CRITERIA FOR THE USE OF MONOCLONAL-ANTIBODIES, LEGISLATION AND ETHICAL CONSIDERATIONS

The criteria governing the in vivo use of monoclonal antibodies in hum ans are based upon a number of legal requirements with respect to radi ation hygiene, pharmaceutical legislation, radiopharmaceutical legisla tion and regulations with respect to products arising from biotechnolo gy. This in itself has led to a complicated situation which has undoub tedly restricted the development of valuable diagnostic and potential therapeutic agents. From the ethical point of view there are also impo rtant considerations, firstly with respect to the methods of producing antibodies, which has resulted in the discontinuation of the raising of antibodies in murine ascites, and secondly in consideration of the ethics of administering labelled antibodies to healthy volunteers and to patients who may not necessarily benefit personally from the proced ure. These factors must be evaluated in the light of the EEC document 'Good clinical practice for trials in medicinal products in the Europe an Community from the CPMP working party on Efficacy of Medicinal Prod ucts'.