Particular patient supply

The use by the medical profession of medicines with no current marketing authorisation and of authorised medicines outside the terms of their marketing authorisation raises various regulatory issues. Leaving aside use in a clinical trial, such products are also used to treat the particular clinical needs of individual patients. This is known variously as named patient, particular patient or compassionate use supply. The first of these terms is misleading, because there has never been any requirement to identify a particular patient and for the purposes of this chapter the term particular patient supply is used instead. 

The UK legislation has for many years permitted particular patient supply in specified circumstances. 

The original provisions date back to the early 1970s. Under section 7(2) of the Medicines Act 1968, it was necessary to hold a product licence in order to sell, supply, export or import a medicinal product to procure those activities or for the manufacture or assembly of the product. However, various exemptions from the licensing requirements, including those relating to particular patient supply, were provided for in the act and in related statutory instruments. The most important exemptions were contained in sections 9 and 13 of the act, the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and the Medicines (Exemptions from Licences) (Importation) Order 1984. ... 

Medicines Act for relevant medicinal products, including section 7 (and consequently all exemptions relating to section 7). Relevant medicinal products are defined in the 1994 Regulations as those medicinal products for human use to the provisions of Directive 2001/83/EC apply. This broad definition includes most medicinal products. The exceptions are medicinal products for clinical trial use, products prepared in a pharmacy in accordance with a pharmacopoeial formula for direct supply to a patient, intermediate products, registered homoeopathic products, non-industrially produced herbal remedies and some products which are not medicinal products within the meaning of the Directive, but which by order have been made subject to control under the Medicines Act 1968. For products designated under such an order, the old provisions on particular patient supply are still applicable. In practice, there are very few such products. 

The Medicines (Exemption from Licences) (Importation) Order 1984 set out additional conditions to be complied with in the case of unauthorised medicinal products imported for particular patient supply but, as noted above, that order was disapplied by the 1994... 

Where a patient orders a product for his own use direct from a supplier in another country, that will not normally be caught by the rules on particular patient supply, since the product will not be placed on the market. However, it is possible that the supplier of that product (which is likely to be a prescription-only medicine) will be committing an offence in the country in which it operates, particularly if it has advertised the product or supplied it otherwise, than in response to a prescription. 

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

Clinical trials are sometimes continued for an open extension period. This is permissible, provided there are genuine scientific reasons for continuing the study (rather than commercial reasons, such as attempting to create demand for the product) and that the appropriate regulatory clearance has been obtained. If the company does not wish to do this, it would be open to the doctor to request further supplies of the product, but the company must not invite him to do this. Any further supply to the doctor would then need to comply with the provisions regarding particular patient supply, unless the doctor has decided to carry out his own clinical trial. 

The distinction between supply for use by particular patients and supply for use in a clinical trial is therefore important, particularly since the rules in the latter case are stricter, and companies must be certain about the basis upon which supply of imlicensed products is made. Various factors are relevant in determining the basis of supply, such as the purpose of the administration (particular patient supply is concerned with treatment clinical trials are concerning with... 

At the operational level, manufacturers must apply proper care and rigorous quality control during production, to ensure that they supply unlicensed medicinal products of the highest quality. They must also have in place proper systems for dealing with requests for particular patient supply and for keeping all the necessary records. 

The Medicines (Exemption from Licences) (Importation) Order 1984 set out additional conditions to be complied with in the case of unauthorised medicinal products imported for particular patient supply but, as noted above, that Order was disapplied by the 1994 Regulations. There were no provisions in the 1994 Regulations to parallel the 1984 Order and consequently the controls on imported unlicensed products were reduced to the level of those on products manufactured in the UK. This was clearly the result of an oversight, and additional controls were reinstated in February 1999 by the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999. ... 

Section 8(3) of the Act requires those involved in the wholesale dealing of a medicinal product to hold a wholesale dealer s licence. If the product is imported from another Member State, a wholesale dealer s licence will be required. If it is imported from a country outside the EU, a wholesale dealer s (importation) licence will be required. Schedule 1 to the 1994 Regulations confirms that these provisions apply equally to particular patient supply. 

In contrast with the position of the manufacturer involved in particular patient supply, section 35(2) of the Act currently exempts from the requirement to hold a manufacturer s licence the manufacturer or assembler of products for the sole purpose of clinical trial use. 

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