§ '.—(1) Subject to subsection (4) below, no information shall be made available under this Act which would or might identify or lead to the identification of— 1302
- (a) any individual; or
- (b) the place at which any test involving the administration of a medicinal product to an animal has been carried out.
§ (2) Subject to subsection (4) below, the licensing authority shall not make any information available under this Act if they consider that to do so would—
- (a) involve the disclosure of a formula, process, device or invention of commercial value; or
- (b) make it more difficult for the holder of a product licence in respect of a product to which the information relates to compete with other persons; or
- (c) impair the ability of the licensing authority thereafter to obtain similar information;
§ but no information contained in or accompanying an application for a product licence shall be withheld on the ground that paragraph (a) or (b) above applies unless it is designated under subsection (3) below.
§ (3) An application for a product licence under section 16 of the 1968 Act shall designate the information contained in or accompanying the application to which, in the opinion of the applicant, subsection (2) (a) or (b) above applies.
§ (4) Nothing in this section shall prevent the making available under this Act of information which has been published in the United Kingdom.
§ (5) Where the licensing authority consider that this section requires them to refuse any request under this Act, they shall so inform the person making the request.'.—[Mr. Waterson.]
§ Brought up, and read the First time.
§ Mr. WatersonI beg to move, That the clause be read a Second time.
§ Mr. Deputy SpeakerWith this, it will be convenient to consider the following amendments: No. 21, in clause 1, page 1, line 6, at end insert—
`animal" has the same meaning as in the 1968 Act;'.No. 8, in clause 4, page 4, leave out lines 6 to 37.
§ Mr. WatersonThis is a more substantial proposed change to the Bill, and I shall speak at greater length on the intent and proposed effect of the new clause. I have moved the new clause because I am not happy about the proposed protection for commercial information and for individuals under clause 4, as drafted. My philosophy, as I have already said, is to keep any extra burden on the pharmaceutical industry to the minimum.
One of the first things that the new clause does is to prevent information from being revealed about any individual. That seems to me to be eminently fair and sensible. For some reason, the Bill, as drafted, allows individuals to be identified if they have given permission. I do not see why that is necessary. Information of the kind with which the Bill deals should not mean that individuals can be identified.
I see no point in people wandering throughout the country knocking on doors and demanding the signature of someone who might have taken part in a clinical trial, simply in order that their name can be made public. In both this and other contexts, the problem in this country is keeping people's names out of publication rather than inventing new ways of identifying them. My new clause will ensure that individuals are protected from identification.
As to the provision relating to experiments on animals, I hope that its reasoning is reasonably predictable. I refer to subsection (1)(b) which refers to
the place at which any test involving the administration of a medicinal product to an animal has been carried out.In recent years, there have been examples of the activities of animal rights activists who have caused destruction to property, particularly to property where they believe that 1303 experiments on animals of a certain kind are being carried out. That is another reasonable safeguard to include in the Bill.
§ Mr. RadiceHas the hon. Gentleman had the opportunity to look at amendment No. 104 which, after consultation with the industry, deals with precisely the question that he has just raised?
§ Mr. WatersonNew clause 4 offers clearer protection of commercial information than the original clause. In a sense, the principle is already accepted in the Bill. I do not believe, with the greatest respect, that the hon. Member for Durham, North has placed sufficient importance on the need to protect commercial information. The original clause 4, which contained a requirement for all safety and efficacy information to be published, was evidence of that. The hon. Member was forced to withdraw the clause in the face of universal condemnation from the pharmaceutical industry.
§ 1 pm
§ Mr. RadiceThat is a somewhat churlish way of putting it. I dropped the clause. I was not forced to do so; I offered to do it.
§ Mr. WatersonI should not like to be thought of as being churlish, so I am happy to accept the hon. Gentleman's explanation.
There is no doubt that the Association of the British Pharmaceutical Industry is opposed to the underlying purpose of the Bill. It argues that it would lead to commercially valuable information being disclosed. It claims that companies will seek licences in Europe, not Britain, as the new Europewide licensing system comes in under the single market, thus denying the NHS access to approved medicine.
§ Ms Liz Lynne (Rochdale)The hon. Gentleman said that the British pharmaceutical industry opposed the Bill. As the hon. Member for Durham, North (Mr. Radice) has already said, discussions were held with the British pharmaceutical industry, after which clauses 4 and 5 were deleted. The hon. Member for Durham, North has already mentioned amendments Nos. 104 and 105, which propose the same as the new clause. Glaxo was telephoned this morning and asked whether it opposed the Bill. It said that its position had not changed. We were led to believe that, as long as we withdrew clauses 4 and 5, the British pharmaceutical industry would be happy with the Bill. The suggestion of the hon. Member for Eastbourne (Mr. Waterson) that the industry is totally opposed to the Bill is slightly misleading. The industry does not seem to know whether it is for or against the Bill: it says one thing to myself and the hon. Member for Durham, North and another to Ministers.
§ Mr. WatersonI am grateful for that lengthy intervention. The point that I think I just made was that the association opposed the underlying principle of the Bill. I was careful to use the phrase, "underlying principle". There is nothing wrong in the association holding discussions on detail with Opposition Members, as it has throughout the passage of the Bill, as a damage-limitation exercise, but no Opposition Member is in a position to say that the pharmaceutical industry or the 1304 association favours the Bill, or at least the underlying principle. What the association has done quite properly —this is the way things are in the real world—is hold discussions with hon. Members, particularly the hon. Member for Durham, North, in which, no doubt, it attempted better to inform the hon. Gentleman and to persuade him of the damage of some of the Bill's provisions. In some of the discussions, its arguments prevailed, in others perhaps not.
§ Mr. Roger Knapman (Stroud)Has not the ABPI said that it is in favour, in general terms, of providing better information on medicines to doctors and patients—a view which we all share? In February, it said that the Bill is not needed because of the amount of information that is already available. It also said that the Bill presents a threat to the continued viability of the United Kingdom pharmaceutical industry. Surely that is the reality of the ABPI's approach, which is perfectly clear.
§ Mr. WatersonMy hon. Friend puts the point succinctly. The association has two basic answers to the hon. Member for Rochdale (Ms Lynne). The first is that a great deal of information is currently available from the industry about particular drugs. The second is what I call the level playing field problem, which I shall develop in much more detail in a moment. We are talking about multinational companies that operate worldwide, and especially Europewide. Their supreme difficulty with the Bill is that it may put them at a competitive disadvantage in this country.
§ Mr. Richard Spring (Bury St. Edmonds)One of the points that has come to light in my discussions with representatives of the pharmaceutical industry is the fact that there are negotiations for a European Communitywide licensing authority and until that comes about, pharmaceutical companies operating here believe that the move would be unilateral and to their disadvantage.
§ Mr. WatersonI am grateful for my hon. Friend's intervention. I shall develop that issue later, but I now wish to continue what I was saying before the hon. Member for Rochdale intervened.
The association has argued that the Bill would be a "charter for foreign copyists" of drugs and for counterfeiters which, as we know, pose a threat to this industry and to many others.
§ Mr. CouchmanI did not intervene when my hon. Friend was moving new clause 3 which deals with the passing on of information. Even with the penalties prescribed under new clause 3, the passing on of information causes only a comparatively minor fear to companies if they have considerable commercial interest in getting hold of information that would be available under the Bill.
