Volume 7: Medicines and Cosmetics
2. The operation of medicines licensing
Introduction

2.1 In the UK the sale and supply of medicines is subject to a licensing regime, under which the safety, quality and efficacy of both human and veterinary medicinal products is regulated. This licensing regime set the framework in which the implications of BSE for medicinal products were addressed.

2.2 The licensing regime was established by the Medicines Act 1968. After the UK became a member of the European Community on 1 January 1973, EC rules governing the safety of medicinal products became applicable. Until 1995, the principal legislation under which this was achieved remained the Medicines Act 1968. ¹ We focus here on the system in place in 1988/89, when the implications of BSE for medicinal products were first addressed.

2.3 In essence, a medicinal product could not be sold unless it had been granted a 'product licence' by the Licensing Authority. The Licensing Authority was in principle the relevant Minister, although in practice his or her functions were delegated to officials in the Medicines Division of DH (medicines for human use) or in MAFF (veterinary medicines). They received advice from a number of committees of experts, set up under section 4 of the Medicines Act, known as 'section 4 committees'.

2.4 This chapter begins with a brief explanation of the licensing regime. We then discuss the options that were therefore available to officials and Ministers to tackle the risks posed by BSE to the safety of licensed medicinal products, and medicinal products for which a licence had not yet been granted.

2.5 We then consider the Departments or Divisions within MAFF and DH responsible for operating the licensing regime, outlining the structures in place and identifying the personnel involved. We go on to discuss the findings of two reports published in December 1987 and February 1988, which reviewed the arrangements that were in place for the control of human medicines and veterinary medicines respectively. These reports led to the establishment of Executive Agencies to fulfil the medicines licensing functions, and we briefly describe these agencies at the end of the chapter.

2.6 Medical devices, ie, medical products that work by physical rather than pharmacological means, fell outside the licensing regime. Instead a voluntary manufacturers' registration scheme was operated by a different part of DH; in 1989/90 this was the Supplies Technology Division (STD) of the NHS Procurement Directorate (PD). We conclude with a description of the arrangements for ensuring the safety of medical devices.