Public health ethical perspectives on the values of the European Commission's White Paper "Together for Health".

BACKGROUND: In 2007 the European Commission issued the White Paper: "Together for Health". Considered the EU Health Strategy for the years 2008-2013, it offers the cornerstones for setting priorities in EU health actions. OBJECTIVES: The public health framework offered in this strategy is explicitly built on shared values--including the overarching values of universality, access to good quality care, equity and solidarity that reacted to certain health care challenges within the EU. This article analyses the Health Strategy via its ethical scope and considers implications for future health policy making. METHODS: The Health Strategy and related documents are scrutinised to explore how the mentioned values are defined and enfolded. Additionally, scientific databases are searched for critical discussions of the value base of the Health Strategy. The results are discussed and reasoned from a public health ethical perspective. RESULTS: The Health Strategy is barely documented and discussed in the scientific literature. Furthermore, no attention was given to the value base of the Health Strategy. Our analysis shows that the mentioned values are particularly focussed on health care in general rather than on public health in particular. Besides this, the given values of the Health Strategy are redundant. CONCLUSIONS: An additional consideration of consequentialist public health ethics values would normatively strengthen a population-based health approach of EU health policy making.

Public health and valorization of genome-based technologies: a new model.

BACKGROUND: The success rate of timely translation of genome-based technologies to commercially feasible products/services with applicability in health care systems is significantly low. We identified both industry and scientists neglect health policy aspects when commercializing their technology, more specifically, Public Health Assessment Tools (PHAT) and early on involvement of decision makers through which market authorization and reimbursements are dependent. While Technology Transfer (TT) aims to facilitate translation of ideas into products, Health Technology Assessment, one component of PHAT, for example, facilitates translation of products/processes into healthcare services and eventually comes up with recommendations for decision makers. We aim to propose a new model of valorization to optimize integration of genome-based technologies into the healthcare system. METHODS: The method used to develop our model is an adapted version of the Fish Trap Model and the Basic Design Cycle. RESULTS: We found although different, similarities exist between TT and PHAT. Realizing the potential of being mutually beneficial justified our proposal of their relative parallel initiation. We observed that the Public Health Genomics Wheel should be included in this relative parallel activity to ensure all societal/policy aspects are dealt with preemptively by both stakeholders. On further analysis, we found out this whole process is dependent on the Value of Information. As a result, we present our LAL (Learning Adapting Leveling) model which proposes, based on market demand; TT and PHAT by consultation/bi-lateral communication should advocate for relevant technologies. This can be achieved by public-private partnerships (PPPs). These widely defined PPPs create the innovation network which is a developing, consultative/collaborative-networking platform between TT and PHAT. This network has iterations and requires learning, assimilating and using knowledge developed and is called absorption capacity. We hypothesize that the higher absorption capacity, higher success possibility. Our model however does not address the phasing out of technology although we believe the same model can be used to simultaneously phase out a technology. CONCLUSIONS: This model proposes to facilitate optimization/decrease the timeframe of integration in healthcare. It also helps industry and researchers to come to a strategic decision at an early stage, about technology being developed thus, saving on resources, hence minimizing failures.

Health technology assessment in the era of personalized health care.

OBJECTIVES: This article examines the challenges for health technology assessment (HTA) in the light of new developments of personalized health care, focusing on European HTA perspectives. METHODS: Using the example of the Integrated Genome Research Network - Mutanom (IG Mutanom) project, with focus on personalized cancer diagnostics and treatment, we assess the scope of current HTA and examine it prospectively in the context of the translation of basic and clinical research into public health genomics and personalized health care. RESULTS: The approaches developed within the IG-Mutanom project are based on innovative technology potentially providing targeted therapies for cancer; making translation into clinical practice requires a novel course of action, however. New models of HTA are needed that can account for the unique types of evidence inherent to individualized targeted therapies. Using constructive health technology assessment (CTA) models is an option, but further suitable models should be developed. CONCLUSIONS: Integrative, systems biology-based approaches toward personalized medicine call for novel assessment methods. The translation of their highly innovative technologies into the practice of health care requires the development of new HTA concepts.

