Study «Personalised Medicine»
Personalisierte Medizin. Study of the Centre for Technology Assessment, Anne Eckhardt, Alexander A. Navarini, Alecs Recher, Klaus Peter Rippe, Bernhard Rütsche, Harry Telser, Michèle Marti, vdf Hochschulverlag AG, 418 p., 358 p., CHF 39.00 /
EUR 34.00 (D), ISBN 978-3-7281-3591-9 (Book) / Download open access. vdf Hochschulverlag AG
What is Personalised Medicine?
The aim of Personalised Medicine is to offer patients tailored therapies that are targeted as much as possible to their individual clinical picture, based on genetic or biochemical values («biomarkers»), or to identify risks of disease early on so that the persons affected can take preventive measures to inhibit the condition, delay it or reduce its severity. The term «Personalised Medicine» refers to specific applications and research projects, as well as to the utopian concept for medicine to be able to identify the medications best suited to each individual person on the basis of diagnostic tests.
Opportunities and risks of Personalised Medicine
One of the most important publicised fields of application for Personalised Medicine is prevention. This is also where the group of users is the largest – because each one might be a carrier of hereditary factors that are associated with increased risks of disease. In those cases where the persons affected can take appropriate measures to beneficially influence the course of a disease, it is certainly useful to know about the risks of disease. But on the other hand, there are unresolved questions: How meaningful are the tests for disease risks currently available? How are the results notified to those concerned, so that they can modify their behaviour in a suitable way? Who has access to the test results?
Why conduct a TA-SWISS study on this subject?
Genome analysis enables ever-broader statements to be made about the causes and risks of disease. There are already providers who for a few hundred US dollars will carry out «Gene testing for all». Because of the rapid advances in genome analysis, the importance of the subject is still growing. There is some controversy about whether those persons who allow their DNA to be tested actually receive data from such tests that is of any use. Moreover, efforts are being made to revise the Swiss Federal law on genetic testing on human beings.
Objectives of the study
The study will include an investigation of the following key issues, which deal primarily with novel aspects of the subject of «Personalised Medicine»:
Biomedical and clinical aspects
- What do we understand by Personalised Medicine? What is the view on the current status of knowledge and the application of Personalised Medicine? What developments should we expect in the coming years? How is Personalised Medicine distinctive from related concepts, e.g. pharmacogenomics or preventive medicine? Will Personalised Medicine lead to a new understanding of health and disease?
- Which areas of medicine can Personalised Medicine be used in? How well are findings from Personalised Medicine scientifically validated in view of the often small number of cases? How important is Personalised Medicine in connection with psychosocial factors which affect the health of patients?
- How should Personalised Medicine be assessed in the context of other developments in technology and the natural sciences, e.g. in informatics, genetics, diagnostic imaging? What requirements does Personalised Medicine impose on the storage and management of data?
- To what extent does Personalised Medicine take the interests of patients into account? Are patients in a position to deal with the probability forecasts that are inherent to Personalised Medicine? How does Personalised Medicine, which is often scientifically demanding, impact on the «informed consent» of patients? What are the likely effects on the relationship between attending physicians and patients?
- What is the situation with the system for research and innovation in Personalised Medicine, particularly in respect of universities and the pharmaceutical and medical technology industries? What are the motives behind the development and spread of Personalised Medicine? What are the motives behind the opposition to Personalised Medicine?
- How does Personalised Medicine impact on structures and occupational profiles in healthcare? Is there a need for the networking of service providers who make joint use of the data obtained within the context of Personalised Medicine? Are certain treatments transferred to appropriately specialised centres? Will new occupational profiles evolve?
Social and ethical aspects
- How should we view Personalised Medicine in the context of social developments such as individualisation and globalisation? How is Personalised Medicine incorporated into other developments that are relevant to health policy, e.g. E-Health or Managed Care?
- How should Personalised Medicine be assessed in respect of privacy protection and patient autonomy? What rights to know and not to know must be guaranteed? How should the relationship between individual autonomy and solidarity with others be classified – e.g. in the provision of data for medical research or in the motivation for individual prevention?
- What questions arise with regard to fairness? This applies, for instance, in respect of possible discrimination against sections of the population which are particularly susceptible to illness, with access to new, costly products of Personalised Medicine, or if as a result of Personalised Medicine risks are transferred from the benefit providers and health insurers to patient.
Economic aspects and healthcare system
- What does Personalised Medicine mean for Switzerland as a centre for research and business? What economic incentives are provided by current regulation and other policy measures for the further development of Personalised Medicine?
- How does the concept of Personalised Medicine fit into current developments in healthcare, as they are being deal with, e.g. in the project investigating the future of medicine in Switzerland, «Zukunft Medizin Schweiz», at the Swiss Academy of Medical Sciences? What are the economic effects likely to be? Where will Personalised Medicine lead to cost increases, e.g. because of higher development costs for small groups of patients? And where to savings, e.g. because of early detection?
- Under what preconditions will Personalised Medicine contribute to the hoped-for improvement in efficiency in healthcare? Are any additional costs justified by better performance and therefore greater benefits for patients (e.g. prevention)? Who will bear the costs?
- How are research into and the development of Personalised Medicine regulated today? In particular, how is the protection of subjects in clinical trials guaranteed? How does the current regulation impact on the research and innovation system? What are the existing regulatory trends nationally and internationally?
