§ Mr. Trotter
I beg to move Amendment No. 48, in page 9, line 3, after 'agreement', insert'or under an agreement for the hiring of goods (other than a hire-purchase agreement)'.
§ Mr. Trotter
This amendment arose as a result of consultations with the Finance Houses Association. The original drafting of the Bill dealt with goods under hire-purchase agreements. The company providing the finance for the hire-purchase agreement in the normal way never even sees the goods involved. Obviously, therefore, it would be wrong for that company to be held responsible if those goods were found to be dangerous. However, hon. Members will appreciate that 1918 the ownership of the goods under the agreement rests with the hire-purchase company. The Bill was correctly drafted, so that there would be no liability for the hire-purchase company.
However, the drafting did not take account of the fact that nowadays there are hiring agreements which operate in a similar way to hire-purchase agreements. They work on the same sort of principle as hire-purchase agreements but are technically different. This is a technical amendment to bring hiring agreements into line with hire-purchase agreements.
§ Amendment agreed to.
§ Amendments made: No. 49, in page 9, line 4, leave out 'acquisition of goods by' and insert 'provision of goods for'.
No. 50, in page 9, line 8, leave out
'acquisition of them by the other person from'
'provision of them for the other person by'.
§ No. 51, in page 9, leave out lines 22 to 27.—[Mr. Trotter.]
§ Mr. Robin Hodgson (Walsall, North)
I beg to move Amendment No. 52, in page 9, line 35, leave out 'and' and insert 'or'.
Mr. Deputy Speaker
With this we may take the following amendments:
No. 53, in page 9, line 37, after '1970', insert'and medicinal products as defined in section 130(1) of the Medicines Act 1968'.No. 54, in page 9, line 37, at end insert'or medicinal products as defined in section 130(1) of the Medicines Act 1968'.
§ Mr. Hodgson
The purpose of these three amendments is to add to the list of exclusions to the goods definition contained in Clause 8—medicines and drugs covered under the Medicines Act 1968, which would then be added to the other exclusions—food under the Food and Drugs Act 1955 and feedingstuffs and fertilisers under the Agriculture Act 1970.
When I came into the House to listen to the debate earlier today, not having been a member of the Standing Committee, I was interested to hear the discussion on the definition of the words "safe" and "not safe". It brought to 1919 my notice the additional reasons for excluding medicines and drugs from the Bill, because so much of what is safe and what is not safe in the medical sense depends upon the metabolism of the person who is receiving the drug.
The Minister may be allergic to penicillin, for example, but that antibiotic, which might not be safe for him, has benefited millions of people throughout the country.
§ Mr. Hodgson
However, I hope that the Minister will not mind if I say that I did not find his reply to a general debate on this matter in Committee entirely satisfactory. The underlying reason for moving this amendment is to avoid duplication of controls. While I would be the first, and I am sure the Minister would be the second, to agree that the safety of a person who is using a medicine or drug is paramount, I shall seek to show that existing restrictions and requirements that are available, not just to the Minister himself but to the Department of Health and Social Security, are entirely sufficient. I hope to show that this clause, unamended, will lead to a multiplication of bureaucracy and legislative requirements, and may well lead to inefficiencies and extra cost to the public in the supply of drugs.
In this connection I point out to the Minister that his colleague, the Secretary of State for Social Services, is pressing for the extension of the Prescription Pricing Authority with the express purpose of trying to cut the cost of drugs prescribed on the NHS.
Further, the clause will lead to potential conflicts between Departments of State—between the Minister's Department and the DHSS. Finally, it will lead to uncertainty among manufacturers, particularly in the pharmaceutical industry, who have already been bashed fairly hard.
Asked about these overlapping powers in Committee the Minister said:I reaffirm that other Departments, such as the Department of Health and Social Security, would not use the powers in the Bill if the powers under, say, the Medicines Act were adequate.When pressed to give examples of where the Medicines Act would not give sufficient powers, the Minister was forced to reply: 1920To be blunt, I cannot think offhand of any example under the Medicines Act. I can think of examples in relation to the construction of motor vehicles.Later he referred to a specific case:What I had in mind is that warning that is issued where a product has broken the regulations and there has been a slip in quality control. Where the product is on the market it is necessary to tell everyone, for example, to be careful of drug XY2, Batch 10, because something is wrong with it."—[Official Report, Standing Committee C, 12th April 1978; cc. 36–40.]If the Minister thinks that he has a case on the above grounds, I do not think that he has been entirely fully briefed by his colleagues in the DHSS. Obviously it is not his Department, and I do not suggest that he is at fault. I am not being critical of him. However, the truth is that the DHSS has extensive powers over this highly complex and difficult subject.
