§ Order for Second Reading read.12.15 pm
§ Mr. Giles Radice (Durham, North)
I beg to move, That the Bill be now read a Second time.
This is an important Bill which has all-party support, as the list of sponsors on the back of the Bill shows. Several other Members of Parliament have spoken to me to say that they support the principles of the Bill. Outside Parliament the Bill has the support of the National Consumer Council, the Freedom of Information Campaign and Social Audit. Significantly, it is also supported by a wide range of medical and patients groups, including the British Medical Association, the Association of Community Health Councils, the Patients Association, the Association for Consumer Research and MIND.
I also understand that the Government, committed as they are in their manifesto to greater openness and providing more information for patients, are sympathetic to the principles behind the Bill. The Secretary of State was reported in a newspaper two days ago as saying that she thought that the Bill ought to get a fair wind. The Chancellor of the Duchy of Lancaster told the Treasury and Civil Service Select Committee on Wednesday that he was broadly sympathetic to the aims of the Bill, charged as he is by the Prime Minister with the duty of creating more openness in government.
The purpose of the Bill is to remove the all-embracing secrecy that surrounds all aspects of the licensing of medicines, both human and veterinary. Section 118 of the Medicines Act 1968 prevents the licensing authorities from giving any information about the licensing process. That means that at present the licensing authorities cannot disclose the safety studies that they obtain from manufacturers, including the results of trials of new medicines on patients. They cannot disclose their reasons for granting, suspending or revoking the licence. They cannot disclose the advice received by Ministers from bodies such as the Committee on Safety of Medicines and the Veterinary Products Committee. They cannot disclose the results of inspections showing whether pharmaceutical plants comply with quality control and hygiene standards.
Indeed, when Members of Parliament ask questions of Ministers they come up against a brick wall. For example, when my hon. Friend the Member for Huddersfield (Mr. Sheerman) asked what was being done to deal with the problem of counterfeit medicines, he was told by the Secretary of State that section 118 prevented an answer being given to him. That is the problem which faces all of us when we want to ask questions on behalf of our constituents about drugs and their side effects. That is unacceptable.
Section 118 prevents doctors and medical experts from examining the safety aspects of drugs that they prescribe, which is even more important than the problem facing Members of Parliament when they represent their constituents, and could be to the detriment of patients. While we all accept and admire the benefits that can be derived from modern medicine, powerful drugs, by their very nature, also carry risks. A proper balance can be struck only if we get all the available information about the risks and benefits. We rest our case on the fact that, under the present licensing system, one cannot achieve a proper balance. Doctors are made familiar with the 1208 benefits of drugs by the drug companies and receive a book on drugs being produced and licensed, but, because of the secrecy surrounding the licensing system, it is much harder to establish a full picture of the risks.
May I use a visual aid, Madam Deputy Speaker? There is a drug called Retrovir—I always find it difficult to pronounce the names of modern drugs, but I think that that is correct—and I now show the House the information about it provided for doctors by the industry. As hon. Members know, information about licensing is much more open in the United States of America, and I also show hon. Members the information provided there about the same drug—the summary basis of approval.
§ Madam Deputy Speaker (Dame Janet Fookes)
Order. Could the hon. Member give a brief description of the information, as I think he knows that it is not in order to use a visual aid which cannot be translated into writing?
§ Mr. Radice
Yes, Madam Deputy Speaker, I understand that. I was trying to point out that if a doctor in Britain receives a description from the industry it is likely to be very brief, whereas a doctor in the United States, with the benefit of a more open licensing system, has access to much more information and can therefore draw a more effective conclusion about the balance between the benefits and risks of medicines.
In some instances, the lack of information could be harmful. I am not trying to be sensational, but I shall quote four examples to the House and it is important for hon. Members to understand the problems that can arise.
First, in the case of the painkiller for arthritis, Opren, we did not know that the drug had been inadequately tested on the elderly patients who were the most likely to use it. Later, 7,000 people contacted the Opren action group to report side effects from the drug and to find out more information. However, they were not able to get the information because of the problems inherent in our licensing system.
The anti-depressant drug Prozac is another example. In 1991, Norway and Sweden refused to licence the drug on the ground that the manufacturer Eli Lilly sells the product only in 20 mg capsules. Some patients need only 5 mg, but the product is not available in that dose, which was why the licence was refused in Norway and Sweden. However, Prozac is licensed in the United Kingdom and is widely used at the recommended dose of 20 mg, rising to a maximum of 80 mg. The secrecy over information means that doctors cannot judge why it is recommended here at levels which are apparently regarded in other countries as excessive for some patients.
Another example is in veterinary medicine and has already been mentioned in the House of Lords. There is growing concern about the toxic effects on humans of using organo-phosphate sheep dips, which have been licensed since the 1970s. Under the present system there is no way to find out whether any trials were conducted on the dips before licensing and, if they were, what they showed.
In 1991, the licence of the tranquilliser Halcion was suddenly withdrawn. Neither patients who were taking the drug, which had been available for about 10 years, nor the doctors prescribing it were allowed to know the reasons behind the withdrawal of the licence.
By reducing the secrecy surrounding licenced medicines and by providing more balanced information, the Bill will 1209 lead to more rational prescribing, which will benefit doctors, pharmacists and publications such as the Drug and Therapeutics Bulletin, from which many doctors get their information. Also, it would have the benefit of making the licensing authorities and the industry more accountable. It would be good for consumers to have full confidence in the medicines that they take and in the regulatory system under which those medicines are licensed. The Bill will also ensure that patients either directly or indirectly, which is the more likely, will have access to information about the potential risks and benefits of the medicines that they take, which is essential.
The Bill, and the model that it suggests, follow the precedent set by the Ministry of Agriculture, Fisheries and Food in the case of pesticides, introduced in 1986, which is to be extended. Like the Bill, the pesticide arrangements involve making a detailed evaluation available, which often amounts to about 90 pages, as well as access to the full data on request and it bars commercial requesters, which is important. We are trying to follow a model which has been set up and is working in this country. In a sense, that strengthens the case for the Bill.
I shall briefly describe the main elements of the Bill. Clause 1 is definitional and clause 2 requires the Minister to maintain an index, which can be held in any form—electronic or otherwise. The index would identify three types of information: first, it would identify drugs that are subject to certificates and licences under the 1968 Act; secondly, it would identify types of information to which the public would have access; and thirdly, it would identify convictions under the 1968 Act.
Clause 3 is important because it is central to the Bill. It establishes a right of access to information on licences in force; the summary and evaluation of drugs—notably information about the safety and effectiveness of drugs; information considered by the licensing authority before granting a licence or before suspending, varying or revoking a licence; advice given by bodies such as the Committee on Safety of Medicines; and inspection reports on the manufacture and premises of firms that produce drugs.
May I make it clear that all information available under the Bill will be subject to two safeguards. I realise that a number of hon. Members and the drug companies are worried about that. The two safeguards cover, first, trade secrets and, secondly, the fact that the information will become available only once the product has been licensed and launched.
Clause 4 establishes, subject to ministerial approval, a wider right of access to information and extracts of information about the safety, quality and effectiveness of medicines, which may be necessary if the summary and evaluation are not detailed enough.
Safeguards are considered important by the industry and the country as a whole. Clause 6(2) excludes information about the manufacturing process that would damage commercial interests. It also excludes information about a product being developed, which has not yet been licensed. Clause 8 continues to make it a criminal offence to release information about the manufacturing process or a product being developed.
