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The Parliamentary Under-Secretary of State for Health (Mr. Liam Byrne): I am grateful for the opportunity to respond to this excellent debate. I, too, congratulate former and current members of the Select Committee on its report. I should like to add my own words of praise to those of the hon. Member for Southend, West (Mr. Amess) about the Committee's former Chairman, David Hinchliffe. Mr. Hinchliffe was very generous with his advice to me after I got this job, and I hope to be able to benefit from some of it this afternoon. I want to put on the record my thanks and praise for him.
My right hon. Friend the Member for Rother Valley (Mr. Barron) rightly began by saying that the House should be interested in an industry that develops new medicines from which we all benefit, and on which the national health service spends about £10 billion a year. Thousands of patients survive diseases such as cancer and coronary heart disease from which they would probably have died in the past.
The industry is in no small part responsible for the extraordinary advances that the chief executive of the NHS was able to mention in his report, which was published yesterday. He was able to state, for instance, that over the past few years mortality rates for cardiovascular disease had fallen by more than 31 per cent., and that those for cancer had fallen by 14 per cent. I am sure that the whole House will wish to congratulate the staff of the NHS on the way in which they have harnessed our investment and reform to produce such remarkable results, with the help of Britain's pharmaceutical industry.
My right hon. Friend presented an excellent summary of an excellent report, but before I respond to his points in detail, I want to deal with some of the points made by other Members. The hon. Member for Falmouth and Camborne (Julia Goldsworthy) is a direct beneficiary of some of the pioneering developments produced by the pharmaceutical industry. She referred to a number of issues involved in drug promotion, such as ghost-writing, regulation and Herceptin. I was pleased to learn of her concern about some of the future financing implications for the NHS. Fiscal rectitude does not commonly feature in Liberal Democrat speeches, but I welcome its emergence.
The hon. Lady made an important point about inappropriate promotion of medicines. The MHRA can and does take action against the practice. She mentioned the inappropriate promotion of iPods. In that case the MHRA took action to stop the offer and require corrective statements to be made by the publication in which it appeared. Like a number of other Members, the hon. Lady mentioned the ABPI code. The code has been strengthened, but the key point is that it is underpinned by statutory controls, including criminal sanctions for breach of advertising regulations.
My hon. Friend the Member for Newport, West (Paul Flynn) made an important contribution. His speech was well informed, well argued and backed by good evidence, asI have come to learnare all his speeches.
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He also spoke with great passion. He presented a powerful argument about the medicalisation of society. The Government made their position clear in the public health White Paper "Choosing Health: making healthier choices easier". In the White Paper, we emphasised the need for the NHS to become a health improvement and prevention service. We are tackling that in a number of ways, putting health and prevention at the centre of our national service frameworks but also giving primary care trusts real means with which to tackle health inequalities and improve health.
My hon. Friend highlighted a dilemma. On the one hand, speed is needed in the licensing of drugsmy right hon. Friend the Member for Rother Valley, in particular, mentioned thaton the other hand, there is the need for safety. In that context my hon. Friend cited Vioxx, with which I shall deal later. There are real conflicts and dilemmas, and it was right for my hon. Friend to draw our attention to them.
The hon. Member for Southend, West made a fascinating speech. I cannot wait to see those photographs: I look forward to the arrival of the December edition of The House Magazine. He mentioned issues relating to the ABPI code, with which I shall deal in a moment. He also referred to NICE funding, MHRA statutory controls and industry sponsorship. Let me deal first with the NICE budgets, which were also mentioned by the hon. Member for Windsor (Adam Afriyie).
The Government created NICE for a reason, and recognise the value of its work. Its contribution to the health debate has been extraordinary over the past few years. The NHS and international medical science have benefited from its work. Like all arm's-length bodies, however, it has been asked to make savings in its back-office and accommodation costs. We have taken great care to protect the budget for its core work: the budget for 200405 is some £30 million. We are confident that NICE can deliver its challenging work programme within the existing envelope of those resources. It is, of course, for my right hon. Friend the Chancellor of the Exchequer to consider future spending in the spending review that will start next year.
The issue of statutory powers is important. From 1 January 2005, the MHRA has required pharmaceutical companies to provide all the evidence. The powers have always been robust, but the new requirement to notify the MHRA without delay of all new information impacting on risks and benefits is, I think, very important and the Select Committee will welcome it. Failure to provide such information is a criminal offence to which the sanction of unlimited fines and imprisonment applies. It was right for the Select Committee to highlight that matter. The new measures introduced from the beginning of this year will go some way to addressing some of its concerns.
