26 May 2009

MacKenna Roberts By

Appeared in BioNews 509

Last week, following ten years of debate, the upper house of the German Parliament (the 'Bundesrat') provided the final stage of legislative assent to a strict framework of laws aimed at preventing the misuse of genetic tests. The legal impact is far-reaching setting stringent limits on paternity testing, embryo/fetal testing and the use of genetic information by health insurers and employers. Health Minister Ulla Schmidt welcomed the regulations as 'a crucial step in protecting the rights of patients' and preventing 'abuse of sensitive personal data'. The German Medical Association however has warned that the laws may be too restrictive and lead to medical tourism by individuals travelling abroad seeking the desired genetic testing potentially in places without adequate provision and quality standards.

The new legislation requires that all testing is conducted by a licensed physician with the patient's consent, effectively outlawing direct-to-consumer testing which generally advertises to consumers without doctor involvement. Paternity testing will require consent from both alleged biological parents with the exception of sexual abuse and rape cases in an attempt to prevent surreptitious paternity testing. Offenders who conduct paternity tests without the consent of the other parent face a fine of 5,000 euros under the new law. Anonymous paternity testing services have increased and an estimated 20,000 'secret tests' are taken annually, according to German Justice Minister Brigitte Zypries. These test results are not legally recognised and deeply disrupt families without a legal remedy.

Parents are prevented from using genetic testing to determine the gender an unborn child and all fetal testing must be done for purely medical purposes. Preimplantation genetic diagnosis (PGD) and prenatal testing (PND) may not be used to detect a predisposition for 'late-onset' diseases- diseases that may not develop until adulthood such as Huntington's Disease or breast cancer and many other types of cancer.

Following a continuing debate regarding German lawmaker support of German employers' mandatory use of genetic tests to detect susceptibility for disorders that would adversely affect an employee's ability to perform specific occupations, the new legislation increases restrictions on employer and insurer use of genetic information along similar lines with the Genetic Information and Non-discrimination Act 2008 recently passed in the US. German employers still retain an exception to test staff if there is a specific occupational reason such as testing for allergies to chemical substances when working in a chemical plant. Insurers may not request genetic test results except for high-value policies which allow for a payout greater than 300,000 or an annual pension payment of greater than 30,000 euros.

Australia is currently considering new regulation in this area but both the American and German statutes have been heavily criticised domestically for having too many exceptions and legislative loopholes to effectively prevent future genetic information misuse by employers and insurers. Supporters argue that the laws create crucial protections for patients ushering in the age of preventative medicine. The German law was initially approved by the lower house of the Bundesrat in April and will nationally come into force in July.

