Terminal Illness (Access to Medicines)

Geoffrey Clifton-Brown Excerpts

Wednesday 23rd January 2013 Westminster Hall

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

May I thank you, Mr Caton, and Mr Speaker for allowing me to hold this important debate today and particularly my hon. Friend the Minister for being here to respond? I am pleased to introduce this debate on such an important subject. A number of people have worked hard on this issue for a long time, and I am glad that their work has now come to fruition in this debate. The debate is on access to medicine for people with terminal illness, which is a subject that I and others have wanted to raise.

Ensuring that people with a terminal illness have access to medicine should concern us all. Unfortunately, such illnesses will affect many people, including many people in Westminster Hall today. It is unacceptable that so many people, when they are diagnosed with an illness, find that no drugs are available to help them to overcome their condition.

I hope that it is an area of common ground that we need to speed up the development and availability of drugs to treat life-threatening illnesses. The current testing and development process is too long, cumbersome and expensive. The Minister and I would agree on that, although we may differ slightly about what needs to be done about it.

A recent report from the Office of Health Economics found that, on average, it takes five years after the launch of a new drug for it to win approval from the National Institute for Health and Clinical Excellence. That amount of time can be more than doubled when added to the time taken for a new drug to go from the development stage through to phase 3 and beyond. It is also very expensive, incurring costs of more than £1 billion, and it can take more than 10 years to bring a new drug to market.

The impetus for this debate came from a meeting I had with one of my constituents, Les Halpin, in Portcullis House last year. The way in which Les set out his views on drug development inspired me to do all that I can for him and his campaign. He convinced me that a great deal of political pressure needs to be applied, to ensure that change is made.

Sadly, Les was diagnosed with motor neurone disease in May 2012. He has a doctorate in statistics, and following his diagnosis, he began to conduct a huge amount of research and talked to as many experts as he could to

“understand the disease that is probably going to kill me.”

Indeed, Les had an interview on BBC Radio Gloucestershire this morning and he was barely audible. However, we have kept in constant contact since we met, and I admire his bravery.

Les told me that, equipped with his research, he began to understand MND better than many medical professionals, which is not surprising given his intellectual ability. The internet is a resource that enables many patients, especially those who suffer from a rare disease, to do the same type of research to some degree. Les poses the question on behalf of patients in similar situations:

“Why should they not be allowed to make informed decisions about their treatment?”

MND is an example of a rare disease for which there is no cure. It is a horrible disease, involving—over a period—all the organs of the body shutting down, leading inevitably to death. About 5,000 people in the UK suffer from MND; one in every 100,000 or so people will be diagnosed with it each year. The condition affects twice as many men as women.

The outlook for people with MND is very poor. People with limb-onset MND will live for three to five years, and people with bulbar-onset and respiratory-onset MND will live for even less time—probably two to three years—but slightly more fortunately, people with other less common types of MND can live for much longer and some people have lived with MND for decades; for example, the physicist Stephen Hawking, who was diagnosed with MND more than 40 years ago.

One medication, called riluzole, can extend the lifespan of some people with MND, but it has a very limited effect; on average, it only extends life expectancy by about three to six months. The drug was developed more than 20 years ago, and in the subsequent years, no new drug for MND has been developed or approved. So the real purpose of the debate is to highlight the lack of new drug development for people with rare and life-threatening diseases.

Having applied his statistical approach to the problem and having talked to leading experts from around the world, Les has concluded that it is very probable that it will require more than one drug to treat MND effectively. The problem is that clinical drug trials normally only test a single drug, which ignores the possibility that, as with the treatment of HIV, a cocktail of more than one drug is required. That is the key. Reform of how we develop, test and approve drugs is therefore crucial. Les sums it up in his own words:

“Imagine a world where MND patients worldwide have access to drugs at this stage of testing—they are proven safe for humans, and possibly known to be efficacious in other neurological diseases, just not for MND specifically. Patients are given the freedom to choose which drugs they think might help them; the process is monitored, and patients and doctors alike can report on their effects. Data is stored centrally, and thus can be analysed to determine the effects of individual drugs and of drug combinations. Ideally this requires some way of objectively measuring the progress of the disease—something which has not been possible in the case of MND in the past.