Clause 5 allows Ministers to exclude from wider access under clause 4 any person acting on behalf of a commercial interest. The Minister must be satisfied that the person has no commercial interest and may require legally enforceable undertakings to that effect.
§ Mr. James Couchman (Gillingham)
May I first declare an interest? I advise a pharmaceutical company, so there should be no misunderstandings on that. I am particularly worried about what the hon. Gentleman has just said, because the safeguards in the Bill seem to be weak in the extreme. Although undertakings may be given, it would not be the first time if such undertakings were not adhered to. What real safeguards is the hon. Gentleman putting into the Bill to prevent someone who has signed an undertaking from passing that information on to copyists or, in some ways more frightening, to an animal liberation outfit that could gain information about animal testing? That is of considerable concern to people working in the industry.
§ Mr. Radice
I understand the hon. Gentleman's concerns, but the Bill is modelled on the pesticides arrangements and they have not led to the problems that he suggests might arise. After all, he must bear in mind the fact that some of the companies that produce drugs also produce pesticides. I am well aware of the problem. If the Bill is given a Second Reading, I hope that he will give his advice and help in Committee so that we can tighen up any weaknesses in the Bill. I hope that he will consider what I have said in a sympathetic light.
§ Mr. Andrew Hunter (Basingstoke)
I do not have an interest to declare, but I have major pharmaceutical companies in my constituency. A great deal of investment in the United Kingdom industry comes from foreign companies. It is feared that a regime such as that outlined by the hon. Gentleman will deter investment. It is not just a question of its implications in practice; it would deter further investment and thus undermine the prosperity of the United Kingdom's pharmaceutical industry.
§ Mr. Radice
My understanding is that the very open system of regulation that operates in the United States has not deterred investment by foreign companies. I am not convinced that the problem is as serious as the hon. Gentleman suggests, but clearly we should examine that aspect. I do not believe that companies will have anything to fear if their drugs are properly tested. The trend that the hon. Gentleman suggested has not been seen under the pesticides model—neither does it occur in the United States.
If foreign companies want to market their products in the United Kingdom, they will have to license them here, which means that we shall have access to their data. That will ultimately be useful to United Kingdom companies. Again, that matter can be reviewed in Committee. It does concern me, and it is important that we get it right.
Clause 3(2) and clause 4 make it clear that information will be available only after the product has been licensed and launched. The Bill also provides protection for other groups. The identity of patients, doctors, and researchers undertaking animal experimentation will not be disclosed.
The industry has suggested that the Bill could become a counterfeiters' charter. We have tried to bar commercial interests, on the pesticides model. Only extracts will be published, not full data, and information about the manufacturing process and about products under development and not yet licensed will not be divulged. All those safeguards should be taken into consideration.
The hon. Gentleman raised the question of cost. That matter is for discussion and for the Government to decide. As the Bill bars commercial interests, the cost is likely to 1211 be far smaller than in the United States where, because commercial interests are not barred, the system is more expensive. I suspect that the system proposed by the Bill would not he very costly. I pray in aid again the pesticide arrangements, which are not costly. Costs can be exaggerated as an argument against giving the Bill a Second Reading.
In any case, as I have made clear, I fully expect the Bill to be amended in Committee. I have had helpful discussions with the Department of Health at six meetings over a number of months, but they have not yet been concluded. The Government have not produced any firm, detailed proposals of their own, so the Bill is inevitably in draft form. I do not pretend otherwise. I would of course have responded before Second Reading if the Government had made their intentions clear and said what they wanted. I could not, so perhaps some of the Bill's imperfections—if it has any—are not entirely of my own making or that of the Bill's sponsors or outside groups that support it.
I hope that those who have problems with the Bill will sit on the Committee and try to improve it, so that we can introduce more openness in regard to important licensing decisions, while protecting the legitimate commercial interests of drug companies, which I am anxious to do.
The Bill will give doctors more information about the medicines that they prescribe, and will let patients know more about the possible side effects of those medicines. The licensing agencies will be able to explain the reasons for their decisions and pharmaceutical manufacturers will have the discipline of knowing that the safety of their medicines will be subject to wider scrutiny. That will be good for doctors, patients, the licensing authorities and, I believe, the pharmaceutical industry. I hope that the House will give my Bill a Second Reading.
§ Mr. David Atkinson (Bournemouth, East)
I welcome the Bill, in the light of the experiences of a number of my constituents and many other people who have written to me about the often permanent damage to children's skin which has resulted from long-term application of steroid creams to combat eczema. A recent Sunday Express campaign exposed the extent of those sad cases; I believe that the Bill will do much to reduce them by providing GPs, patients and their families with more information about the products concerned. It will also concentrate the minds of GPs who prescribe ointments without regard to either their efficacy or their effects on patients.
The ointments most frequently mentioned are Betnovate N, Dermovate, Eumovate and Propaderm A. They should of course be used sparingly; certainly they should not be persevered with if they are not working. Unfortunately, the Sunday Express and I have been informed of all too many cases of such prescriptions being repeated by GPs—sometimes for years—without any evidence of their efficacy. Permanent scarring has resulted; skins has become almost transparent in places, with blood vessels and veins becoming clearly visible. We can only imagine the psychological distress caused, to, in particular, young people of both sexes. Indeed, suicides have been known. Other side effects are obesity, owing to the cortisone ingredients absorbed into the bloodstream, and a loss of natural immunisation against infection.
1212 Some GPs are clearly unaware of those dangers, and some do not appear to be particularly interested when patients discover alternative therapies—for instance, homoeopathic or aromatherapeutic herbal medicines—that succeed, often within weeks, where pharmaceutical products have failed, as well as being much cheaper. Producers will claim that they provide the widest possible advice on the application and administration of their products—which, in any case, must satisfy the Committee on Safety of Medicines before a licence can be issued.
I hope that my hon. Friend the Minister will investigate the worst of the cases of which I have been informed. I shall send him the details.
I am sure that the Bill will go a long way towards ensuring that such sad and unnecessary cases of suffering are never repeated, and I hope that it will be given a clear passage. I congratulate the hon. Member for Durham, North (Mr. Radice) on introducing it.
§ Ms. Liz Lynne (Rochdale)
I welcome the Bill, which is a positive step towards ensuring that patients and doctors have more information. We should ensure that we get rid of the secrecy that surrounds so many areas of our life.
I know several patients who have been to doctors and been prescribed treatment without being told of the side effects. They have seen their doctors numerous times and said, "I am suffering from this," but quite often their doctors do not know what the side effects are. That is why I support the Bill, which will bring our legislation into line with the extremely good legislation of the United States, under which people are able to discover the side effects of treatment.
I know that some European countries do not have such strong legislation. If the Bill is passed, we should put pressure on our European colleagues to ensure that legislation is introduced across Europe. That would go some way to allay the fears of some Conservative Members that competition would be difficult and that people would not want to invest in this country. It would help if we could make legislation apply across Europe.
I can understand the fears of the pharmaceutical industry about, for example, trade secrets, but that is covered by the Bill. Perhaps, as the hon. Member for Durham, North (Mr. Radice) said, the Bill's provisions need tightening, but that can be addressed in Committee. The most important thing to remember is that people's health is paramount, as the Government suggest in their White Paper "The Health of the Nation". People should take more responsibility for their health care needs. If the Government believe in the proposals set out in the White Paper, they should support the Bill.