§ Mr. WatersonI believe that during the second world war a poster appeared at times saying, "Loose talk costs lives". In this case, loose talk could cost jobs and money. In high-tech industries, and especially in the pharmaceutical industry, information is power and money, and many people have an interest in getting their hands on information and on formulas for new developments or prospects of new developments. Companies can rise or fall on the fortunes of a particular new product.
§ Mr. McCartneyWill the hon. Gentleman give way?
§ Mr. WatersonNo, I shall not give way now, because I must make some progress. I may allow the hon. Gentleman to intervene later.
I was trying to conclude my point that the industry itself has warned that future investment could go elsewhere in Europe, thus damaging job prospects in this country. As we know, Britain has a £1.2 billion trade surplus in pharmaceuticals.
The concerns of the pharceutical industry were noted in particular by the Under-Secretary of State for Health, my hon. Friend the Member for Bolton, West (Mr. Sackville) on Second Reading. He said:
The Government are committed to making more information available.Despite some of the things that the hon. Member for Durham, North has said inside and outside the House, I believe that that basic principle still stands. The Minister continued:It must be acknowledged., however, that the pharmaceutical industry sends an enormous amount of commercially sensitive data to the licensing authority. This has been protected by the requirements of the Medicines Act and by the common law presumption that confidentiality would be maintained. Information on medicinal products is potentially highly sensitive commercially and there is a risk that without adequate safeguards the provision of public information could be seriously abused.The pharmaceutical industry is concerned about the commercial sensitivity of the data that it provides and about the additional burden that the Bill could place on it and the extent to which it would be taking the United Kingdom out of line with other member states. This is a particular crucial issue at a time when new EC licensing systems are in the process of being agreed".—[Official Report, 15 January 1993; Vol. 216, c. 1225]
§ Mr. McCartneyThe hon. Gentleman says that the Bill would be a dangerous precedent for United Kingdom companies. Although Glaxo used the American Freedom of Information Act to obtain information about Smith Kline Beecham, one of the foremost companies in the world, that company has not been affected. The Medicines Control Agency and the Ministry of Agriculture, Fisheries and Food, the Government's own bodies, have used the American Freedom of Information Act to look into companies such as Fisons. Pfizer, a company which the hon. Member for Gillingham (Mr. Couchman) is paid to represent here, has also used the legislation to seek information about Glaxo, a British company. No one suggests that Pfizer's action has led to a deterioration in Glaxo's financial or trading position either here or in the United States.
§ Mr. Deputy SpeakerMr. Waterstone.
§ Mr. WatersonIf I may say so, Mr. Deputy Speaker, it is Waterson, not Waterstone. Unfortunately, I am not: the owner of a chain of bookshops. There we are, we cannot have everything in this life.
I am not here to defend the working of the United States Freedom of Information Act, although it is worth a debate in itself.
§ Mr. McCartneyAnswer the question.
§ Mr. WatersonI will answer the question. There are serious flaws in the Act's workings. It is primarily directed at information generated by Government agencies in the United States, so it does not assist the hon. Gentleman's argument. The examples the hon. Gentleman give show 1306 that there is a great hunger among commercial organisations in pharmaceuticals to get their hands on information about their competitors and rivals. That is the position I seek to address in the new clause.
§ Mr. SpringDoes my hon. Friend agree that in the United States, it is perfectly possible by Government order —by presidential decree—to prevent information from being made available by pharmaceutical industries to protect their commercial interests? That is exactly what happens in practice.
§ Mr. WatersonI am grateful for that intervention.
§ Mr. Bowen Wells (Hertford and Stortford)Is not it true that under the United States Freedom of Information Act, the information required is, as my hon. Friend has said, information generated by Government agencies? The Act does not oblige the Government to make public details of medicinal products submitted by pharmaceutical companies. The Bill's proposals for British law are entirely different from the Freedom of Information Act in the United States.
§ Mr. WatersonI am grateful for that intervention. On the basis that that is the correct position, it is an effective answer.
§ Ms LynneMy information leads me to believe that the intervention by the hon. Member for Hertford and Stortford (Mr. Wells) was entirely wrong. The United States legislation is very similar to the Bill.
§ Mr. WatersonI hope that I shall be forgiven for pressing on. My hon. Friend the Minister may wish to arbitrate on the point later.
The pharmaceutical industry is important to this country and that is why we must get the Bill absolutely right—hence the debate today. It has been said more than once that there are 90,000 jobs in the United Kingdom that are dependent on the pharmaceutical industry. I have already mentioned Rhone-Poulenc Rorer which is the largest private employer in Eastbourne and very pleased we are to have it there. I mentioned the £1.2 billion trade surplus.
We all know the difficulties involved in developing new products. The pharmaceutical industry is a highly competitive, high-tech industry. It can take up to 12 years to develop, to finalise and to test the safety of a new drug, at a cost of up to £150 million. There are particular difficulties, in which I have been involved, if a patent lasts only for 20 years. That leaves a short time for the commercial exploitation of the product and a short time in which to recoup the enormous investment in research and development.
Some £550 million worth of capital investment was made by the industry in 1990. It has about £3 billion worth of exports, making it the second largest contributor to our balance of payments. About £1 billion is invested in research and development, which represents a staggering 10 per cent. of all British manufacturing investment in research and development as a whole. In short, the pharmaceuticals industry is a major British success story.
I have already referred to the European dimension., which was touched on by the Minister on Second Reading. Let me quote from the remarks of the hon. Member for Durham, North in Committee:
1307 "everybody accepts that there will be a European directive which will lay down rules for openness across the European Community … all its details have not yet been finalised." The hon. Gentleman conceded that the Bill would be in advance of legislation in one or two other EC countries. He went on
Why not lead other EC countries on the issue of openness?"—[Official Report, Standing Committee C, 24 February 1993, c. 33.]I do not believe that those quotations are in any sense out of context.That is a legitimate and respectable point of view, but it is not the point of view which I take. I think that I am right in saying that, with the exception of Denmark, we would be the only EC country to take the bold step envisaged in the Bill unilaterally. The result would be that we would be out in front of our EC competitors, and perhaps the hon. Member for Durham, North still thinks that that is something to be applauded. I do not believe that it would be good news for the British pharmaceutical industry.
§ Mr. CouchmanDoes my hon. Friend agree that to saddle the British industry with a burden with which our European competitors are not saddled will prejudice Britain's chances as a site for the location of new manufacturing?
§ Mr. RadiceThat is a total red herring.
§ Mr. CouchmanPerhaps you would protect me against sedentary interventions, Mr. Deputy Speaker.
That will predicate against British locations for new manufacturing operations by the pharmaceutical industry, and it is manufacturing which produces the trade balance surplus that is so important to us. There is at present a huge overcapacity of manufacturing capacity in Europe. There will be a rationalisation, and we should do nothing to prejudice our position.
§ Mr. WatersonI could not agree more. Manufacturing not only produces the trade surplus; it also produces jobs in constituencies such as mine. My hon. Friend the Member for Gillingham (Mr. Couchman) is absolutely right to refer to the overall problem of overcapacity in Europe. Coupled with that, the companies involved are almost invariably true multinationals, which move backwards and forwards across frontiers with considerable ease. Some of them have plants all over Europe or even all over the world:
§ Mr. RadiceExactly.