However, huge strides have been made recently in determining biomarkers for MND—measurable characteristics that reflect the progress of the disease. Biomarkers are also being developed or are available for other rare diseases that would benefit from this approach. Once a volume of data has been collected from thousands of patients worldwide, this can then be analysed and used to inform future research into these diseases, and influence investment from pharmaceutical companies.”

To his immense credit, Les has initiated a campaign to bring focus to such issues. It is called Empower: Access to Medicine and is designed to provide a new platform to open up the debate about the lack of drug development for patients with rare or life-threatening conditions. I am proud to be a trustee of the campaign, which is now a registered charity.

The campaign has already sought out the views and ideas of a range of respected individuals and organisations. For example, Dr Richard Barker, director of the Centre for the Advancement of Sustainable Medical Innovation, has rightly remarked that

“opening up the discussion around the lack of availability of effective drugs for rare and life-threatening diseases is a vital first step on the path towards accelerating new innovative drugs.”

I hosted an event in the House last June to enable a wide range of such people to meet Les and discuss his thoughts. I was particularly grateful to Lord Howe for meeting Les on the same day to discuss his thoughts in more detail.

As a patient-led movement, I believe that the Empower: Access to Medicine campaign has a real role to play in bringing all the stakeholders together. Also, I echo the words of Baroness Masham in a debate in the other place on 20 November last year, when she said that the campaign is

“a unique one, created for patients by patients. It is a powerful voice, rarely heard, but one that I believe could have a real impact on how pharmaceutical companies, regulators, politicians and the general public view drug development.”—[Official Report, House of Lords, 20 November 2012; Vol. 740, c. 1785.]

I will now take a few minutes to raise some of the issues that I believe require consideration by the Minister and her officials.

All drugs can have side effects. It is only through a full understanding of the efficacy of a drug or treatment that a patient can make an informed decision about what they want. From my conversations with Les, I have been struck by the fact that, for patients with life-threatening illnesses, the risk ratio—this is an important point—of “doing nothing”, as Les puts it, is hugely significant. Patients should have the ability to access all information on a drug, even if the risk of adverse effects or failure is great.

The director of Genetic Alliance UK, Dr Alastair Kent, sums it up well:

“Given that there is no such thing as a completely safe drug, the issue becomes one of establishing whether or not the anticipated health gains for patients are sufficient to outweigh the risks inevitably associated with prescribing a powerful (and potentially somewhat toxic) medicine to a patient with a serious and possibly life limiting disease.

Traditionally the evaluation”

of drug safety

“has been made by committees of experts—scientists, ethicists, clinicians etc sitting without patient and family input to their processes in order to reach a conclusion about whether or not patients can be allowed to take the risk. While it is clear that these experts have an important contribution to make, patients and families are”

in these days of openness and information

“increasingly demanding a say in this decision making process.”

The real kernel of the debate is that we address the risk aversion that can too often hold back the development of a new drug. Professor Sir Peter Lachmann, a former president of the Academy of Medical Sciences, and professor of immunology at the university of Cambridge, has argued that risk aversion has

“led to a false perception that most prescription drugs on the shelf are almost entirely safe. Unfortunately this is not (and never will be) the case. This misconception has meant that when things do go wrong people often, if understandably, look for someone to blame. This blame normally involves litigation; and that normally involves significant cost.”

In a recent article for QJM: An International Journal of Medicine, Professor Lachmann sets out his argument in more detail, and I warn Members that this bit of my speech is slightly legalistic. He focuses on the change in legislation in the 1980s, when the Consumer Safety Act 1978 was supplanted by the Consumer Protection Act 1987, which introduced the European product liability directive into UK law. In Professor Lachmann’s view, under the Consumer Safety Act, if a patient agreed to take a medicine that they knew had not been fully tested and thereby assumed the risk themselves, that prohibited any claim by them if some harm later materialised. Unfortunately, the Consumer Protection Act changed that, by introducing a system of strict liability, under which a person or company is legally responsible for the damage or loss caused by their acts or omissions, regardless of culpability.

