2016
DOI: 10.5582/irdr.2016.01054
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An overview of Compassionate Use Programs in the European Union member states

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Cited by 61 publications
(69 citation statements)
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“…According to Balasubramanian et al, 20 out of 28 EU member states had an established compassionate use programme (CUP) (82). A CUP exists in all EU countries selected for this review, except Poland (work on implementation of a national CUP is ongoing) 23 (82).…”
Section: Rare Disease Policies and Access To Orphan Drugsmentioning
confidence: 99%
“…According to Balasubramanian et al, 20 out of 28 EU member states had an established compassionate use programme (CUP) (82). A CUP exists in all EU countries selected for this review, except Poland (work on implementation of a national CUP is ongoing) 23 (82).…”
Section: Rare Disease Policies and Access To Orphan Drugsmentioning
confidence: 99%
“…Furthermore, most, but not all, EU member states have an established compassionate use program, with different regulations and access criteria, adding to disparity within Europe. 17 …”
Section: Regulatory and Systemic Issuesmentioning
confidence: 99%
“…While these regulations differ by country, in principle, expanded access treatment can be performed in patients with serious, including life‐threatening diseases who cannot be treated satisfactorily with authorized drugs. In addition, the use of an investigational drug must be supported by sufficient evidence of its safety and efficacy, and a doctor must obtain informed consent from the patient .…”
Section: Expanded Access and Off‐label Applications Of Drugs: Generalmentioning
confidence: 99%