§ Mr. WatersonThe hon. Gentleman says, "Exactly." It seems that we start from the same premise but reach diametrically opposed conclusions. My conclusion is that, there is an ever-present danger that, if we do anything to rock the boat—to give other countries in Europe any kind of competitive edge in pharmaceuticals—the companies will vote with their feet or with their investment.
§ Mr. SpringMay I refer to one of myths surrounding this subject? Although there is a Freedom of Information Act in Denmark, its application is nothing like what is proposed in the Bill. The commercial sensitivity provisions are restrictive in Denmark to protect the pharmaceuticals 1308 industry there. It is not true that it is open season for information in Denmark, although—uniquely in the EC —that country has a Freedom of Information Act.
§ Mr. WatersonLet me continue on the subject of the European dimension. The expression "a level playing field" is an overused Euro-analogy, but it has some relevance in this connection.
My right hon. Friend the Prime Minister has gone to great lengths to negotiate an opt-out for this country on the social chapter. That means that companies in this and other sectors, like tourism which is also important for my constituency, will not be saddled with yet another layer of bureaucracy and associated costs. That will assist them to compete with other firms in the European Community. I should like to believe that this Government's initiative on deregulation has begun to infect all member states and that we are seeing a major turnround in the approach to bureaucracy and over-regulation.
I believe that the Bill would unilaterally impose a requirement on this country which would increase regulation and costs to industry. In some respects, it could negate the benefits of the opt-out on the social chapter for pharmaceutical companies.
The Government are in the business of maintaining and enhancing the competitive edge of British companies in Europe. That does not mean that we are not committed to the European ideal. However, we want to see our companies do well in terms of selling our products in the Community and also in terms of attracting inward investment from the Community and from further afield from countries such as Japan and the United States.
To return to what the pharmaceutical industry is saying now, I am sure that the hon. Member for Durham, North saw the letter to the British Medical Journal in March which states that there is no need for the Bill. Mr. John Griffin of the Association of the British Pharmaceutical Industry argued in the letter that it is the licensing agencies, and not the drug companies, which have been responsible for the secrecy surrounding licensing decisions. He said that EC directive 92/27/EEC, which is supported by the pharmaceutical industry,
will require all European licensing agencies to provide … a summary basis of approval' on granting a licence for a new medicine.At least one of my hon. Friends has said that a vast array of information is already available through the industry. The association claims that the objective of the hon. Member for Durham, North of providing more and better information to patients will be met by the publication by the industry next year of a compendium of user-friendly patient information leaflets covering more than 1,000 products.
§ Mr. RadiceMr. Griffin wrote that letter before the Committee stage of the Bill. To that extent, it is out of date and he was kind enough to let me apologise for the fact that the letter in the BMJ took the unamended version of the Bill as its basis.
§ Mr. WatersonI am grateful for that. I should have called Mr. Griffin "Dr. Griffin" and I apologise for that. I look forward to a letter in the BMJ from Dr. Griffin taking a diametrically different view of the Bill.
We are stepping into a very difficult area when we pass this kind of legislation. The high-tech development of intellectual property is a very delicate area. If the Bill is not 1309 absolutely right—and that is what we are here to ensure today—there will be a real danger that properly patented rights, in which a particular company may have invested millions of pounds, could be rendered worthless.
Subsection (2)(a) is the heart of the new clause. It refers to
the disclosure of a formula, process, device or invention of commercial value;".That is the nub of the clause and it is an important issue. It is designed to protect information of sensitive commercial value because there is a perceived danger of abuse and commercial exploitation by competitors.If the Bill were to reach the statute book in its present form, why should companies make product licence applications to the United Kingdom Medicines Control Agency? Who will bear the costs of the provisions in the Bill if not the pharmaceutical industry? Is it right to place extra burdens on a successful and competitive international business of this kind?
We badly need a good, constructive, on-going dialogue with the pharmaceutical industry. We have a major bone of contention as part of the Government's efforts to control the ever-escalating NHS drugs bill. We have a bone of contention in the shape of the proposed extension of the limited list. Of course, there are arguments on both sides, but it can have a crucial effect on employment in certain parts of the United Kingdom. Perhaps on another occasion I shall have more to say to my hon. Friend the Minister on that topic—
§ Mr. CouchmanI should have something to say as well.
§ Mr. Waterson—despite the encouragement otherwise of my hon. Friend the Member for Gillingham.
I shall add some additional points of explanation, which I hope will be fairly obvious, with regard to the wording of the new clause. First, the Bill does not seem to appreciate the basic point that information submitted by companies to help with the licensing process does not belong to the Government. As I explained earlier, it is simply held by the Government on a privileged and confidential basis to help them to make good decisions —and the right decisions—about the licensing of medicines.
Precisely because it is company information, it is entirely right and appropriate that companies should be involved in the process of making it available to the public. Companies should retain some element of control over the dissemination of information, so in new clause 4 I place the onus on them to designate what information in the license applications is commercially sensitive. That reflects the procedure in the United States under the Freedom of Information Act where a presidential order requires agencies to ask companies to identify information that should not be released. I do not know whether the hon. Member for Makerfield (Mr. McCarthy) wishes to intervene to disagree with that.
§ Mr. McCartneyI shall make my own speech in my own time, thank you.
§ Mr. WatersonI thought I would give the hon. Member the opportunity.
§ Mr. RadiceI shall say something about the Americans later.
§ Mr. Deputy SpeakerOrder.
§ Mr. WatersonThe clause also makes it clear that final decisions about what information should be disclosed will rest with Ministers. We should not create a whole new area of expenditure on legal costs by allowing interminable challenges and appeals in the courts. I say that as a lawyer. At the end of the day, we pay Ministers to make decisions. When companies have said what information should or should not be made public, it is entirely appropriate that the final decision should be taken by Ministers.
I have included a provision that information should not be protected if it has already been published in the United Kingdom. It would be ludicrous if the Bill prevented Ministers from disclosing information, even if it had been published in full in a national newspaper.
New clause 4 is a genuine attempt to improve the Bill and to make it more workable and more reasonable. Above all, it will protect the sort of unwanted and unintentional damage that could be done by the Bill. I commend the new clause to the House and hope that I have explained its intention.
§ Mr. RadiceMr. Morris, Mr. Deputy Speaker—I apologise for calling you Mr. Morris; it is too much of the European Communities (Amendment) Bill. New clause 4 goes to the heart of the debate between the Government, those who support the Bill—they are in the majority, especially on a free vote—and the industry because it raises the issue of confidentiality and commercial secrets. They are legitimate concerns of the industry which we have been trying to meet and deal with throughout the passage of the Bill.
Let us look at new clause 4 against the background of our deletion of clauses 4 and 5 in Committee. Clause 4 is fairly tightly defined and excludes all legitimate areas of commercial secrets and, taking into account my amendments Nos. 104 and 105, the new clause is unnecessary.
