German Medicines Law

Today, the pharmaceutical industry is subject to strict controls during the development and introduction of new drugs and chemical agents. However, this was not always the case. The significant advances in regulation and drug safety were ultimately a result of the thalidomide tragedy.

In fact, no guidelines for the development, production and distribution of drugs as they are known today existed in the Federal Republic of Germany at the time of the thalidomide tragedy. No legal regulations, such as a drug law, or supervisory bodies, such as the current Federal Institute for Drugs and Medical Devices (BfArM), existed. The first German Drug Law was established in 1961 and the German Federal Parliament defined in 1964 the requirements for the testing of drugs in "the Law amending the Drug Law". In support, the Deutsche Pharmakologische Gesellschaft (German pharmacological association) as the medical expert association generated scientific guidelines.

When thalidomide was introduced to the market on October 1st, 1957 in Germany and in April 1958 in the United Kingdom, those standards of drug testing had not been established yet. Lacking further guideline by supervisory bodies, companies still had to follow the principle of self-monitoring.

Grünenthal developed and tested thalidomide in accordance with the state of scientific knowledge and the standards for the development and testing of medicines within the pharmaceutical industry prevailing at that time. It was not standard to test for damage to the embryo or fetus in pregnancy (teratogenic effects) at that time. Only after the drug had been withdrawn from the market, did targeted tests on a specific kind of rabbit (the New Zealand white rabbit) reproduce, in an animal model, the birth defects caused by thalidomide in humans. In non-primate laboratory animals, only the New Zealand white rabbit shows the teratogenetic effect of thalidomide. Since the New Zealand white rabbit does not react to other substances with teratogenic properties it cannot be used as model to demonstrate the teratogenetic effect of other substances. Even today there is no specific species which manifests the teratogenic effect of all substances known to be teratogenic in humans.

The German Drug Law was comprehensively reformed in 1978 and was characterised as "the outstanding social consequence of the thalidomide disaster". This sounds terrible for those affected. However, it was an important step in the direction of greater drug safety for millions of patients. For the first time, a strict process for the approval and registration of new drugs was implemented in the Federal Republic of Germany. Since that time, companies must present comprehensive documentation about the efficacy, safety and quality of their drugs to the public authorities for assessment before new drugs are approved for sale.

In other European countries, this development of medicines law was similar. For example, there was no standardised set of rules for the development and marketing of pharmaceuticals in the United Kingdom before the thalidomide tragedy. Testing on pregnant animals was not mandatory. After the thalidomide tragedy, for the first time some testing for teratogenicity was suggested in 1964 by the newly established Committee on Safety of Drugs. With the Medicines Act of 1968, a comprehensive legal framework for medicines law was established in the UK.

In Spain, the goal of its medicines law before the thalidomide tragedy was to ensure the quality and purity of pharmaceuticals. In 1963 newly enacted regulations demanded the analysis of possible side effects (Decree 2464/1963 on August 10, 1963); Standards for testing of teratogenicity were still not established back then.