Consumers have many possibilities to undergo a form of screening to acquire health information via the Internet or otherwise by purchasing health checks, medical check-ups, total body scans and... Show moreConsumers have many possibilities to undergo a form of screening to acquire health information via the Internet or otherwise by purchasing health checks, medical check-ups, total body scans and direct-to-consumer (DTC) genetic tests. More and more providers place screenings on the market before they have been assessed properly. In the Netherlands the Act on population screening ( __Wet op het bevolkingsonderzoek__) sets strict quality criteria for screening. In accordance with this Act a licence is required for offering and performing screening with ionising radiation or for detecting (risk factors of) cancer and untreatable diseases. This system, which aims to protect individuals against health damage and also to ensure patients (rights), wards off __commercial screening__ of the Dutch market. In society this meets with criticism. Individuals increasingly perceive the limited access to screening as an unnecessary restriction of their self-determination. However, the Dutch State has a special responsibility regarding the health of individuals. This thesis focuses on the following central question: __What are the normative criteria for the access to and supply of genetic screening from constitutional and European law perspectives?__ As a corollary the author will explore what this means for the Dutch legal framework regulating genetic screening, particularly DTC genetic tests. Show less
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... Show moreAn 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.European Journal of Human Genetics advance online publication, 25 January 2012; doi:10.1038/ejhg.2011.278. Show less
