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The UK’s Early Access Scheme: Breakthrough Or Mixed Blessing?

The UK's Early Access to Medicines Scheme is designed to give patients with high unmet needs access to certain therapies before they are licensed for use, but it presents a number of challenges that will only be addressed in real-world testing. Part one of a two-part series on European programs for improving patient access to new therapies.

The Early Access to Medicines Scheme (EAMS), launched in April 2014, is intended to get products for high unmet needs to patients up to a year before they are licensed. In most cases it will be used for new drugs that have completed Phase III trials, but exceptionally it could kick in at the end of Phase II. Products most likely to enter the scheme include drugs for oncology indications and rare diseases.

According to the UK government, the EAMS reflects the changes, driven by genomics, Big Data, and the rise in stratified...

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