The hon. Member for Southend, West mentioned Herceptin, as did the hon. Members for South Cambridgeshire (Mr. Lansley) and for Windsor. As we know, it has received considerable publicity from our constituents and also in the media. The drug is already licensed for women with advanced breast cancer, but not yet for those with early breast cancer. As the hon.
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Member for South Cambridgeshire said, a number of oncologists have pointed to its quite extraordinary potential.
It is already possible for clinicians to prescribe a drug outside licensing indications. It is then down to individual clinicians to decide whether it is suitable to prescribe a specific drug after discussions with patients, taking into account the potential risks, not least those suggested by the patient's medical history. Primary care trusts then have to be involved, as they have to decide whether to support a clinician's decision and supply the drug at NHS expense. They will have to take a range of factors, including the circumstances of the individual patient, into account in taking those decisions.
The position that my right hon. Friend the Secretary of State sketched out is really threefold. At the momentpre-licence and pre-NICEit is for individual clinicians to consider with patients whether Herceptin is an appropriate course of treatment. Secondly, PCTs should not rule out treatment in principle, but should consider individual circumstances in taking their decisions. Thirdly, PCTs should not refuse to fund Herceptin solely on the grounds of cost.
My hon. Friend the Member for Bolton, South-East (Dr. Iddon) made a number of important points about parallel trade. It is, of course, a legitimate trade that is allowed under EU law, but there are controls on it. If safety concerns arise out of parallel trade, I am sure that the MHRA will be keen to know about them and will subsequently investigate. My hon. Friend trained as an organic chemist, so I know that he is well qualified to comment about the risks in the process of counterfeiting. I completely agree that it is a growing concern. The MHRA is working with regulators worldwide to combat what is an international problem. Evidence at the moment suggests that incidence in the UK is low, and tools are in place, carrying criminal sanctions, to deal with it.
We certainly cannot afford to be complacent about that problem, particularly in the light of growing internet sales. I completely share the concern of my hon. Friend the Member for Bolton, South-East about the potential risk to the public. Public and patients are well advised to exercise great caution in purchasing medicines on the internet. My hon. Friend will know that the MHRA has had considerable success in taking action against illegal internet sales, which has been extensively covered in the media this week. It remains a difficult area to police and the MHRA continues to find new ways of impacting on illegal sales. I am sure that, as the hon. Member for Broxbourne (Mr. Walker) suggested, that matter will benefit from our further attention on the Floor of the House.
The hon. Member for Wyre Forest (Dr. Taylor) talked about many matters, particularly highlighting the need to align industry research priorities with NHS public health aims. As we are spending about £10 billion a year, that is not an unreasonable expectation. The Government found the Select Committee's conclusion extremely helpful. One of the ways in which we are taking its recommendations forward is through the UK's clinical research collaboration. As a first step, we have asked that a futures forum be held, to bring together many of the key stakeholders to advise Ministers on the future priorities for innovation in health care. The forum will be held in 2006 and it will be
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informed by the results of an ongoing strategic analysis of current research, funded by partner organisations. The pharmaceutical industry will be included, and the report will be available next spring.
The hon. Member for Wyre Forest spoke about Vioxx with some import. Vioxx is an important part of the debate, particularly if we contrast the associated issues with those associated with Herceptin. There is a central dilemma and we are very grateful to the Committee for highlighting it. My questions, and those of other Ministers, are essentially the same as the Committee's. Why did pre-licence clinical trials not illustrate some of the problems? Were the trials long enough? Why did spontaneous adverse reporting not show up some of the problems post-introduction? As my hon. Friend the Member for Newport, West asked, what lessons can be learned to mitigate the possibility of such problems occurring again?
Like Herceptin, Vioxx was seen as an incredibly important drug. It had the potential to provide an important level of pain relief and it did not have the side-effects associated with many existing drugs. The pre-clinical trials did not show up all the various problems and although there were differences with the placebo group, they were on a pretty shallow curve. Indeed, it can take up to 18 months for some of the side-effects to become apparent. That said, patients were obviously anxious for this new and potentially very valuable drug to come on to the market as quickly as possible. Adverse reporting was not going to help because many of the associated side-effects can be attributed to underlying patient conditions, such as heart disease and diabetes.
Since then, an extremely important change has occurred. From the end of October this year, the licensing requirements for new drugs include the requirement for a risk-management plan, which must be agreed with licensing authorities. It can stipulate a range of requirements to monitor the effects and side-effects of new drugs, so for the first time, regulators have a degree of latitude in specifying, for example, the long-term clinical trials necessary in the new drugs field. That was an important issue for the Committee to highlight.