Professor Lachmann rightly concluded that it is often the fear of litigation that drives a great deal of the regulation of medicines and, therefore, a significant amount of the cost behind drug development. Let us not forget that the cost of new drugs is also preventing small and medium-sized enterprises in the life sciences sector—many of them in our constituencies—from developing in the way that they should.

Professor Lachmann sets out four solutions, and I should be grateful to the Minister if she considered them carefully. First, we should abolish strict liability in this area and replace it with liability based on negligence. Secondly, we should revise the definition of negligence, so that in deciding whether it was negligent to seek to develop a new drug, account is taken of the consequences of doing nothing, as well as the consequences of trying to do something. Thirdly, we should change the law on waivers, so that any patient who is prepared to try a new medicine, with the risk that it may have unknown side effects, is at liberty to do so. Finally, we should, at least in this area, abolish the no win, no fee arrangements.

I was pleased to introduce Les to Lord Howe at a meeting in the Department of Health last June. I should therefore be grateful to the Minister if she set out the latest progress on the early-access scheme, which was first mentioned in the life sciences strategy published in 2011. As Lord Willis of Knaresborough said in the other place recently, the scheme could allow earlier access to drugs than the current regime permits. That is promising, but will the Minister confirm that the Government aim for the scheme is to produce just two to five new drugs a year? What can the Government do to significantly scale that up?

I would appreciate an update on adaptive licensing. There are different interpretations of what it means; but, in essence, it is a more flexible and streamlined approach to research and, I hope, the licensing of new drugs. One objective of the European Medicines Agency is to pilot a new approach along those lines, and my hon. Friend the Minister is to be commended for her decision to bid to host the pilot. Will she therefore outline the latest situation and what plans the Government have to ensure that the UK continues to take a lead on this issue?

I turn now to the report by the Select Committee on Health on NICE. The report, published on 16 January, touched on issues that are highly relevant to the debate. The Committee was highly critical of the delay in setting out precisely what a value-based pricing system for drugs entails. I share its concern, yet the section of the report focusing on research data and access to clinical trial data troubled me most. It is deeply concerning that drug companies have been allowed to withhold information about drug trials. Members should think about that for a minute. If a drug is developed, but it has unwarranted side effects and does not do the job it is supposed to, no one will know about research. Other drug companies will come along, do exactly the same research all over again and will have exactly the same problems. Surely, therefore, it is in everyone’s interests that the information is published.

I therefore fully support the Committee’s recommendation that there should be a professional and legal obligation to ensure that all regulators, including NICE, have access to all available research data about the efficacy and safety of new pharmaceutical products. Stephen Whitehead of the Association of the British Pharmaceutical Industry summed it up well when he told the Committee:

“negative trials often give you as much information that is helpful as positive trials.”

Few people would disagree with the Committee’s argument that it should be neither legal nor ethical to withhold research data about pharmaceutical products that are in clinical use. The Department will respond to the Committee’s report in the coming weeks, and I urge the Minister to reflect on this issue, even if she cannot say anything about it because her response to the Committee is still pending.

The ongoing consultation on the NHS constitution is another opportunity to strengthen patient rights and enshrine them in law. In particular, I urge the Government to seize the opportunity offered by the consultation to give more weight to individual patient choice and to allow patients greater freedom to determine what existing and new medical treatments they undertake. Will the Minister say when the Government will respond to the consultation on the NHS constitution and whether any proposed changes to it will be approved by Parliament?

I want now to move to a slightly different issue, because it would be relevant to mention the accessibility of end-of-life care. If it were not for the fantastic work that nurses and others do, many people who have had an experience similar to that of Les would have suffered a great deal more than was necessary. Some 73% of people, when they reach the terminal stage of an illness, want to die at home, surrounded and comforted by their family and friends, and it is a dismal fact that only 27% are currently able to do so. Access to a community or specialist nurse is a requirement for those who want access to medicine but who are unable to self-administer. This is a twofold problem, which can be solved only when adequate time is spent on the issues of access to medicine and end-of-life care.

