Statement by BIO Deutschland on the Genetic Diagnostics Law

At the end of July, a hearing on the Draft Genetic Diagnostics Law was held in Bonn, prompting BIO Deutschland to make a statement in which it asked for improvements to be made to the German Federal Health Ministry’s draft. BIO Deutschland’s view is that the current draft treats consumers like minors and will cause conflict in the private sphere. Peter Heinrich, President of the Board of BIO Deutschland, said that consumers will look for advice on genetic diagnostics abroad, if a more citizen-oriented and practical solution than that provided by the current draft is not found. "This will damage innovative small and medium-sized diagnostics companies located in Germany and will lead to patients being left to deal alone with the results of all types of unregulated genetics analyses outside the German legal system," Heinrich went on to explain.

As a result, one of BIO Deutschland’s demands is that the law should distinguish between genetic testing for personal and medical purposes. In addition, the association advocates a stronger differentiation in the so-called provision of doctors rule so that gaps in patients’ growing needs for information can be filled. BIO Deutschland is also in favour of including the genetic testing used to determine parentage in a context other than the Genetics Diagnostics Law.

In its statement, BIO Deutschland welcomes that the Federal Ministry of Health’s draft law will provide the basis for setting parameters for genetic testing in Germany and prevent disadvantages resulting from genetic characteristics. However, Peter Pohl, Chairperson of BIO Deutschland’s Working Group on Competition and Regulatory Policy, added: "By no means may the state, which in this legislation specifically declares its aim to respect and protect human dignity and the right to information-based self-determination, be allowed to use loopholes to dictate to consumers."