The hon. Member for Wyre Forest also discussed the promotion of new medicines. The ABPI code now restricts promotion on the launch of new products, but to underpin that code the MHRA is vetting the advertising material for new drugs. However, we will monitor the new measures and if they do not deliver the change that the Committee and the Government are looking for, we will have to look again at the current controls.
Expert advisory groups is another important issue that was raised. The Committee on Safety of Medicines will have expert advisory groupssome 14 of themand they are in the process of being appointed. As Members know, the Government adhere very closely to the Nolan principles, so the appointments being madefrom some 400 to 500 candidates and from every area of expertise, including lay memberswill take a little longer. In the meantime, however, the committee can call on the expertise of an external panel of experts in order to cover specialist areas.
The hon. Member for Broxbourne, who has worked at the coal face of many of the issues that we have discussed today, raised the question of SSRIs, as did my
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hon. Friend the Member for Newport, West. The UK has gone further and has acted much faster in reviewing SSRIs than any regulator worldwide. The CSM's expert working group's report, which was published a year ago almost to the day, has been recognised as the most thorough review of a class of medicines ever undertaken. It resulted in new advicebacked by an unprecedented release of summaries of clinical trial datawhich was published alongside NICE guidelines. The MHRA continues to monitor the safety of selective serotonin reuptake inhibitors, and this week issued new advice on the use of Seroxat in pregnancy. I do not think that that is a record of complacency.
I turn now to the points of substance contained in the Select Committee report, which my right hon. Friend the Member for Rother Valley spelled out with great eloquence. If I may, I shall take a slight detour through the vexed question of how many conclusions and recommendations the Government have accepted.
From what I understand, the Select Committee report grouped a number of recommendations into one overall recommendation. The Government responded to all the recommendations, and to the sub-recommendations that they contained. Of the 32 recommendations, 26 were accepted in full or in part. I know that the Government response took some time, but the Committee took 10 months to write the report, and it was felt that the response needed proper consideration. After all, as my right hon. Friend the Member for Rother Valley said, this is the first such report for many years.
My right hon. Friend the Member for Rother Valley raised various points, and I shall try to deal with each in turn. First, he asked about MHRA governance arrangements, an issue also highlighted by the hon. Member for Southend, West. When it was reviewed by the National Audit Office, the MHRAwhich was then known as the Medicines Control Agencywas found to be a major contributor to public health in the UK. That was a welcome finding, as was the assessment that it was a world leader in some respects, such as in the field of drug safety.
The agency is tackling directly some of the issues raised in the NAO report, and the Government response strongly welcomes the Select Committee's suggestion that there should be a further review once current reforms have bedded in. In addition, and as is to be expected, Ministers continue to monitor the MHRA's performance. The agency has been strengthened by the adoption of many new internal controls of its own, which will ensure that the agency remains independent and its staff free of conflict.
Nevertheless, I welcome the suggestion from my right hon. Friend the Member for Rother Valley that the House should monitor the agency's progress closely. I am sure that his proposal that the House and the Select Committee should provide input in respect of the review's terms of reference will be of great interest to my right hon. Friend the Secretary of State.
As part of the ongoing reform process, the MHRA recently revised its medicines advisory committee structure. The Commission on Human Medicines came into being on 1 November. It is not a direct result of the Select Committee report, but it does deal with some of the issues raised in that report. For example, each
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advisory committee now contains two lay members, to ensure that wider judgments are made about risk benefit as well as about medical and scientific matters. Importantly, the new structure allows the patient voice to be heard in the regulatory process, and the rules on the interests of committee members have also been strengthened. As a result, the new committee's chairman and members will not be allowed to hold financial interests in the pharmaceutical industry.
My right hon. Friend the Member for Rother Valley also raised issues to do with promotion and industry information, both pre and post-licensing, and six or seven points are relevant in that context. First, since the Government's response was published, much progress has been made on ensuring high standards in the promotion of medicine. For instance, initial advertising is now vetted before publication.
Secondly, the agency has delivered on its commitment to agree a memorandum of understanding with the prescription industry's self-regulatory body, which was published last month. Thirdly, and as the hon. Member for South Cambridgeshire pointed out, the ABPI code has now been strengthened.
Fourthly, a great deal of progress has been made in improving the quality of patient information, about which the hon. Member for Wyre Forest spoke most cogently. I have not had the benefit of visiting Australia to see how matters are handled there, but if I behave myself that opportunity may be afforded me at some time in the future.
