In its ruling of 10 July 1954 (ref. no. VI ZR 45/54) the Federal Court of Justice determined for the first time that a patient must have recognized the fundamentals of the "nature, significance and implications" of a medical intervention in order to be able to give effective consent. This formula was also subsequently incorporated into the Pharmaceutical Act. The Federal Court of Justice spoke out in greater detail on these concepts - albeit in a different context - in its ruling of 2 December 1963 (ref. no. III ZR 222/62): "Consent in this sense is the existing, voluntary, serious and morally assenting intention of the affected holder of a legally protected right to a certain violation of this legally protected right at the moment of the act. [...] This consent is conditional upon knowledge of the intervention as well as knowledge of the facts and circumstances and hence the ability to understand the nature and significance of the intervention. No specific age is needed for this purpose and it is immaterial whether the affected party is under care or guardianship; it is only necessary that the affected party has the natural understanding and power of judgement to recognize the implications of the intervention. In other words, it is sufficient to have adequate understanding, namely a rational, intellectual and moral maturity that makes it possible to recognize the significance and implications of the intervention, as well as the power of judgement to weigh up the pros and cons and the ability to determine actions according to this insight." The Federal Court of Justice dealt specifically with the issue of biomedical research on humans in the so-called "Thorotrast ruling" (ruling dated 13 February 1956 (ref. no. III ZR 175/54)).