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Access to Unlicensed Medicines UK — SCE Medical Oncology MCQ

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EasyClinical Trials & StatisticsAccess to Unlicensed Medicines UKSCE Medical Oncology

A 62-year-old man with cancer asks about the 'right to try' experimental treatments outside clinical trials. In the UK, what regulatory framework allows access to unlicensed medicines?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: E — The EAMS (Early Access to Medicines Scheme) and individual patient access/compassionate use programmes allow pre-licensing access to promising investigational medicines in life-threatening conditions; the Cancer Drugs Fund also provides managed access to drugs with clinical uncertainty

UK frameworks for accessing unlicensed/investigational cancer medicines include: (1) EAMS (Early Access to Medicines Scheme) — MHRA-approved compassionate access before licensing, (2) manufacturer compassionate use/expanded access programmes, (3) Cancer Drugs Fund (NICE) — managed access for drugs with clinical promise but insufficient evidence for routine commissioning, (4) individual funding requests (IFR) for exceptional clinical circumstances. These pathways require clinical justification and are not guaranteed. Clinical trial participation remains the primary mechanism for accessing novel therapies.

Reference: NICE Cancer Drugs Fund; MHRA EAMS; JRCPTB Curriculum