The Bill has considerable all-party support—it was sponsored by hon. Members from all parties—and it could not have got through the Committee without the support of Conservative Members. There were certain moments in Committee when the only Conservative Member who voted against a specific amendment or clause was the Minister. It was rightly thought that I tried to meet most of the legitimate concerns expressed. I have studied the Division records and I know that the majority of Conservative Members came out in support for the Bill. I accept that the hon. Member for Beckenham (Mr. Merchant) may have abstained on most votes, but he gave us his support on one occasion. The hon. Member for Sutton and Cheam (Lady Olga Maitland) certainly gave the Bill valuable and useful support throughout the Committee. I wish to make it clear, therefore, that the Bill would not have reached the House today without the support of Conservative Members. It is an all-party Bill, with all-party support.
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I made it clear on Second Reading, which was unopposed, that I should be happy to talk to representatives of the industry about any of its concerns. Before and after the Committee stage, I met representatives of the British Pharma Group, the Association of the British Pharmaceutical Industry, Upjohns, Schwering and the National Office of Animal Health—NOAH. I have 1311 taken a constructive and responsible attitude throughout the passage of the Bill and I do not believe that anyone could pretend otherwise.
I know that the briefing that has been supplied by the Government to hon. Members, which I was fortunate to glance at, claims that the American Pharmaceutical Manufacturers Association expressed its opposition to the Bill in a letter to the Secretary of State for Health, which is quoted in that briefing. That letter was written before the Committee stage and its attack was based on clauses 4 and 5, which have now been deleted. I do not want that argument to be used against the Bill in its present form.
Hon. Members should note that since the Committee stage a number of people have come out in support of the Bill, including Sir William Asscher, the distinguished former chairman of the Committee on the Safety of Medicines, which advises the licensing authority. NOAH, which speaks for the veterinary medicines industry, has also placed on record its support for the Bill, as amended.
It is true that the British Pharma Group has displayed considerable ambivalence to the Bill. It said that it could live with clauses 2 and 3 if the original clauses 4 and 5 were deleted. Now that that has happened, however, it is still doubtful about the Bill. It believes that we should wait for European legislation—it wants to be virtuous, but not yet, Lord. The same is probably true of the ABPI. It accepts that there must be legislation along the lines of the Bill, but not just yet. Why should those organisations be frightened of it?
There has been much talk about the United States. We were fortunate enough to have a representative of the Food and Drug Administration at a meeting yesterday in the House of Commons in support of the Bill. It was clear, first, that our model was the same as theirs. It was also clear that the American industry has gained considerable advances, not in finding out rivals' commercial secrets—an old canard—but in discovering factors such as adverse drug reactions and how the summary basis of approval should be approached. Such information is extremely useful. I am stating what the FDA representative said yesterday.
§ Lady Olga Maitland (Sutton and Cheam)The idea seems to be that, in the United States, the Freedom of Information Act is the great panacea for all problems and grants freedom to all. However, the United States Government can refuse to disclose information that would harm the privacy of an individual or the proprietary interests of a business. Such provision goes much wider than mere trade secrets. They can release information generated through Government agencies.
§ Mr. RadiceThey release the summary basis of approval, which is the main aim of my Bill. In some respects, they reveal more than we do. They reveal the raw material of the adverse drug reactions, whereas we are merely suggesting that we should reveal a summary, and we have talked to the industry about that. Therefore, the American model is in advance of the model proposed in the Bill.
§ Mr. SpringSurely the hon. Gentleman is aware that the FDA has a relationship with individual drug companies, and the onus is on the drug companies to decide what information they should supply and on what basis they should protect their own commercial interests. The onus is on the pharmaceutical companies to decide 1312 which information they regard as important for their own commercial survival. With respect, the hon. Gentleman is not accurately representing the relationship between the FDA and private pharmaceutical companies.
§ Mr. RadiceI do not think that the hon. Gentleman is aware of the tightly defined list, both with the FDA and in the Bill, of matters that can be revealed. It does not cover commercial interests, which are specifically excluded under clause 4. I suggest that one or two hon. Members may not be sufficiently familiar with the Bill. I do not blame them for that, as they were not present in Committee and may have been alerted to the contents of the Bill only recently.
§ Mr. WatersonI was not a member of the Standing Committee that considered the Bill as I was engaged in discussing a major piece of legislation in another Standing Committee, but I have carefully read the Committee proceedings. That was not an arduous task as the Committee sat only twice and on each occasion rose well before 1 pm. Therefore, I feel that I know as much about the Committee stage as any of the members of the Committee.
§ Mr. RadiceI am glad that the hon. Member read our deliberations—
§ Mr. McCartneyThere was agreement.
§ Mr. RadiceAs my hon. Friend said, there was considerable agreement—with the exception of the Minister—in Committee, which was the good thing about it.
§ Mr. WellsWill the hon. Gentleman tell the House exactly how many Conservative Members supported the Bill? As I understand the Bill, only one of our number supported it, and it seems to be slightly misleading to say that the Bill has all-party support.
§ Mr. RadiceAs the hon. Gentleman knows, Standing Committees must have a Conservative majority. I had the support of the majority of the Conservatives on the Committee for the clauses that were amended—I did not have the Minister's support, however, or the support of the hon. Member for Beckenham who, as a Parliamentary Private Secretary, had to abstain. The hon. Members for Bournemouth, East (Mr. Atkinson) and for Holland with Boston (Sir R. Body) supported me. True, the hon. Member for Gillingham (Mr. Couchman) had a prior engagement in the United States. The hon. Member for Sutton and Cheam supported us. I was surprised that even the hon. Member for Hendon, South (Mr. Marshall) started to support us towards the end—perhaps he has been told to. The hon. Members for Taunton (Mr. Nicholson) and for Havant (Mr. Willetts) supported us, too. It can be seen that I invited quite a lot of distinguished Conservative Members to serve on the Committee. The Bill's promoter does not, of course, do the selecting, but he has to suggest names. I suggested those names, with the results that I have described. I hope therefore that no one will say that the Bill does not have considerable support.
§ Mr. Piers Merchant (Beckenham)I do not want to pursue the point too far, but I feel that the hon. Gentleman is glossing over the degree of the differences between us. He is in danger of muddling two separate arguments—one about the principle, the other about the practical applications of the Bill. Although there is widespread 1313 support for and agreement with the principle and objective of the Bill, there have been many disagreements about certain aspects of the Bill—hence the amendments in Committee and on Report. To try to give the impression that everyone supports everything in the Bill is somewhat disingenuous.
§ Mr. RadiceI note the hon. Gentleman's comments, and I think that he will retain his position as a PPS having made them.
