HC Deb 21 June 1978 vol 952 cc225-8W
Mr. Ashley

asked the Secretary of State for Social Services (1) how many new drugs have been licensed each year by the Committee on Safety of Medicines since it was set up;

(2) how many old drugs which were being marketed when the Committee on Safety of Medicines was first set up have been given licences and allowed to stay on the market; and how many of these old drugs have gone through the tests which new drugs undergo before they receive licences;

(3) if he will estimate the total of new approved drugs and old drugs currently on the market;

(4) if he will give the number of old drugs which the Committee on Safety of Medicines rejected after testing; and if he will give the number of new drugs which the Committee on Safety of Medicines rejected after clinical trials;

(5) if he will give details of the testing procedures which the Committee on Safety of Medicines applies before it gives approval to old drugs and to new drugs; (6) whether the Committee on Safety of Medicines has the results of a company's testing on drugs available to it when deciding whether or not to license the drugs; and whether it has powers to order any drug company to submit results of tests at any time;

(7) if he will invite the Committee on Safety of Medicines to consider the advantages and disadvantages of all testing results by companies to be given automatically to the Committee of Safety on Medicines.

Mr. Moyle

I would refer my hon. Friend to the reply I gave to him on 9th June. Further details are given in the annual report of the Committee on Safety of Medicines (CSM).

An applicant for a product licence is required to provide evidence of the safety, quality and efficacy of his product. In the case of a product containing a new drug, substance particulars of toxicity testing and clinical trials are required. I am sending my hon. Friend a copy of the department's leaflet MAL 2 which gives full details of the requirements.

Data received in connection with applications is considered by the CSM before it advises the licensing authority.

Licence holders are not normally required to conduct further clinical trials after a product has been approved for marketing, but it is a requirement of the product licence that the holder shall provide information as to reports of adverse effects and any other information received by him which casts doubt on the continual validity of the information taken into account in assessing the safety, quality or efficacy of the product. Such information is considered by the CSM.

There is no comprehensive information as to the extent of testing of products which were brought on to the market before 1st September 1971. In general, those first marketed in 1964 or later would have been referred to the Committee on Safety of Drugs under the voluntary arrangements with the pharmaceutical industry: in matters of safety the requirements of that committee broadly corresponded to the licensing requirements. All the pre-1971 products will in due course be considered by the Committee on Review of Medicines.

Under Section 44 of the Medicines Act, holders of a licence of right—pre1971 products—may be required to furnish any information which would be appropriate in the case of a new application. Holders of ordinary—post-1971 —licences may be required to give any information which is considered requisite by the licensing authority or a Section 4 committee for the purpose of considering any question whether the licence should be suspended, varied or revoked. In view of these provisions and those described in the fourth paragraph, I do not consider that there is occasion to ask the CSM to consider any change in the arrangements on the lines envisaged in my hon. Friend's Question.

Mr. Ashley

asked the Secretary of State for Social Services (1) what are the criteria which determine the issuing of a yellow warning notice; and when the Committee on Safety of Medicines is deciding whether or not to issue a yellow warning notice, if it considers the benefits derived from the drug as well as the risks of the drug;

(2) for how many drugs yellow warning notices have been issued, subdivided into those drugs on the market before the Committee on Safety of Medicines was established and those which came on the market subsequently;

(3) if he will categorise the reasons for yellow warning notices into the follow- ing: (a) the results of research undertaken by the Committee on Safety of Medicines, (b) the results of research undertaken elsewhere in the United Kingdom, (c) the results of research overseas and (d) other reasons.

Mr. Moyle

In general, adverse reactions warning leaflets are reserved by the Committee on Safety of Medicines for urgent warnings to the medical, dental and, when appropriate, pharmaceutical professions whenever evidence on a particular drug substance or class of drugs suggests that a serious hazard may exist. Each case for the issue of a leaflet is considered on its merits; benefits derived from treatment and the possibility and nature of the hazard are important factors in the consideration. Other forms of communication such as a chairman's letter, an item in the committee's "Current Problems" leaflets or publication in professional journals are also employed.

16 warning leaflets have been issued by the Committee on Safety of Medicines and its predecessor, the Committee on Safety of Drugs. Two early leaflets were general notices about adverse reactions reporting and several covered whole groups of drugs. Those issued by the Committee on Safety of Medicines referred to six drug substances, of which two had been marketed since the committee's inception in 1971. The evidence to warrant issue of a warning leaflet was broadly derived from one or more of the following sources:

  1. (a) Collected reports on individual cases sent to the Committee by doctors—7 leaflets.
  2. (b) Research undertaken by the Committee on Safety of Medicines and Committee on Safety of Drugs-2 leaflets.
  3. (c) Research elsewhere in this country—3 leaflets.
  4. (d) Research abroad—2 leaflets.
  5. (e) Results of studies reported in professional journals—2 leaflets.