Compassionate Use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval
Under Spanish Law (ROYAL DECREE 223/2004) the Agencia Española del Medicamento allows medicines without marketing authorization to be released for consumption in individual cases for special therapeutic reasons. The reason for granting special permits for compassionate use of medicinal products is that there will always be individuals outside large sub-populations who may justifiably be authorized to use medicinal products that are not necessarily considered appropriate for general use.
Compassionate Use has been restricted to exceptional cases in which no other therapy is possible or gives the desired result. Products under the provisions for compassionate use may be prescribed by doctors who carry responsibility for the therapy prescribed. The patient must be informed and s/he must sign his/her consent.
An apotransferrin treatment for compassionate use has been decided for Violet. Now our main problem is that it seems that apotransferrin will not be produced anymore, and no other medical product in investigation is available.
In our case we have had to import an early investigational medicinal product from Finland to Spain. Since we already have not got an operating legislation in force in the EU as regards liabilities of the medicinal products manufacturers in “compassionate use treatments”, we have had to deal with people concerns and reluctancies in this issue.
According to the EU rules each member state in the European Union has the responsibility of “compassionate use treatments”, and the responsibility of compliance of investigational medicinal products with good clinical and manufacturing practice. According to the Spanish law, the responsibility of a the suitability of a certain drug and therapy in a compassionate use treatment belongs exclusively to the treating physicians.
We think that this legal
opinion will be helpful to whom may deal with manufacturer
liability concerns so as to get the medecine needed in a compassionate
use treatment.
ROYAL
DECREE 223/2004
MANUFACTURER
CIVIL AND CRIMINAL LIABILITY ISSUES
CIRCULAR
15/2001 SOBRE ENSAYOS CLINICOS
AGENCIA
ESPAÑOLA DEL MEDICAMENTO