I refer the Minister to the regulations made under Part I, Schedule 1, to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971. I should like to quote three paragraphs which seem to meet the thrust of the point that I want to make. Paragraph 6 states:The licence holder shall keep such documents as will facilitate the withdrawal or recall from sale, supply or exportation of any medicinal product to which the licence relates.Paragraph 7 states:When the licence holder has been informed by the licensing authority that any batch of any medicinal product to which the licence relates has been found not to conform as regards strength, quality or purity with the specification of the product or with the provisions of the Act or of any regulations under the Act that are applicable to the medicinal product, he shall, if so directed, withhold such batch from sale, supply or exportation, so far as may be specified by the licensing authority.Finally, paragraph 8 states:The licence holder shall notify the licensing authority forthwith of any decision to withdraw from sale, supply or exportation any medicinal product to which the licence relates, and shall state the reason for that decision.The legal interpretation of the phrase "withdraw from sale" implies, I am told, the total withdrawal of the product from the market, and "recall" refers to the removal from the market of a specified batch or batches.
Therefore, we are dealing with a matter over which the Minister, not directly but through his colleagues in the DHSS, has 1921 considerable powers. The only area not specifically covered is the Minister's powers under Clause 2(1)(c) to compel publicity.
Does the Minister seriously suggest that a responsible drug company will knowingly allow to go on sale and will continue to sell faulty drugs? I suggest that he only has to imagine the damage to that company's reputation in such circumstances. Indeed, it would want to publicise the danger, because in that way it would be likely to be able to limit the potential liability that it would face in the courts for having sold a faulty medicinal or drug product.
The Minister will note that the tide is going still further against drug manufacturers. In the report of the Royal Commission on Civil Liability and Compensation for Personal Injury, Lord Pearson, in paragraph 1253, states thatSubject to any element of contributory negligence—we discuss this defence below—we recommend that it should not be a defence for the producer merely to prove that he had withdrawn, or attempted to withdraw, his product.That part of the Pearson Commission's Report relates specifically to problems with drugs.
If the Minister says that we are dealing with only a small number of yet unspecified rogue drug companies, I suggest that colleagues at the DHSS have totally adequate powers in this respect. First, the DHSS can publicise the matter. Secondly, a faulty drug is the kind of thing on which the newspapers, television and radio seize and publicise. The National Health Service is the largest single buyer of drugs and medicinal products in the country. It has enormous powers as a semi-monopoly buyer.
In any case, the powers under the Medicines Act are enormous. The Act is a massive tome, with 165 pages, 136 sections and eight schedules. It covers all the matters that could possibly be considered and it involves all the powers that the Minister is seeking.
The Act often refers to the power to make regulations. Under the Medicines Act the Secretary of State for Health and Social Security has considerable powers which he has used. There are 1922 over 70 Statutory Instruments under the Medicines Act and more are on the way. Further Statutory Instruments are in draft and are the subject of discussion between the Department and the drug companies. These will be an addition to the already wide range of powers that enable the DHSS to compel the pharmaceutical companies to comply with the rules governing drug manufacture.
We must not forget that we are talking about a 10–12 year period of commitment for drug companies. Millions of pounds are involved which would be put at risk if the company acted irresponsibly. The commercial requirements of the companies and the needs of the drug user are already pulling in the same direction. Where they are not, the Medicine Act takes care of it. Statutory Instruments cover content, manufacturing methods, packaging, labelling, usage, dosage and shelf life.
I have a summary of the Statutory Instruments that cover labelling. It involves several pages and schedules. That deals only with labelling. By seeking to bring the pharmaceutical industry within the terms of the Bill the Minister is taking a sledgehammer to crack an invisible nut. The system already exists and is highly developed and complex. It involves the drug industry, drug users, the medical profession and the DHSS.
The industry pays for this administration and advisory service. The Medicines Act imposes a levy of ¼ per cent. on turnover. There are also levies for product and manufacturers licences. If the amendment is not passed, another complicated and unnecessary legislative requirement will be imposed upon the industry.
I turn to the question of divided masters. I think that it was Clausewitz who said "Better a bad general than a divided command". The industry will be responsible not only to the DHSS but to the Department of Prices and Consumer Protection which has no experience of drugs, side effects or usage. This makes one wonder whether there could not be a political conflict if the Secretary of State in one Ministry wished to make his reputation by making specific and special demands upon the industry.
