Named patient supply

Definition

A medicine is supplied to a named, identified patient on the responsibility of the prescriber who is treating that patient, outside the terms of any marketing authorisation in the country of use. The prescriber, not the supplier, carries the clinical responsibility for the decision to use the product.

Because the product is unlicensed in that country, the normal consumer-protection framework of a marketing authorisation does not apply. Every regulatory system that permits this route therefore constrains it tightly: a specific patient, a specific prescriber, a genuine clinical need, limited quantities, and notification to the authority.

The clearest codified example: UK MHRA Guidance Note 14

Regulation 167 of the Human Medicines Regulations 2012 sets out the exemption in the most precisely drafted form available in English. Four conditions must ALL be met.

• The medicine is supplied in response to an unsolicited order.
• It is manufactured to the specification of a registered doctor, dentist, or independent or supplementary prescriber.
• It is for a patient for whose treatment that prescriber is directly responsible, in order to meet that patient's special needs.
• There is a genuine special clinical need.

Import notification and quantity limits

These figures are the UK numbers. They are set out here because they are the clearest published quantitative expression of what "individual patient" supply means in practice: small quantities, patient-scale, notified in advance. Other jurisdictions express the same principle with different mechanics — always confirm the applicable requirement with the destination authority.

• Importing an unlicensed medicine requires at least 28 days' written notice to the MHRA before importation.
• The quantity notified must not exceed 25 single administrations, or 25 treatment courses of a maximum of three months each.
• The MHRA may object within the 28-day period, in which case the importation does not proceed.

The advertising prohibition

Under Guidance Note 14, specials must not be advertised. The only communications permitted are factual answers to specific enquiries, price lists that carry no product claims, and trade catalogues that carry no product claims.

Related pathways, distinguished properly

These four routes are routinely conflated. They are not the same and they do not carry the same obligations.

EU — Article 5(1), Directive 2001/83/EC

The named-patient exemption. A Member State may exclude from the Directive medicines supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional, for use by an individual patient under that professional's direct personal responsibility. Individual patient, individual prescriber.

EU compassionate use — Article 83, Regulation (EC) 726/2004

Cohort-based, not individual. A medicinal product may be made available for compassionate reasons to a GROUP of patients with a chronically or seriously debilitating disease, or whose disease is considered life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product. The product must be the subject of a marketing-authorisation application or be undergoing clinical trials. This is a programme, opened for a defined population — not a supply route for one patient.

US — FDA Expanded Access

Also called compassionate use. A pathway for a patient with a serious or immediately life-threatening disease to gain access to an investigational medical product outside clinical trials, where there is no comparable satisfactory alternative. It covers individual patients (including emergency use), intermediate-size populations and treatment protocols. It concerns investigational products under FDA oversight — it is not an import route for a product already marketed elsewhere.

Named patient supply of a product licensed elsewhere

The situation this section addresses most often: the medicine holds a marketing authorisation in another country but not in the country of treatment. The route is the named-patient exemption plus the destination country's import authorisation — not compassionate use and not expanded access.

Gulf-specific import routes

Named patient supply into the Gulf additionally requires the destination authority's import authorisation. The national procedure governs.

United Arab Emirates

Import permit issued by MOHAP (Ministry of Health and Prevention). See the UAE import guide for the documentation set.

Saudi Arabia

SFDA (Saudi Food and Drug Authority), including the personal/patient importation route administered through its electronic services. See the Saudi import guide.

Qatar

MOPH (Ministry of Public Health), Pharmacy and Drug Control. See the Qatar import guide.

Kuwait and Bahrain

Requirements must be confirmed directly with the national authority before any consignment is prepared. The published procedure is not reproduced here because it could not be verified from a primary source, and inventing one would be worse than saying so.

What is required before supply

• A valid prescription issued by the physician clinically responsible for the named patient.
• The specification: INN, brand, strength, presentation, quantity, required delivery window.
• Where the destination authority requires it: a medical report or physicians' council protocol stating the clinical justification.
• Where the destination authority requires it: an import permit issued before despatch.