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Westminster Hall
Wednesday 10 November 2004
[David Taylor in the Chair]
Medicines and Healthcare Products Regulatory Agency
Motion made, and Question proposed, That the sitting be now adjourned.—[Margaret Moran.]
9.30 am
Dr. Ian Gibson (Norwich, North) (Lab): First, may I thank you, Mr. Taylor, for chairing the sitting? It is the first time that we have crossed paths like this, and I welcome the chance to discuss such a subject with you in the Chair. Secondly, although we are few this morning, that does not reflect on the importance of the issue, and I hope that that fact will come out during the debate.
The Medicines and Healthcare products Regulatory Agency—MHRA for short, although not many people know what the acronym stands for—is an executive agency of the Department of Health with trading fund status. It replaced or merged with the Medical Devices Agency, or MDA, and the Medicines Control Agency, or MCA, on 1 April 2003.
The MHRA's aims are to ensure that medicines for human use, sold or supplied in the United Kingdom, are of an acceptable standard of safety, quality and efficacy; to ensure that medical devices meet appropriate standards of safety, quality and performance; and to promote the safe use of medicines and devices. That is a sterling task. Its stated objectives are to make a major and effective contribution to public health, to provide authoritative and accessible information, to influence international regulation, to support industry and scientific innovation, to operate a successful and fully integrated business, and to minimise the cost of regulation.
The agency's many activities include overseeing those notified bodies that audit device manufacturers, regulating clinical trials of medicines and medical devices, and promoting good practice in the safe use of medicines and devices. Those are some of its functions.
My interest in this area stems from a visit I made to the MHRA during the summer. As a result of that meeting, I felt that not enough people were aware of its work, or of how medicines are regulated. Not enough is being made of its work on public health policy and it could have a far more extensive public profile. I am concerned about the bad press it has attracted recently, which is the result of underlying problems in the organisation and how it functions. Those problems must be addressed before an increasingly bad media reputation damages its future credibility. In short, the agency could be a disaster waiting to happen.
There is nothing more damaging to public trust than a regulatory system that is seen to have no clout, or that seems unwilling to use its power effectively. As the chief executive of the MHRA recently told the Health Committee,
With that stated priority, and with a forthcoming public health White Paper, it seems timely to take a look at one of the major agencies charged with safeguarding it.
As I said, I decided to raise the issue in Parliament following a visit to the MHRA to see how it works and what it does. I was enthused by the resources and data that its staff had at their fingertips, but thought that much more needed to be made of it. My concern is primarily to raise the profile of the agency and to see it impact more effectively on public health policy.
I have not been impressed by the agency's communication skills since I secured today's debate. Given its recent bad press over issues such as Seroxat and the Chiron flu vaccine, I would have expected it to take the chance to come forward with some positive messages. However, it sent me a briefing that left me with the impression that it is not interested in putting its name out into the world, or simply that it does not know how to do so.
The agency points out in its briefing that it has just appointed a director of communications—a 21st century activity, and I would not argue with the need for it. I hope that the appointment is not merely cosmetic and that it is backed up by a well thought through communications strategy that can help to build public confidence and improve the flow and exchange of information. That is vital, given the growing public perception that the workings of the drugs industry and its regulators are clouded in secrecy and governed by behind-the-scenes manipulation—a well-nurtured view in communities across the country. It is also vital given that the MHRA is the only regulatory agency that is fully industry funded.
It is a difficult task to convince people that a regulator entirely funded by the industry it regulates is completely impartial. That is why transparency should be at the heart of its agenda. The MHRA is gaining a reputation for not giving out information. It suspended Chiron's licence at the factory at Speke in Liverpool because of concerns about a bacterial contamination blocking half the United States' vaccine supply—48 million doses and 2 million United Kingdom doses. It was alleged in The Times that that had happened and that inspectors had been aware of potential problems for some time, but had done nothing about it.
Let me put the matter straight: I do not believe anything much that I read in the press, but I have not read any robust replies to the accusations. On 4 October, The Guardian revealed that the relationship between the industry through its organisation, the Association of the British Pharmaceutical Industry, and the regulator might be too close, with evidence of a joint lobbying campaign in Europe, a blueprint by industry for how the MHRA should be run and higher board level representation. Most notoriously, there has been a continuing controversy surrounding the drug Seroxat, the alleged withholding of clinical trial information by GlaxoSmithKline and questionable analysis of the data by the MHRA, as exposed and documented by "Panorama".
Most recently, claims of increased suicide risk in young adults led the European Agency for the Evaluation of Medicinal Products, which licences drugs for use in the European Union, to recommend that Seroxat be prescribed with extra caution for 18 to
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29-year-olds whose treatment should be monitored closely. The MHRA endorsed those findings, but has dragged its feet over issuing the necessary warnings and information to GPs and the public.
It is time for the culture of secrecy to be dealt with. The legal basis for the giving and withholding of information by the MHRA will change with the implementation of the Freedom of Information Act 2000, but the damage done by the public believing that they have been lied to or defrauded is extremely difficult to repair. The workings of the agency need to be reviewed thoroughly. There should be more lay involvement on the committees, openly published minutes and a greater engagement with the public.
I should acknowledge that there is lay representation on the Committee on Safety of Medicines, which advises the MHRA and runs the yellow card scheme for reporting suspected adverse drug reactions, in which most GPs are involved. I have examined the system and there are piles of yellow cards. The Government have just announced direct reporting by consumers, but, as Mind has stated,
"consumer representation and the championing of consumer rights is not built into the MHRA's structures and processes".
There is a legal requirement to protect genuinely sensitive market information, but sharing information as openly as possible is of optimum importance. People should be able to find out easily what the organisation does, readily access its services and find out what decisions it is taking and how it is taking them. It seems that the MHRA adopts a restrictive approach to sharing information. As the 2003 National Audit Office report on the MCA pointed out, its public profile is weak compared with that of the Food and Drug Administration in the United States of America. That limits its ability to communicate safety messages to the public and engage with them as a source of information on the effects of medicines.
The exemplary model of best practice in this country is the Food Standards Agency, which states on its website that its aims are putting the consumer first, being open and accessible, and being an independent voice. It holds its board meetings and key committee meetings in public, which it advertises well in advance. The independence of the agency is reinforced by its arm's-length relationship with the Government. The FSA website states:
"Although the FSA is a Government agency, it works at 'arm's length' from Government because it doesn't report to a specific minister and is free to publish any advice it issues."
Therefore, I am inclined to support Mind on that issue. It calls for a drug regulatory system that puts consumer safety before commercial pressure and cost. Such a system would require agency access to all trial results, which should be put in the domain of researchers and reviewers and, once a drug is licensed, made available to all.
There should also be a well-supported consumer committee and consumer representation on other MHRA committees. Also, membership and operations should be transparent and accountable. People should have no personal—or even non-personal—interest in the industry that they are reviewing and regulating. The information on which decisions are based should be made available in suitable form.