Some drugs have been withdrawn. The tranquilliser Halcion was withdrawn in 1991, but none of us has been told why. We are unaware of the side effects of similar drugs that are on the market. More drugs are being produced without our knowing their side effects, but we need to know in order to protect our health and that of our constituents. It is unacceptable to use the trade secret argument when the health of people should be paramount.
I should like to give my wholehearted support to the Bill. Obviously amendments will be tabled in Committee, but I should like to give the Bill the support of my party.
§ Mr. James Couchman (Gillingham)
I had not intended to speak, but I repeat that I advise a pharmaceutical company in Kent. I make no apology for offering the hon. Member for Durham, North (Mr. Radice) some of the fears of the industry. I know that he has been approached by companies and by the industry's association, the Association of the British Pharmaceutical Industry, in various letters and meetings.
§ Mr. Radice
I have had meetings with the industry, but more meetings, particularly at the Committee stage, would be extremely useful.
§ Mr. Couchman
I welcome the hon. Gentleman's assurance on that point. It is important that, if the Bill gets its Second Reading and goes into Committee, a better Bill emerges.
The pharmaceutical industry is one of our success industries. Our companies lead the world. Four out of 10 of the world's leading products come from the British industry, which is a strong industry that provides the country with a substantial trade surplus of £1.2 billion. Not too many of our industries are in that happy state. It is important that we maintain the investment confidence of the industry. I am worried about that confidence, given that, unhappily, the Bill is being presented at the same time as the Department is threatening an extension of the limited list provisions, which is also seen as a threat to investment by the pharmaceutical industry.
One reason why this country has attracted industry from overseas is the strength of our research and science, and our development of the pharmaceutical industry. It is a shining example to other manufacturing and research-based industries. I am worried that, as a result of the unhappy concomitants of the perceived threats to the industry, investment decisions prejudicial to the United Kingdom will be taken.
I hope that I may be able to take up the invitation extended by the hon. Member for Durham, North to join the Committee, but I am also tied up with a number of other Friday Bills, which may have to take precedence over his for my services.
I see the Bill as a threat to the intellectual property rights of the research-based pharmaceutical industry. In my intervention in his speech, I told the hon. Gentleman that the safeguards in the Bill to prevent dissemination of information are weak. They are seen as highly threatening because of the danger that generic copyists, or even people who might make fraudulent applications for product licences, as has happened recently in the United States, might get their hands on the information. Research workers in the industry are also worried by the prospect that their safety could be threatened by the Animal Liberation Front, which has extreme views on people doing research in the industry.
The hon. Gentleman placed great store on comparisons with the pesticides industry, but the two are not the same. The pesticides industry does not have the same amount of generic competition as the pharmaceutical industry, and the scale of the industries is also different. The pesticides industry has an annual turnover of £700 million, whereas that for the pharmaceutical industry is almost 10 times bigger. In addition, although innovative pharmaceutical 1214 manufacturers receive limited patent protection, no such protection exists for vaccines and products of bio-technology.
I am also concerned that the European agency proposed for pharmaceutical licensing will not come here if we pass the Bill. That would be regrettable, because, in respect of the pharmaceutical industry, we lead in Europe. It would be a great benefit if the European Medicines Evaluation Agency were to be located in this country when it is formed.
The hon. Member for Durham, North pre-empted my second intervention in respect of the cost of the legislation. At the moment, the pharmaceutical industry pays money to the Medicines Control Agency for product licences, because it perceives the licence as a service provided by the MCA to the industry. The industry would view the Bill as a disservice rather than a service to it. It would certainly be highly unlikely to be a willing contributor to the cost of the dissemination of the information.
Therefore, the hon. Member for Durham, North must recognise that the people who seek information under the Bill will have to pay for it themselves—which could amount to more than just the cost of providing a large quantity of photocopied material—or the cost will fall on the taxpayer. I am sure that the Parliamentary Under-Secretary of State for Health, my hon. Friend the Member for Bolton, West (Mr. Sackville) will have something to say about the likelihood of the Treasury wishing to pay for information to be disseminated at a time when the Treasury is seeking to curb the drugs bill.
I have probably said enough now to show the industry's concerns. The industry is taking steps to disseminate more information about medicines. It would much prefer to see a basis whereby the Medicines Control Agency acceded to the EC initiative to provide summary bases of approval in respect of all newly licensed medicines. That certainly seems to be a way forward to provide more information to doctors and to patients.
While I wish the hon. Gentleman's Bill a fair wind, I hope that, in Committee or on Report, if necessary, he will be prepared to accept amendments that truly safeguard the rights and justified commercial interests of an important industry—the pharmaceutical industry.
§ Mrs. Judith Chaplin (Newbury)
Like motherhood and apple pie, we are all in favour of as much information as possible being given to as many people as possible in all aspects of life. Having worked in government, I know that many papers that cross one's desk marked "confidential" probably need not have been confidential. I welcome the fact that the Government are committed to much more open government in all its aspects and to extending the information that is provided to people. However, there must be a balance. We should not go to the opposite extreme and remove confidentiality, when there are valid reasons for it. As other hon. Members have said, there is a risk that the Bill could damage commercial interests.
Most medicines take many years to develop. I believe that the average time is 12 years. Their development involves substantial costs. Up to £150 million can be involved in the development of a medicine. Even when medicines are developed and licensed, many are not commercial successes. Therefore, there is a high cost to the 1215 pharmaceutical industry in respect of developing medicines which we all want to deal with illnesses that afflict us today.
Patents can cover 20 years, but they are registered at the beginning of the process. Therefore, medicines are not protected for a particularly long period. The Bill could provide competitors with an unfair advantage. Indeed, it could damage the pharmaceutical industry in this country and, as my hon. Friend the Member for Gillingham (Mr. Couchman) said, the pharmaceutical industry is a very important industry in this country.
I have examined the Bill carefully, and I do not see how clause 5 can be enforced or effective. I am always worried about legislation which cannot be enforced correctly.
For example, people involved in industrial espionage do not pull a hat down over their faces and put on dark glasses. One cannot tell who is a spy and who is an ordinary person making innocent inquiries about the ingredients of a medicine. Therefore, it is extremely unlikely that the clauses which seek to prevent commercial spying will be effective. If they are not effective, there is the risk of damage to the industry in this country, and the risk that it will go elsewhere.
It has been suggested that it would be acceptable if similar legislation were in force across Europe, but that would still not be sufficient to prevent companies from manufacturing in other countries and therefore reducing the amount of work they carry out here. It is extremely easy for most of the companies involved, many of which are in any case international companies, to re-base where they do the bulk of their work, which could do great damage to our balance of trade if several moved overseas. As my hon. Friend the Member for Gillingham (Mr. Couchman) said, there is a great trade surplus from the pharmaceutical industry, and we need to keep it here.
We also need to protect the jobs provided by the industry—about 80,000 direct and about 200,000 indirect jobs. Even more important, we must keep the research and development skills of people in the industry. By that I mean research and development not only in the industry itself but in universities and elsewhere. We should not wish skilled people to go overseas, which would be a possibility if there were a threat to the industry. The Labour party shares those aims, so I am sure that the hon. Member for Durham, North (Mr. Radice) has borne them in mind when considering the Bill.
The Bill leads us to ask whether the current secrecy is too great. I entirely agree with the hon. Member for Durham, North that it is, but that does not mean that we should go to the other extreme and give too much information. I hope that I have made it clear that I would not wish us to go to the extreme proposed in the Bill, but there is no reason why the data sheets, or compendiums, about medicines available to people should not be re-examined to ascertain whether more information can be given without running the risk of damage to commercial interests.