The issue of promoting information to patients is important, especially in a world in which, as my hon. Friend the Member for Bolton, South-East (Dr. Iddon) mentioned, people are beginning to buy products on the internet. The new requirement for user testing of information in patient information leaflets came into force in the UK in July, ahead of the time frame in European law. That will deliver potentially the most powerful tool to ensure that the needs of patients are properly met. In the same month, the expert group of the Committee on Safety of Medicines published its report, "Always read the leaflet", with new guidance on user testing, risk communication and, importantly, the usability of patient information leaflets.
The fifth measure was on the safety monitoring of medicines, to which many hon. Members referred. As my right hon. Friend the Member for Rother Valley mentioned, patients and members of the public have been able to report suspected adverse drug reactions through the yellow card scheme since January 2005. Since then, around 750 yellow card reports from patients and members of the public have been received. Since the Committee reported, the UK-wide patient reporting pilot was launched in October, developed on the basis of considerable engagement with stakeholders, and supported by a major promotional campaign.
The sixth area, which many hon. Members on both sides of the House will welcome, is the registration of clinical trials. The Health Committee argued in favour of the registration of all clinical trials and the publication of the results of trials. The Government largely accept that argument. We fully support the case for transparency and accountability, and we are
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working nationally and internationally to get the principles applied in practice. A number of important developments have taken place in the past year, and it is now clear that the movement towards registering trials and providing much better public access to research evidence about safety and effectiveness is unstoppable. Much of the momentum comes from a shared aim of the Government and the industry to build public confidence. International pharmaceutical industry associations have made public commitments, which have been strengthened by the understandings in the UK. At the same time, the World Health Organisation is working on standards for trial registration and international agreement on systems to give easy access to information, and the European Medicines Agency is about to launch a public database called EuroPharm. We very much welcome all those developments.
To go further, however, the Government strongly support more openness and transparency in the regulation of medicines. The MHRA is making good progress in that field, as we highlighted in our response. A communication strategy is now in place, which considers how we raise the profile of the agency and increase the understanding of medicines-related issues among the general public. In our published regulatory information, all newly licensed programmes will be accompanied by a UK public assessment report, which will be posted on the MHRA website. The agency also regularly publishes summaries of clinical trial data to support key communications on drug safety, along with all details of adverse drug reactions.
Several Members, such as the hon. Member for Falmouth and Camborne and my right hon. Friend the Member for Rother Valley, mentioned the report in The Observer a week or two ago about the alleged case of research misconduct involving a comparative study of two drugs for the treatment of osteoporosis. The MHRA is investigating that at the request of the chief medical officer. The aim of the investigation is to establish whether there has been an abuse of the regulations governing clinical trials, but it will also seek to establish whether legislation requiring companies to submit immediately to the MHRA any new information that might affect the risk-benefit balance of the product has been breached. The Government view that as a very serious matterfalse research can lead to the wrong treatment being given.
For academics who might be involved, who are not part of a profession, criminal sanctions are not yet available. At the moment, we rely on employers to take action. That is why we warmly welcome Universities UK's initiative in setting up a UK panel for research integrity in health and biomedical science. One of its functions will be to help research employers, including universities, the NHS and industry, to take effective action against allegations of scientific misconduct.
My right hon. Friend the Member for Rother Valley, in his concluding remarks, highlighted the need for speed in introducing drugs to market. That is something that is being addressed in part through the ministerial industry steering group, which brings together leaders from the pharmaceutical industry and Ministers to consider issues that might impact on the industry. One of those issues is how regulation can be adopted to accelerate the pace of introduction of new drugs to market, including what kind of controls are needed and
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how can we gather safety data to avoid scares such as the withdrawal of Vioxx. We have to keep in mind the balance between public safety and the difference that new drugs can make.
The issue of NICE is part and parcel of that. I have dealt with the question of its funding and it is now out to public consultation on fast-track assessment on single therapies. Those assessments will sit alongside full appraisals. NICE is now prioritising its work plan to ensure that new needs are met.
I welcome much of the Committee's report, but I also welcome much of what the hon. Member for South Cambridgeshire said. He was right, in particular, to say that connecting for health has extraordinary power to help. I know that I am not supposed to say this in the new mood of consensus that has broken out on the Floor of the House, but connecting for health is not free. Its future rests on investmentthe kind of investment that is precluded by policies such as the patient's passport. After the events of the past two days, I look forward to hearing about its future.
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