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Such a drug regulatory system should have sufficient legal powers to ensure access to all drug trial information and adequate funding to verify the accuracy of that information. It may need enhanced legal powers to obtain the information it needs from companies and better funding to ensure it has the resources to use the information fully, act promptly on it and publicise any safety messages effectively. Trial data should be provided as soon as they are available. Finally, the system should give consumer experience of drugs comparable weighting to information from drug trials.
I am encouraged by initiatives such as the extension of the yellow card system to include direct reporting of adverse effects by patients and the new paediatric medicines initiative, but we probably need an independent inquiry on the workings of the MHRA. That is a priority. I do not in any way want to suggest anything about individuals, but I and others have looked at the records of heads of enforcement who had long careers with GlaxoSmithKline. There is also a head of licensing who held a major post with that firm. We need to ensure that the workings of the agency are investigated externally as independently as possible.
I want to discuss a few further issues related to the MHRA's remit. The greater emphasis, in terms of discussing its work, seems to be on the medicines side; the medical devices side has been somewhat sidelined since the merger and may well have suffered from it. The MDA was once a leading organisation in Europe, but a senior person has just left it and there is no independence in that area. There is a problem as regards the two arms coming together and both parts having equal weight. It would be interesting to know why there is no head of devices services and diagnostics, and what the agency's intentions are in that regard.
I want to talk briefly about drug reclassification, because it is part of the choice agenda. The Government, in their December 2003 report "Building on the Best: Choice, Responsiveness and Equity in the NHS", make a commitment to doubling the rate of medicine reclassifications from five to 10 a year, which is welcome. However, that should be driven by strong evidence of efficacy and safety, and should not be seen to boost industry's profits in any way—that is a problem—or to shift the cost of treatment from the NHS to the consumer. The process needs to take into account possible consumer detriment resulting from reclassification. I would like to hear something about that from the Minister.
I have looked at some advertising overseen by the agency. In particular, I have a personal interest, as do many others here, in the drug simvastatin, a statin, which has been available in a 10 mg dose over the counter since July 2004.
I do not believe that clinical trials have been conducted in over-the-counter conditions on people deemed to be at moderate risk of coronary heart disease. The public are being subjected to a world-first experiment, as there is no evidence on the safety and efficacy of a 10 mg daily dose of simvastatin for the target group under those OTC conditions. The public need to be alerted to that, although I know that general practitioners have already been alerted. There needs to be a real opening up.
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In relation to the drug, we have heard about the issues to do with drinking grapefruit juice and the likelihood of severe muscular damage and so on. Again, although those claims have appeared in one or two newspapers, it is not generally known whether there is good solid evidence for them. Let us hear from the organisation.
Decisions should be based on adequate data and data on efficacy, and nothing should be reclassified if there is doubt about the safety of the target population at the dose specified. It is essential that we have a robust, transparent, impartial regulatory process.
Perhaps we should think seriously about having an inquiry into this organisation. Is it, for example, best equipped to vet pharmaceutical advertising? There are some wonderful advertisements about heart conditions, which I find vague. I know that the words have been changed over the past few months, after various protests but, again, it is the public who see those adverts and think, "I'll have that drug." Sometimes the evidence changes in midstream, or there is no evidence. We need to know that there is good solid evidence and where we can get it.
Are the organisation's aims and objectives beyond its means and is it being pulled in too many directions to be effective? Where do its priorities lie in practice? Is it serving commercial interests and arbitrary targets, such as in reclassification, at the cost of public benefit? We need to know. Do the public even know what it is and what it does, or is that brought to their notice only when things go wrong? In fact, do many MPs know about it?
9.46 am
Paul Flynn (Newport, West) (Lab): I congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson) on securing this important debate. I question one thing that he said. When he referred to the credibility of the organisation, one was tempted to ask, "What credibility?" Recent events have proven that it is not a watchdog; it is a pussycat that purrs in front of the pharmaceutical industry and does what it is told. It has an incestuous relationship with the big pharmas and has a close association with the Association of the British Pharmaceutical Industry. It has a disgraceful recent record. We can look with gratitude to the work not of the Medicines and Healthcare products Regulatory Agency in protecting the public, but of people such as Sarah Boseley of The Guardian for her exposé of the organisation, the television programme "Panorama" and Richard Brook of Mind, who courageously resigned from the MHRA in disgust at its activities.
It is a matter of enormous importance that, in recent history, the regulator is not protecting the 25,000 people who suffered heart attacks and the 7,000 who died from taking a painkilling drug for arthritics that was withdrawn by Merck Sharpe and Dohme in September after being promoted by the regulator and by organisations that exist to defend arthritics. I had a conversation the day that it was withdrawn with one of the executives of Arthritis Care—a splendid organisation that I have worked with for many years. It has done pioneering work for people with arthritis, particularly in promoting the real beneficial therapies for arthritis, such as exercise, losing weight and displacing the pain through coping mechanisms: all the non-drug treatments. On the day that Vioxx was
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withdrawn, it was interesting that those who should have been defending the patients suggested that those who were taking the drug should not panic. I should have thought that panic was the appropriate response when someone was taking a drug that was likely to kill them.
The organisations advised people not to panic, but to find another drug. Over my lifetime, 50 per cent. of medicinal drugs have had nasty, unpleasant side effects, and the other 50 per cent. have nasty side effects that are yet to be discovered. That has been the continuous history of medicinal drugs over the years. Protection did not come from the MHRA.
Neither did protection come with Seroxat. When business collapsed in the House on one day in March, we had an hour and a half to discuss Seroxat at some length. The contribution of the regulatory body has been derisory. Given the lamentable performance of its group when it gave evidence to the Health Committee, I hope that the Committee will produce a hard-hitting report that will finally put the last nail in the coffin. I do not think that the body can be reformed. We have to set up another. We cannot have the public exposed to the greed of the pharmaceutical industry any longer without protection.
That is not a criticism. My hon. Friend the Member for Norwich, North is a distinguished scientist. There is no criticism of the science or the quality of the miraculous discoveries that have been made over the past 200 years in pharmaceuticals. However, there is serious criticism of the marketing of those products, which has been based on obtaining maximum profits, with only a cursory glance at safety.
Seroxat is a licensed drug that is proved to have significant side effects and to induce suicide, particularly in young people. Data have been held on this since 1990. We now know that the MHRA reviewed it five times and always gave it a clean bill of health. However, that organisation, which treats itself seriously and is proud of its qualifications, held information on Seroxat for 10 years, which suggested that dosages above 20 mg were unnecessary and possibly dangerous. Consequently many people may have been wrongly prescribed. It did not do anything about that until 2003.
We believe that 17,000 people were prescribed doses above that level and advice was given very late in the day to doctors to remind them of the recommended dose. It was not the official watchdog that caused something to be done; it was publicity by energetic, intelligent, resourceful journalists—people we often criticise. The real watchdogs are those journalists and organisations such as Mind. It is not an insignificant consideration that Mind does not take a penny in support or sponsorship from the pharmaceutical industry.
