Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what provision is available to allow NHS patients to access specialised medication and drugs only available in the US.

The Human Medicines Regulations 2012 as amended contain provisions for the import of unlicensed medicinal products to meet the special clinical needs of particular patients. The importer (who must hold a licence for that purpose) must notify the Medicines and Healthcare products Regulatory Agency (MHRA) that such importation is taking place. The MHRA may object to the importation if there is a known safety or quality issue with the product, or if an equivalent United Kingdom-licensed product is available.

Such products are used on the direct personal responsibility of the prescriber, who would retain clinical responsibility for the patient while prescribing the product in question.

In primary care, prescribers are allowed to prescribe any product, including any unlicensed product, which they consider to be a medicine necessary for the treatment of their patients under the National Health Service, as long as that product is not included in Schedules 1 or 2 to the NHS (General Medical Services Contract) Regulations 2004 and that the prescriber is prepared to justify any challenges to their prescribing by the relevant commissioning organisation.

When a patient is being treated by a hospital the consultant can arrange for the supply of any product, even one not normally available on NHS prescription, provided the relevant commissioning organisation or NHS trust agrees to supply it at NHS expense.