Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, persuant to the Answer of 5 January 2015 to Question 218547, if he will adapt the Early Access to Medicines Scheme to better accommodate off-patent indications of drugs, by creating incentives for pharmaceutical companies to submit applications to the scheme.

Since the launch of the Early Access to Medicines Scheme in April 2014, three Promising Innovative Medicine (PIM) designations have already been granted. By 9 January 2015 there had been 428 downloads of the PIM designation form and 187 downloads of the scientific opinion form, which indicates the high level of interest in the scheme.

The Early Access to Medicines Scheme already has a number of incentives for pharmaceutical companies. The PIM designation provides an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme and is of particular value to smaller companies because it will act as a signal to potential investors. At the next stage of scientific review, the Medicines and Healthcare products Regulatory Agency will consider the evidence and can issue an Early Access to Medicines scientific opinion. This opinion will support the prescriber to make a decision with the patient on using this medicine, when still unlicensed or used off-label. Earlier clinical use of new innovative medicines will also provide valuable real world data to companies for use in subsequent health technology appraisal processes.

We committed to review the Early Access to Medicines Scheme when we launched the scheme in April 2014. Through the Innovative Medicine and Medical Technologies Review we will also be taking forward a major review over the coming months to make recommendations to Government on opportunities to accelerate access for National Health Service patients to innovative medicines, devices and diagnostics.