It is interesting that Arthritis Care, which promoted Vioxx over the years, states on its website:
"The redevelopment of Arthritis Care's website has been made possible with support from Merck Sharp & Dohme Limited."
The Depression Alliance Cymru takes very little money from the drugs industry, but the Depression Alliance nationally takes 80 per cent. of its funds from the pharmaceutical industry. As far as I can see its mouth has been bandaged against any criticism of any drug. I have never known it to criticise any drug at any time. That incestuous relationship is something else that the Health Committee is examining.
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It is almost laughable to see the interests of the members of the MHRA. They will all tell us that they are professional people and that they can be regulators at one moment and servants of the pharmaceutical industry the next. However, it is difficult to believe that they can carry out their jobs independently when we look at the relationship of the committee and its sub-committees with the pharmaceutical industry. In the 2002 annual report, 17 of the 34 members of the main committee declare personal interests, which include receiving travel expenses and fees, employment as consultants and the ownership of shares. Fourteen declare non-personal interests such as the receipt of research grants.
All the main pharmaceutical companies are represented, from AstraZeneca to Roche and the trend continues through the sub-committees of the committee on the safety of medicine. The biological sub-committee has 11 members: 10 of them declare personal interests and three declare non-personal interests. These interests run to several pages. I do not want to weary the Chamber, but the chemistry, pharmacy and standards committee has 14 members, seven declaring personal interests and nine declaring non-personal interests. The pharmacovigilance committee has eight members: two have declared personal interests and six have declared non-personal interests.
The whole body is part of the pharmaceutical industry, an industry that has a dreadful record of overselling its products, of disease mongering, of trying to encourage a therapy culture in society by convincing every human being that for every moment of pain, boredom, distress, anxiety they feel in their life, they should take a pill of some kind. The whole myth has been built up, not to help humanity, but to serve the greedy interests of the pharmaceutical industry. Many of the marvellous advances that have been made have been damaged by the overselling of many dangerous and damaging drugs. The problems that we now have with selective serotonin reuptake inhibitors reveal how the system has not worked in the interests of patients and how the agency has been colonised by the drugs companies, whose commercial interests have been protected as a result.
The agency has shown itself not to be worthy of our respect or of continuing in its role. At best, it is ramshackle and ineffective; at worst, it could be corrupt. We cannot give examples by which we can say, "Things haven't happened." I do not think that my hon. Friend the Member for Norwich, North mentioned any names, although I am sorely tempted to. In a newspaper article on 4 October, Sarah Boseley mentioned the name of someone who was in the extraordinary position of advising and serving a drugs company while working for the agency at the same time. That cannot be right. However, the issue would have remained unnoticed had it not been brought to our attention by that newspaper.
Almost everyone in the country relies on medicinal drugs at some time in their lives, and we deserve protection. We deserve a body whose independence is beyond question, but we do not have one now. We have been badly served by the MHRA.
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9.56 am
Mr. Paul Burstow (Sutton and Cheam) (LD): I, too, welcome you to the Chair, Mr. Taylor. This is the first time that I have spoken in Westminster Hall under your chairmanship.
I thank the hon. Member for Norwich, North (Dr. Gibson) and congratulate him on securing the debate. He has given us the opportunity to explore an important watchdog regulatory function, which perhaps does not get enough attention in the House, although one or two hon. Members question the agency closely about its work. It is useful to have this debate and to have quite a bit of time to go over the details.
I want to pick up on several points. In opening the debate, the hon. Gentleman made some powerful points about the remit and work of the Medicines and Healthcare products Regulatory Agency. He posed important questions, which the Minister needs to answer, about the degree of transparency and the nature of the engagement between the regulatory agency and the industry, and between the agency, consumers and their interests. We need to ensure that the agency is not only seen to be acting independently, but that it is acting independently. I shall return to that point in a minute.
The hon. Gentleman suggested that there needs to be an inquiry. It is worth noting that the Health Committee is conducting an inquiry into the pharmaceutical industry—it is attempting to paint a very large canvas. I have read the report of some of the evidence sessions that it has conducted so far, and it is clearly looking at the agency's role. Only time will tell whether it concludes that it or someone else needs to do more work and whether it makes specific recommendations about changing the agency and tipping the balance somewhat in favour of the consumer. However, some of the strong points that have been made in the debate lead me to the view that we need to look again at the balance of interests in the agency.
We need to ensure that the public interest is seen to be properly reflected in how medicines are made available to the public. In particular, we need to ensure that the industry is properly involved in the process. We need to consider the large sums that it invests in the development of drugs and in trials and examine how information about such issues is made available in a timely fashion to the regulatory bodies. Furthermore, I take the hon. Gentleman's point that we need to think about how consumer interests are represented. In answers to parliamentary questions, Ministers have rightly made the point that lay people have been involved in the agency since its inception. However, it is important to be clear about how much the lay and consumer interest permeates the whole organisation and its culture. That is the question being asked today and it would be useful to get a response from the Minister.
Reference has already been made to Richard Brook, who served on the Committee on Safety of Medicines working group on SSRIs—selective serotonin reuptake inhibitors. In his evidence, he said:
"The last point I would make, which I think is a very relevant point, is it takes 40 days for the MHRA on average, in the last annual report, to license a drug and yet it takes two years to review antidepressants; and so there is something about the balance that Andrew was talking about that raises a real issue. If it takes eight weeks to get a drug into the market, why does it take two years to sort out its safety afterwards?"
Some may question whether it really takes eight weeks, but it is relevant to note that Risperidone, a strong anti-psychotic drug that caused concern earlier this year—the hon. Member for Newport, West (Paul Flynn) has taken a close interest in anti-psychotic medication—was being used unlicensed in the UK to treat older people with dementia. The relevant Government watchdog received information in 2002 that the risk of strokes was three times higher among older people prescribed this medication, but it finally warned that the drug should not be used only on 9 March 2004. Patients in Canada were warned of the risk of strokes two years earlier. In an answer I received from the Department of Health on 24 March, it was said that:
"The MHRA is represented on the CPMP and its Pharmacovigilance Working Party (PhVWP), which meet monthly and provide a regular forum for discussion of drug safety issues within the European Union. An electronic communication system allows rapid exchange of drug safety information between member states."—[Official Report, 24 March 2004; Vol. 419, c. 825W.]
The point is that mechanisms are supposed to be in place to allow our regulator to be aware at an early stage of concerns and of the weight to be attached to them. The pharmacovigilance working party is apparently in regular video conference contact with the US Food and Drug Administration yet it took two years for our agencies to come to a conclusion that had already been reached across the Atlantic in Canada and the United States, and to take the necessary protective measures. How many elderly people in care homes or elsewhere suffered strokes or great disability or even lost their lives as a result of being prescribed this drug?
Dr. Gibson : Why does the hon. Gentleman think that it takes two years? Where are the pressures?
