Select Committee on Trade and Industry Minutes of Evidence


Examination of witnesses (Questions 474 - 479)

TUESDAY 11 MAY 1998

MR J BARKER and MR T BROWN

Chairman

  474. Good morning. A couple of weeks ago we had in the ABPI and they questioned the idea of imports being identical in all respects and they gave us examples of different appearances of parallel imported products, tablets that have been broken from larger sets and no longer have batch numbers etc. We have seen examples where the appearance of parallel imports is different from the UK version. Is it not misleading to talk of parallel imports being identical when there are examples of them varying in appearance? How do you control that process of importing? How do you control the goods going out to pharmacies and then to patients which do not have the instructions in English, are not part of the proper pack, do not have bar codes or do not have sourcing information? How do you deal with that? Do you recognise it as a problem and if you do, how do you deal with it with regard to your people?
  (Mr Barker) Good morning. May I start by apologising for the sound of my voice. Unfortunately it is only in the last couple of months that it came back to me. This is going to sound very tedious but it will be brief, I can assure you. The trachea broke into two so I could not speak at all for eight months. Thanks to the National Health Service and an absolutely brilliant surgeon in Birmingham, he reconstructed that trachea so I can now babble away to you to my heart's content this morning. I do apologise but I only have one vocal cord. In answer to your question, the Association does not accept the contention which was apparently made to you by our colleagues in the ABPI. You have to understand that as far as pharmaceuticals are concerned, and I am sure you know, it is probably the most heavily regulated industry of all industries, quite rightly so, because of course we are dealing with public health. It is a regulatory side largely governed by the Medicines Control Agency within the Department of Health that confirms that all parallel imports, products which are brought in from another Member State within the European Union, are therapeutically identical. So far as the ultimate patient is concerned, the key is whether the product is therapeutically identical not whether it is the same colour, the same shape or whether the packaging is the same. Members of the ABPI manufacturing industry have for a long time attempted to hinder the parallel trade by quite deliberately making tablets of different colours, deliberately making them a different shape and deliberately using different packaging. That is a conscious attempt to impede the trade to which they will privately admit. We have to live with that situation and you have to remember that before we can place a product on the market we have to send a sample of that product, the new packaging if that is what we are going to use, a copy of the patient leaflet, to the regulatory authority. It all has to be approved. No product can go onto the market unless that approval has been obtained and no product goes onto the market and no approval would ever be obtained for a product the constituent packaging elements of which were not in the English language. I have no evidence to suggest that any product which is not packaged in the English language comes onto the British market. I am sorry, but I have no evidence of that.

  475. We have had evidence relating to the drug Zoladex, which apparently is used in the treatment of Parkinson's Disease and the Parkinson's Disease Society have said to us that there have been instances where drugs like Zoladex have been made available to their patients and the instructions have been in Spanish. They say this is not unusual. Are there other sources of parallel importing of medicines in the United Kingdom apart from your members?
  (Mr Barker) The answer to that question is yes. You and I could both go out tomorrow and start to import medicines into this country, but that is all we could do. The question is not whether we could import, but whether we could put into the supply chain, in other words distribute. That we could not do unless we were authorised by the Medicines Control Agency so to do. In order to get that authorisation, we would need a Manufacturer's Assembly only licence as it is known, we have to comply with certain standards. One of those is that we must employ a Qualified Person. That Qualified Person, who is not in fact employed by the company but is answerable direct to the Medicines Control Agency, has to be satisfied that every product which goes out is in accordance with the Terms of the marketing licence, in other words it has been packaged correctly, etcetera. That is mandatory. In the event that there is an example of a product which is coming into the market which has not gone through that quality control procedure, which incidentally is far greater for the parallel importer than applies to the manufacturer, if that happens—

  476. In what ways is it more difficult?
  (Mr Barker) Let me explain by way of one example. If we take Bayer as such an example, the large German pharmaceutical group which manufactures ADALAT, which is a hypertension reduction drug, ADALAT is only made in Germany. There is no manufacturing facility here at all. A truck can leave Bayer's property, Bayer's manufacturing plant and come to the UK with no checks whatsoever and the product can be immediately placed onto the market. If I want to bring a truck in with the product from the wholesaler nextdoor to Bayer's plant in Germany, it has to be checked as soon as it comes into this country, it has to go through the quality control system, it is liable to be inspected by the MCA, the product is liable to be analysed in the Edinburgh laboratory, etcetera. Consequently there are more checks for the importer to ensure, or try to ensure, that products of inferior quality or whatever never come into this market. Indeed when we look at products of inferior quality, when we look at counterfeit products, there have only ever been two examples of counterfeit pharmaceutical products identified and in both cases members of my Association identified them.

Mr Butterfill

  477. May I just say that I personally have had drugs prescribed for me which have arrived packaged with Spanish leaflets with them and instructions in Spanish. This was the drug Zocal, which you probably know. I have also had experience of the product arriving partly in the original pack and part of it being snipped off so you do not always see the batch number, which is the other complaint. Fortunately in my case it is a drug with which I am familiar, but if I had been a first time user of that drug and the instructions were in Spanish, I might have had difficulty.
  (Mr Barker) You would indeed, I can imagine, have had some difficulty. As you will appreciate, you have recognised that the responsibility for dispensing the drug to you lies with the pharmacist. The pharmacist should not have dispensed to you in the event that there was a pack, as you apparently had, with a non-English leaflet inside it. He should not have dispensed it to you. He has additional leaflets which are always made available to pharmacists.

  478. Would he have known? Would he always open the pack and find out what was in there?
  (Mr Barker) It depends on the pharmacist because there are some pharmacists who never use the outer carton, that is the manufacturers carton; even when a member of my Association repackages in his own in-house carton he will still destroy that and repackage in his own carton with his own label. What you would have found, I would submit, with your example, is that there would have been a label in English on that outer carton. There would have been a label on the blister. The fact that you did not have a leaflet in English is deplorable and that should not have happened. One of the responsible persons within the chain—we are responsible for that—is also the pharmacist. If you like, he is a fallback check. He does have supplies of leaflets, so if one has gone through the system, such that the foreign leaflet has not been taken out, which is highly unusual I must say in the millions of packs which are dispensed, if that has happened he would have a replacement leaflet he could insert.

  479. Do you think there are any consumer benefits of parallel imported medicines?
  (Mr Barker) The consumer benefit, if by consumer you mean patient, the ultimate consumer—


 
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