- How is the licensing of Personalised Medicine regulated today? What are the requirements imposed by Personalised Medicine on the licensing authorities, e.g. swissmedic? Will Personalised Medicine create new requirements, e.g. with regard to international standardisation?
- How is the application of Personalised Medicine regulated? Are there new questions arising in respect of patients’ rights, e.g. protection of privacy? What are the requirements regarding the use of data that is obtained within the context of Personalised Medicine, especially for (commercial) research purposes? Is there a guarantee of adequate protection for patients against discrimination based on the results of Personalised Medicine? Is an obligation for prevention conceivable on the basis of current legislation, and would such a thing a good idea?
- How is the quality of Personalised Medicine products guaranteed, including Internet products from abroad? Does this create new liability issues? Are the legal constraints available now and planned in the near future sufficient to regulate the growing number of applications of Personalised Medicine?
The study will be conducted in six stages:
- Actual status analysis: Analysis of literature on current developments and prototypes, and on the use of robots and autonomous devices in practice.
- Environmental analysis: Survey of macro trends according to the “PESTEL” factors: Political, Economic, Sociocultural, Technological, Environmental and Legal analysis.
- Analysis of needs: Consultation with actors in focus groups with regard to need, requirements and fears.
- Reflection and evaluation: Consultation with experts on technology (feasibility), economics (viability), society, ethics and law.
- Preparation of an overall impact report, analysis of opportunities and risks, possibly in the form of scenarios.
- Formulation of recommendations for various target groups.
Project start: june 2011| completion: autumn 2012
Results and downloads
Study in German:
Abridged version of the study:
- Centre for Technology Assessment TA-SWISS
- Swiss Federal Office of Public Health FOPH
- Swiss Academy of Medical Sciences SAMS
- National Advisory Commission on Biomedical Ethics NEK-CNE
TA-SWISS project supervisor
- Dr. Adrian Rüegsegger, TA-SWISS. E-mail
- Dr Anne Eckhardt (project manager), risicare GmbH, Zollikerberg
- Michèle Marti, risicare GmbH, Zollikerberg
- Dr Alexander Navarini, Department of Dermatology, Zürich University Hospital
- Alecs Recher, Faculty of Law, University of Lucerne
- Prof. Dr Klaus-Peter Rippe, Ethik im Diskurs GmbH, Zürich
- Prof. Dr Bernhard Rütsche, Faculty of Law, University of Lucerne
- Dr Harry Telser, Polynomics AG, Olten
- Prof. Dr Giatgen Spinas, Zürich University Hospital, Chair of the supervisory group
- Dr Hermann Amstad, Swiss Academy of Medical Sciences SAMS, Basel
- Cristina Benedetti, Commission of Experts for Genetic Testing on Human Beings GUMEK-CEAGH, Bern
- Prof. Dr Sven Bergmann, Computational Biology, University of Lausanne
- Heidi Blattmann, science journalist, Herrliberg
- Prof. Dr Verena Briner, Lucerne Cantonal Hospital
- Dr Matthias Bürgin, Swiss Federal Office of Public Health, Bern
- Prof. Dr Daniel Gygax, Life Sciences, University of Applied Sciences Northwestern Switzerland, Muttenz
- Pius Gyger, Helsana Health Insurance, Zürich
- Dr Bertrand Kiefer, National Advisory Commission on Biomedical Ethics NEK-CNE
- Dr. med. Pedro Koch, Senior Health Consultant, Küsnacht
- Prof. Dr Donald Kossmann, Institute of Information Systems, ETH Zürich
- Prof. Dr Sabine Maasen, Programme for Scientific Research, University of Basel
- Thomas Müller, Editor Schweizer Radio SRF, Bern
- Prof. Dr Andreas Papassotiropoulos, Department of Molecular Neuroscience, University of Basel
- Dr Simone Romagnoli, National Advisory Commission on Biomedical Ethics NEK-CNE
- Dr Heiner Sandmeier, Interpharma, Basel
- Prof. Dr Brigitte Tag, Institute of Law, University of Zürich
- Dr Effy Vayena, Institute for Biomedical Ethics, University of Zürich
Report of the European Academies Science Advisory Councils EASAC and the Federation of European Academies of Medicine FEAM (2012): «Direct-to-consumer genetic testing for health-related purposes in the European Union»: http://www.easac.eu/fileadmin/Reports/EASAC_Genetic_Testing_Web_complete.pdf
Report of the Office for Technology Assessment at the German Bundestag TAB (2008): «Individualisierte Medizin und Gesundheitssystem»: http://www.tab-beim-bundestag.de/de/aktuelles/20090303.html
CH-3011 Bern T + 41 31 310 99 60
F + 41 31 310 99 61
The project in brief
With diagnostics methods becoming ever more efficient, it is possible to make increasingly precise statements on disposition and physiological functions. There are already companies offering genetic tests on the Internet for a few hundred US dollars – a saliva sample is all that is needed. In theory these findings should lead to us receiving treatment that is tailored precisely to our requirements if we fall ill. In addition, such data should also help to detect risks of disease early on. The study will examine the current possibilities and consequences of this «Personalised Medicine».
Project: August 2012 to autumn 2013
Project mandataries: Dr Anne Eckhardt, risicare GmbH, Zollikerberg