Regulating Privacy and Biobanks in the Netherlands.

The Netherlands does not have any specific legislation pertaining to human biological materials and data collection by biobanks. Instead, these issues are governed by a patchwork of laws, codes of practices, and other ethical instruments, where special emphasis is given to the right to privacy and self-determination. While draft legislation for biobanking was scheduled to enter into force in 2007, as of mid-2015 such legislation was still under consideration, with the intent that it would focus particularly on individual self-determination, the interests of research, the use of bodily materials collected by biobanks for criminal law purposes, and dilemmas around results that are clinically relevant for biobank participants. Under the current framework, the amount of privacy protection afforded to data is linked to its level of identifiability. International sharing of personal data to non-EU/European Economic Area countries is allowed if these countries provide adequate protection.

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.