Volume 7: Medicines and Cosmetics
2. The operation of medicines licensing
New structures responsible for medicines licensing
Medicines Control Agency
Veterinary Medicines Directorate

Medicines Control Agency

2.100 The MCA was created, following the Evans-Cunliffe Report, in April 1989, although it remained at that stage a division of DH. On 11 July 1991 it became an Executive Agency of DH. Crucially, the three parallel hierarchies were replaced with multi-disciplinary teams. The freedoms of Agency status were intended to help it meet the challenges of new developments in medicine; of completion of the EC single market; and of a European system for regulating medicines. ¹

2.101 In place of the old structure of the Medicines Division, the new MCA had several Business Groups. Management lines were reorganised and the pharmaceutical and medical staff integrated. ² The new Business Groups were in place by June 1990, although the reporting lines remained as under the Medicines Division until July 1991. ³

2.102 These Business Groups were:

1. Business A: New drugs and European Licensing
2. Business B: Abridged licensing
3. Business C: Pharmacovigilance
4. Business D: Inspection and enforcement
5. Business E: Executive support ⁴

2.103 The Agency was headed by a Director or Chief Executive, Dr Keith Jones, and each Business Group by a Business Manager (of Grade 4 level) who reported to the Chief Executive. The Chief Executive was fully responsible and accountable to the Secretary of State for Health for the efficient management, overall performance and future development of the Agency. Neither Ministers nor DH were involved in the day-to-day management of the MCA. In addition, a Departmental Board made up of Departmental and outside members and a Chairman from DH was set up. It was responsible, after consultation with the Chief Executive, for providing independent advice on corporate planning and strategic issues to the Secretary of State. ⁵

2.104 Dr Keith Jones clarified his role in a written statement:

On my appointment as Director of the MCA all staff within the Medicines Division nominally reported to me. However, in practice the existing lines of command continued and I reported jointly to the Deputy Secretary responsible for medicines policy and to the Deputy Chief Medical Officer (DCMO) until MCA became a Next Steps Agency in 1991. ⁶

. . .

When the MCA became an executive agency on 11 July 1991, my title changed to that of Chief Executive, and I became responsible and accountable directly to the Secretary of State for the efficient management, overall performance and future development of the MCA. My role is primarily that of a medically, scientifically informed manager: I am there to oversee the running of the MCA and since July 1991, to advise Ministers on matters of medicines control. ⁷

2.105 Under the new structure Dr Jefferys was given wider responsibility as the Business Manager for Business A: New drugs and European Licensing. He was responsible for the medical, scientific and pharmaceutical staff involved in the assessment of new drugs including biological products. In addition he was responsible for the secretariat to the CSM and for the Biological and Biotechnological Unit that was headed by Dr Purves. Dr Jefferys reported to Dr Keith Jones. ⁸

2.106 The Biological and Biotechnological Unit was set up shortly after the MCA became operational. Dr Purves was appointed unit manager in late 1990 and Dr Rotblat was the Senior Medical Officer (SMO). ⁹

2.107 Business B, headed by Mr David Hagger, was responsible for abridged product licensing, variations to existing licences and product licence renewals as well as licensing work and administrative support for the CRM and CDSM. ¹⁰ Dr June Raine, a Group Manager reporting to Mr Hagger, was Principal Medical Assessor to the CDSM. ¹¹

2.108 Of the other businesses in the MCA structure, Business C was headed by Dr Susan Wood, Business D by Mr Bryan Hartley, Business E by Mr Roy Alder, and Business F by Dr Alan Rogers. ¹²

2.109 In the autumn of 1994 there was a further reorganisation of the MCA ¹³ into the following five divisions:

1. Licensing Division
2. Post Licensing Division
3. Inspection and Enforcement Division
4. Executive Support Division
5. Finance Division. ¹⁴

2.110 The Agency was still headed by the Chief Executive, Dr Keith Jones, and each Division by a Grade 4 Business Manager. ¹⁵

Veterinary Medicines Directorate

2.111 As noted above, in April 1989, just over a year after Mr Cunliffe produced his Report, the three divisions of MAFF responsible for medicines licensing merged to become VMD. A year later VMD became an Executive Agency. An Ownership Board was established consisting of a Chairman from MAFF, senior Departmental representatives and Dr Rutter, as Chief Executive. The Chief Executive reported directly to the MAFF Ministers. ¹⁶ VMD was responsible for the licensing of veterinary medicines, post-licensing surveillance (including adverse reactions), the control of animal medicines and medicated feedstuffs, the control of veterinary residues, and for providing policy advice to MAFF. ¹⁷ Throughout these organisational changes, most of the same staff continued in post to operate the established licensing and consultation procedures under the Medicines Act. ¹⁸

2.112 Within VMD, work was allocated between three multi-disciplinary professional and administrative teams, each headed by a professional (Grade 6 level) and administrative (Grade 7 level) team leader reporting to the appropriate Deputy Director (Mr Kidd on the professional side and Mr Lawson on the administrative side). The three teams which reported to the Deputy Directors were:

1. Pharmaceuticals responsible for assessing applications and administering product licences for pharmaceutical products. Also responsible for international and European aspects of market authorisations and legislation for these products. This team coordinated VMD interests on policy developments relating to these matters. Head of the professional team was Dr K N Woodward and head of the administrative team was Mr A F Harvey;
2. Biologicals and recombinant products responsible for assessing applications and administering product licences for biological and recombinant products. Also responsible for administering the Suspected Adverse Reactions Scheme (SARS) for all veterinary products. This team also coordinated VMD interest in policy developments relating to biologicals and recombinant products. The administrative staff in this team provided the secretariat for the Veterinary Products Committee. Head of the professional team was Dr Aileen Lee and head of the administrative team was Mr A J C Taylor; and
3. Feed additives responsible for assessing applications and administering product licences for all veterinary medicinal products administered in feed or drinking water with the exception of oral vaccines. Also responsible for coordinating VMD interests in policy developments relating to these matters. The Finance team reported to the Head of Administration in this team. Head of the professional team was Mr J O'Brien and head of the administrative team was Mr C Bean. ¹⁹