I hope that the debate will ensure that these issues remain firmly on the agenda of my hon. Friend and her fellow Ministers. Many colleagues, from all parties and in both Houses, have taken a keen interest in these and related issues. Through his Medical Innovation Bill, my noble Friend Lord Saatchi seeks to address the issues that hold back innovative practice in the treatment of patients with life-threatening conditions. He has spoken movingly of his experience and that of his wife in this regard.

If the debate can in any way contribute to that process, it will be a fitting legacy for Les Halpin and his excellent campaign. Several people have asked me what the debate is all about, and the answer is simple: how would any of us who, God forbid, might develop a terminal illness gain access to an effective medicine? In future, what we need are not terminal illnesses, but treatable illnesses.

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[Jim Shannon]

Those are the sort of responses we hope to hear, because they show that the Government are working. The Minister, as we knew she would, has come up with a practical, physical response, and is doing the things that we have been hoping will come out of the debate. I thank her for initiating the process she outlined, and for moving things forward.

I am pleased to support the hon. Member for The Cotswolds in his cause of drawing attention to motor neurone disease, cancer and other illnesses, so that a treatment path will not be simply a step along the road to the end of life, but may enhance the quality of life. Perhaps a successful treatment path can be developed. According to Empower: Access to Medicine,

“Speeding up the development and availability of drugs that treat life-threatening diseases would benefit everyone in society.”

I believe that too. Everyone present will know people whom new drugs could help. The current testing and development process is long, cumbersome and expensive. In fact, a recent report by the Office of Health Economics found that it takes five years, on average, after the launch of a new drug, to win NICE approval. That time scale can be more than doubled when the time taken for a new drug to go from the development stage through to phase 3 and beyond is added. As an example, no new drug has been approved for motor neurone disease since riluzole was approved 20 years ago. Are we happy to sit back and rely on that one drug, or should there be more research? We need more research; we need to fund it, and we need it to be made possible.

Currently, pharmaceutical companies do not have a financial incentive to invest in developing new drugs for rare or “orphan” diseases—I am being careful in my terminology—because of the small number of the population who are affected and the high and uncertain costs of the drug development process. The drug regulatory regime is therefore clearly having a significant impact on those with life-threatening and rare diseases.

Just yesterday, the shadow Secretary of State held a meeting on special commissioning. Five speakers introduced the issues. The gentleman who spoke on cystic fibrosis said that drugs are available only in certain parts of the United Kingdom. He is worried that we are setting an imbalance, which I have taken up with my colleague back home, Edwin Poots, the Minister of Health, Social Services and Public Safety, to ensure that cystic fibrosis drugs are available to sufferers when they need them not only in England, but in Northern Ireland, Scotland and Wales.

The panel hosted by the shadow Secretary of State outlined the need for drugs allocation. There was a guy representing HIV patients, and 100,000 people in the United Kingdom are receiving HIV drugs to prolong their life. The man who spoke yesterday has lived for 20 years with the drugs that are available, but are those drugs available across the whole United Kingdom?

[Geoffrey Clifton-Brown]

I am extremely grateful to the hon. Gentleman for making those extremely good points. The point he makes about cystic fibrosis crystallises the health service’s dilemma. A small drug company came to me the other day, and told me that it has developed an absolute cure for a certain type of cystic fibrosis if it is caught very early in life. The problem is that the drug will have to be administered for life, and the life cost of the drug for the very small number of people whom the drug will absolutely cure, and whose quality of life it will improve, is £180,000. That is why his remarks on the need to drive down the cost of developing drugs in this country are so important.

[Jim Shannon]

I thank the hon. Gentleman for his constructive intervention. I take his comments on board, and I believe the Minister has a willing ear, too.

[Geoffrey Clifton-Brown]

My hon. Friend the Minister reminds me sotto voce that I was corresponding with her, and I am extremely pleased to say that she has approved the drug I mentioned. So that small number of people will now have an absolute cure.

[Jim Shannon]

If this goes on much longer, I would want the Minister to reply to every Westminster Hall debate, because we have asked for two things and got them both, which is good news.

