Risk-Adjusted Cancer Screening and Prevention (RiskAP): Complementing Screening for Early Disease Detection by a Learning Screening Based on Risk Factors.

Background: Risk-adjusted cancer screening and prevention is a promising and continuously emerging option for improving cancer prevention. It is driven by increasing knowledge of risk factors and the ability to determine them for individual risk prediction. However, there is a knowledge gap between evidence of increased risk and evidence of the effectiveness and efficiency of clinical preventive interventions based on increased risk. This gap is, in particular, aggravated by the extensive availability of genetic risk factor diagnostics, since the question of appropriate preventive measures immediately arises when an increased risk is identified. However, collecting proof of effective preventive measures, ideally by prospective randomized preventive studies, typically requires very long periods of time, while the knowledge about an increased risk immediately creates a high demand for action. Summary: Therefore, we propose a risk-adjusted prevention concept that is based on the best current evidence making needed and appropriate preventive measures available, and which is constantly evaluated through outcome evaluation, and continuously improved based on these results. We further discuss the structural and procedural requirements as well as legal and socioeconomical aspects relevant for the implementation of this concept.

The European Court of Justice's decision regarding the Brüstle patent and its implications for the legality of stem cell research within the European Union.

In 2011 the European Court of Justice issued a decision regarding the patentability of technologies derived from human embryonic stem cells. The finding will have an impact on the framework of stem cell research within the European Union and its Member States and has already triggered several political initiatives regarding the funding of research with human embryonic stem cells on the European level as well as a renewed public debate. This article will take a short look at the case history and the findings of the court. It offers some critical comments regarding the findings' consistency with European and international regulations on intellectual property rights as well as some considerations on the possible impact of the case for other fields of law.

Legislation on direct-to-consumer genetic testing in seven European countries.

An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests.

From moral to legal judgment: the influence of normative context in lawyers and other academics.

Various kinds of normative judgments are an integral part of everyday life. We extended the scrutiny of social cognitive neuroscience into the domain of legal decisions, investigating two groups, lawyers and other academics, during moral and legal decision-making. While we found activation of brain areas comprising the so-called 'moral brain' in both conditions, there was stronger activation in the left dorsolateral prefrontal cortex and middle temporal gyrus particularly when subjects made legal decisions, suggesting that these were made in respect to more explicit rules and demanded more complex semantic processing. Comparing both groups, our data show that behaviorally lawyers conceived themselves as emotionally less involved during normative decision-making in general. A group × condition interaction in the dorsal anterior cingulate cortex suggests a modulation of normative decision-making by attention based on subjects' normative expertise.

Patent protection for stem cell procedures under the law of the European Union.

Stem cell research shows an immense diagnostic and therapeutic potential. The procedures based on human stem cells seem to allow new medical treatments for serious diseases like Parkinson's or Alzheimer's disease, leukaemia or diabetes. However, as no company or inventor would take the risk of immense investments without an adequate legal protection of the possible benefits arising out of their work, intellectual property law plays a pivotal role for the further development of stem cell techniques. Although international patent law knows protection of inventions using biological substances and living matter for about 160 years, patents on stem cells, DNA and other parts of the human body raise specific objections. Nevertheless, from a strictly legal angle, there are no barriers to patents on stem cell procedures. In particular, Art. 6 of the "Directive 98/44/EC of the European Parliament and of the Council of the European Union of July 6, 1998 on the legal protection of biotechnological inventions" - which qualifies inventions as unpatentable where their commercial exploitation would be contrary to ordre public or morality - does not hinder patent protection for stem cell research.