The impact of genetics and genomics on public health.

Public health practice has to date concerned itself with environmental or social determinants of health and disease and has paid scant attention to genomic variations within the population. The advances brought about by genomics are changing these perceptions. In the long run, this knowledge will enable health promotion messages and disease prevention programmes to be specifically directed at susceptible individuals and families, or at subgroups of the population, based on their genomic risk profile. As the controversial discourse in science and health politics shows, the integration of genomics into public health research, policy and practice is one of the major challenges that our health-care system is currently facing.

Concepts for the translation of genome-based innovations into public health: a comprehensive overview.

Recent vast and rapid development of genome-related sciences is followed by the development of different assessment techniques or attempts to adapt the existing ones. The aim of this article is to give an overview of existing concepts for the assessment and translation of innovations into healthcare, applying a descriptive analysis of their present use by public health specialists and policy makers. The international literature review identified eight concepts including Health Technology Assessment, analytic validity, clinical validity, clinical utility, ethical, legal and social implications, Public Health Wheel and others. This study gives an overview of these concepts (including the level of current use) applying a descriptive analysis of their present use by public health specialists and policy makers. Despite the heterogeneity of the analyzed concepts and difference in use in everyday healthcare practice, the cross-integration of these concepts is important in order to improve translation speed and quality. Finally, some recommendations are made regarding the most applicable translational concepts.

Data protection in biobanks--a European challenge for the long-term sustainability of biobanking.

The final decoding of the human genome has marked the beginning of a new era of biomedical research and both the European Commission (EC) and the Member States try to facilitate this new research direction. In most European countries biobanks are set up to improve the capacities for research. These new research infrastructures require a specific governance framework to ensure public trust and accountability.

Sample, data use and protection in biobanking in Europe: legal issues.

The sharing of samples and data stored in biobanks for research has implications for donor privacy, but also raises questions on the regulation of research within Europe. Many legal documents and principles within Europe, with a direct impact on biobanking, have not been developed specifically to support this activity. Moreover, while some new regulations have been set up at national level, there are many variations in the definitions, scope and purpose of these legal instruments. This has resulted in unnecessary hurdles for genome-based research, particularly if samples are shared across national borders. The question is also raised on whether new, specific legislative and governance frameworks designed for biobanking are needed, or whether it is sufficient to modify current general law and to develop specific guidelines, or to accommodate issues raised by biobanking in the current regulation. A workshop with experts from academia and industry, lawyers, national data protection authorities, representatives from the European Commission and the European Data Protection Supervisor was held to review the existing legal bottlenecks and future needs of biobanking, with special regard to the collection, exchange and linkage of samples and data. This report presents highlights of the presentations and discussions from the workshop held in Sevilla, Spain, in March 2007 and the conclusions that followed. The workshop focused on the internal linkage of data and samples stored in a biobank, and the external linkage of biobanks with secondary information resources, such as cancer registries.

[Human genetic data from a data protection law perspective]. / Genetische (Individual-) Informationen aus Sicht des Datenschutzrechts.

The collection and use of genetic data have caused much concern in the German population. Data protection is widely seen as the tool to address these fears. The term genetic data is not self-explanatory, as it depends on the different types of genetic diseases. The protection of genetic data as defined with regard to the different sets of diseases needs to fit into the preexisting data protection legislation. Still, the particularities of genetic data such as the multipersonal impact need to be considered. A balance between the information needs of society and the right to privacy requires a medically driven criteria. The medical term of indication which corresponds with the data protection term of purpose should serve as a tool in order to balance the rights of the patients and their relatives or between clients and third persons involved. Some countries have set up new legislative acts to address the challenges of human genetics. The current state of German data protection law leaves citizen rather unprotected as long as the data are used for medical purposes in a wider sense. A special law on the collection of genetic data has been discussed for several years, but it should be questioned whether the scope of a sector-specific law would serve citizens better. It seems to be preferable to adjust the existing Data Protection Act rather than drafting a specific law which covers the field of human genetics. This adaptation should reflect upon the different technical ways in which genetic data are collected and used.