I will now illustrate the need for drugs for three categories of people. The first category is those with dementia. There has been debate in the House and in the papers over the past week on dementia treatment. In Northern Ireland, we do not have the highest diagnosis rate for dementia in the United Kingdom, but at 63% the diagnosis rate is high. The support services are perhaps not as equal to that as they should be, which we will take up with the Minister to see how we can improve.

The facts are that some 370,000 people have not yet been diagnosed for dementia treatment—first it is diagnosis, and then it is drugs—so there is a combination of how the health system works best. People are given drugs including Aricept, which reduces symptoms and slows progression. The drugs might not always cure the ailment or disease, but they certainly can improve life and make it a wee bit more amenable.

The second category is cancer, and there will not be a family in the whole country that has not been touched in some way by cancer. The Government have set up what they refer to as a “fast track” for cancer patients. There is some indication that the fast track is perhaps not working in the way that it should, but the Government have a £750 million cancer strategy, which plays a key role. As with dementia, the strategy is diagnosis, early intervention and prevention through all the surgeries and clinics across the United Kingdom.

The third category is breast cancer. A new breast cancer drug has had some coverage in the press over the past few weeks. The Minister has been tremendous in her response to our points, and perhaps she could give us some indication of how that drug will be made available to those with breast cancer. The drug has the potential to prolong life. The papers have said that, for some people, the drug can prolong life for 20 years. Such drugs must be available if that is the case. I am keen to hear how that will go.

It is long past time to take active steps to ensure that terminally ill patients or patients with life-threatening conditions are not simply given a form of end-of-life care—it has to be more than that—but are treated for their conditions. New drugs and medications should be actively sought, instead of accepting a diagnosis of illness as a death sentence.

The hon. Member for The Cotswolds mentioned hospice care. We are fortunate to have so many organisations, and if I name some, I will leave some out, so I am not going to name any. They all do tremendous work. The hospice care those organisations deliver to the person who is dying or recuperating and the help they give to families is tremendous. We owe them a lot.

I support the hon. Gentleman in this debate, and I am disappointed there are not more people here, because it is a debate that affects us all. Our constituents would be keen to ensure that we are involved in this debate.

We have been fortunate this morning to have very positive responses from the Minister, and I look for more. What steps are this Government, and our Government in Northern Ireland, taking to ensure that another five years are not lost and that we can make a change to bring hope, instead of despair, to those who refuse to accept a one-size-fits-all diagnosis and who wish to have access to the best drugs available at a price we can afford and that delivers more treatment and care for everyone?

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[Mr Jamie Reed (Copeland) (Lab)]

It is a pleasure to be called to speak under your chairmanship again, Mr Caton.

I extend my sincere thanks to the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) for securing this important, emotive and timely debate. He laid out the issues in a compelling fashion, complemented by the testimony of other Members from across the House. The debate comes a day after my right hon. Friend the shadow Secretary of State held a specialist commissioning summit in the House to discuss some of the very issues before us today.

When dealing with terminal illnesses, it is important to recognise all of the lives affected by terminal and degenerative illness. It is important that stories and experiences of those with such diseases inform our debate, so that we do not focus purely on statistics. Behind every statistic is an individual and a family with real human issues that wear no party colours, and they may have no interest in our party colours. I am sure that all hon. Members have experience of constituents who have suffered from such debilitating illnesses and realise the importance of doing whatever we can whenever we can to improve their access to treatments that could improve their quality of life. I express my most sincere best wishes to those people dealing with terminal conditions today, and to their families, carers and everyone whose lives they touch.

I also praise the constituent of the hon. Gentleman, Mr Halpin, for the work that he does to highlight the issue and to push for improvements and greater access to drugs to improve palliative care. Today’s debate is proof that this place can be influenced by the public and by individuals—individuals can make a difference. We must look at what we can do to improve access to medicines and we must continue to explore ways and methods to encourage the synthesis of new drugs and to make those available to patients as soon as possible, while also maintaining the fundamental focus on patient safety, as has been said. That is a fine balance to strike and I look forward to learning how the Minister plans to address it.