§ Mr. Radice
I hope that, in making her measured speech, the hon. Lady has taken on board the fact that we are discussing safety studies, not general information about the manufactured product or the development process. I should have thought that safety studies should be available in the public interest.
§ Mrs. Chaplin
I agree that more detail should be available of studies and tests that have been carried out and what effects have been recorded. However, the difficulties relating to Opren or some medicines for eczema appear to have occurred because of inadequate testing rather than the lack of information available on them. It is absolutely right that there should be wider discussion about such tests, but that does not mean giving information that could damage the competitive advantages of those who have produced a drug.
I agree that section 118 of the Medicines Act 1968 must be reconsidered, but not to the extent of an excessive removal of restrictions, which could lead to a greater threat of our industry going overseas. I also agree that the Medicines Control Agency should give details on, for example, why it has withdrawn a drug, further details of standard testing and what has been decided about different aspects of a drug. All these issues could be reconsidered so that more information could be given, enabling people to decide for themselves whether a drug's side effects are too great.
I have some doubt about whether that is the best approach. All of us know that, when looking at an encyclopedia of the 100 most common diseases, many people decide that they have at least 90 per cent. of them, and that their death is imminent. I am concerned about people being made nervous about a medicine which they could take quite safely and which would benefit them.
I believe that an area of information can be expanded without going to the extremes that appear in the Bill. The Bill requires substantial alteration before I can support it.
§ 1.4 pm
§ Mr. Piers Merchant (Beckenham)
I congratulate the hon. Member for Durham, North (Mr. Radice) on introducing the Bill, which is principally designed to push back the frontiers of secrecy. Incidentally, the Bill seeks to reverse a measure passed by a Labour Administration in 1968. I am glad that the Bill commands obvious support in the House and beyond. I support the basic principles behind the Bill and although I have some reservations of detail, none would stop my general support for the Bill.
There are two particular reasons why I am keen on the Bill. I am strongly committed to freedom of information. I believe that all information should be freely available unless there are overwhelming reasons against that availability. That point should be as relevant to all appointed statutory bodies, such as those governing the safety of medicines, as it is to elected bodies.
The spirit that applies is the same as that eloquently set out by Lady Thatcher in her maiden speech in this House. She said:The public has the right, in the first instance, to know what its elected representatives are doing."—[Official Report, 5 February 1960; Vol. 616, c. 1350.]She was speaking on what became the Public Bodies (Admissions to Meetings) Act 1960. The public has an equal right to know what those appointed to guard its safety on medicine and drugs are doing and why they are doing it.
Freedom of information was further enhanced as a general subject in 1985 with the Local Government (Access to Information) Bill, which was introduced by my hon. Friend the Member for Hornchurch (Mr. Squire). I was lucky enough to be able to support it in a speech in the House. The same principles that drove me to do that 1217 encourage me to support the Bill today. In both cases, there are exceptions to the general principle of freedom of information. The Bill recognises that and it specifically grants exclusions to genuine trade and commercial secrets. The Local Government (Access to Information) Act grants exclusions for personnel matters. It is right that the Bill should allow exclusions.
I attach great importance to the need to protect pharmaceutical companies in that way. I do not believe that the hon. Member for Durham, North seeks to diminish that protection. However, I have some doubt about the sufficiency of the Bill in that respect. The hon. Member has been gracious enough to say that he is willing to be flexible in that area.
We must be careful not to discourage the huge investment that pharmaceutical companies put into the commercially risky and uncertain area of research. It is difficult for companies to assess in advance exactly how great the resources need to be to bring a research project to fruition. In many cases, research projects do not come to fruition.
We must ensure that pharmaceutical companies, which are strongly based in this country, do not lose confidence as a result of the Bill to the extent that they seriously consider moving their operations offshore where they could use a safety regime that might not be as onerous in its requirement to publicise the information gained in research and in bringing the drug to the market.
I am a little worried, too, about the implications that may flow from the single European market. Directives governing such matters are, of course, in train, but we all know that, although on paper such directives may place the various countries of Europe on an equal footing, in practice, there are some countries whose regimes may be less onerous and therefore more acceptable to companies that are worried about such matters. I am not as convinced as some of my hon. Friends that that is a real danger. I agree that the possibility exists, but feel that the difference between the safety regime established under the Bill and the safety regimes of other countries would have to be very great to persuade companies to move offshore. Given that many countries are now moving to tighten their safety regimes, I doubt whether the differences would be sufficiently great for that situation to arise. It is, however, something which needs to be watched.
I am especially doubtful about the clause to which my hon. Friend the Member for Newbury (Mrs. Chaplin) referred, which permits access to certain information on a selective basis; access must be given only to people who the Minister is satisfied are not connected with the drugs industry. In the age of photocopiers and faxes, not to mention telephoto lenses and listening devices, it is hard to imagine that those involved in a highly competitive industry will for long be denied information that is available to other people—no matter how that informa-tion might be transmitted. We need to examine more closely the practice of that clause, rather than confining ourselves to the theory behind it.
Having made those cautionary points, I come to my second reason for supporting the Bill. More and more medicines are available and more and more are prescribed. The public are more aware and better educated than ever before about medical matters. That is a good thing and, as has been said, the process is being encouraged by the Government: the public are being urged to look in detail to their own medical care. They are rightly entitled to 1218 information about the drugs that may be prescribed to them. There have been some tragic safety lapses. It is only right, therefore, that there should be an effective and credible system to protect the public which is not just thorough and fair but is clearly seen to be thorough and fair.
At present, the system is not seen to be thorough and fair because of the restrictions imposed under the Medicines Act 1968, some of which are clearly absurd. To my mind, the restriction on reporting by factory inspectors on quality control and hygiene in pharmaceutical manufacturing plants is quite unacceptable. Information concerning manufacturing units in Britain that is not available publicly in this country because of the 1968 Act is available in the United States of America, so any argument against making such information available falls at the first hurdle.
Hon. Members who have asked parliamentary questions on entirely innocuous matters have been given no information because of the requirements of the Act. For example, on 5 February 1987, the hon. Member for Kingston upon Hull, North (Mr. McNamara) asked about the location—only about the location—of overseas manufacturing sites of Generics UK Limited that had been inspected and was given the answer that the information was not available because of the requirements of the 1968 Act. The Bill corrects such problems and, at the same time, makes vital information available to doctors, patients and the public. With such information, they can play an active role in monitoring the system not only of drug safety but the drugs themselves. They can feed back vital information which can play an important part in establishing whether the drugs in use are safe. That would extend not simply the feeding of information but the safety of medicines generally.
§ Mr. Richard Alexander (Newark)
On the face of it, this Bill looks like a good idea. However, on close investigation, it could prove more harmful than all the benefits it could give. It could have devastating effects on the pharmaceutical industry which, without doubt, is one of the United Kingdom's greatest success stories.
The hon. Member for Durham, North (Mr. Radice) proposed the Bill in a most reasonable way. He said that he expected the Committee to be able to provide the safeguards. However, people who are anxious about safeguards expect them to be better spelt out and agreed with the industry involved, rather than the matter being left to the speculative results of the Standing Committee.
As with many other Bills with good intentions, this Bill, which gives patients and doctors more information on which the safety of medicines will be judged, is flawed because it increases access to commercially confidential information in a way that no other country allows. It is a recipe for ensuring that pharmaceutical companies in the United Kingdom will seriously consider leaving this country. I know that that is not the wish of the Bill's sponsors, but they must recognise the side effects which it could produce.
