The current advisory bodies’ arrangements have remained broadly unchanged since their introduction under the Medicines Act 1968. They provide advice to Ministers (who are the Licensing Authority) on aspects of medicines regulation.
Many changes have taken place in the regulation of medicines over the past 30 years, in particular in the extensive development of the European system of medicines regulation and EU legislation. Further EU changes are planned, including greater use of expert groups to review products in specific therapeutic areas and to give scientific advice. Taking account of these changes, Ministers therefore decided to review the UK advisory committee system to reflect increasing specialisation and to ensure that the UK continues to play a leading role within the EU system.
Following public consultation (MLX 300) on proposals for the structure, and on the approach to dealing with potential conflicts of interest of chairmen and members of the new committees (MLX 316), Ministers have agreed on the following revised committee structure, which was introduced on 30 October 2005:
- A Commission for Human Medicines (CHM) that combines the functions of the current Medicines Commission and Committee on Safety of Medicines.
- Section 4 committees dealing with herbal medicinal products (Herbal Medicines Advisory Committee – HMAC) and homoeopathic products (Advisory Board for the Registration of Homoeopathic Products – ABRH) which will advise Ministers direct, and have their own appeals and persons appointed arrangements.
- The British Pharmacopoeia Commission – which continues as a Section 4 committee.
- A range of Expert Advisory Groups (EAGs) to undertake detailed examination of issues prior to referral to the CHM (or one of the Section 4 committees). These will be established by the CHM and will mostly be therapeutically aligned. The chairmen of the Chemistry, Pharmacy and Standards EAG, the Pharmacovigilance EAG and the Biologicals EAG will be part of the CHM.
- The chairman of each other EAG, or his nominee, will attend the CHM as and when required – for example, when products reviewed by his EAG are to be discussed.
- The persons appointed procedure will address only issues remaining after the CHM hearing. They will be able to consider scientific data and procedural matters that can relatively easily and appropriately be resolved and which would otherwise result in judicial review.
The Veterinary Medicines Directorate (VMD) are creating an advisory committee structure and appeals procedure that will separate veterinary medicines from the Medicines Act and its advisory bodies.
There is a revised Code of Practice dealing with conflicts of interest. Key features include:
- the chairman and members of the Commission for Human Medicines, the HMAC and ABRH may not hold personal interests in the pharmaceutical industry (this is defined to include the herbals and homoeopathics industries);
- all other interests must be declared and managed;
- the chairmen of the EAGs who are permanent members of the CHM may not hold personal interests in the pharmaceutical industry; and
- the chairmen and members of all other EAGs may hold interests in the pharmaceutical industry but they must declare these and the management of their interests will restrict their participation in certain discussions.