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.

Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct-to-consumer genetic tests?

The legal framework of the European Union (EU) for regulating access to and supply of direct-to-consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorising the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic tests purchased through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic tests on the European regulatory agenda.

Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct to consumer genetic tests?

El marco legal de la Unión Europea (UE) que regula el acceso y la oferta de pruebas genéticas dirigidas al consumidor (DTC) es muy liberal en comparación con las leyes y normativas aplicables a productos médicos (Internet). Si embargo ambos productos relacionados con la sanidad humana pueden causar perjuicios igualmente graves en el bienestar del individuo. En este artículo examinamos si el marco legal de la Unión Europea para la utilización responsable de productos de medicina (Internet) puede servir como ejemplo para regular las pruebas genéticas caseras. Las leyes de la Unión Europea que rigen el área de productos de medicina pueden servir como ejemplo para regular las pruebes genéticas caseras. Las leyes de la Unión Europea que rigen el área de productos de medicina pueden servirnos de ejemplo, a pesar de contener algunos defectos, para modelar la autorización (a nivel comunitario) del marketing en las pruebas genéticas caseras (DTC) sobre el mercado interno, en consonancia con los estrictos criterios sobre valores preditivos y utilidad clínica. Además, el marco legal que regule las pruebas genéticas caseras debería también introducir la supervisión del sistema, así como los criterios de calidad con respecto a la información que se ofrece al consumidor, con el objeto de ampliar la protección sanitaria. No obstante, resulta difícil supervisar, para cualquier agencia que se anime a ello, las pruebas genéticas caseras adquiridas por Internet. Ofrecer protección adecuada al individuo frente a kits de pruebas de calidad discutible requiere vigilancia internacional y a adopción de medidas globales adaptadas por la comunidad internacional. Para Europa es importante incluir la regulación de pruebas genéticas caseras dentro de la agencia legisladora europea (AU)

The legal framework of the European Union (EU) for regulating Access to and supply of direct to consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorizing the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic test purcharsed through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic test on the European regulatory agenda (AU)

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.