The United Kingdom has always recognised intellectual property rights. The Bill undermines those rights; they could be swept away with one blow. Industries that have built up commercial know-how and expertise, and which 1219 always believed that Britain would protect them, now find that properly patented rights are worthless. That is the danger with the Bill.
The sponsor of the Bill seems to recognise that both the Association of the British Pharmaceutical Industry, to which reference has been made, and the National Office of Animal Health Ltd. think that the safeguards in the Bill are meaningless. Those organisations live with the facts of that daily. The piracy of patented goods and products is an international problem, as any owner of a genuine Rolex watch will soon tell us. The Bill will immediately make confidential secrets and know-how international property. If it is to see the light of day, it must contain more meaningful safeguards.
Pharmaceutical companies in the United Kingdom cannot introduce expensive research, knowing that the patent protection which existed previously will be worthless. The potential loss of employment in companies, universities and medical and veterinary schools will be considerable. People outside Britain sometimes think that we can never have a successful industry without a politician wanting to interfere with it, for very good reasons, and ruin it by a side wind.
My hon. Friend the Member for Gillingham (Mr. Couchman) said that there is hope that the European Medicines Valuation Agency will be sited in the United Kingdom. There is expertise here on which it could draw. We could say goodbye to any such prospect if the Bill were passed.
Of course patients should receive more information about the benefits and risks of medicines prescribed to them. Patient information is growing in Britain and we all welcome that. Of course regulatory authorities must have access to the facts on which newly patented medicines are approved. But a Bill giving access to all safety, quality and efficacy data in support of a product licence application would be open to abuse and commercial exploitation by competitors.
§ Mr. Radice
It is not all the information. It is a summary of the information. It is the information provided by the licensing authority. While I have every sympathy with the anxieties of the industry, it does not help to exaggerate in the way that the hon. Gentleman has just done.
§ Mr. Alexander
I am not a spokesman for the industry. I have studied the Bill. I have no commercial interest to declare. The hon. Gentleman has made his points and I am making mine.
It is all very well to say that the information could not be passed on to a person with a commercial interest in that product. But how can anyone prevent the information from being passed on? That is the nub of the objections to the Bill. I understand that, apart from Denmark, no country has comparable legislation or proposes to introduce it.
As a result of the Bill, British and foreign-owned companies would no longer make product licence applications to the United Kingdom Medicines Control Agency. That is a genuine fear. They would be sensible to go elsewhere. Another of Britain's major industries would fade away as a result of well-meaning politicians interfering in matters about which industry knows best.
1220 As our pharmaceutical industry obtains product licences in Britain, British patients are often the first to benefit from new medicines. That advantage would also be lost if the Bill proceeded. We could forget the prospect of foreign companies considering pharmaceutical research and production in Britain if they had not already obtained licences.
The industry produces a trade surplus of £ 1.2 billion for Britain. The Bill would put much of that at risk. The danger is as strong as that. The National Office of Animal Health Ltd. has described the Bill aswell meaning but potentially damaging and dangerous".For that reason, I cannot give it my support.
§ Lady Olga Maitland (Sutton and Cheam)
I have listened to the debate with tremendous interest and sympathy. I congratulate the hon. Member for Durham, North (Mr. Radice) on having the spirit and enterprise to concentrate on removing secrecy where it is not needed. We have covered a tremendous amount of ground in that regard. The secrecy element of section 118 of the Medicines Act 1968 is clearly outdated.
In the anxiety to make good a weakness, there is a tremendous danger that we could throw out the baby with the bath water. As other hon. Members have said, we must be careful about hitting the pharmaceutical industry too hard and therefore killing the golden goose—if I may use two metaphors in a row. This is almost a case of overkill.
The United Kingdom pharmaceutical industry is the best in the world. It is the fourth largest exporter after Switzerland, Germany and the United States of America. It employs, directly and indirectly, more than 300,000 people. That is many jobs. The industry made about £550 million worth of capital investment in 1990. Four of the world's top-selling medicines were developed in Britain. The industry's exports are valued at nearly £3 billion, making it the second largest contributor to Britain's net balance of trade after power generating machinery.
In short, we owe the industry a debt for its research, investment and innovative science, which raises a valid question about the balance between the interests of customers, the consumers, patients, doctors and the industry. I acknowledge that the hon. Member for Durham, North and his sponsors recognise that that is a sensitive area which must be examined. The problems have been highlighted by my hon. Friends the Members for Gillingham (Mr. Couchman), for Newbury (Mrs. Chaplin) and for Beckenham (Mr. Merchant) and I make no apologies for repeating some of their concerns. We should consider the industry's fears that commercial interests could be adversely affected if it has to make all the data available, as set out in clause 4. It sounds reasonable enough to say that information on safety, quality and efficacy should be given, but that could cover a wealth of information which could be poached by an industrial rival, such as detailed results from clinical trials.
I should like to know what the hon. Member for Durham, North means by a "summary"—I think that that would allow abuses of the system. The Bill does not go far enough to safeguard commercial interests. Under the 1968 Act, volumes of information could be made publicly available because companies have freely submitted information in the knowledge that it would not be revealed to a competitor or a third party. As the data are so 1221 detailed, it could be abused by potential counterfeitors. Companies might use the information as a basis for a fraudulent licence application, as has happened several times in the United States in recent months, where such material is available under freedom of information legislation. That might also happen here as the Bill could aid potential generic copyists here or abroad. An example of such a case in America was when Bolar and Vitarine were charged in 1990 with undercutting Smith, Kline and Beecham in a generic drug scandal. PharmaKinetics was charged with fraud in a similar case in 1991. Those are serious occupational hazards.
The safeguards in the Bill against data being used and exploited are flimsy and easily open to abuse. The Bill seeks to give access to all data to everyone excepta person with a commercial interest in the industry".Who will decide who is a suitable person? How does one prove that they are not? How can one assess someone's intentions? The Bill is fraught with dangers, which could result in legislation and plenty of work for the lawyers, but I am not sure that it would have much benefit for other people.
The Bill states that it will keep from the public only genuine trade secrets, such as techniques for manufacturing drugs, but people will have access to information on the rest of the trials submitted if it can be shown that they wish to further "public discussion" of the safety and efficacy of the drugs concerned. It would therefore be wise for the sponsors to stiffen the safeguards against the misuse and exploitation of such information.
We must bear in mind companies' reactions if they are faced with the almost crippling requirements in the Bill. They would take off elsewhere and that would be a great shame, as the industry has such high standards in this country. That would mean that our launch pad for the pharmaceutical industry would never be the same again.
The hon. Member for Durham, North mentioned parallel legislation in the pesticides industry. However, pesticides manufacturers are not subject to the same intensity of generic competition as the pharmaceutical industry, so it is not a real parallel.
In spirit, I welcome the proposed Bill, despite my remarks. Section 118 of the Medicines Act 1968 is a suitable case for treatment. There are benefits, but, as with all drugs, they must be taken with care.
§ The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)
I congratulate the hon. Member for Durham, North (Mr. Radice) on introducing the Bill. He was characteristically well informed in his assessment of the Government's attitude. We do not object to the principle of the Bill.
