BioCentury
ARTICLE | Politics & Policy

U.K introduces early access scheme

March 15, 2014 12:21 AM UTC

Next month, the U.K.'s Department of Health plans to launch the Early Access to Medicines Scheme, which will allow limited access to unapproved or off-label products based on quality, safety and efficacy data from Phase II or III testing. Under the scheme, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) will issue a scientific opinion describing the risks and benefits of products that have been given a promising innovative medicine (PIM) designation. The designation is given to products that treat conditions that have no treatment options or have unsatisfactory treatment options.

Under the early access scheme, companies are expected to provide the product free of charge to patients "when appropriate" until regulatory approval. Originally, the DoH had proposed that reimbursement under the scheme would be at the discretion of local NHS trusts. ...