Mr. Burstow : I am drawing attention to Richard Brook's contribution and the questions he asked about pressures. I was going to end with this point, but it is worth bringing it up now to respond to that question. Brook's argument, which the Minister must address, is that the organisation is risk averse and is constantly looking over its shoulder, fearful of being a victim of legal action or a challenge in the courts for acting peremptorily.
In his evidence to the Select Committee on 14 October, Richard Brook said:
"Every time we made difficult decisions, there was always this issue of: 'We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes'; and it was very clear that the MRHA officials were very mindful of the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public."
"it is a very difficult thing to be confident about the transparency of the regulator when so many people have got long histories, career histories, in the pharmaceutical company."
That pressure, real or imagined, is clearly having an effect—certainly in Mr. Brook's view.
Dr. Gibson : Is the hon. Gentleman saying that he could never foresee a situation arising in which John Humphrys faced up to Sir John Krebs of the Food
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Standards Agency and asked, "Come on, have the sheep got BSE?" and Krebs said, "Quite honestly, I really don't know."? Is the Committee on Safety of Medicines so frightened to tell the truth about the accuracy of the data or does it dodge giving any messages at all? Has it ever appeared on Radio 4?
Mr. Burstow : I listen to Radio 4 quite a bit, but not enough to say whether the CSM has appeared on it. The hon. Gentleman's point about a communications director having only recently been appointed says a lot about the organisation's posture. Is it a public-facing organisation or is it an industry-facing organisation? Perhaps it urgently needs to take advantage of that appointment to ensure not only that it informs Members of its work more effectively, but that it makes the public more aware.
To come to my second point, the Government have indicated their willingness in principle for the patient—the consumer—to be much more directly involved in the reporting of adverse reactions, through the yellow card system or a parallel system. That has to be welcome. A number of those who submitted evidence to the Select Committee said that the best way to ensure that more information about adverse reactions was captured in the system would be to involve the person affected directly. The people concerned have the greatest vested interest in reporting, but they are outwith the system.
We know from parliamentary answers that more than 150 people a day are admitted to hospital because of bad reactions to medicine. Approximately 20,000 adverse drug reactions a year are reported to the MHRA and the CSM through the yellow card scheme, of which approximately 3 per cent. are suspected adverse drug reactions with a fatal outcome.
Mr. Iain Luke (Dundee, East) (Lab): The hon. Gentleman is making an important point about communication with individual patients, but does he not also think that the organisation should liaise more closely with the user groups that have sprung up to draw attention to the SSRIs that my hon. Friend the Member for Newport, West mentioned? For instance, the Seroxat group is keen for the new body to take cognisance of its troubles when it regulates new drugs.
Mr. Burstow : The organisation must be seen as genuinely even-handed in its treatment of all parties. It must be more permeable and open to engagement with consumer and interest groups of the kind that the hon. Gentleman mentioned. His point is fair and must be part of any review of how the new body works. That is something that I hope the Select Committee will consider carefully, especially given the recent experiences that the hon. Member for Newport, West described.
I was outlining some of the figures. There were 722 fatal suspected adverse drug reactions in 2003, the last year for which figures are available.
Paul Flynn : Will the hon. Gentleman give way?
Mr. Burstow : Let me finish the figures, then I will be happy to give way. Back in 1997, the figure was 446, so there has been a 62 per cent. increase in the number of
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reported adverse drug reactions with a fatal outcome. That is a significant increase. Adverse drug reactions make up 6 per cent. of hospital admissions, but they are, according to a study by researchers from the university of Liverpool in the British Medical Journal earlier this year, in most cases avoidable. Nearly 10 per cent. of adverse drug reactions were definitely avoidable through drug treatment procedure that is consistent with knowledge of good medicine practice, whereas nearly two thirds—63 per cent.—were possibly avoidable.
I recently asked a parliamentary question about what plans the Government had to introduce a system to use the yellow card system to learn about correct dosage and prescribing methods, particularly for children. The answer that I received said:
"The yellow card scheme is not designed to enable lessons to be drawn about correct dosage or prescribing methods for medicines for children. There are no plans to introduce a system of learning in this context."—[Official Report, 3 November 2004; Vol. 426, c. 319W.]
However, the research shows clearly that an awful lot of poor prescribing practice results in people being admitted to hospital. Surely the Government have an interest in reducing inappropriate admissions as a result of such prescribing practices. Will the Minister say whether the Government might still consider action on that?
Paul Flynn : I remind the hon. Gentleman of a previous Minister's answer to my question about the number of deaths from a particular drug. He might be pleased to know that the yellow card figure showed that the number of deaths went down last year from 62 to 48. However, the true figure obtained from coroners' courts showed that the number of deaths had risen from 580 to 640. The yellow card scheme has never given anything but a ludicrous underestimate—a snapshot—of the figures. The system has no credibility.
Mr. Burstow : I am not sure that it has no credibility. The hon. Gentleman is right that it is probably not used anything like as much as it should be, and that there is significant under-reporting. The question that I have to ask the Minister—I believe that the hon. Gentleman has also asked it—is how data collected from the system are analysed and used in the public interest, and who has access to them. The Government have said that they are carrying out a review about who might have access to that data and how and when they are used.
That data could and should be a valuable tool. Some 500,000 records are kept of adverse reactions over the years, which researchers should use much more effectively to obtain a much clearer picture of why there are adverse reactions. I accept the hon. Gentleman's point that often only what amounts to the tip of the iceberg is reported, but the data could be used far better, and I hope that the Minister will say where the Government have got to with the review and when they intend to publish its conclusion. I hope that the conclusion will be that the process will be far more transparent and open.
The hon. Member for Norwich, North referred to access to information, and I was struck by some of the comments made during the Select Committee's
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consideration of the matter about the difference between the attitude in this country to the control of information and access to it by the public and consumer groups, and the attitude across the Atlantic in the United States. The Federal Drugs Administration has a website that will put almost all this information into the public domain.
We can access the information on the FDA website, but we cannot see it on a website provided by our own regulatory agency. That is an anomalous position in a world that has the internet, which has no such boundaries. The public should be able to see our own agency providing the same sort of service to them. Will the Minister comment on that?
The problem of capturing only the tip of the iceberg needs to be addressed. The National Audit Office carried out research on this a few years ago and recommended that we need to move from a non-mandatory to a mandatory system of reporting. There is certainly a very powerful case to be made for that. France has a mandatory reporting system. When will the Government decide whether we should move away from the current voluntary arrangements?
The expansion in the number of people who can report—the inclusion of nurses and the plans to include patients—is welcome, but when will the reporting system become mandatory, given that GPs in particular say that one reason why they do not submit yellow cards is that it never comes to mind at the right time? They say that they are not sure what should be reported, that it takes too long to fill out the form, that it is not easy to find a yellow card when necessary, and that reporting generates too much extra work. Those are just some of the reasons that GPs give for not submitting their yellow cards. That cannot be an acceptable basis for a system that should be about giving clinicians information about what works and what is risky.