I do not want to be accused of filibustering on my own bill, so I conclude by dealing with two issues, before I turn to the Government's position. I have with me a letter written and signed this morning by Mr. Bangemann, who was asked by the chairman of the European Parliament's committee on the environment for a view on how the Bill fits in with European legislation. The letter states:
I would like to confirm that under the existing Community directives, an assessment report written in view of granting a marketing authorition, and reasons for such decisions, may be disclosed by the competent national authority who established the report, provided it does not contain commercially confidential information.Such a possibility of disclosure is not affected by the proposal to introduce a decentralised marketing authorisation system (amendment of directive 75/319. SYN 310).Furthermore, it would be consistent with the Community's policy on transparency since there is already unanimous agreement in council on the proposed regulation for the centralised authorisation (SYN 300), which states, in its Article 12 &4:`4. Upon request from any interested person, the Agency shall make available the evaluation report of the medicinal product by the Committee for proprietary medicinal products and the reasons for its opinion in favour granting authorization, after deletion of any information of a commercially confidential nature'.The Bill is in line with what is happening in Europe.The British industry, with no hard evidence for saying so, claims that in some curious way it will be labouring under a great disadvantage in Europe if we have an open licensing system in this country. That ignores the fact that under the decentralised system, before any product is licensed in this country, it will have to go through our own licensing processes. It is not just a question of accepting on the nod whatever comes from other licensing authorities in the European Community. For example, it is open to our licensing authority to challenge what has been licensed in another country, and we can also make public the basis on which licences have been granted in other countries. That is never said by those who use the European argument, so let us not hear so much of that argument. The Government say that they want to be at the heart of Europe, so it is about time that they took a lead on something in Europe. They could do that on this issue.
That brings me to the Government's position. One of the features of the debate has been the Government's change of heart. Before Second Reading, they said that they would give the Bill a fair wind. On Second Reading, the Minister said that he was in favour of the Bill's principle, that he was against unnecessary secrecy and that there were objections to section 118 of the Medicines Act 1968. However, in Committee I realised, as did all hon. Members, that there had been a change of heart. The Minister who is responsible for promoting open government, the right hon. Member for Bristol, West (Mr. Waldegrave) had clearly lost the argument.
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The Department of Health is the sponsoring Department for the drugs industry, and it is also in charge of the nation's health and is responsible for looking after patients. There is a possible contradiction there because at times conflicts can arise. At any rate, that Department has other fish to fry, and they were mentioned in the debate. They are the issues of cost and the limited list.
It looks as though the Government, to get the industry's support, decided to change their position on my Bill and the idea of the licensing authority being more open. The 113 amendments are a clear attempt to wreck the Bill by talking it out. I therefore accuse the Government of double dealing over the Bill and of collusion with the industry. They are also reneging on their open government commitments. The Bill will be talked out at 2.30, but that will not be the end of the argument or the process. It will be the beginning.
§ Mr. MerchantThe hon. Member for Durham, North (Mr. Radice) played with my intervention a little, but I do not criticise him for doing that. However, my intervention was crucial to the debate on the Bill and the new clause. I drew a distinction between the Bill's principle and its practical application and the other effects that it might have on the pharmaceutical industry and elsewhere.
I have made it clear from the beginning that I strongly support the Bill's principle, but I have little doubt that the hon. Gentleman's final forecast will come to pass. In the fullness of time there will be legislation to alter section 118, which is clearly anachronistic and out of step with the Government's avowed intention to make information more freely available and to encourage open government. I have always been strongly wedded to both principles.
The scope, timing and detail of the Bill raise difficulties. I agree with some of what the hon. Member for Durham, North said, and I have some reservations about the new clause. It is difficult to achieve the right balance and work out exactly where the pharmaceutical industry stands. Since before Second Reading, despite playing an active role, I have received no indication of the industry's stand. Nor have I received an approach from a major pharmaceutical company based in my constituency. I find it slightly strange, but that is a matter for the company concerned. That does not help me in trying to ascertain the industry's position.
The pharmaceutical industry is important arid beneficial to this country, so it is vital not to do anything that would harm it or restrict its competitiveness. I am sure that the hon. Member for Durham, North agrees.
§ Mr. KnapmanWould that the hon. Member for Durham, North (Mr. Radice) had adopted that view. He quoted my hon. Friend the Under-Secretary of State saying that the Government did not object to the principle of the Bill. It might have been fairer if the hon. Gentleman had quoted also the following comment by my hon. Friend the Minister. He said:
These are difficult times for all manufacturers, and I am concerned that at a time when we are determined to reduce the burden that Government place upon industry, the Bill could increase them.Although my hon. Friend accepted the principle, he made it perfectly clear that he had many objections on matters of detail.
§ Mr. MerchantMy hon. Friend emphasises the impact of the legislation on the pharmaceutical industry alongside 1315 other matters affecting it. My hon. Friend the Minister must bear the burden of those decisions. He had a difficult time doing so in Committee. On one occasion, when he seemed to be voting on his own, I felt sorry for him and therefore joined him on two occasions. The other reason, which is more important from the industry's point of view, was the Bill's impact on the industry at this time.
The industry is facing other regulations and the effects of national and European bureaucracy. The hon. Member for Durham, North seemed almost to be scoffing at the agreements that must be reached on the limited list. He seemed to suggest at least that that should not influence the Bill. Right hon. and hon. Members are practical men and realise that all aspects of Government policy will work together, have an impact on each other, and affect the industry. The industry should not be expected to bear too heavy a burden in one go at this time.
The burdens are many. They include controls on labelling and quality that are much more rigid than in most other industries. There is the impact of European legislation. My hon. Friend the Member for Eastbourne (Mr. Waterson) said what would happen if the social chapter were adopted. I referred to the limited list. All are aspects of intervention in an industry that is and must remain competitive in world terms. It is important to take those factors into account, and I make no apology for doing so—and my hon. Friend the Minister should do the same.
§ Mr. SpringI entirely endorse my hon. Friend's point about the principle of openness, which the Government and other right hon. and hon. Members would endorse in many areas. However, can one imagine the French Government allowing their pharmaceutical industry to be disadvantaged in any way? We are seeing the potential for an EEC-wide licensing authority. That will be the moment, on a pan-European basis, for greater openness. If it were to happen unilaterally, it would be costly and difficult for the pharmaceutical industry, employment, our trade balance, and other considerations that are so serious for the future of the industry and of employment in this country.
§ Mr. MerchantThe future of EEC regulation in this specific area should be added to my list. The negotiations and discussions that will have to be carried out in advance of the regulation coming into effect are crucial and should not be obscured by the House of Commons making decisions that will have a deleterious impact.
§ Mr. KnapmanI am not surprised that the hon. Member for Durham, North (Mr. Radice) is about the only hon. Member who cannot wait for Dr. Bangemann to bring forward proposals in this respect.
§ Mr. MerchantI hope that the hon. Member for Durham, North does not have an unhealthy relationship with Dr. Bangemann.
§ Mr. RadiceIt is not a question of having an unhealthy relationship with Dr. Bangemann. However, he is the Commissioner for the industries involved. He may be a figure of fun to some Conservative Members, but, if one is concerned about finding out what is going on in the 1316 European Community, it is only sensible to talk to his office and his department and then to talk to the European Parliament.
§ Mr. MerchantYes. I thought that that, in a sense, was what we were arguing about. I hasten to add that I was inferring only an unhealthy intellectual relationship with Dr. Bangemann. I agree entirely with the hon. Gentleman that it is sensible to discuss these matters with Dr. Bangeman, his office and others, but that, surely, is an argument for proceeding with some caution with the Bill. I do not want to overdo the point. I merely say that it is an element which we should take into account in our discussion of the Bill.
I am concerned about the reference in subsection (1) (b) to animal testing, a very contentious issue upon which I have strong feelings. It is a matter of great concern throughout the country. We have to be careful about being unduly restrictive regarding the amount of information that, rightly, should come into the public domain. In the vast majority of cases, the place at which testing is carried out will be known anyway. That information is widely disseminated and is reasonably easily found out by the pressure groups involved. I see nothing wrong in that.
