Table 2 Summary of 'compassionate use' regulations in ten European countries
Country | 'Compassionate use' | Responsibility | Authorising agency | Reporting |
|---|---|---|---|---|
Austria | Termed 'Named patient use' Treatment of individuals Separate from clinical trials | Treating physician | N/A | No |
Denmark | Termed 'Compassionate use permit' Treatment of individuals Consent to disclose health data required | Treating physician | Danish Medicines Agency (DMA) | Adverse events reported to the DMA |
France | Termed 'Temporary authorisation for use' for individuals, or 'Cohort temporary authorisation for use' Separate from clinical trials | For 'nominative' use the prescribing physician, for 'cohort' use the license holder | Agence Française de sécurité sanitaire des produits de santé (Afssaps) | All adverse reactions. Periodic report for 'temporary authorisation for use' programmes. |
Germany | National legislation and guidelines Informed consent required | 'Responsible person' | Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) or Paul-Ehrlich Institut (PEI) | Serious adverse events reported to authorising agency within 15 days |
Hungary | No specific legislation | N/A | N/A | N/A |
Ireland | The product must be between a phase III trial and marketing authorisation Guidelines | Prescribing physician | Irish Medicines Board (IMB) | No |
Italy | Termed 'Compassionate use' for individuals Informed consent required | Treating physician | Ethics committee | No |
Spain | Termed 'Compassionate use' for individuals Informed consent required Separate from clinical trials | Treating physician | Agencia Española de medicamentos y productes sanitarios (AEMPS) | Efficacy and adverse events reported to AEMPS |
Sweden | Guidelines | N/A | Medical product agency (MPA) | N/A |
UK | Termed 'compassionate use' or 'expanded access' using 'specials' for individual patients Guidelines | Prescribing physician | Medicines and Healthcare products Regulatory Agency (MHRA) | Serious adverse reactions reported to MHRA |