Medicines Commission

The membership of the Committee on Safety of Drugs and its subcommittees changed further following the resignation of Sir Derrick Dunlop in May 1969, as a result of his appointment as the first Chairman of the Medicines Commission (MC), estabhshed under the Medicines Act 1968. 

The Medicines Commission, provided for in section 2 of the Act, was established by the Ministers to give them advice generally relating to the execution of the Act (SI 1970/746), with Sir Derrick Dunlop as its first Chairman. 

Sir Derrick Dunlop s tenure of office ended on 31 December 1971. The Medicines Commission has since then been successively chaired by Lord Rosenheim (from January 1972 to 2 December 1972, when he died suddenly). Professor A Wilson (Acting Chairman December 1972 to the middle of 1973), Sir Ronald Bodley Scott (middle of 1973 to December 1975), Professor WJH Butterfield (later Sir John Butterfield and later still Lord Butterfield, January 1976 to December 1981), Professor Rosalinde Hurley (later Dame Rosalinde Hurley, January 1982 to December 1993), Professor DH Lawson (January 1994 to December 2001) and Professor Parveen Kumar (January 2002 to October 2005). 

The establishment of the Medicines Commission in May 1969 was followed by the establishment of a number of expert committees with specific advisory functions, appointed by Ministers after considering the recommendations of the Commission as proposed in section 4 of the Medicines Act. These expert committees, whose members are appointed by Ministers on the advice of the Medicines Commission, advise the LA and consist of independent experts such as hospital clinicians, general practitioners, pharmacists and clinical pharmacologists, and not the staff of the DHSS. 

In 1974, the Health Ministers consulted the UK Medicines Commission on a proposal to set up a committee under section 4 to advise the LA on applications for product licences for dental and other surgical materials. 

A new Commission on Human Medicines (CHM) that amalgamates the responsibilities of the present Medicines Commission and the Committee of Safety of Medicines, which will advise Ministers direct on matters relating to medicines for human use. 

Her Majesty s Stationery Office, London, 1971. Medicines Commission. First Annual Report to end... 

Medicines Commission. Annual Report for 1971. Her Majesty s Stationery Office, London, 1972. Committee on Safety of Medicines. Report for the year ended 31 December 1971. Her Majesty s Stationery Office, London, 1972. 

In 1975, a paper was produced by the Professional Head of Medicines Division of the Department of Health and Social Security (DHSSKnow DoH) for consideration by the Medicines Commission. It was proposed that a new style BNF should be produced because the DHSS was concerned that doctors were being unduly influenced by promotional material produced by the pharmaceutical industry that was leading to an escalating medicines bill for the NHS. It was suggested that the New Style BNF should fulfill the following criteria ... 

Initially it was proposed that the Medicines Commission should publish this, but neither the BMA or the Pharmaceutical Society were willing to surrender copyright. 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

The Medicines Commission of the UK has reviewed all currently available relevant data and has confirmed that the incidence of venous thromboembolism is about 25 per 100 000 women per year of use (21). The incidence of venous thrombembolism in users of second-generation combined oral contraceptives is about 15 per 100 000 women per year of use. This indicates a small excess risk... 

Managing Variability in Response, Concentration and Dose, COST B1 Medicine, Commission of European Communities, Luxembourg, 1997. 

In 1992 the Inspectorate General gave an overview of the Medicines Commission s annual workload on medicines ... 

Until 1998, the Medicines Commission consisted of an executive board, a chairman, four working parties and outside experts and consultants. Except for one general practitioner, all members are professors at different Belgian universities and are experts in either toxicopharmacology, clinical medicine, drug analysis and galenical pharmaceutics or veterinary medicine. The Secretariat of the Commission falls under the responsibility of the Inspector General, who is a pharmacist. In 1994 the inspectorate consisted in total of 28 civil servants (in 1982 the number was 37). 

Table 1. Internal appointments at the Medicines Commission in Belgium.

The Executive Board is the advisory body of the Medicines Commission. It consists of a chairman, a vice chairman and eight other members. The chairman is a professor in medicines and the vice chairman is a professor in pharmacy. One of the members is a general practitioner, four are professors in pharmacology with a specialisation in pharmacognosy and pharmacology and the other two are professors in galenics. The last is a professor in veterinary science. Nominations for these posts are made through a Royal Decree. 

The Medicines Commission also includes four civil servants (pharmacists) with an advisory capacity the inspector general of pharmacies the director of the Institute of Hygiene and Epidemiology a pharmacist designated by the minister responsible for social security and the inspector general of the Radiation Protection Division (for radiopharmaceuticals and medicincil products treated with ionizing radiation). These civil servants can also be represented by their deputies. 

The Secretariat of the Medicines Commission is placed under the responsibility of the Inspector-General of Pharmaceutical Inspection and is staffed by civil servants appointed by the Minister. 

The Executive Board examines the dossiers and within 14 days following their receipt announces whether working parties are to be consulted. The Board will then determine the working parties to be consulted and designate the rapporteurs, who are either full members of the Medicines Commission or consultants. Almost all evaluations were undertaken by professors or their eissistants (the so-called external experts who are now being replaced by internal experts). 

When the MA application concerns the registration of vaccines, sera, therapeutic substances of human origin or medicinal products treated by ionizing radiation, a copy of the MA application is transmitted for a simultaneous opinion formulated by the High Public Hygiene Council. This opinion has to be given within 2 months of receipt of the MA application. It is then added to the dossier and examined by the Medicines Commission together with the reports of the rapporteurs... 

Each MA has to be renewed every 5 years. This is best done by indicating the minor changes that have occurred (e.g., updating analytical methods). As in the EC Directives, this will also be the time to update the leaflets on post-marketing surveillance issues. The Medicines Commission will also evaluate the legal status of every MA at the 5-year renewal date. Major changes (e.g., inactive ingredients, licence holder) have to be submitted for approval separately before implementation. 

Since 1990 there has been an extra step in the registration procedure in Belgium. After the Medicines Commission has formulated its opinion, the dossier is transferred to the Transparency Commission before the company is then informed about the decision on whether to grant an MA. This Transparency Commission provides rulings on ... 

Article 2 indicates that the Secretariat of the Medicines Commission (defined by Article 14 of the Royal Decree of July 3, 1969 on the registration of medicinal products) has to transmit within 5 days to the Transparency Commission ... 

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