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The Parliamentary Under-Secretary of State for Health (Mr. Liam Byrne): I sincerely congratulate the hon. Member for Bridgwater (Mr. Liddell-Grainger) on giving us the opportunity to debate this important subject.

The cancer drug Herceptin has received a lot of exciting publicity recently, and I am grateful for the opportunity to discuss the issues raised today. Like many families in this country, mine too was once devastated by cancer. I know from bitter personal experience the torture that it brings. It is with that perspective that I respond to the points made by the hon. Gentleman.

At the centre of our debate is a woman, Mrs. Clark, of extraordinary courage, and I join the hon. Gentleman in saluting her. But, as he points out, it takes more than courage to beat cancer. We are therefore extremely fortunate in this country to have the national health service on the side of each and every one of us. The NHS often makes a critical difference for many of the 34,000 women diagnosed with breast cancer in England each year. Today, because of better diagnosis and treatment, 80 per cent. of women are now alive five years after diagnosis, compared with 68 per cent. in the late 1980s.

The fight against cancer is one of the most critical fights that our scientists and health professionals wage every day. I am proud that the NHS spent £103 million on cancer research and development last year—just under a quarter of all NHS research spending. Almost
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every week, new advances are reported—new progress and new hope—and one of our best hopes reported in recent months is Herceptin. The drug has been around for about five years and is one of a new class of drugs known as monoclonal antibodies—drugs that target the cancer cells and cause minimum damage to healthy cells, in stark contrast, as the hon. Gentleman pointed out, to conventional chemotherapy. It is licensed for treating especially aggressive, advanced breast cancer, and accredited by NICE. I understand that it can increase life expectancy by around six months. Any family who have experienced cancer know that every day of that six months often feels like one of the most precious gifts on earth.

What that means in practice is that every PCT should be funding Herceptin for any woman with advanced HER2 positive breast cancer that might benefit from it. The hon. Gentleman's community, as he rightly pointed out, is among those in which the benefits of Herceptin are well understood. My officials tell me that in June 2004 the level of Herceptin prescribing for women with advanced breast cancer in Avon, Somerset and Wiltshire cancer network was found to be well above the national average.

The issue that is centre-stage this evening is that early evidence indicates that Herceptin might be of much wider benefit—in fact, of benefit to the more than 23,000 women who are diagnosed with breast cancer at an early stage each year, before it has had the chance to spread. Herceptin might now benefit around one in five of those women who are diagnosed with HER2 positive breast cancer. That evidence was highlighted in May this year, when interim findings from trials were presented at the American Society of Clinical Oncology conference. Those early results, which remain provisional and unvalidated, show great promise. For example, the data showed that Herceptin in combination with another cancer regime resulted in a 52 per cent. reduction in cancer coming back, and a 33 per cent. reduction in the risk of death. The key point, however, is that those results are not yet validated, and the pharmaceutical company is still analysing the trial results.

It might therefore help the House if I say a few words about the licensing process. To obtain a licence, a drug company will make an application to one of two regulatory bodies, the European Agency for the Evaluation of Medicinal Products—EMEA—or our national agency, the Medicines and Healthcare products Regulatory Agency. For Herceptin, the licensing process that will be used will enable automatic European-wide approval. That special licence is secured by applying to the EMEA, in which a committee of experts from all member states including ours will carry out a detailed evaluation of both the application and the supporting research evidence. In general, that licensing process takes around six to nine months from receipt of an application.

As the hon. Gentleman pointed out, however, because of the existing licence, extended licensing of Herceptin is unlikely to take that long—an application to extend the use of a drug that is already licensed, as in the case of Herceptin, is generally quicker, and possibly as quick as two to three months. Once that work is done, and that licence is applied for and approved, and once NICE has appraised and approved it, two things become possible: a doctor can prescribe the drug, and the PCT must meet the full cost.
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The hon. Gentleman understandably commented that Herceptin has already been deemed safe by virtue of the fact that it already has a licence, and that we just need to extend its use. I know that he has suggested elsewhere that there should be procedures for overriding the licensing process, and I very much understand his point. There must also be a balancing obligation on us, however, to make sure that drugs are safe for other patients before they are widely promoted throughout the national health service. In the past, unfortunately, we have made some terrible mistakes. Thalidomide was one such failure.

