Summary of Named Patient provisions under Medicines Act.

A Named Patient is a particular patient being treated by a doctor or dentist, for whom that doctor or dentist has issued a prescription for a drug not currently licensed in the United Kingdom (UK). Such a patient may have been successfully treated with a drug in a clinical trial, which is ending. The clinician may feel that treatment with the drug should be continued for the benefit of the patient. Alternatively, the clinician may feel that no drug licensed by the MCA, and therefore freely available on prescription from a pharmacist, would be suitable for the particular patient. In this case, if he or she knows of a drug not currently licensed, which would be more appropriate for such a patient, he or she may prescribe it on a Named Patient basis.

The responsibility for ensuring the drug is being used in a proper indication for such a patient, and the ensuing clinical management is wholly that of the prescriber.

The responsibilities of the manufacturer, in this case Bayer plc, are defined in the Statutory Instrument Number 673, Medicines, The Medicines (Exemption from Licences) (Importation) Order 1984; see Annex 1.

The Statutory Instrument

The Medicines (Exemption from Licences) (Importation) Order 1984 dictates the legal requirement for Named Patient requests for a drug for which no product licence has been granted in the UK. It states that the drug must be specified by its non-propriety (generic) name which has been published by the director general of the world health organisation (WHO) in the WHO chronicle. This publication states that the drug is a ‘medicinal product’ and that it has a monograph name as approved by the British Pharmacopoeia, the British Pharmaceutical Codex, the European Pharmacopoeia or a foreign or international compendium of standards.

The instrument allows an authorised person to import or supply such a medicine in response to a prescription by a doctor or dentist for a particular named patient. Such an authorised person can represent any of the following:

1. A hospital
2. A pharmacist
3. A wholesaler to supply any of the above
4. A pharmaceutical manufacturer

Conditions

Under the Statutory Instrument, the MCA must be informed in writing of the proposal to import medicine. After a twenty eight-day period has elapsed, the exemption from the need to hold a PL applies. However the following conditions must be fulfilled;

1. The name of the medicine must have been supplied to the MCA. This can either be the generic name together with a trade mark ™ or the name of the manufacturer, or a brand name with a TM or the name of the manufacturer.
2. The quantity of the medicine to be imported must be supplied to the MCA.
3. The name and address of the manufacturer must be supplied to the MCA.
4. The quantity to be imported must not exceed twenty-five courses of treatment of no more than three months duration.
5. The MCA must be informed of any matter which might affect the safety or quality of the medicine. Therefore safety data must be collected and all suspected adverse drug reactions must be reported.
6. The medicine must not be promoted in any way to the prescriber and request for supply must be unsolicited.
7. Written records must be kept of the importation (name of drug, quantity, and name of manufacturer), and the name and address of the person to whom the drug is supplied (quantity and date of supply). Such records must be kept and made available for inspection by the MCA for a period of five years after the supply date.
8. Appropriate facilities for the safe storage of the medicine to prevent deterioration must be maintained. These facilities must also be made available for inspection by the MCA.

As all drugs supplied by Bayer plc are manufactured by Bayer AG and imported into the UK, the import regulations (see 2 and 4 above) apply in every case.

Termination of exemption

The exemption from PL can be terminated by the MCA in any of the following circumstances:

1. The authorised person importing is found to be in breach of any of the conditions of the exemption, or if the conditions are subsequently found not to have been fulfilled in the first instance.
2. The MCA decide that, on the basis of information received, the medicine is no longer safe or of sufficient quality.
3. A PL has been granted.

Additional Information (Bayer specific)

An internal authorisation must be signed by a fully registered medical practitioner in order that the drug(s) may be supplied for the purpose requested.

The medicine must not be supplied directly to the patient by the company.