I wish to draw to the attention of the House the complexity of the field over which the Minister is proposing to 1923 trample. I hope that the Minister will not mind if I use the word "trample", because even the DHSS does not always get it right. My hon. Friend the Member for Pudsey (Mr. Shaw) talked about the incidence of Statutory Instruments coming in in a hurry. Earlier this year we had the ludicrous situation in which we were going to have to withdraw Dr. Collis Browne's cough remedy because there was an inability on the part of the DHSS to communicate and laise with the company producing this well-known family remedy.
We shall have more regulations, more difficulties, and two Ministries.
§ Mr. John Fraser
I should like to repeat the assurance that I gave earlier today. We shall not have two Ministries dealing with the problem. One Ministry will be dealing with the problem. The drug manufacturers for whom the hon. Gentleman is speaking will still be dealing with the DHSS. The DHSS would use the powers in this Bill only if they did not exist in the Medicines Act. There are one or two cases where the powers do not exist. The hon. Gentleman has cited powers that can be exercised, but those are mostly in relation to licence holders, and it is the rogue person, not the licence holder, to whom the warning may have to be issued.
There would not be a duplication of Departments and there would not be a duplication of powers. The powers under the Medicines Act would be supplemented by the powers in this Bill only where supplementation was absolutely necessary. I am not trying to curtail the hon. Member too much, but I give that assurance.
§ Mr. Hodgson
I hear what the Minister says. I hope that he will hoist on board the fact that I mentioned the rogue company that was not prepared to accept the spirit of the regulations. None the less, we are talking here about very carefully defined medicinal products. Section 130 (1) of the Medicines Act defines the areas with which we are concerned. We are not talking about just a wide range of products. We are talking about carefully defined products within that Act. They are listed there, and the Minister's civil servants can show him how carefully this matter is defined. I do not want to quote 1924 it at length, because I want to finish my speech.
I must say that if the Minister feels that we should have exclusions for the Food and Drugs Act and exclusions for the Agriculture Act in regard to feeding-stuffs and fertiliser, I believe that the Medicines Act and the drugs and medicinal products that are covered by that Act should be similarly excluded.
I do not find the Minister's example so far to be impressive. I did not find his remarks in Committee to be impressive or persuasive. If he is not able to produce specific concrete examples, I must ask him to accept the amendment, because this matter is very important. We do not want to have increased and unnecessary bureaucracy, more costs for the public and more uncertainty to the manufacturers in an industry which is already probably the most heavily regulated of any in Britain.
§ Mr. John Fraser
The hon. Gentleman asked for examples, and I shall give them.
The most likely situation in which the powers in the new Bill would be of use in relation to medicines is by way of notices to warn. There is no provision akin to this in the Medicines Act. A similar obligation can be imposed on licence holders by licence conditions but the facility is of no help if the manufacturer or distributor concerned does not hold the licence in respect of the activity concerned. This can happen either because the firm concerned has been acting illegally or because its position in the distribution chain is such that it does not need to hold licences in respect of the product. So the warning notice is a supplement. It fills a loophole there.
Secondly, it is envisaged that it might sometimes be appropriate to use the powers to issue a prohibition notice under Clause 2(1)(b). This power could be used, for example, to prohibit a particular retailer from continuing to supply dangerous goods. The licence conditions do not in general apply to retailers, so that the only way of prohibiting action by any particular retailer would be by the process of a statutory prohibition order under Section 62 of the Medicines Act.
§ Mr. Hodgson
If the Minister is bringing forward specific examples, that is 1925 fine. Why, then, does his colleague in the DHSS, who is responsible for the administration of the Medicines Act, not take those powers under that Act by Statutory Instrument?
§ Mr. Fraser
I am coming to that point. The answer to that is that it is not possible to exercise these powers by Statutory Instruments under the Medicines Act, but when the opportunity arises for the introduction of legislation to amend the Medicines Act, the appropriate provision will be inserted in the Act so as to provide the powers that are at present lacking. It will then be possible to exclude medicines from the scope of the consumer safety legislatioin, but this should not be done at present.
§ Mr. Trotter
I have never been happy about including medicines, food and fertilisers excluded, and I have been conscious that medicines are a subject already under very careful control. There is a considerable volume of legislation. A massive Act has been shown to us this afternoon. I can see the advantages of including it. It would enable speedier action to be taken in a few directions.
I am also conscious that no examples have been quoted to me of the problems that have resulted from those powers not being present in the past. I believe that the tidier solution is an amendment of the Medicines Act. That would keep the whole question of medicines under one Act, would be tidier, and therefore I am prepared to accept Amendment No. 53.
§ Amendment, by leave, withdrawn.
Amendment made: No. 57, in page 10, leave out lines 2 and 3 and insert:
'might be used or kept;'.—[Mr. Trotter.]