§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will give the most recent figure for the number of the 36,000 product licences of right given in 1971 which are still effective; and how 929W many of those no longer effective were voluntarily surrendered;
(2) of those product licences of right which have been voluntarily withdrawn, how many are estimated to have been withdrawn for the following reasons (a) because of preliminary inquiries by the Committee on Review of Medicines, (b) because they were no longer commercially successful, (c) because they contained an active ingredient which had been assessed by the Committee on Review of Medicines and (d) other reasons;
(3) how many of the existing individual product licences of right have now been individually reviewed by the Committee on Review of Medicines;
(4) what proportion of the drugs which have product licences of right contain active ingredients which have not been assessed by the Committee on Review of Medicines;
(5) how many medicines review letters have now been issued; and if he will publish the names of the main drugs referred to in each.
§ Mr. Moyle,pursuant to his reply [Official Report, 21st July 1978; Vol. 954, c. 458], gave the following information:
Product licences were granted in 1972 for a period of five years in any case where the application showed that the product had been on the market in the 12 months preceding 1st September 1971. There was no requirement that holders should notify subsequent discontinuance of marketing. When, in 1975, at the outset of the review of product licences, holders were asked for further details, holders of a considerable number of licences indicated that they did not wish to continue the licences in force. Reasons were not always given but it appears that in most cases the explanation was either that the product had already ceased to be marketed or that in fact it was not subject to licensing. In 1977 all holders were given the opportunity of renewing their licences. An appreciable number did not respond; no further inquiries were made but it is presumed that in most cases the licence holders had ceased to trade.
The latest estimate of the number of licences of right in force is 22,000. Thus a total of 14,000 of the original 36,000 930W licences have ceased to be effective. The further analysis of this number requested by my hon. Friend is not available. I can say however that in almost 11,000 cases the withdrawal followed the request for further data in pursuance of the review, whilst in about 3,000 cases the licence was not renewed; in the majority of these the company or individual no longer holds any licence.
Much smaller numbers have been withdrawn on other occasions, including some cases where the withdrawal has followed advice given by the Committee on Safety of Medicines and others where a product licence of right has been revoked and replaced by an ordinary licence on reformulation. In three cases formal action has been taken by the licensing authority on grounds of safety or efficacy to remove a product completely from the market.
Forty-two review letters have been issued. They relate to ingredients of 1,500 products. Definitive recommendations have been issued in respect of 128 products and the question of formal licensing action, where necessary, to implement these recommendations is for the licensing authority.
The list of ingredient products covered by the review letter is as follows:
- Aloxiprin
- Amitriptyline
- Aspirin
- Benorylate
- Butriptyline
- Caffeine
- Chloroquine/Hydroxychloroquine
- Codeine
- Cyclophosphamide
- Desipramine
- Dextromotamide
- Diamorphine
- Dihydrocodeine
- Imipramine
- L-Tryptophan
- Morphine
- Nortriptyline
- Papaveretum
- Paracetamol
- Penicillamine
- Pentazocine
- Pethidine
- Phenacetin
- Phenazone
- Piritramide
- Protriptyline
- Quinine
- Salicylamide
- Sassafras
- Sodium Salicylate