Making new, safe and effective treatments available to all patients who require them must be the end goal, but it cannot be an isolated goal. We must look at ways to increase the availability of already licensed drugs and we must look at non-drug-based treatments as well, which can vastly improve the quality of life for patients in need. A number of charities have expressed a view that a move to adaptive licensing of drugs could benefit patients. The European Medicines Agency suggests:

“Adaptive Licensing seeks to maximise the positive impact of new drugs on public health by balancing timely access for patients with the need to provide adequate evolving information on benefits and harms”.

It must be recognised that adaptive licensing would bring a number of benefits, such as encouraging pharmaceutical industries to develop new drugs and to bring them into service quickly. It is suggested that new drugs could be available after phase 2 testing, the main focus of which is safety rather than efficacy.

There are, however, a number of issues with that approach. After phase 2 testing, drugs might be expected to be safe for human consumption, but the efficacy of any drug would still not be proven. Going on to prove efficacy at stage 3 could raise some ethical and personal difficulties. At present, a phase 3 trial is needed to demonstrate that any drug is effective. Under adaptive licensing, would those with early access be classified as part of a conventional phase 3 trial? If early access formed part of a conventional phase 3 trial, would existing trial guidelines be maintained for the use of data received on early access recipients? Clearly, ethical and personal issues would arise from both questions.

First, how can the efficacy of one drug be compared with that of another, existing drug, or with a placebo? Using blind tests in which one drug is administered to one group, and another drug or placebo is administered to another group would raise ethical issues. Doctors might knowingly deny access to a drug that has been proven to be effective because of the chance that a new drug could also be effective. Secondly, on a personal level, how could we be sure that patients are fully comfortable with and aware of the risks of taking medicines before they are fully approved under the current system? I acknowledge the point made by the hon. Gentleman about the patient being in charge of the choices with which they are presented, and more fundamentally in charge of their own treatment and destiny.

We must be careful not to suggest that adaptive licensing is risk-free and the only logical solution to a problem. Patients participating in early adoption of medicines might have better access, but there would be clear and obvious risks. That is not to say that we should discourage the synthesis of drugs that are less effective than those that already exist. The development of drugs is clearly a highly precise science, but the application and treatment of medicines sometimes resembles an art form. For some patients, the most effective available drugs are useless and, for want of a better phrase, less effective drugs could be invaluable.

I raise these issues not because we should oppose the introduction of adaptive licensing, but because we must fully explore the ramifications of introducing a change on this scale, and I look forward to hearing how the Minister plans to tackle these delicate and fine issues. We must also understand what it would mean for our life sciences and our research and development capability in the UK, but first and foremost, and fundamentally, what it would mean for patients and patient choice.

In the spirit of this debate, we should look at ways to improve care and provision of other types of available treatment, such as care facilities in communities, and assistance for patients at home. The care a patient receives does not depend solely on the medicines they receive, although clearly that is hugely important, and we should continue to explore ways in which that can be widened.

It must be noted that, as other hon. Members have said, very few drug options are available to people with terminal illnesses such as multiple sclerosis and motor neurone disease. As well as doing everything we can to speed up the development of new drugs while protecting patients’ well-being, we should explore other methods of treatment for those with terminal illnesses. We must all acknowledge that the NHS is always changing as society changes. The art of drug and medicine application demands a more bespoke and tailored patient experience and more wide-ranging treatments.

The principle behind adaptive licensing is commendable, and one that anyone would find difficult to oppose. It would ensure better access to drugs, but it would not necessarily alter things that much. As has been said, pharmacology recycling bins are filled with trials for promising new medicines that ultimately proved to be ineffective or even dangerous. Loosening access to trial drugs requires greater peer reviewing of early data and methodology to ensure patient safety.

There is a strong argument for allowing more off-label prescribing of drugs that have already passed safety tests. They could be an option open to doctors and patients if they are believed to be effective in treating a condition they were not originally intended for, and I would be extremely interested in hearing what the Minister has to say about that. Even if adaptive licensing was adopted now with a robust system of safeguards in place to protect the well-being of patients, those with terminal illnesses would not start to see improved access for a number of years. We are all aware that drug manufacturing does not happen overnight.