§ Mr. WatersonI appreciate the strength of my hon. Friend's views, but does he agree that revelation of the place where experiments or tests are carried out has nothing to do with the contents of this Bill? That may be a matter for another Bill, but it does not legitimately come within the scope of this Bill.
§ Mr. MerchantThat is precisely why I question this provision. I do not understand why it has been included in new clause 4.
§ Mr. CouchmanThat point has been made consistently to me throughout the proceedings on the Bill. Both the location of establishments where animal testing takes place and, particularly, the names of the people involved in the testing are matters that the industry regards as being of the highest importance. My hon. Friend knows well the major centre in his constituency where animal testing takes place. I am aware of others where it takes place. The attentions of the animal liberationists have given rise to the most elaborate security precautions having to be introduced in places where research should take place in a more free and happy atmosphere.
§ Mr. MerchantIt is also a matter of concern to the general public. I am not talking specifically about individual pressure groups. Research involving animals is an important aspect of the law to be upheld. There have been recent examples of abuse where the law was slow to enforce and to correct what should not have happened in the first place. I therefore view with some concern anything that would hinder the flow of such information, although I accept that there must be some controls on freedom of information in this area, especially on patents, competition and other trade secrets. The provison should not extend as far the new clause proposes.
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I do not want to take up much more time as I know that other hon. Members want to speak. I will conclude by referring to a point that was made about the French situation. My hon. Friend the Member for Bury St. Edmunds (Mr. Spring) rightly focused attention on France 1317 and asked whether the French Government would allow the pharmaceutical industry to fail to compete with other European countries. Of course the French Government would not allow that. They would do all that they could to protect and encourage their industry and would bend every regulation that they could. The British Government and our laws should do likewise.
The same can be said of the United States. The United States has a Freedom of Information Act and the free flow of information and open government are well advanced, which I entirely applaud, but the United States Government are never backward in coming forward when they deem it necessary to protect their own big industries against foreign competitors—and understandably so. We must keep that in our sights, because it is in the overwhelming interests of the British people, employees in the industry and the industry itself. Economic advantages flow from the industry successfully competing in the world, so we must advance under the Bill with the principal objective of making information as free as possible. I would not wish us to step down from that high objective, but we must realise that the pure principle must, to an extent, be limited by practice. We must, therefore, limit it by our best judgment of what is in the competitive interest of our pharmaceutical industry.
§ The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)I have listened with much interest and have given the Bill quite a lot of thought in the past months. I have reached a conclusion. With so much being done in Europe on the issue, it would be unhelpful for the United Kingdom to find itself with legal obligations in advance of decisions in Europe.
§ Mr. SackvilleI shall press on; we are fairly short of time.
I believe that we would run a serious risk of putting the United Kingdom at a grave competitive disadvantage vis-a-vis other licensing authorities in Europe if we were to introduce legislation at this stage. This is not only the Government's view; it is shared by the pharmaceutical industry, although I admit that the picture has been muddy at different times. The industry remains unhappy with the Bill and does not want legislation until the position in Europe has been clarified and until we all know what will have to be disclosed in the new centralised and decentralised procedures. That could take a great deal of time, and I shall explain the issue further.
The future systems, as they are known, will come into force about 18 months after a decision has been taken on the siting of the European medicines evaluation agency—the EMEA—which the Government are keen to see sited in the United Kingdom. The Commission believes that a decision on siting will be taken at the Heads of Government meeting in June in Copenhagen. If that occurs, the proposals will come into force on 1 January 1995. If not, the proposals will not come into force until a later date.
The proposals are currently before the European Parliament and provide for a new regulation and directives that will bind the EC together and provide for common procedures. The United Kingdom will be a signatory to those proposals, which will probably be adopted by the Council of Ministers towards the end of this year. The proposals envisage a centralised procedure—
§ Ms LynneHave the British Government been pressing for legislation in the European Parliament to introduce more open government in respect of medicinal information?
§ Mr. SackvilleYes, and I shall deal with that issue later.
The proposals envisage a centralised procedure for handling innovative and biotechnology products and a decentralised procedure for other products. The essential feature of the centralised procedure is that applications will be made centrally to the EMEA and information supplied by companies will be entrusted to the EMEA and the Commission which will make the decision on whether a licence should be granted.
When member states are asked by the EMEA to assess a company's dossier, they will do so on behalf of the EMEA. In that respect, member states will be handling data for the EMEA. The subsequent making available of that information would be for the Commission to determine. That contrasts sharply with the position of member states currently and in the new decentralised procedures where licensing information will continue to be exchanged but in which each member state will remain responsible for determining the degree of confidentiality to be afforded various pieces of information.
At present, there is no agreement whatsoever among member states on what should be disclosed to the public in the decentralised procedures and only a vague reference to the making available of the
assessment report and the reasons for the CPMP's opinion, after deletion of any information of a commercially confidential naturein the centralised procedure.There are still many details of the operation of the centralised procedure to be worked out, and that is likely to take the whole of the period between now and 1995.
§ Mr. RadiceAre the Government pressing for a more effective open system at the European level? I do not agree that the centralised procedure is vague. Are the Government pressing for a common open system in the decentralised licensing system?
§ Mr. SackvilleYes, and I shall deal with that in a moment. Questions such as the layout, the amount of detail and the nature of the confidential information to be deleted have yet to be determined. Officials from the Medicines Control Agency and the Veterinary Medicines Directorate will, of course, play a full part in the discussions and will do so on the basis of two clear principles. The first is that the definition of confidential information must be sufficient to protect the commercial interests of the United Kingdom pharmaceutical industry. The second, which is subject to the first, is that they must press our Community partners to agree arrangements that will make available the maximum amount of information in as clear and as lucid a form as possible. I think that that answers the interventions from the hon. Members for Rochdale (Ms Lynne) and for Durham, North (Mr. Radice).
Those arrangements would apply only to licences issued by the Commission under the centralised procedure. Under the decentralised procedure, member states will remain responsible in accordance with their own national arrangements for issuing licences and for making information available. Subject to further consultation with all interested parties, it will be the Government's intention 1319 to see how far national arrangements can be modelled on those agreed as suitable for the centralised procedure. We shall be urging other member states to do likewise.
I hope the House can see, therefore, that if the United Kingdom jumped the gun and had a requirement in law to produce information with which the industry was not content, it would be reasonable to expect companies to go somewhere else first to market their products. Companies will look at what each member state is required by its laws to publish and at which would expose the least amount of their commercial interests. They would then take a commercial decision on where to place the application in the first instance, knowing that under the new decentralised procedures, that would be a passport to obtaining a similar licence from any other member state in which they chose to apply.
§ Mr. RadiceWill the Minister give way?
§ Mr. SackvilleI will press on because I do not want to be accused of talking out the Bill. Companies would choose first to obtain a licence from the member state offering the most safeguards. From the United Kingdom perspective, that would not only divert important licensing work from here, but would severely risk reducing the United Kingdom's influence on the high scientific standards that we are concerned should be applied to all licence applications in Europe.
