ΙΑΤΡΙΚΗ, ΔΙΚΑΙΟ ΚΑΙ ΔΙΑΔΙΚΤΥΟ

6 Offer of medical services and genetic tests via internet: The German legal situation For prescription-only medicines the prices are fixed by regulation in Germany and have to be the same in every pharmacy. This also counts for internet pharmacies. But in October 2016 the European Court of Justice held that the German regulation violates European law. We are now waiting how the German legislator will react. E. Genetic testing via internet Through genetic tests it is possible to know a lot about one's own genes, for example concerning his / her own ancestry or genetic vulnerabilities. All what is needed is a specimen of saliva. The easiest way to do such a test is using the internet. One of the most known websites for such tests is “23andme.com” . On that page, a full genetic test is offered for less than 200 Dollars with the promise “Receive 75+ online reports on your ancestry, traits and health - and more”. Consumers have to order a set and they receive a tube for their specimen of saliva. They send it back after using it and six to eight weeks later it is possible to see the results online. The results tell the client many facts about his or her vulnerabilities and reactions on specific medicines. But most of the information is only based on probabilities. And it is not assured that the client really understands the information, especially the relevance of mere probabilities. For example, the doubling of the probability of developing a certain disease does not say anything if you don’t know the basis: If the normal probability is 0,1 %, then “double risk” means that you will develop the disease with a probability of 0,2 %, which really is negligible. But “double risk” sounds very dangerous for the patient. Since 2010 a special Genetic Diagnostics Act exists in Germany. It aims to protect the right to personality, the right to self-determination and especially the right to decide whether a genetic diagnosis may be executed or not and what shall happen with the genetic information. In the end, it aims to protect the right to know and the opposite right not to know. And it aims to avoid discrimination and other disadvantages as a result of genetic testing, especially in the areas of insurance and labour. In Germany “direct-to-consumer” genetic tests in the proper sense are prohibited as according to the Genetic Diagnostics Act an inclusion of a doctor is indispensable with regard to diagnostic and predictive genetic tests. Firstly, such a genetic test can only be originated (induced) by a medical professional. The law requests an explicit and written consent of the patient / client for the responsible medical professional to originate (induce) a genetic test. A permission for the laboratory is not enough. Therefore, a company as 23andme.com would have to comply with this restriction of genetic tests to doctors, and very often this will not be the case. Furthermore, according to the Genetic Diagnostics Act there must be information and counselling of the patient / client by a doctor before and after the test. But apart from the general practical problems of the enforcement of regulation with regard to internet offerings from abroad (e.g. it is not possible to prevent people from sending a specimen of saliva to a foreign company and receive the results by e-mail or via the homepage of the company) it is quite unclear whether those provisions of the Genetic Diagnostics Act really request a face-to-face contact between doctor and client. On the one hand, many argue that the general rules of medical law demand an oral and personal conversation giving the opportunity of asking questions directly, and that genetic tests have to follow this rule too. On the other hand, some authors think that an electronic contact via internet / e-mail is enough to fulfill the requirements of the Genetic