First, may I give a little background to drug regulation in this country? The drug regulation system in the United Kingdom is one of the most stringent in the world and provides the nation with the reassurance that the medicines they take are safe, efficacious and of good quality. That is something we should be grateful for. But this has not always been so. The pharmaceutical market remained comparatively free from controls until the early 1960s, when the promotional claims for a specific drug were seen to be tragically inaccurate. The Medicines Act 1968 provided a framework for the regulation of the safety, quality and efficacy of all medicinal products and was designed to close regulatory loopholes that allowed a 1222 drug such as thalidomide to be given to women in early pregnancy, with consequences of which we are all sadly too well aware. The Act achieves its aim by a number of integrated controls but chiefly by means of a licensing system that grants, renews, refuses or revokes permission for the supply of medicinal products for human or animal consumption. Those controls include the manufacture, distribution, marketing and advertising of medicinal products.
However, medicines regulation is an area where there are extensive restrictions on the disclosure of information. Under section 118 of the Medicines Act 1968, the disclosure of information supplied to the licensing authority is generally forbidden. The only exception to that is where there is a "duty" to do so—either as part of the function of licensing or where public health or safety are at risk. That is because there is an underpinning common law obligation to respect the confidentiality of the information presented by companies seeking marketing authorisations. There is also a duty to maintain the anonymity of individuals whose identities may be known because they have taken part in clinical trials or post-marketing surveillance studies. The amendment to section 118 is at the heart of the Bill.
The hon. Member for Durham, North has already eloquently outlined the benefits of the Bill as he sees them, and I need not take up the House's time in repeating them. None the less, it is worth making it clear that the Government are committed to promoting greater openness in government. To make more information available to the public in the field of medicines and medicines control in general would no doubt contribute a positive step in that direction. I recognise that the Medicines Act has been regarded and quoted as one of the long-standing statutes that provide for little or no information to be provided publicly, and I am sure that it is right to view very positively the prospects for opening up to public scrutiny at least some of the information held by the United Kingdom Medicines Licensing Authority. I am sure that steps in that direction are, in principle, something which the Government would wish to consider very positively.
The Bill would require the licensing authories dealing with both human and veterinary medicines to publish detailed information about their decisions and make available on request full information about the safety, quality and efficacy of medicinal products. Again, I am sure that access to increased information would represent a very important contribution to public information in an area that impinges on the day-to-day lives of virtually every member of the community.
Information about the medicines that people are taking, their side effects, and warnings that need to be given are important pieces of information with which individuals can balance the risks against the benefits of medicines. The consumer safety information provided with applications for veterinary medicines for use in food-producing animals, the residues of which might enter the food chain, is also very important. In addition, and importantly, doctors and vets could obtain more information about the medicines that they prescribe to enable them, too, to learn more about the medicines, benefits and their potential side effects, so that they would be in a position to give fuller advice to their patients and users of animal medicines.
1223 Access by the public to information on adverse drug reactions is also a potentially important development. Great care would need to be taken in ensuring that the data that are available to individual members of the public are fully validated, and presented in a balanced way which avoids the risk of unnecessary public anxieties—or, worse, patients being panicked into no longer taking medicines that are in fact remarkably safe and efficacious for them. Where animal medicines are involved, withholding them could lead to animal welfare risks. In addition to information on medicines, their benefits and their risks, the public could also benefit greatly from more informed discussion in the scientific and medical community and also by patient and consumer bodies of the advantages and risks of particular medicines. Again, that would contribute to ensuring that medicines are prescribed and used appropriately.
However, the issues are more complex than might at first be apparent. Against the advantages that greater freedom of information would bring, some of which I have just outlined, we also need to consider some potential disadvantages and dangers. Some of the proposals in the Bill as drafted may go further in providing information than is necessary to permit informed analysis of the medicines available. Clause 4, for example, would require all data files to be opened up.
We need to consider very carefully the additional burden that the proposals would put on the pharmaceutical industry and the very real risks that the Bill, as drafted, would run in endangering the information—some of which is commercially highly sensitive—that companies have lodged with the licensing authority. There is also the danger that the United Kingdom may get too far out of line and prejudice its position as the European Community develops systems for the future licensing and control of medicines.
As everyone knows, the pharmaceutical industry is one of the jewels in our trading crown. It is a buoyant industry. United Kingdom drug manufacturers have produced a large balance of trade surplus over the decades. The United Kingdom pharmaceutical industry is the third largest exporter of medicines in the world. In 1990, the value of exports topped £2.2 billion. However, these are difficult times for all manufacturers and I am concerned that at a time when we are determined to reduce the burden government places upon industry, the Bill could increase them. Not only would there be the additional cost of establishing the scheme, which would add significantly to the fees industry pays to license human medicines—
§ Mr. Couchman
I touched on that aspect during my speech. Is my hon. Friend saying that he expects that if the Bill reached the statute book the industry would have to pay for that imposition on it?
§ Mr. Sackville
That would be a matter for discussion. Either way, it would become a burden on industry—directly or indirectly.
There would also be the additional cost, which cannot be estimated but could be very significant, that industry and the Government would face in ensuring the security of commercially sensitive information. The threat of legal challenge should not be underestimated; nor should the 1224 level of open-ended legal costs. In that respect it is worth bearing in mind the experience in the United States, where every year three or four significant judicial reviews are undertaken in the medicines field alone.
As currently drafted, the Bill provides for, among other things, unlimited access to data. There are a number of exclusions, including most products that are under development—although not animal medicines being tested in field trials in food-producing animals. The industry has expressed concern that that will inhibit the research and development work necessary to bring new products on to the United Kingdom market. Details of the manufacturing process itself are also excluded. While those definitions may look straightforward, as has already been said, in practice a good deal of work and difficulty could be involved in identifying the data to be excluded. That could add significantly to burdens on the industry, and to the regulatory authority's costs, which in the United Kingdom, uniquely, are provided entirely by the industry through fees.
The provisions seek to prevent persons with a commercial interest from obtaining sight of data that has been classified as commercially sensitive would surely be open to abuse. The definition of "commercial interest" is so narrow that it would seem to enable those who are prepared to make a living out of buying and selling commercial information to do so, particularly in view of the potential benefits to be gained from obtaining a competitor's confidential data in a multi-million-pound industry.
§ Mr. Radice
Has the Minister any evidence that such practices have taken place under the pesticides regime?
§ Mr. Sackville
I have no specific information, but I can imagine the potential scope.
In the United States of America, for example—where freedom of information legislation exists—commercial interests have sprung up to provide competitors with data. The Americans—one can see why—do not think it feasible to try to limit either access to information for those with a commercial interest, or the uses to be made of the data. They take the view that the most practicable approach is to restrict the type of information to be made available, rather than trying—inevitably, unsuccessfully—to restrict the number of people with access, or the use to which it will be put without its being necessary for the competitors to disclose their interest. An obvious benefit of that approach is the reduction of the threat of the legal challenge, which is significant in any event even with those provisions in place.
I know that the industry supports, in principle, the right of patients and animal owners to be more fully informed about the benefits and risks of licensed medicines prescribed for them by their doctors and veterinary practitioners. Currently, the Association of the British Pharmaceutical Industry and the National Office of Animal Health make available data sheets in the form of compendiums, and I know that the Pharmaceutical Association of Great Britain is planning to do the same for non-prescription products. Although those publications are compiled specifically for prescribing practitioners and dispensing pharmacists, they are made available to public libraries and, on request, are sold to individual members of the public via bookshops.
1225 On the human medicines side, I also know that the ABPI is committed to publishing in 1994 a compendium of "user-friendly" patient information leaflets designed essentially to meet the specific needs of patients. I am sure that that will provide very useful information, but although data sheets give a detailed description of the licensed medicine, they cannot give the reason why licensing decisions were taken, the risk/benefit ratio that has applied or data on adverse reactions. For veterinary medicines, the National Office of Animal Health has launched what it calls QEST—pronounced "quest"—initiative to provide user-friendly descriptions of each medicine, including a contribution from the Veterinary Medicines Directorate summarising the pre-licensing assessment.
