Statement by BIO Deutschland on the Draft Law on Genetic Testing of Human Beings (Genetic Diagnostics Law) of 30 June 2008


The German Biotechnology Industry Organisation (BIO Deutschland) welcomes the Federal Ministry of Health’s draft law on genetic testing of human beings (the Genetic Diagnostics Law) of 30 June 2008, which will provide the basis for a framework for genetic testing in Germany and prevent disadvantages resulting from genetic characteristics. However, the range of problems, inter-related issues and information that are involved in genetic testing make it necessary to proceed in a more precise way than is foreseen in the current draft law. By no means may the state, which in this legislation expressly declares its aim to respect and protect human dignity and the right to information-based self-determination, be allowed to use loopholes to make personal decisions for the individual and cause conflicts in the private sphere. This also applies particularly where new technologies and possibilities are concerned. As a result of the rapid development of science and industry in biotechnology in general and genetic diagnostics in particular, one is faced with medical challenges in previously unknown dimensions, but also with the possibility to fulfil people’s need for safe personal information about their genetic make-up. If no better solution is found here, this need – in spite of the legislators’ best intentions concerning consumer and data protection and quality assurance – will be met by foreign markets. This harms German companies.

The sector association, BIO Deutschland, therefore demands the following in order to achieve a feasible and citizen-friendly Genetic Diagnostics Law:

  • The differentiation between genetic testing for personal and medical purposes: Genetic analyses that concern the body and health are not automatically genetic analyses for medical purposes. Every individual should have the freedom to commission genetic tests for personal reasons, such as the planning of his or her lifestyle, in qualified laboratories and on his or her own authority.
  • A more liberal allowance in the number and type of doctors authorised to carry out genetic testing in order to avoid patients being faced with a shortage of doctors: Currently, only a few hundred doctors specialising in genetic consultation are supposed to meet the right of 80 million people in Germany to qualified advice on individual medical problems. The authorisation of further suitable consultants such as gynaecologists and oncologists would help to meet the increasing demand.
  • The integration of legislation on genetic tests used to clarify parentage in a context other than the Genetic Diagnostics Law: Neither the DNA analysis used to prove parentage nor the blood group analyses still used today to determine the probability of biological parentage concern the determination of individual genetic make-up,. Legal parents must be given the freedom to carry out a safe and discreet clarification of parentage in Germany while maintaining good family relations. The draft law’s current suggested regulation implies unnecessary interference by the state and does not provide any improvement to those involved – it can therefore be deleted.

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