House of Commons Hansard Debates for 30 Apr 1993

Mr. Nigel Waterson (Eastbourne) : I beg to move, That the clause be read a Second time.

Mr. James Couchman (Gillingham) : On a point of order, Mr. Deputy Speaker. Before my hon. Friend begins his remarks, I want to declare my interest to the House as an adviser to a pharmaceutical company. Insinuating sedentary remarks have been made about that today. I make it clear to the House, particularly in respect of press reports that have appeared in recent days, that I advise Pfizer in Kent, which is a major pharmaceutical company. That is in the Register of Members' Interests. It has also been drawn to the attention of the House--and this, too, has appeared in the press--that I advise the Gin and Vodka Association of Great Britain, although that is not germane to this debate. I should like that declaration on record, so that no further sedentary insinuations will be made by members of the Labour Front Bench.

Mr. Deputy Speaker (Mr. Michael Morris) : I am grateful to the hon. Gentleman.

Mr. Ian McCartney (Makerfield) : Further to that point of order, Mr. Deputy Speaker. The matter to which the hon. Member for Gillingham (Mr. Couchman) referred was not only the subject of sedentary interventions but was raised officially during all stages of the Bill. I refer to the hon. Gentleman's involvement with a company that has objected to the Bill and lobbied against it, and his meetings with that company in respect of the Bill. We have raised serious objections about the hon. Gentleman's connections with the company, and his ability--as a paid adviser--to filibuster and try to destroy the Bill. It is not a question of impugning the hon. Gentleman's character--it is a fact that is the case.

Mr. Couchman rose --

Mr. Deputy Speaker : Order. The hon. Member for Gillingham (Mr. Couchman) declared his interest and used the appropriate method dictated by the House. The hon. Gentleman's declaration is now firmly on the record.

Mr. Waterson : New clause 3 and others, and amendments in my name, make a genuine attempt to

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improve the Bill. I have no formal interest to declare in these proceedings, but, in view of the ill-tempered and ill- advised interventions, sedentary and otherwise, made by Opposition Members, I will make two points clear. I am fortunate enough to have in my constituency the northern European headquarters of Rhone-Poulenc Rorer, which is one of the most successful and innovative of the pharmaceutical giants in this country. Also, as a lawyer myself, I have an interest in good law and good legislation. I do not want this or any other Bill to leave the House with loose ends or with provisions that would be difficult if not impossible to interpret or enforce.

Mr. Giles Radice (Durham, North) : Will the hon. Gentleman tell the House who drafted his new clause?

Mr. Waterson : Although I received a little research assistance, the authorship of the new clause is mine and I am delighted to commend it to the House. If the hon. Gentleman believes that it does not have the intended effect, I shall be delighted to hear from him, but I will take any credit and any blame for the wording of new clasue 3 and of my other new clauses and amendments.

I hope that new clause 3 will command the agreement of right hon. and hon. Member in all parts of the House. I believe that it is accepted, including by the hon. Member for Durham, North (Mr. Radice), that, somewhere along the line, some restriction must be placed on the information to be supplied and the circumstances in which it is to be supplied. Any legitimate debate that there may be will be about where one is to draw the line--a point which I will develop at greater length later.

The new clause would make it an offence for people who had successfully applied for information under the Act to make copies of the information without the permission of the licensing authority. It also draws in the provisions of section 124 of the Medicines Act 1968, which takes account of offences involving corporate entities. The clause makes it possible for the licensing authority to charge for copies of information, whether the authority supplies that information directly or it is supplied by a third party.

Without such a clause, the licensing authority would find it harder to offset the cost of preparing the information. If the licensing authority receives less money than it should from applicants for information, that cost will ultimately fall on the pharmaceutical industry through licence fees. It wil be part of the leitmotiv of my comments on other amendments and new clauses that that is something which I wish to try to avoid, wherever possible.

I consider the new clause to be essential if we are to ensure that applicants for information can be charged a reasonable amount for copies from any source. It is a perfectly reasonable provision. It is not out of line with the usual approach in such a situation to books and magazines, for example, where copyright applies. Therefore, I have no hesitation in commending what I hope is an uncontroversial new clause to the House.

Question put and agreed to.

Clause read a Second time, and added to the Bill.

New clause 4

Restrictions on the provision of information

.--(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--

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((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

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. Waterson : I beg to move, That the clause be rea 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. Waterson : This 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

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experiments on animals of a certain kind are being carried out. That is another reasonable safeguard to include in the Bill.

Mr. Radice : Has 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. Waterson : New 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. Radice : That 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. Waterson : I 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. Waterson : I 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

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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. Waterson : My 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. Waterson : I 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. Couchman : I 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. Waterson : I 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.

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Mr. McCartney : Will the hon. Gentleman give way?

Mr. Waterson : No, 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. McCartney : The 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 Speaker : Mr. Waterstone.

Mr. Waterson : If 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. McCartney : Answer the question.

Mr. Waterson : I 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

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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. Spring : Does 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. Waterson : I 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. Waterson : I am grateful for that intervention. On the basis that that is the correct position, it is an effective answer.

Ms Lynne : My 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. Waterson : I 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 :

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"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.

1.15 pm

Mr. Couchman : Does 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. Radice : That is a total red herring.

Mr. Couchman : Perhaps 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. Waterson : I 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. Radice : Exactly.

Mr. Waterson : The 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. Spring : May 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

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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. Waterson : Let 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. Radice : Mr. 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. Waterson : I 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

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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. Couchman : I 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.

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