Named Patient Supplies

Named Patient Supplies enable healthcare professionals, on behalf of their patients, to access medicines approved or nearing approval in other countries before marketing authorisation has been granted in their home country.

The treating healthcare professional makes the clinical judgment that no comparable or satisfactory alternative approved therapy is currently available for a given patient and that the probable risks from the investigational drug are not greater than the probable risks from the condition itself.

In the UK, provision for granting access to investigational drugs for patients is governed by The Medicines and Healthcare Regulatory Agency (MHRA), who are responsible for ensuring the safe supply of medicines to patients. The MHRA may provide licenses to companies who demonstrate the capabilities and facilities to manage the provision of unlicensed medicines in accordance with MHRA guidelines. In the US, the Food and Drug Administration (FDA) governs the equivalent process.

Often grouped under the labels of compassionate use, special access, expanded access, or named patient supply, these provisions allow companies to provide patients with access to their medicines while the drugs are still in the preapproval phase. Strict regulations governing such access define access criteria, data collection, non-promotion, and control of drug distribution.

Companies such as BTG which are authorised to distribute on a named patient basis merely distribute and are not involved in the patient doctor relationship. All information regarding patients is controlled under specific privacy and data protection legislation. BTG can only distribute where permitted to do so and only in response to an unsolicited information or product supply request.