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