Specials in the UK – A model for Europe ?

Medicines Legislation in the UK is detailed in law by the Medicines Act 1968, which governs the control of medicines for human and veterinary use. This has recently been undated to the “Human Medicines Regulations 2012.

In the UK medicines can be provided for patients that are either licensed or unlicensed. Licensed medicines are regulated by either the Medicines and Healthcare Regulations Authority (MHRA) in the UK or European Medicines Association (EMA) in Europe. The Marketing Authorisations (Product License) provided by these bodies detail that a medicine has to be manufactured to a specific formulation, by a specific method by a specific licensed manufacturer. Unlicensed medicines allow prescribers clinical freedom by providing exemptions from full control for patients with special needs. There is an important distinction between licensed and unlicensed medicines as to who is responsible, accountable and liable for patient harm that results from the use of these medicines. For unlicensed medicines the prescriber, purchaser (pharmacist) and Health Care Provider are generally responsible for harm these products may cause to patients. Whereas, for licensed products the Marketing Authorisation holder (Manufacturer is responsible for the public liability.

There are a number of different categories of unlicensed medicines. These include: medicines imported into the UK that are licensed abroad but not licensed in the UK; medicines imported into the UK that are not licensed abroad or in the UK; medicines that are licensed in the UK, but not used for their licensed indication (off label); medicines prepared as “Specials” by licensed manufacturers but do not hold marketing authorisations; and dispensed medicines (Section 10).

The preparation of Specials in the UK is regulated by the MHRA. Dispensing activities are controlled by the General Pharmaceutical Council (GPhC). A “Specials” manufacture must hold a “Specials” manufacturing license issued by the MHRA and the manufacturing facility must be licensed by the MHRA. The product specification should be supplied or agreed with the purchaser (pharmacist) and the prescriber.

Generally it is agreed that medicines required for patients with special needs can be supplied as either “specials” (Licensed manufacturer) or extemporaneously dispensed (Section 10) preparations. The essential distinction between these two types of preparation is based on risk. Extemporaneous (Section 10) preparations are generally expected to present an increased risk of harming patients than products prepared as “Specials” in a licensed unit. However, extemporaneously dispensed preparations are generally more readily available and can be provided to patients in a shorter time frame. Other basic distinctions are presented in table 1.

The provision of "Special" pharmaceutical products in the UK has resulted in a number of commercial companies supplying these products to Health Care Providers. The supply of unlicensed medicines is no longer solely the domain of hospital practice.