It is vital to consider the European perspective. Although the European Commission has been asked to consider measures to improve public access to information by the end of 1993, it is becoming increasingly clear that other EC member states are showing little enthusiasm for more openness in the pharmaceutical field. It is argued that the Bill could put us out of step with our EC partners in terms of freedom of information. Even Denmark, which has had a freedom of information Act for some years, does not permit the disclosure of information that it considers to be commercially sensitive; nor does it open its data files to public scrutiny. I shall leave the hon. Member for Durham, North, with his enthusiasm for European matters, to say what he thinks of that, but the point that cannot be underestimated is the potential for United Kingdom applicant companies to choose not only to submit their product licence applications to one of the other European Community regulatory agencies but to make new investment decisions to the United Kingdom's disadvantage. They may not wait until the new EC proposals come into force in 1996.
The Government are committed to making more information available. We are conscious that medicines and medicines control affect the day-to-day lives of virtually everyone in this country and therefore seek to be as open as possible. The Medicines Act 1968 has been seen as providing a virtual block on the making available of relevant information, but that is not entirely true. For example, it provides no bar to the disclosure of information necessary to protect public and animal safety. 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 provisions 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 burdens 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 particularly crucial issue at a time when new EC licensing systems are in the process of being agreed, under which there will be a choice about where medicines licensing business is placed. We should not wish to see the position of the United Kingdom, as the licensing authority or a centre of pharmaceutical excellence, jeopardised.
1226 I said that we do not object to the principles of the Bill. A number of its aspects on more freedom of information in the medicinal licensing field would be beneficial, but we would have difficulty in accepting a number of specific aspects in their present form.
§ Mr. Ian McCartney (Makerfield)
On behalf of the Opposition, I support the Bill. The previous Bill on which my hon. Friend the Member for Durham, North (Mr. Radice) and I worked together was on electricity privatisation, at the end of which he said that one day I would speak from the Dispatch Box. Neither of us thought that the first time that I would do so in this Parliament would be in support of his Bill. It gives me much pleasure to do so.
It is the second occasion in 24 hours that the Under-Secretary and I have faced each other. Yesterday morning, we clashed swords about district health authorities, but, having listened to him this afternoon, I can say that we share more areas of agreement than disagreement on this Bill.
A number of key factors lead the official Opposition, the Liberal party and some Conservative Members to support the Bill, although the hon. Member for Sutton and Cheam (Lady Olga Maitland) adopted a toe-in-both camps approach. I look forward to discovering in Committee which camp she will finally jump into, although I already have a view about that. I shall deal briefly with the objections of the hon. Members for Gillingham (Mr. Couchman), for Basingstoke (Mr. Hunter), for Newbury (Mrs. Chaplin) and for Newark (Mr. Alexander). which fell into three general patterns. I do so because the Under-Secretary and I both represent constituencies in the region that is the heart of the pharmaceutical industry—the north-west. I am a member of the parliamentary pharmaceutical group and have been since I came to the House in 1987. Hon. Members on both sides of the House who support the Bill are not necessarily anti the industry. Indeed, a long-term supporter of the industry and of the development of its product base, its standing in the community and its ability to sell its products should support the Bill and its proposals on the availability of information.
The industry would do itself a disservice if it used the Bill to squeeze the Department and the Minister in its clashes over the pricing policy negotiations with the NHS. It would over-egg the pudding if it used the Bill as such a vehicle, and would also put out the wrong message both to the international community and the British public. For a long time, the British public has been a purchaser of pharmaceutical goods in their billions. That purchasing power of the NHS and the British public has been of the greatest benefit to the development of the industry in the United Kingdom.
Access to information has been denied by the draconian powers of section 118 of the Medicines Act 1968. As the hon. Member for Beckenham (Mr. Merchant) said, that Act was passed by a Labour Government. I am trying to make amends for my forefathers. In the 1960s, 1970s and the early part of the 1980s, legislation from Governments of both parties leant towards curtailing the provision of information to the public. The Bill will enhance the ability of the British people to obtain information that will enable them to take decisions about their daily lives. Much of 1227 British society is blighted by lack of information and secrecy about all aspects of life. That is another basic reason why the Bill should be given a fair wind.
The Bill will remove the blanket secrecy imposed by the pharmaceutical industry. Speeches in the debate have shown us what that has meant in respect of some of the difficulties that have arisen as a result of mistakes. Often, those mistakes have been identified through medical accidents that the provision of information would have prevented.
The Bill will immediately improve the quality of information provided to patients, the clients of doctors, to pharmacists and the veterinary profession. It will enable them to determine the potential risks and benefits of the medicines that we take or those given to animals that eventually end up in the human food chain. It will provide equality of access for national comparisons and for regulation. It is nonsense when United Kingdom companies have to produce information in the United States marketplace that can be looked at by their competitors but that information cannot be looked at by patients, doctors, vets and pharmacists in the United Kingdom. Even if he wished to give us that information, the Minister could not do so. The Bill would rectify that anomaly.
The Bill will improve the equality of access needed to monitor safety and efficacy. All those involved in the health business will want to retain that principle in the whole gamut of health care issues, including the prevention of sickness and the alleviation of illness. That is why it is vital that the Bill is supported not just on the Floor of the House today but in Committee. I hope that no one will table wrecking amendments aimed at preventing the Bill from becoming law. When we know that the Bill is right, we must not take steps in privacy in Committee to strangle the measure and prevent it from reaching the statute book.
The Bill will also develop more rational prescribing regimes and thus benefit doctors, pharmacists and the national health service. That is vital given that on 12 November 1992, the Government indicated in a press statement that negotiations are likely to commence in respect of further restrictions on drugs that doctors can prescribe and increased generic prescribing and negotiations with the industry in respect of the cost to be borne by the NHS for purchasing drugs from United Kingdom manufacturers.
If the Government intend to reduce the amount and type of drugs that general practitioners and pharmacists can prescribe, it is important that when GPs change prescribing patterns they have information to ensure that their decisions are professional in the sense that they can improve and monitor the drugs that they issue and that those drugs benefit the individual to whom they are prescribed.
Little or no academic work has been carried out by the Department of Health into the cost to the national health service of the side effect of drugs since the early 1960s. However, it is commonly accepted that hundreds of thousands of people receive corrective treatment and counselling to regulate the side effects of prescribed drugs. For many unfortunate citizens, that treatment and counselling will continue for many years.
1228 The cost to the national health service is huge while so many of our fellow citizens are restricted by unnecessary and avoidable pain and suffering. The hon. Member for Bournemouth, East (Mr. Atkinson) supported that point and the Bill will seek to address that problem. It will not address the issue completely, but it will be a step on the preventive path to ensure that people are not prescribed individually or collectively drugs that are inappropriate to their condition and which, being inappropriate, cause them years of suffering thereafter. That is another important reason why the Bill should be supported.
I want now to consider the objections to the Bill. In some respects, the objections are legitimate in that no legislation that passes through this Parliament should fail to take account of the effects that it will have on those who need to operate within the constraints of that legislation. Legislation from this place should be the best possible legislation. However, it should not be part of the process of determining that legislation to be frightened off at the outset by interests which do not believe in providing the necessary information to promote the interests of patient care in the United Kingdom.
