerging epidemics (e.g. SARS and highly pathogenic influenza).

– Translational research in major diseases: cancer, cardiovascular disease, diabetes/obesity; rare diseases; other chronic diseases including rheumatoid diseases, arthritis and musco-skeletal diseases. To develop patient-oriented strategies from prevention to diagnosis with particular emphasis in treatment including clinical research. Aspects of palliative medicine will be taken into account.

• Optimising the delivery of health care to European citizens

– Translating clinical outcome into clinical practice. To create the knowledge base for clinical decision-making and how to translate outcomes of clinical research into clinical practice and especially addressing patient safety and the better use of medicines (including some aspects of pharmacovigilance and scientifically tested complementary and alternative medicines) as well as he specificities of children, women and the elderly population.

– Quality, efficiency and solidarity of health care systems including transitional health care systems and home care strategies. To translate effective interventions into management decisions, to assess the cost, efficiency and benefits of different interventions including as regards patient safety, to define the needs and conditions for an adequate supply of human resources, to analyse factors influencing equity of access to high quality health care (also by disadvantaged groups), including analyses of changes in population (e.g. ageing, mobility and migration, and the changing workplace).

– Enhanced disease prevention and better use of medicines. To develop efficient public health interventions addressing wider determinants of health (such as stress, diet, lifestyle or environmental factors and their interaction with medication). To identify successful interventions in different health care settings for improving the prescription of medicines and improving their use by patients (including pharmacovigilance aspects and interactions of medicines).

– Appropriate use of new health therapies and technologies. Long-term safety and effectiveness assessment and monitoring of large scale use of new medical technologies (including devices) and advanced therapies ensuring a high level of protection and benefit for public health.