One of the harsh realities of debates such as this is that changing regulations today will not benefit patients tomorrow or the day after. What we need right now is improved care for those with terminal illnesses, and support for their carers. Improved facilities offering specialised care would go some way to improving patients’ quality of life, as would earlier, faster diagnosis of terminal conditions. All Members of Parliament have heard of cases of suffering that could have been prevented, and diagnosis that could have been earlier, resulting in a better experience for patients and their families.

Access to drugs may vary throughout the country and that cannot be tackled by a fractured system. That is a huge concern as we move towards April and beyond. I hope the Minister will explain how she can guarantee that a clinical commissioning group in Cornwall meets the same standard in access to medicine as a group in Cumbria. Adaptive licensing would improve access to drugs, but not without risks, and I hope the Minister will be able to outline a safe and secure framework that could be put to the House for greater scrutiny. At this stage, not enough research has been done to guarantee that access to drugs can be expanded through adaptive licensing without exposing patients to ineffective and potentially dangerous drugs. I hope that much more work will be done to show that a patient’s well-being and quality of life can be protected while ensuring that more drugs are made available.

[Geoffrey Clifton-Brown]

The hon. Gentleman has touched on an important matter than has not yet arisen in this debate: the possibility of different protocols for prescription of medicines by different clinical commissioning groups. My gentle suggestion to the Minister is that it would be unacceptable if the new system developed a postcode lottery whereby people in some areas had access to a new drug, but people in others did not.

[Mr Reed]

I thank the hon. Gentleman for his contribution. He is entirely right, and I do not believe that any hon. Member in the House would want that. Many of us have seen and read accounts of the problem he illustrates, and we must not hasten any further move towards that. We should all seek to address such issues as and when they occur.

The hon. Gentleman intervened just as I was coming to the end of my remarks, and I look forward to hearing the Minister’s response.

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[Anna Soubry]

I cannot give a short answer in this debate, but that is important and it has been raised by a number of hon. Members. On that basis, I will ensure that a proper and full written response is given, both to the hon. Gentleman and all other hon. Members—I suspect that my hon. Friend the Member for Southport and the hon. Member for Strangford will also be interested in the answer. All present will certainly get a written answer to that, because it is an important point; clarity is clearly being sought, and it will be given.

Returning to NICE, once effective new drugs are brought to market, it is important, as we all know, that they are made available to the patients who will benefit most from them on terms that represent value to the NHS—that means, of course, value to the taxpayer. NICE has played an important role in that by providing robust, evidence-based guidance to the NHS on drugs and treatments. In the great majority of cases, NICE now publishes draft or final guidance on significant new drugs within a few months of their launch. In 2011, for drugs appraised using its single technology appraisal methodology—the methodology used for the great majority of new drugs—NICE issued draft or final guidance an average of four months after the date of market authorisation. The end-of-life flexibilities introduced into NICE’s appraisal process from 2009 have allowed a number of important drugs for terminal illnesses affecting a small number of patients to be made available on the NHS.

The NHS constitution sets out patients’ rights to medicines positively appraised by NICE, underpinned by a statutory funding direction. In December 2011, the NHS chief executive’s report, entitled “Innovation, Health and Wealth”, introduced a NICE compliance regime to help to ensure that medicines approved by NICE are made available on the NHS quickly and consistently. Furthermore, since the cancer drugs fund started operating in October 2010, more than 25,000 patients have received cancer drugs that they would previously have been denied. Our priority is to give NHS patients better access to effective and innovative medicines. That is why we will move to a system of value-based pricing for new branded medicines from January 2014, following the end of the current pharmaceutical price regulation scheme.

[Geoffrey Clifton-Brown]

I am grateful to the Minister for giving way, because I sense that she is coming to the end of her speech. Could she comment on two aspects that I raised? The first is the early access to medicines scheme. Quite rightly, the current licensing scheme is intended to eliminate all risk, but could there not be a system whereby, for people with a terminal illness, a drug might be given a provisional licence on a fully informed patient basis so that it could be trialled by those people, perhaps for the benefit of others coming along afterwards? Secondly, could she comment on the issue of strict liability—the legal liability for drugs of this sort being given, which makes it very difficult for people to use such techniques?