The objections raised today fell into three basic categories in respect of safeguards for the industry—intellectual property rights, patent product development and retail rights and research and development. All those are outwith the gambit of the Bill. They were all dealt with in two ways.
Intellectual property rights and patent product development and retail rights were dealt with exclusively in the previous Parliament when the Government, with the Opposition's support, provided additional safeguards to the United Kingdom pharmaceutical industry with the patent legislation. Although the industry still believes that the legislation is inadequate, we cannot emasculate this Bill to try to improve product and patent legislation.
If there are problems with patent legislation here, in Europe or in the international context, the matter should come back here and we will examine it and try to improve legislation to ensure that the United Kingdom-based industry is not placed in a difficult position because of trading relationships.
Research and development is very important in the north-west and much of the resources involved in research and development are spent in constituencies like mine. Much of those resources do not arise through a partnership with the Government. Through the pharmaceutical price regulation scheme, the Government take account of the cost of development and production of drugs.
If, in advance of the negotiations, the industry wants more from the negotiations than the Government, the industry should be honest enough to state that. The industry should tell the Government precisely why it believes that the Government are not going to offer a proper deal for its products. However, it must not try to emasculate the legislation in an attempt to put pressure on the Government to give it a far better deal in the negotiations which will soon take place on a price regulation scheme. It is important that the industry gets a return on research and development, but it is also important that it recognises the need to ensure safety and that access to information on product development is available to doctors, pharmacists and the general public.
§ Mr. Couchman
Does the hon. Gentleman not understand that there is a perception that the Bill is an attack on the industry and that perception will prejudice investment decisions for research and development facilities in this country? Companies from abroad have no need to put their facilities in this country—they have done so for very good reasons, but the Bill will prejudice that situation.
§ Mr. McCartney
The hon. Gentleman's fears are unfounded. First, as I said, information is already freely available to competitors in the United States and elsewhere. Secondly, companies base their research and development in this country because the product base is excellent and there are massive customers in the form of the national health service and the British public who buy off-the-shelf medicines. We also have a massive work force who are probably the most expert and skilled in Europe; indeed, we are internationally renowned for our skills. Such circumstances could not be replicated outside the United Kingdom, certainly not in the short term, let alone in the long term.
We have a partnership with the industry—it provides research and employment opportunities, but, in return, the United Kindom mark, in the form of the health service and the public, provides it with billions of pounds of resources and a product base which is safe, unlike many of its international markets which come and go. The House will do nothing to undermine the industry's ability to maintain its research and development projects.
The hon. Member for Gillingham is an adviser to Pfizers and also an adviser to the Gin and Vodka Association. I do not know whether that means one has to have a double gin or a bloody mary whenever one takes a tablet from Pfizers, but it is interesting that he is an adviser to the drink and drugs industries at the same time.
There is common ground between our parties on the European evaluation project—I do not want to embarrass the Under-Secretary by repeatedly citing our agreement on it. The Government support the project and a submission from the north-west of England for it to be situated in the Manchester conurbation. Much work has been done to ensure that the project comes to the United Kingdom. It has the full support of the pharmaceutical group in the House, of which I am a member.
The House can be assured that my party will do nothing during the passage of the Bill to undermine the industry's ability to ensure that the project comes to the United Kingdom and that the industry benefits in terms of inward investment and the possible by-product of the sales of products in markets outside the United Kingdom.
The Bill deals with the important consideration of confidentiality and tries to ensure that it is not destroyed and that the levels of disclosure of information are appropriate by ending the blanket secrecy of section 118 of the Medicines Act 1968. The Bill deals exclusively with those issues and does not cover wider issues such as the exclusion of information, which are currently protected by other legislation.
It was wrong of the industry in principle and in tactical terms to cause a misunderstanding about the type of information that the Bill will be able to unlock to the public and the medical profession. Although the notion has been rubbished in some quarters today, it is true that the Safety of Pesticides Regulations 1986 are not a model to compare with this legislation. Let us compare the bulk 1230 expenditure and resources of the pesticide industry with those of the pharmaceutical industry. The issue is not about the purchasing power of each industry. It is about the principle of how information is released in the public domain without damaging or destroying the confidentiality required in the development and research of products prior to distribution in the marketplace. It is not an issue determined by the size of the market. The issue is how the market is developed and how products reach the market. The regulations provide clear guidance—[Interruption.]
My hon. Friend the Member for Bristol, South (Ms. Primarolo) is making it clear that before I sit down, I must commend the Bill. The Bill requires further and adequate consideration, but its principles should commend it to the House. I hope that hon. Members who are worried about the Bill do not take their concerns to the extent of trying to wreck the Bill's chances in Committee. Those outside the House would misread such an action and it would do a disservice to the Government and to their attempts through the White Paper to improve information to patients, to doctors and to the wider community involved in health. For those reasons, I commend the Bill and I believe that it deserves a safe passage through Committee.
§ 2.5 pm
§ Mr. Radice
This has been a debate with many constructive contributions. I congratulated my hon. Friend the Member for Makerfield (Mr. McCartney) on his notable speech at the Dispatch Box. I also congratulate the Minister on a positive contribution on the subject which has helped to put the debate into balance.
There has been general support for the principle of the Bill in the debate—with one or two exceptions—in the sense that most hon. Members agree that section 118 is outdated. The hon. Member for Sutton and Cheam (Lady Olga Maitland)—I refer to her words in an effort to get her on my side—rightly said that section 118 was a suitable case for treatment.
Concerns have been expressed on behalf of the industry about the Bill's impact on it. It is true that the industry is very important—the jewel in our trading crown, as the Minister said. That is why we have gone to such lengths in the Bill to try to safeguard the legitimate commercial innterest of the industry. However, we are also concerned about the safety of medicines and about freedom of information.
What we have tried to do—I believe that we have done it—is not to open up commercial secrets to competitors, as one or two hon. Members have suggested. We are trying to be more open about the safety of medicines and about safety trials. That is the Bill's purpose. Those who say that the Bill will lead to a wholesale plundering of commercial property are exaggerating greatly.
We shall look at all the details of the Bill. We must also consider the Bill in the wider European context. I point out to the Minister that a number of countries are adopting more open systems, so there will be pressure at European level for our Government to take similar action. It would be nice if we were in the lead on one or two issues rather than always opting out or following behind.
§ Mr. Jeremy Corbyn (Islington, North)
I very much support the Bill, so my intervention is not hostile. My hon. Friend must be aware that many doctors have problems in prescribing because of the restrictions on the NHS 1231 prescribing list. Will the Bill assist doctors in finding other medicines as a result of their having better descriptions of the contents of medicines?
§ Mr. Radice
I will not follow my hon. Friend exactly down that line. All I can say is that doctors will certainly have more information about the safety of drugs because they will be able to find out the reasons licensing authorities give for licensing and for withdrawing licences. That is the basic principle of the Bill.
Despite the criticisms, there is general agreement that section 118 of the 1968 Act is outdated. I even detect a consensus on the idea of publishing summary bases of approval.
If the Bill has faults, as I realise it may, I hope that they can be rectified in Committee. I hope that those who are interested will serve on the Committee so that we can build on the consensus that exists to produce legislation that has the support of the House and the general public and takes into account the legitimate concerns of the industry. I hope that the House will give the Bill its Second Reading.
§ Question put and agreed to.
§ Bill accordingly read a Second time, and committed to a Standing Committee, pursuant to Standing Order No. 61 (Committal of Bills).