Dr. Andrew Murrison (Westbury) (Con): Does the hon. Gentleman agree that these vital forms might not be filled out because what is really important is sidelined in the great welter of paperwork with which GPs now have to cope?
Mr. Burstow : The hon. Gentleman makes a very fair point about the ever-growing burden of form filling and paperwork on GPs and others, and about the consequences of the target and tick-box culture that drives that. That means that yellow cards are missed on the radar, which is another reason why they must be made mandatory to ensure that more information is captured.
Only 74 incidents were reported in the first year of the electronic yellow card system, which was introduced back in October 2002. It would be useful if the Minister could tell us what is being done to promote wider use of that service and to publicise it. That uptake is surprisingly low for what should be a much simpler way of providing information to the MHRA.
I want to conclude by mentioning the relationship between the MHRA and the pharmaceutical industry. At the beginning of the year Mr. Brooks said to The Guardian:
"At present the MHRA listens far too closely to the concerns of major pharmaceutical companies and not nearly closely enough to people experiencing side effects from drugs that should be making them better, not worse."
His criticism came two months after he resigned from the MHRA experts group on selective serotonin reuptake inhibitors, claiming that it failed to protect patients from potentially harmful doses of the antidepressant Seroxat.
The debate today is about whether the agency, which is funded solely by the industry, provides the safeguards and reassurance that the public should have about the medicines being made available to them. The hon. Member for Newport, West described in very strong terms the concerns that those outside the agency have about its role. It might be characterised as a paper tiger, or a toothless tiger—he described it as a pussycat.
Whether it is a pussycat or a watchdog, there are serious concerns about the fact that two years are spent on some matters by an agency that can give a licence in 40 days; that will not necessarily carry public confidence. The example of the Food Standards Agency given by the hon. Member for Norwich, North is a good one. It has set a benchmark for credibility and confidence building that other Government agencies should perhaps be trying to reach. We need to maintain confidence so that the industry and the public will benefit and, as a result, society as a whole will benefit from medicines.
10.17 am
Dr. Andrew Murrison (Westbury) (Con): It is a great pleasure to serve under your chairmanship, Mr. Taylor. As is the case for other hon. Members, I think this is the first time I have done so. I congratulate the hon. Member for Norwich, North (Dr. Gibson) on obtaining the debate. Although it is sparsely attended, this is one of the more memorable debates that I have attended here and I am sure that the Minister will take home some important material to reflect on.
I confess that, before doing my research for the debate, my knowledge of the Medicines and Healthcare products Regulatory Agency was perhaps a little sketchy. Perhaps the sketchiness of my knowledge will shine through in my remarks.
Dr. Gibson : Will the hon. Gentleman confirm that he was a GP before he became a Member of Parliament?
Dr. Murrison : The hon. Gentleman makes a good point, which rather underscores the one I was about to make—if I, as a shadow health spokesman and, indeed, an ex-GP, know little about the organisation in question, perhaps the general public know even less. That is dreadful, particularly when we compare it with knowledge of the equivalents on the continent and in America. The relevant bodies there are well known and well respected. Importantly, they are listened to.
I suspect that what is already emerging in our debate is the fact that the agency has very few friends. It appears not to be on particularly good terms with patients and the organisations that represent them. Indeed, it seems not to be on particularly good terms with the industry, despite the apparent over-representation of the industry on its board.
I am reluctant to lay into individuals, however. When organisations are being considered, I prefer to examine their structures and how they are constituted. The fault in that context lies with the Government, Ministers and,
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ultimately, Parliament. We need first to look to ourselves to discover why the organisation, which is apparently failing rather badly, is as it is and how we can either reform or replace it so that it can carry out its stated functions more effectively. I sincerely hope that after this debate, given the strength of feeling that has legitimately been expressed, the Minister will think about the organisation and how to improve it.
I want to focus on some structural problems that I believe have inhibited the agency from doing its job properly. The hon. Member for Norwich, North mentioned my background. My dealings with the MHRA and its predecessors chiefly involved the yellow card system. I was rather horrified to hear him describe seeing piles and piles of yellow cards when he visited the MHRA recently. What were those cards being used for? How was the information on them being collated and transformed by the agency into useful information that might inform any decisions or recommendations that it makes?
Under-reporting is a feature of our health care system. Indeed, the Minister of State, Department of Health, the hon. Member for Doncaster, Central (Ms Winterton), admitted in a recent parliamentary answer:
"The number of reports received via the yellow card scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons including an unknown level of under-reporting."—[Official Report, 19 April 2004; Vol. 420, c. 222W.]
That is a gross understatement. A small minority of adverse reactions to medicinal products are reported through the yellow card system or in any other way. To be fair to the MHRA, if it is basing what it does on inadequate information input of that sort, it is hardly surprising that it is failing.
I am very concerned about Seroxat, which is the flagship product that has drawn attention to the MHRA in a negative way. There appears to have been a significant delay after concerns were initially expressed, which perhaps stem from the excess of suicidal behaviour among those taking the product over and above what one would expect from people on a placebo. Such a delay is unacceptable, which is what set alarm bells ringing in relation to the agency.
Paul Flynn : Does not a significant criticism of this body relate to its competence, because in its examinations of Seroxat it did not get into the raw data from the trials that took place? All the agency looked at, and all it had in its possession, were the conclusions. We now know that had the data been looked at, it would have been known that the firm, GlaxoSmithKline, suppressed information. The trials showed that the drug had no utility; it was no better than placebos. Furthermore, it increased suicidal tendencies in the young. This is a question not just of delay, but of whether this body is competent, given that it looked only at the conclusions, not the raw data.
Dr. Murrison : I am grateful for that intervention. I intend to raise the difficulty that we have with the publication of negative conclusions. I think that 38 per cent. of independent studies of medicines produce unfavourable conclusions, whereas only 5 per cent. of studies funded by pharmaceutical companies produce negative conclusions. That is published information. So,
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there is a problem with negative reporting. The Minister must think carefully about how we can encourage negative reports to appear in the literature and require pharmaceutical companies to publish all data, whether negative or positive, because clearly the pharmaceutical industry has an interest in suppressing information showing that its products have a negative or neutral effect. I suspect that some difficulties surrounding Seroxat revolve around that.
These problems do not stop with Seroxat, however, as 3,000 children in this country are on a product that is marketed here as Effexor. Again, that product can cause suicidal and aggressive behaviour. In that connection, we are worried about trialling the product specifically on children—an issue that others have raised—and the possibility of suppression of negative reporting. It is extremely important to realise that the medical press favours positive reports; it does not particularly like negative ones. However, if we are to get a true impression of whether a product has a positive effect that outweighs the negative effects, which I have to say most products have, it is vital that negative reports, as well as the positive ones, are in the public domain and accessible for those such as the MHRA, which, in a reformed state, one hopes would consider all the evidence available when making its recommendations to Ministers and others.
The system for reporting adverse effects stems from the 1960s and relates to thalidomide. At that time, GPs were very willing to report adverse effects and it was assumed that they would report them all fairly rigorously. That practice has fallen away dramatically and we need better surveillance methods to determine whether a product has adverse effects.