The Government want to be helpful. We propose, therefore, that we should take up the reins in Europe and drive the debate towards more openness. We should want to look at the practical issues involved before deciding what would be beneficial and what might be harmful, but I can assure the House that the Government will wish to be at the forefront of developments. Officials in the Medicines Control Agency and the Veterinary Medicines Directorate will pursue new initiatives in Europe. Not only will they initiate discussion leading to the disclosure of meaningful evaluation reports in the centralised procedure for which the Commission will be liable, but they will pursue with the other member states the possibilities for opening up more information to the public in the decentralised procedures without jeopardising legitimate commercial interests. In particular, they will consider the shape and content of an acceptable assessment report and will also consider how more information on adverse drug reactions can be made available in a meaningful way without raising unnecessary fears in the public. In doing so, we shall build on the Medicines Control Agency's most advanced system in Europe for reporting adverse reactions —ADROIT, the adverse drug reaction on-line information tracking system—and the Veterinary Medicines Directorate's suspected adverse reactions surveillance scheme.
On all those aspects, we shall want to discuss the details with industry and with consumer interests, taking account of what has happened in the United States and other parts of the world with freedom of information provisions about which there has been some discussion today.
I have mentioned our proposals for Europe, but, of course, we have not been inactive in the United Kingdom. In health as in other areas of government, we are working hard to improve public access to information. For the first time, the public now have the right to information about 1320 the performance and plans of their local hospitals and health services, and to attend annual meetings with senior hospital managers. In our patients charter for the NHS, we have introduced a new right for patients to be given detailed information on local health services, including quality standards and maximum waiting times. For the first time, patients and their doctors have access to information that empowers them to decide where they can secure appropriate treatment most promptly. We have also created a new right for patients to receive prompt and full answers to complaints about NHS services. By increasing openess in this way, we shall maintain and build on the confidence of the public in the excellent service that the NHS provides.
With medicines, as with other aspects of health, we are continuing to increase the amount of information available to the public. For example, the "British Pharmacopoeia", which gives very detailed information about the specification, safety and quality of medicinal products, has been available publicly for some years. The Association of the British Pharmaceutical Industry publishes a compendium of data sheets. The Medicines Control Agency has been making available to doctors and pharmacists an increasing number of summaries of drug reaction data. Additionally, we have always been concerned that labels, leaflets and promotional material should be presented so that they are understandable and accurate, and do not mislead the public. That was our position even before the appearance of the recent EC directives on these issues.
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Where there are problems with licensed medicines, details of the problems and the outcome of analyses and investigations are published by the Medicines Control Agency three or four times a year in the publication "Current Problems". This is made available to doctors, dentists, coroners and a range of other interested parties, including "Social Audit"—one of the sponsors of the hon. Member for Durham, North (Mr. Radice). That publication is in the public domain and there is no reason why members of the public should not see it. I hope that I have shown that our commitment to more openness in government is being matched by real increases in the availability of information about medicines to the public.
What is more, it is our intention to continue to increase the amount of publicly available information about medicines. We have begun to discuss with the pharmaceutical industry a new voluntary code of practice to increase the amount of information that they give the public. That approach is consistent with our determination to ensure that companies in the United Kingdom are not weighed down by too many regulations and can compete on equal terms with foreign companies. Nevertheless, the House should rest assured that, where public safety is at risk, we will not rely on a voluntary code but will use our existing powers to inform the public of the dangers.
§ Mr. McCartneyThe Minister suggested some months ago that he would give the Bill a fair wind. In Committee, however, and today especially, it has been wrecked on rocks put in its way by Conservative Back Benchers. Conservative Members have tabled spurious amendments and mounted spurious campaigns. Behind the scenes, they have deliberately tried to block measures to promote the 1321 Bill. We have witnessed scurrilous attempts by the industry and its supporters in the House to undermine a Bill which would allow doctors and patients information that is available to doctors and patients in other nations—information about the safety of medicines, practical information about the way in which prescribing relates to specific patients and information relating to the efficacy of particular drugs.
Is it not interesting to reflect that if this debate were taking place in the United States, the Minister and his civil servants could give information about drugs that were produced in this country without being prosecuted, whereas in this country it is a criminal offence for a civil servant, a Minister or an hon. Member to place the same information in the public domain?
We have heard nothing about the victims. There has been no word about the consumer—the patient. We have received plenty of information about the interests of big business and the big pharmaceutical companies, which want to ensure that the British public are kept in the dark about some of their products. That same industry hypocritically—
§ Lady Olga MaitlandWill the hon. Gentleman give way?
§ Mr. McCartneyI will give way to the hon. Lady at some point.
§ Mr. WatersonWill the hon. Gentleman give way?
§ Mr. McCartneyNo. I will not.
§ Mr. WatersonOn a point of order, Mr. Deputy Speaker. On mature reflection, I think that my remarks are more appropriate to a point of order than to an intervention. The hon. Member for Makerfield (Mr. McCartney) has used the word "spurious" and the word "scurrilous", both in connection with a proposal that I tabled in the best possible faith, and I believe that he should be required to withdraw. As I have explained, I have no particular axe to grind; I merely want the legislation to be done properly. That is my only interest in giving up a Friday in my delightful constituency.
§ Mr. Deputy SpeakerThe House will have heard what the hon. Member for Eastbourne (Mr. Waterson) said, but I am afraid that the words that have been used so far are parliamentary words.
§ Mr. McCartneyWe have parliamentary words that can be used to protect our constituents from the scurrilous and scandalous activities surrounding the progress of this Bill and other Bills through the House.
It is interesting to note the companies that are involved in trying to ensure that the Bill does not reach the statute book: Glaxo; Boots; the company of the hon. Member for Gillingham (Mr. Couchman), Pfizer; ICI; Wellcome; Ciba Geigy—
§ Mr. CouchmanOn a point of order, Mr. Deputy Speaker. It is true that I advise Pfizer and it is true that I have discussed the Bill with that company. But not one word of written information has come from it to brief me, nor has one word in any of the amendments that I have tabled in Committee or on Report come from it. I take the most extreme exception to the imputation that the hon. Member for Makerfield (Mr. McCartney) makes. It is quite wrong and he should withdraw what he has just said.
§ Mr. Deputy SpeakerThe hon. Gentleman has placed his position on the record. The hon. Member for Makerfield (Mr. McCartney) referred to the hon. Gentleman's company. I imagine that that was a slip of the tongue.
§ Mr. McCartneyIt was not a slip of the tongue. It was a reference to the Register of Members' Interests. I have no problems with what I said. The hon. Gentleman obviously has a problem to explain to his constituents.
The position is that Ciba Geigy, Smith Kline Beecham, Boots Pharmaceuticals, Fisons Pharmaceuticals, Lilley Research, the Government's own Medicines Control Agency and the Ministry of Agriculture, Fisheries and Food are using legislation in the United States to seek information, but that information is being denied to the public today.
Why should that happen? Why have not the hon. Member for Gillingham and those who support his views said anything about the victims? More than 100 medicines have had their licences withdrawn or suspended since 1979. They include Opren, which was withdrawn in 1982, and the tranquilliser Halcion, which it seems some people are trying to get back on to the market. However, nothing has been said about the victims of those drugs. There has been no explanation or apology.