Despite the fact that Herceptin is only licensed for treatment of some HER2 breast cancer patients, as the hon. Gentleman pointed out, it is possible for a doctor to prescribe Herceptin for other patients, subject to two conditions. First, as he pointed out, the PCT or NHS trust must agree to supply it at NHS expense. Secondly, the doctor must retain clinical responsibility for the patient while prescribing the drug in question. Prescribing unlicensed drugs is the exception rather than the rule for the very good reason that the licensing process is designed to ensure that widespread use of a drug for particular conditions does not cause side effects that are so serious that they outweigh the benefits for which the drug was prescribed. Herceptin may—I stress "may"—produce side effects which, for example, damage the heart in some patients. Those side effects therefore need to be taken into account when balancing the advantages and disadvantages of using this drug for treating early breast cancer sufferers who have the prospect of living for many more years.

The hon. Gentleman hinted at concern that, even once licensed, there will be delays in patients accessing Herceptin on the national health service. I know that he has suggested elsewhere that it could be a very long time before it is widely available, because the NHS will not be able to use it until it has been fully appraised by NICE. I must tell the House this evening that that will not be the case.

It has been made clear to primary care trusts in national guidance that they should not refuse to fund a newly licensed drug on the grounds that NICE guidance is not available when the product is launched. In those circumstances they are expected to make their own assessment of available evidence before deciding how to fund the drug locally. The Government are happy to reiterate that message to PCTs, via strategic health authorities, if there are local concerns that that is not happening.

I know that the hon. Gentleman wants NICE to review Herceptin to treat early breast cancer as soon as possible. So do I. That is why I can tell the House this evening that we are considering referring Herceptin to NICE outside the normal referral waves, so that NICE can react as soon as possible after the drug is licensed—assuming, of course, that it receives a licence.

There is a related question of whether NICE should appraise Herceptin in tandem with the licensing process. That would cause two sorts of problem. First, it would not be possible because before a licence is granted, there is simply not the available evidence base on which NICE can produce guidance. In addition, much of the data on
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the efficacy of a drug before its launch is commercially sensitive, and NICE would therefore not be able to consult openly on guidance using that evidence.

Secondly, it is perhaps inappropriate for NICE to determine the clinical effectiveness and cost-effectiveness of a drug while its safety and efficacy are still under consideration. For example, if a licence is not granted or the licence application withdrawn, which does happen, NICE would have spent considerable time and expense with no discernable output.

Sometimes it is said that NICE takes too long to appraise a drug. I appreciate that there are concerns about how long it takes to produce guidance once an appraisal starts. But I underline the fact that it is crucial for NICE to get the right answer. No one's interests are served if it rushes a decision and, tragically, gets it wrong. That is why NICE considers all available evidence, consults widely and takes comments into account. That takes time, but its processes are one of the reasons for its reputation as an international model for producing technology appraisals.

Over the next ten years we will make extraordinary progress on the war on cancer, and this country is at the forefront of that battle. I do not want Mrs. Clark to have to sell her home to get Herceptin. But equally, we cannot override the drug licensing process so that a drug is licensed before trial data have been properly reviewed and side effects fully understood.
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I believe that as new drugs are developed, we will turn again and again to the ethical dilemma at the heart of this debate: how do we balance the possibility of introducing the new benefits that new drugs bring as fast as is humanly possible, with the need to ensure that the new drugs available are safe and without downsides that undermine the very reasons for their prescription.

Because of the importance of this debate, and because I think that the subject will come up again and again in the years to come, I add my personal thanks to the hon. Member for Bridgwater for his valuable contribution. As he rightly said, the national cancer director was recently in touch, and he is at present putting together a group that will consult on how to get the infrastructure in place in the national health service so that when, as we hope, Herceptin is licensed and receives its appraisal from NICE, we can ensure that much more widespread diagnosis services are available for HER2. The procedure is not available throughout the country, and we need to ensure that that preparation has been done, so that if Herceptin lives up to its reputation, it will be made widely available to the right people.

In concluding, I again thank the hon. Member for Bridgwater for his valuable contribution to the debate, and join him in saluting the courage of Mrs. Barbara Clark.

Question put and agreed to.

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