Legislation on direct-to-consumer genetic testing in Spain

RESUMEN Los Test Genéticos Directos al Consumidor (TGDC) han aparecido en el mercado en las dos últimas décadas como consecuencia del desarrollo de la terapia genética y en respuesta a las nuevas posibilidades de hacer frente a las enfermedades desde la opción de su predicción. El término “análisis genéticos directos al consumidor” se ha generalizado utilizándose para describir servicios analíticos que se ofertan para detectar polimorfismos y variaciones genéticas relacionadas con la salud. El procedimiento habitual de uso consiste en la toma de una muestra biológica a nivel domiciliario, la cual es enviada al laboratorio comercializador para ser analizada. Los resultados del análisis del laboratorio se comunican al sujeto por vía telefónica, por correo postal o electrónico, o bien a través de un acceso seguro a un portal de internet. Los TGDC tienen el valor de poder predecir que se pueda desarrollar una enfermedad y poder frenar su aparición mediante hábitos de vida concretos, elementos nutricionales o de otro tipo. Es una realidad que el ámbito preventivo de la genética es fundamental para que una persona no desarrolle una enfermedad a la que puede tener genéticamente predisposición y que con medidas preventivas puede evitarse. La venta de los TGDC se realiza mayoritariamente a través de internet y resulta necesaria una regulación específica que contemple sus características en cuanto a su finalidad y régimen de comercialización respecto a los distintos tipos de análisis genéticos con objeto de que su uso se haga con unas garantías éticas, jurídicas y sociales mínimas para el consumidor.

ABSTRACT The Direct-to-Consumer Genetic Testing (TGDC) has appeared in the market in the last two decades as a consequence of the development of genetic therapy and in response to the new possibilities of facing diseases from the option of their prediction. The TGDC has been generalized to describe analytical services that are offered to detect polymorphisms and genetic variations related to health. The TGDC includes any type of genetic analysis available to people outside a healthcare context, including genetic analyzes related to lifestyle, which would provide recommendations about diet or daily life (sports, etc.). The usual procedure of use consists in taking a biological sample at home, which is sent to the commercialization laboratory to be analyzed. The results of the laboratory analysis are communicated to the subject by telephone, by postal or electronic mail, or through secure access to an Internet portal. The TGDC have the value of being able to predict that a disease can develop and, therefore, be able to stop their appearance by means of specific life habits, nutritional or other elements that contribute to slowing down their appearance or even preventing their appearance. It is a reality that the preventive field of genetics is fundamental for a person not to develop a cancer or any other type of disease to which he may have a genetic predisposition and with preventive measures can be avoided. At the present time when they are being marketed mainly through the internet, a specific regulation is necessary that contemplates their characteristics in terms of their purpose and marketing regime with respect to the different types of genetic analysis in order that their use is done with minimum ethical, legal and social guarantees for the consumer.

Ars Pharmaceutica (Internet)

Legislation on direct-to-consumer genetic testing in Spain