In the face of that, hon. Members are trying to ensure that the Bill does not reach the statute book today. The Bill would, for the first time, put people in Britain, doctors and the industry on the same footing as people in the United States. Why is the British industry and its colleagues overseas so opposed to this minimal measure? Why should the industry undermine its own credibility by ensuring that the Bill does not reach the statute book today?
The Minister said that there will be measures in Europe. However, as usual with this Government, the Minister used that information not as a positive attempt to support the Bill, but as a negative reason to oppose it. The Minister was right to say that there will be a system of centralisation in Europe. However, that will be a two-tier system—centralised and decentralised. The Bill is about the decentralised part of the system.
If we are to accept the centralised part, as the Minister indicated, it is our responsibility to pass the Bill. It would be the basis for a decentralised system under the centralised arrangements which the Minister has already said that he supports. From his own mouth, the Minister has condemned his own position.
The reason for that is clear and simple. On the Conservative Back Benches there is the naked interest of the pharmaceutical companies. On the Front Bench there is a Minister who is prepared to talk tough about the way in which drug companies are ripping us off in the national health service in respect of contract prices. The Government talk tough and they do tough things to patients. They would rather increase prescription charges and deny information to patients than have an adequate arrangement about the way in which drugs are charged in relation to the national health service.
This is a clear and simple naked trade-off between the Department and the industry. The Minister will go easy on the Bill in the hope that, in the negotiations over contract prices, the drugs industry will go easy in terms of the profits that it wants to make from the national health service. That is the plain fact of the matter.
1323 The debates in Committee and on the Floor of the House today have done the House a disservice in respect of the way in which Conservative Members and their industry interests have nakedly attempted to ensure that the Bill does not reach the statute book. I suggest that they should look to their consciences and consider the victims. Those accidents would not have happened if the information had been in the public domain in the first place.
§ Ms LynneDoes the hon. Gentleman agree that it is disgraceful that Conservative Members have denied us time to debate the Bill properly by filibustering in the debate on the Sexual Offences Bill? They should be ashamed of themselves. They should look to their consciences and answer to their constituents for their disgraceful behaviour.
§ Mr. McCartneyThe hon. Lady is right. The action was deliberate. It is interesting to note that some of the Conservative Members who took part in the debate on the earlier Bill have been most vociferous in their opposition to this Bill or, at least, were rather negative about ensuring that it reaches the statute book.
The hon. Member for Eastbourne (Mr. Waterson), who moved the new clause from a constituency interest, represents one of the large drug companies.
§ Mr. WatersonWill the hon. Gentleman give way?
§ Mr. McCartneyI promised to give way to the hon. Gentleman and I will keep that promise. I am not sure when I will give way to him—I might do that at 29 and a half minutes past—but I will give way.
The new clause is largely a wrecking amendment. The hon. Member for Eastbourne used arguments that were rejected on Second Reading. However, he was not in the Chamber then. Today, he used arguments that were made in Committee and rejected. He referred to proposals that have been raised in the general discussions between the parties—but he did not participate in them.
One is left with the clear conclusion that the hon. Gentleman has been wheeled in—as other Conservative Members have been wheeled in—to ensure that the Bill does not get the fair wind that the Secretary of State and the Minister promised. It is on the back of the interests of our constituents. He has raised issues, but there has been no evidence whatever to substantiate the points made.
§ Mr. WatersonI must stress, not for the first time, that I do not speak as a representative of, or consultant to, a company, or any sort of spokesman for any sort of company. The hon. Gentleman said that I represented a company in my constituency. The only entity that I represent in this and other debates is my constituency and constituents. I have taken a view of what is best for them and the country as a whole.
§ Mr. McCartneyI accept what the hon. Gentleman says. Perhaps he will reflect on the promises that he and other Conservative Members made about secrets and open government not simply at the general election but in the patients charter. The Minister is supposedly responsible for the publication of the patients charter which says that patients have the right to 1324
a clear explanation of any treatment proposed, including any risks".Is that not what the Bill is about?
§ Lady Olga MaitlandWill the hon. Gentleman give way?
§ Mr. McCartneyNo, I will not give way. The Under-Secretary of State for Health participated in the production of the Government's White Paper, "The Health of the Nation", which says that the Government are responsible for
providing reliable information on which individuals can base their decisions on matters which affect their health" and thatpeople need information to help make the right choices". The Government also aim to encourage better prescribing. Is that not what the Bill is about? Does it give effect to those principles?Not one Conservative Member has shown any support for the proposals. The Minister did not mention them. All we got was a litany of excuses, half-baked ideas, untruths and squalid interventions about the industry itself. We did not hear anything about the right of consumers—who spend a great deal of money, either as taxpayers through the national health service or as consumers, in buying a variety of brands over the counter—to have information about the products that they purchase.
§ Mr. RadiceI agree with my hon. Friend. Would not we take more seriously the Government's position—which they have apparently proposed in the last gasp—that they would press for a more open licensing system in Europe if at least they said that they would accept the principles of the Bill and use them to press the matter? They have not said that and, therefore, we cannot take what they have said seriously.
§ Mr. McCartneyThe Minister avoided saying anything about the Bill. He talked about the citizens charter—about how people can telephone their local manager or local district general hospital trust number and have a word once a year. He said that people could have more information about the waiting lists—instead of waiting for two years, people may have to wait for 12 or 18 months. We heard nothing about the detail of the Bill or why he opposes it. He gave us no alternative to it, although he has had months to put forward an alternative. He could have tabled amendments in Committee but did not do so.
§ Lady Olga MaitlandWill the hon. Gentleman give way?
§ Mr. McCartneyI will not give way to the hon. Lady. because she simply wants to filibuster in the last three minutes.
§ Mr. Deputy SpeakerOrder. The hon. Lady must resume her seat when the hon. Gentleman does not give way.
§ Mr. McCartneyThe only hon. Member to whom I will give way is the Minister.
§ Mr. Sackvillerose—
§ Mr. McCartneyThe Minister is enthusiastic. Will he give a commitment that he will have further discussions with the sponsors of the Bill and openly with the Department about making proposals in line with what he said to ensure that we can incorporate in those 1325 Government proposals the aspects that Labour Members in Committee wanted to see in place? If the Bill is talked out, will the Minister ensure that there is a way forward?
§ Mr. KnapmanOn a point of order, Mr. Deputy Speaker. A headline in The Guardian today states, "Tories to talk out drug secrecy bill". Frankly, some of us would not mind that, bearing in mind that we do not agree wholly with the Bill. Do you agree, however, that if I am lucky enough to catch your eye at 2.29 pm, I should not be accused on the morrow by The Guardian of talking the Bill out?
§ Mr. Deputy SpeakerIt is not for the Chair to rule on what is written in The Guardian.
§ Mr. McCartneyThe accusation is accurate because Conservative Members tabled more than 100 amendments to the Bill and spoke at length on the Sexual Offences Bill to ensure that this Bill was not subject to a proper debate.
In the final minute of the debate, will the Minister clearly state whether he will agree to talks to ensure that the Bill is able to reach the statute book?
§ Question put and agreed to.
§ Clause read a Second time, and added to the Bill.
§ It being half-past Two o'clock, further consideration of the Bill stood adjourned.
§ Bill, as amended, (in the Standing Committee), to be further considered on Friday 7 May.