I am pleased that the yellow card system has been extended to other health care professionals, principally nurses, and that it is easier for patients to report adverse effects. I am interested in the use of NHS Direct in that connection and I hope that the Minister tells us the early results of that initiative, as they would be useful to know. I am doubtful that it will be particularly effective, given my experience of telephoning NHS Direct: I was kept on hold for 20 minutes. My strong suspicion is that most people who telephone the service, especially those who want to report minor adverse effects, would probably give up in half that time. Nevertheless, it would be interesting to know what part the Minister thinks NHS Direct can play in reporting adverse effects.
Dr. Andrew Herxheimer said recently in the International Journal of Risk and Safety in Medicine that the yellow card system is "chaotic and misconceived". I know from my own experience that that is the case. The fault lies with those who are tasked with reporting using the yellow card system. However, the paperwork and bureaucracy—the tick-box culture—among which practitioners now have to work do not help, because they dilute what is essential in reporting.
The yellow card system was set up a long time ago in a different environment, in the downdraft from the thalidomide scandal, and it has perhaps become less important in the minds of many practitioners. However, it is vital that it is brought to the fore. Making reporting mandatory may be a way ahead, but that would be difficult to police. The current system is not acceptable,
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although I do not entirely share the view expressed by the hon. Member for Newport, West (Paul Flynn) that it is pretty useless.
Paul Flynn : I know of no academic researcher who takes any notice of the yellow card system. If people want data on the side effects of medicines, they go elsewhere for them. The system has never had any such reputation. The Library never quotes the yellow card system when asked for information. In the example I gave, not only did that system underestimate the number of deaths by 90 per cent., but it also gave the wrong trend.
Dr. Murrison : I am grateful to the hon. Gentleman for that information, which perhaps accounts for the piles of yellow cards that the hon. Member for Norwich, North saw and the implication that they were sitting there unattended. I hope that that message does not go out to GPs. I have filled in yellow cards and if I thought that they were not being attended to, I would be even less likely to do anything about them. I suspect that they are filled in if there are severe adverse effects, but not if there are lesser ones.
I entirely agree with the hon. Member for Newport, West that the system is likely to be flawed, but I hope that it is not fatally flawed and that it flags up some serious side effects. I filled in the yellow cards when I was a GP; if I was being honest, I would have to say that I did so when there was a severe side effect, rather than something I was uncertain about.
That is important, especially in the context of side effects associated with the underlying condition, particularly when one is dealing with mental health, for example. Indeed, one side effect of Seroxat appears to be suicidal behaviour, but some would say that that is a feature of the underlying condition for which Seroxat is being prescribed. In those circumstances, one has to feel sympathy for the doctor, who is trying to disentangle what, on the balance of probabilities, is due to the drug and what is due to the underlying condition. I say in all candour that it is often very difficult to determine that.
The cases that I remember reporting using the yellow card system were reasonably barn-door. There were, for example, cases in which hyperkalemia—raised potassium levels—occurred in relation to a drug for which that was a reported known side effect, and in which there was no other particular reason for the patient to have a raised potassium level. In such cases, I suspect that the yellow card system is used reasonably well and in a way that might be effective and might prompt the MHRA, with all its faults, to take some note—providing the data are being collated. However, for the rest, I agree that if the system is to be useful it must be radically overhauled. We need to ensure that all practitioners are aware of it, have confidence in it and feel that the data they are submitting will be useful and used.
I am also concerned about the proliferation of agencies in the field. I wonder whether some problems that the MHRA experiences are related to confusion about the boundaries. We now have, in addition to the National Patient Safety Agency in the immediate area, the National Coordinating Centre for Health Technology Assessment, the National Institute for
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Clinical Excellence and the Committee on Safety of Medicines. I am confused about the boundaries between those various organisations. There are many different voices—that does not tend to be the case in other countries—and I wonder whether that dilutes the voice of the MHRA in performing its important function. Will the Minister comment on that?
I said earlier that the MHRA has few friends. The industry—particularly small-scale industry—seems not to be particularly impressed with it. It involves cost that does not apply on the continent. I have been contacted by someone in the field who works across the European Union. He says that in no other health economy is there quite such a burdensome system that applies particularly to small organisations and start-up organisations working out of universities and that that is causing a real problem for those who are trying to bring innovations online.
We need a rigorous way to regulate the industry—one of our tasks in this place is to ensure that public health is protected—but I worry that we have an organisation that is both burdensome to innovators and failing to protect the public adequately. I hope the Minister takes away the comments that have been made in the debate and has a serious look at the organisation.
10.33 am
The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson) : I am pleased to answer the points raised in the debate and to congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson) on raising the topic of the Medicines and Healthcare products Regulatory Agency.
As patients and carers become increasingly aware of their own health care choices, it is important that the impact of the work of the UK regulator of medicines and medical devices is better known. Having access to information, in this case about medicines and devices, is at the heart of patient choice, which is a Government priority for the NHS.
In my opening remarks, I want to underline a number of key points about what the agency is, what it is responsible for and the impact that it has. Without doubt, products regulated by the agency have a major impact on all our lives. I will try to give hon. Members a sense of the scale of that impact. In 2001, nearly 600 million prescriptions were dispensed in the UK and some 700 million packages of non-prescription medicines were supplied. Those range from innovative products designed to treat major, life-threatening illnesses to generic versions of common painkillers. Devices ranging from walking aids and examination gloves to radiotherapy machines and resuscitators are used in our hospitals, care homes and, increasingly, in our homes. It is estimated that more than half the UK population has contact with a medical device in any one day.
The MHRA is an executive agency of the Department of Health, which employs some 750 people, and it has an annual budget of about £65 million. It was created on 1 April 2003 from the merger of the Medicines Control Agency and the Medical Devices Agency. Most of its staff are medical, scientific or technical, but the MHRA is also responsible for providing policy advice to Ministers on medicines and devices issues.
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The merger was a logical step in the development of the two agencies. Hon. Members have not particularly touched on this, but the boundaries between medicines and devices are blurring: we already have many drug-device combination products such as drug-eluting stents on the market, and emerging technologies, such as nanotechnology and tissue engineering, will require a new approach to regulation. Ultimately, patients, users of medicines and medical devices, and health care professionals who rely on the safety advice of the agency should benefit most from the merger.
I will briefly explain what the agency does. To put it simply, medicines have to be authorised before they can be placed on the market in the UK or European Union. The regulator must be satisfied that the product meets set standards of safety, quality and efficacy. The MHRA also regulates the manufacture of pharmaceuticals, and ensures that rules governing the sale, labelling and advertising of medicinal products are followed. Crucially, it operates a system for the surveillance of products on the market, in which suspected adverse reactions are reported and stored on a database on which more than 500,000 reports have been collected over 40 years. That is the yellow card scheme to which my hon. Friend the Member for Norwich, North and other Members referred.
