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The new Pharmacovigilance Directive [Council Directive 2010/84/EC] requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change. The EC has engaged consultants to produce this report and publication is expected in the summer of 2013.
Background to establishment
The Medicines and Healthcare products Regulatory Agency undertook a public consultation on proposals to amend the advisory body structure laid down in the Medicines Act 1968 in February 2005. Ministers agreed to a new structure with the establishment of the Commission that amalgamated the responsibilities of the Medicines Commission and the Committee on Safety of Medicines. The Commission was established under Section 2 of the Medicines Act 1968 (SI 2005 No. 1094).
Terms of reference
The duties of the Commission which came into being on 30 October 2005 are set out in Section 3 of the Medicines Act 1968, as amended by the Medicines (Advisory Bodies) Regulations 2005 and include the following:
- to advise ministers on matters relating to human medicinal products (except those that fall under the remit of Advisory Board on the Registration of Homoeopathic Products (ABRH) and Herbal Medicines Advisory Committee (HMAC))
- to advise the licensing authority (LA) where the LA has a duty to consult the Commission or where the LA chooses to consult the Commission including giving advice in relation to the safety, quality and efficacy of human medicinal products
- to consider representations made in relation to the Commission’s advice (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder
- to promote the collection and investigation of information relating to adverse reactions for human medicines (except for those products that fall within the remit of ABRH or HMAC) for the purposes of enabling such advice to be given.
Commission membership, Code of Practice and meetings
The appointment of the Chairman and members including two lay representatives were carried out by the NHS Appointments Commission in accordance with Nolan procedures and the approval of UK health ministers. The Chair and Commissioners follow a published Code of Practice (60Kb) and their interests in the pharmaceutical industry are published in the Commission's annual report each July. Under the new code Commissioners are precluded from holding personal interests.
The Commission meets monthly in London. The Commission is supported in its work by Expert Advisory Groups covering various therapeutic areas of medicine. In addition, the Commission calls on experts not readily available on the Commission or any of its EAGs provide supplementary expert opinion, either written or by attending meetings.
Expert Advisory Groups (EAGs)
The chairs of the three statutory EAGs namely Pharmacovigilance, Chemistry, Pharmacy and Standards and the Biologicals/Vaccines were also appointed by the NHS Appointments Commission because they are also standing members of the Commission. A list of other EAGs is given below.
The EAG chairs and members are also required to follow the Code of Practice.
List of established Expert Advisory Groups
- Anti-infectives / HIV / Hepatology
- Biologicals / Vaccines
- Cardiovascular / Diabetes / Renal / Respiratory / Allergy
- Chemistry, Pharmacy and Standards
- Clinical Trials
- Dermatology / Rheumatology / Gastroenterology / Immunology
- Medicines for Women’s Health
- Neurology / Pain Management / Psychiatry
- Oncology and Haematology
- Paediatric Medicines
- Patient and Public Engagement
Activities will include:
- The Commission gives advice on applications for both national and European marketing authorisations and considers further representation against its provisional advice in respect of national applications, either in writing or in person by the company.
- Commissioners also frequently attend the European Committee on Human Medicinal Products (CHMP) meetings as part of the United Kingdom delegation.
- The Commission advises on the nee d for, and content of, risk management plans for new medicines.
- The Commission promotes the collection of reports of suspected adverse drug reactions from health professionals and patients through the 'Yellow Card Scheme'. Data from the Yellow Card Scheme is used for the detection of new safety issues and in the investigation of issues raised from other data sources.
- The Commission provides advice on the impact of new safety issues on the balance of risks and benefits of licensed medicines and advises on appropriate risk minimisation measures. These may include adding warnings to product information for health professional and patients, restricting the use of a product or, in exceptional circumstances, suspending use of a product and/or revoking the marketing authorisation. In the event of urgent safety issues, health professionals will be informed via a letter from the Chairman of the Commission. Less urgent issues are communicated via a bulletin entitled 'Drug Safety Update', which is issued in conjunction with the MHRA.
- The Commission also advises the licensing authority on changes to legal status of marketing authorisations.