HC Deb 02 November 1989 vol 159 cc311-2W
Mr. David Nicholson

To ask the Secretary of State for Health how many incidents of counterfeit medicines reaching the United Kingdom distribution system have been reported to his Department in the last 12 months; what countries were the alleged sources of fake products; and what estimates he has of the number of National Health Service patients who have been dispensed counterfeit medicines in the current year.

Mrs. Virginia Bottomley

During the past 12 months the Department has had one report of a counterfeit medicine entering the United Kingdom distribution chain. The product was a copy of Greek Zantac 150 mg. The source is under investigation.

The counterfeit was marked with a genuine batch number. The evidence suggests that only one importer may have been supplied with counterfeits. He distributed 240 packs from the batch in question, each containing 20 tablets. This would be sufficient for one month's supply for 80 patients. But it is not known what proportion of the 240 packs may have been counterfeit so no accurate figure can be given of the number of patients to whom counterfeits may have been dispensd. On analysis the counterfeit product appeared to present no hazard to patients. As a fast-moving product, it proved impossible to recall any of the batch from retail pharmacies.

A separate incident also involving counterfeiting of Greek Zantac was reported to the Department in which the importer recognised the product as outside specifications and returned it to his supplier before any of the product was distributed within the United Kingdom. I refer my hon. Friend to the reply that my hon. and learned Friend gave on 10 March at columns 718–19.

Mr. David Nicholson

To ask the Secretary of State for Health what action he proposes to ensure that National Health Service patients are protected from receiving counterfeit medicines; and whether he has any proposals to tighten the regulations covering the licensing of parallel imports of pharmaceuticals.

Mrs. Virginia Bottomley

Existing controls involve;

  1. (1) a sampling and testing programme operated by the Medicines Inspectorate with analysis undertaken by the Royal Pharmaceutical Society's medicines testing laboratory at Edinburgh.
  2. (2) An annual programme of inspection carried out by inspectors of the Medicines Control Agency and the Royal Pharmaceutical Society. All manufacturers, importers, wholesalers and community pharmacists are inspected regularly.
  3. (3) particular checks carried out by licensed importers to verify the identity of each batch of imported material.

We are considering whether any changes may be necessary to the United Kingdom parallel import licensing scheme. We have received proposals and need to consult with all interested parties, taking account of our European Community obligations.