Devices are regulated quite differently in many respects. I have already mentioned the diversity of products; that diversity influences the way in which the sector is regulated. For most products, the system involves the monitoring of safety in use, rather than pre-authorisation, and is based on the CE mark, which is awarded by a notified body in one of the member states. The regulator audits the notified body to ensure that its decisions are correct.
Before I address the specific issues raised by hon. Members, I will briefly touch on the role of stakeholders. A body with such diverse functions has a wide range of stakeholders. First, of course, come members of the public, patients, clients of social services departments, carers, and all users of medicines and medical equipment, but stakeholders also include professionals in health and social services who need to act on the safety advice broadcast by the agency. Manufacturers of pharmaceuticals and medical devices also have a right to expect high standards of service from the agency.
I turn to the impact of the agency on public health and point out that it regulates products that are in common use. It is therefore of crucial importance. Protecting public health is at the heart of the regulation of devices and medicines. The yellow card scheme is the cornerstone of the UK monitoring scheme. The agency has recently reviewed its policy in that area, and is considering, on behalf of Ministers, ways of increasing access by researchers to the yellow card database.
Monitoring systems for devices, and the system of liaison officers set up in NHS trusts, ensure that any devices issues can be resolved through prompt action by the agency. Surveillance programmes have allowed the agency to lead the way in several high profile areas of drug and device safety to ensure that there is a consistent approach to important issues for public health.
Mr. Burstow : Will the Minister give way?
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Miss Johnson : I will in a moment, but I have not addressed any of the points that have been raised. If the hon. Gentleman raised one such point, perhaps he will give me the chance to get to it.
The surveillance programmes include hormone replacement therapy, which has not been mentioned, anti-psychotics, which have the risk of stroke, and selective serotonin reuptake inhibitors, or SSRIs. I will come to those specific points.
The agency uses other resources to protect public health: another key database is the general practice research database, which holds anonymised clinical records supplied by GPs. The database, which has not been mentioned much in the debate, is used by the MHRA and internationally for regulatory pharmacovigilance decision making. The value of such a unique resource has been recognised by the United States Food and Drug Administration, which hon. Members have cited as an exemplar in such matters. The FDA is using the MHRA's database, by acquiring a five-year licence to use the data, to support its own drug safety monitoring programmes, which I hope brings a little doubt to the minds of hon. Members about some of the aspersions that they have cast in the direction of the agency.
Seroxat and selective serotonin reuptake inhibitors have benefited millions of people. I thought that the account of my hon. Friend the Member for Newport, West (Paul Flynn) rather neglected the benefits of medicines and drugs, although he made a passing reference to them, as well as the occasional risks and difficulties—some serious and some not so serious—that are experienced by people who take such medicine. Serious side effects are rare in the case of Seroxat and SSRIs. Seroxat has been used by more than 160 million people worldwide. Suicidal behaviour during treatment may be linked to illness and may not necessarily be due to the drug. However, the Government and the MHRA take such issues seriously.
All medicines, including Seroxat, are licensed on the available data at the time, but their benefits are kept under constant review. Seroxat and the other SSRIs are associated with an improvement in safety in overdose and are better tolerated by patients than other main classes of medicines used in the treatment of depression, the tricyclic antidepressants. An expert working group of the Committee on Safety of Medicines is undertaking a comprehensive, independent scientific assessment of the available data relating to the safety of SSRIs, particularly withdrawal reactions and suicide behaviour.
The expert group sought and considered evidence from a wide range of sources, including a specific objective to listen to the patient voice. I hope that hon. Members know that it has already reached conclusions on the use of SSRIs in children and the Government have published the findings on that, including the results of the clinical trials. That unprecedented step goes further than any regulator has ever done and demonstrates our commitment to being as open as possible in drug regulation. The expert group is now focusing its attention on the use of SSRIs in adults and hopes to conclude its full and thorough review before Christmas. No doubt hon. Members will be interested to receive that information when it is published and to examine the findings.
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I want now to discuss the withdrawal of Vioxx and point out to the hon. Member for Sutton and Cheam (Mr. Burstow) that the Canadians took action on Risperdal, which is an anti-psychotic drug, not the drug Vioxx that was withdrawn worldwide in September. The United Kingdom acted on Risperdal as soon as the evidence was available. The drug was licensed for different uses in Canada and was licensed specifically for use by elderly people. That was not replicated in this country. From the advice that I have received, the hon. Gentleman gave the wrong impression about the time scale. The company, Merck Sharp and Dohme, withdrew Vioxx based on the emerging findings of clinical trials, which showed an increased risk, as hon. Members have said, of coronary heart events when people had taken the drug for more 18 months.
We thought carefully about the advice given to patients, but the advice that we received both from the MHRA and our advisers within the Department about the time scale of withdrawal was to allow patients to spend a week or so to see their GPs before they were taken off the drug and put on to another one. The risk was not great enough to necessitate more rapid action. Had it been, we would, of course, have given different advice.
Paul Flynn : Has the Minister communicated with Merck Sharp and Dohme about claims that it knew of the side effects as long ago as 2000?
Miss Johnson : I have not. My noble Friend Lord Warner deals daily with these matters in the Department, but I cannot tell my hon. Friend whether he has communicated with the company on this matter because I have no briefing on it at the moment.
Mr. Burstow : Will the Minister check again and write to me about the chronology of decisions taken by this country's regulatory agencies and the Canadian regulatory agencies? The latter took their decisions some two years ago, or possibly even earlier. The answers that I have so far received to parliamentary questions led me to make the comments that I did. The period of two years seems relevant.
Miss Johnson : All I can comment on at the moment is the advice that I have received and relayed to the hon. Gentleman. I will, of course, reconsider the issues that he raises, and see whether a further point needs to be made. He will not necessarily learn anything new from our simply standing by our answer to an earlier written question.
I will make a point about the agency's relationship with industry that I believe hon. Members will be keen to hear. The working relationship that the agency needs to have with industry does not inhibit the scientific and regulatory independence of the MHRA. Industry representatives do not participate in any management, executive or advisory functions, with the exception of the statutory representation on the agency's medicines commission bodies.
A significant proportion of the MHRA's senior scientific staff are, of course, recruited from, or have a history in, the industry. That is necessary, as they make up the largest single pool of specialist advice for effective
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drug regulation. They must be drawn from the industry; there is no other source. We do not operate the sort of secondment programme operated by other bodies because of the relationship between the two.
I alert hon. Members to the fact that the agency has been reviewing the advisory committee structure, and has taken the opportunity to reconsider the arrangements in place for managing interests—an issue that my hon. Friend the Member for Norwich, North and others have raised a great deal. Proposals are being drafted that will bring UK policy into line with new EU legislation, which requires that experts should have no financial or other interest in the pharmaceutical industry that could affect their impartiality. My noble Friend Lord Warner will make a more detailed announcement on the issue very shortly. Members will therefore appreciate that there are other issues that I cannot discuss this morning.
Dr. Murrison : I am little confused. I believe that the Minister said that there were no sources other than the industry for the expertise that the MHRA needs. I dispute that.
