Regulatory Aspects — Examples from Sweden

Abstract

I have been asked to describe the development in Sweden, to review my own experience during this work and to give my opinion on the effect to our new law on radiopharmaceuticals with regard to its effects on practical work within nuclear medicine. Up to 1982 there was no special legislation on radioactive drugs, since they were explicitly exempted from the Drug Act when it was introduced in 1962. Since no other rules were laid down at the same time, this field has in practice been without regulations from many years. Existing rules have mainly dealt with radiation protection, while very few prescriptions have existed regarding requirements as to pharmaceutical or biological properties. This has implied a great freedom in choosing products and methods in clinical work and also in developing and testing of new compounds. In spite of this lawlessness an extensive activity within nuclear medicine has taken place without serious incidents. To my knowledge, only one serious reaction has been reported, namely an aseptic meningitis after intrathecal injection of labelled albumin for cisternography. It must be admitted, however, that reporting of adverse reactions has certainly been incomplete just because of the exemption of radiopharmaceuticals from the Drug Act.