Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, which Off-patent drugs will be considered under the Early Access Scheme.

Off-patent drugs are those whose patent period has expired and consequently manufacturers may make available generic or non-branded versions of the products.

An “off-label” medicine is any medicine prescribed outside the terms of its licence (as set out in the prescribing information in the Summary of product Characteristics). Medicines legislation permits prescribers to prescribe a product outside the terms of its licence where they judge it to be in the best interests of the patient to address a medical need. For example to prescribe for a different use or to different category of patients but in doing so the prescriber takes personal responsibility for the treatment, inform the patient(s) of the licensing status of the product and obtain consent from the patient for its use.

The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission. The scheme is voluntary and as such the MHRA is dependent on companies submitting potential products that may fulfil the EAMS criteria.

In the government response to the public consultation, it was confirmed that off-label supply of existing medicines would be eligible for the scheme, but only if they meet the EAMS criteria. Thus companies can submit an application to the EAMS for a new indication for an already marketed drug (which may be off patent).