Miss Johnson : That is not quite what I said.
Dr. Murrison : The Minister can correct me in a minute. She then said that the new EU directives would mean that we will ensure that there are no conflicts of interest of the sort that I believe she was describing. Will she clarify that?
Miss Johnson : We need to accept that the pool of people who may have a background in the drugs industry and who understand how it works are likely to be from the industry. The question is where Members believe we would acquire experts who at no point in their past have some sort of background connected with the drugs industry. The second question relates to the nature of their ongoing relationship. My noble Friend will make an announcement on that point. I repeat for the hon. Gentleman's information that we will bring UK policy into line with the new EU legislation on these matters, which requires that experts should have no financial or other interest in the pharmaceutical industry that could affect their impartiality. That is what we will elucidate soon.
Paul Flynn : The Minister made an appalling statement to back up the nonsense that only people with years of experience in the pharmaceutical industry should police it. That does not happen in any other body—there must be lay members on regulatory bodies. Someone does not need years of experience in an industry to decide to work on the raw data rather than on conclusions provided by the industry to reach life-and-death decisions for millions of people.
Miss Johnson : If I am to make progress, I need to continue without too many interventions. However, in response to my hon. Friend, I am not saying that those are the only people who should be involved with a regulator, but that the expertise should come from those with a background of experience. Lay members are, of course, crucial—we accept and welcome lay involvement. The MHRA seeks to engage patients as
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stakeholders in a number of ways, including formally through the Committee on the Safety of Medicines and its sub-committees, and in less formal ways that I do not have time to go through. Both the CSM expert group on patient information and the recently established group on patient reporting of suspected adverse drug reactions have lay chairmen and are heavily weighted towards lay membership to reflect medicine users' views. The crucial role of lay people is well accepted; I was making the point that the expert view will often come from people with a background in the industry.
In addition, the agency is seeking to be more transparent in its working, and I point out to my hon. Friend the Member for Norwich, North that it already publishes details of all complaints received about medicines advertising and of the outcomes of its investigations, as well as being more open about how such decisions are made. It has also published summaries of clinical trial data to support key communications on drug safety, when it has been in the public interest to do so—the public interest being an overriding demand.
Freedom of information legislation will make such arrangements even more open from January, and my noble Friend indicated that section 118 of the Medicines Act 1968 will be repealed as part of the preparation for that. My hon. Friend the Member for Norwich, North made a specific point about minutes being published, and I am advised that those minutes are published and will continue to be.
Dr. Gibson : I want to ask my hon. Friend about advertising. There are some very glossy ads for statins. People go to their pharmacies, get statins and are advised by the pharmacist, but many of the adverts are misleading. What does the regulator do to control those advertisements? Should it not publicise what it does? As I said, it changed one advert, but only in a small way. We need to know what the regulator does in terms of its influence on the public buying drugs.
Miss Johnson : I am happy to write to my hon. Friend about advertising, partly because of the growing pressure of time, but also to give him more detail on that subject. As I said, lay members are involved in that work and play a key role in considering those questions.
The points made in the review about a lack of understanding of the role of the agency and the fact that more work has to be done on communications have been accepted. The National Audit Office made a number of recommendations in its value for money review of the agency. Those are being taken forward, including work on communications and more engagement with the public.
We can only consider whether the agency's communications are effective if the safety messages that it generates are properly communicated and acted upon. I hope that the fact that we are having this debate is a sign that the profile of the agency could be, and is being, further improved.
On the creation of the MHRA, as I mentioned, a review was carried out on, among other things, the agency's external profile. The findings are being implemented. For example, work is being done on the redesign of the agency's website to make it more accessible and usable by a range of stakeholders.
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My hon. Friend the Member for Norwich, North asked about the role of the agency in relation to wider public health. Before I come to that, I shall touch on the issue of secrecy and openness and point out that the principle underpinning the existing code is that information should be released except where disclosure would not be in the public interest—for example, on the grounds of personal or commercial confidentiality. In fact, information can be released if that is done in performance of the MHRA's duty. Where there is a risk to public safety or health, the MHRA has an overriding obligation to remove or reduce the risk, even if confidentiality is broken. As I mentioned, that provision is effectively being strengthened by changes under freedom of information that will be implemented from the new year. Of course, there remain some common-law protections in relation to confidentiality, but otherwise the provisions I mentioned are all that would in any way impede the publication of a lot more information.
Regulation does not happen in isolation, and I was honestly confused by the remarks of the hon. Member for Westbury (Dr. Murrison) on the subject. On the one hand, he alleges bureaucracy and complaints about under-reporting on health care; on the other, the official Opposition, for whom he is a spokesman on the subject, believe in no targets, and hence, presumably, on no reporting on many subjects. They also believe in removing bureaucracy—as, indeed, do we where it is pointless.
Dr. Murrison : Will the Minister give way?
Miss Johnson : No, I have only three more minutes to make my closing comments. The hon. Gentleman is giving a confusing message on whether he would welcome a strengthening of provisions.
Dr. Murrison : Will the Minister give way?
Miss Johnson : Very quickly, so that the hon. Gentleman can clarify his position.
Dr. Murrison : That is a disgraceful thing that the Minister said; she must know that reporting adverse affects is completely different from setting central targets. I hope that she will withdraw her comments.
Miss Johnson : I am afraid that I have no intention of withdrawing them. The under-reporting point sounded
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very much like a desire to have more information at the centre about what is going on. That is exactly what has led us to set targets, which have already lead to huge improvements of more than 12 per cent. in respect of cancer mortality, and to improvements in relation to coronary heart disease of more than 23 per cent. We must recognise that we are making huge progress as a result of the developments that the hon. Gentleman is criticising.
Ministers have been strong advocates of policies to broaden the range of products available over the counter. We believe, importantly, in the concept of patient choice. At the time of the adoption of the NHS plan, there was emphasis on smoking cessation products to support our initiative to reduce coronary heart disease, and on emergency contraception in relation to the issue of unwanted pregnancies. On all those matters, we had the possibility of moving forward as a result of work done on the reclassification of medicines from prescription only to pharmacy.
Regulation can also be used to address the lack of availability of medicines in specific sectors, medicines for children being a key example. The European Commission has now formally issued a draft regulation with the aim of improving the availability of medicines licensed specifically for use in the treatment of children. The Government welcome that initiative, which will complement the work that the UK is already undertaking to address that important issue. We will play a leading role in negotiations on the regulation in the coming months to make sure that it meets the needs of the UK and addresses the points that hon. Members raised in relation to children.
To conclude, I would like to illustrate how regulation really does contribute to the protection of individual patients. In September 1998, the MCA, as it then was, moved to restrict the pack size of paracetamol and aspirin through a change in legislation. Research just completed by Oxford university researchers has shown that suicides have been reduced by 25 per cent. in three years.
David Taylor (in the Chair): Order. We now come to the debate on the closure of the Birds Eye factory in Grimsby.
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