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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.
Jim Shannon (Strangford) (DUP)
I congratulate the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) on bringing the matter to the House. I want to focus on the end-of-life issues that he dealt with in the second part of his speech. Obviously those concern us all, but I want to concentrate on them because of several interactions that I have had with constituents on the subject, and because there is a need for drugs. I am confident that the Minister will respond positively and I look forward to her comments.
I have spoken recently about ending the so-called GP death list—a term that I use very carefully; some people see end-of-life issues in that way and are concerned. I was shocked when I read an article that stated that thousands of patients have already been put on those so-called registers,
“which single them out to be allowed to die in comfort rather than be given life-saving treatment in hospital”.
That is one thing that has emerged from discussions that have taken place. The article states that nearly 3,000 doctors have promised to draw up a list of patients they believe are likely to pass away within a year. It is claimed:
“As part of an unpublicised campaign endorsed by ministers, GPs have been encouraged to make lists—officially known as End of Life Care Registers”—
which the hon. Gentleman mentioned towards the end of his speech—
“of people they believe are going to die soon and should be helped to do so in comfort.”
That is the terminology that is used. In my opinion if a patient refuses further treatment this is their decision, not the doctor’s. Treatments must be made available throughout the NHS to those who want and need them—those who need care.
How many times have we heard of patients with no hope suddenly going into remission? An example concerning a child with cancer recently came to my attention. The doctor advised no more treatment, but the sister of the little boy was not ready to say goodbye, and for her sake the family asked for one more course of chemo to prolong the time left and prepare the other child for the expected death. The little boy responded to the chemo that was given in the hope of allowing a few more weeks of life; but that time has turned into six months. Who knows what the future holds? The point I am making is that there are probably many examples from across the United Kingdom where a wee bit of extra effort can be made and where it may not be necessary to prepare for the inevitability of death, if there is also a possibility of life through drug treatment. Imagine if that family had not been allowed to ask for, or the doctor had had the power simply to refuse, the last bout of chemotherapy. That is not an everyday occurrence, but it does happen and it should give us reason to pause and think before making drastic moves.
In 2008 the Labour Government announced a range of proposals aimed at improving the care available to patients with life-threatening conditions. They stated that a key part of the new proposals was a change to the way the National Institute for Health and Clinical Excellence decides which medicines are approved for diseases that affect only small numbers of people. The hon. Gentleman focused in his speech on some diseases that do not kill a great many people in the United Kingdom, and on which, therefore, drugs companies do not spend money; but perhaps they should. I want to discuss that issue. What has changed in the past five years? Is there a greater availability of drugs? I am not sure that that is the case, and would appreciate confirmation from the Minister of how many more medicines have been approved on the list. Many UK universities do great work investigating drugs and conducting research with pharmaceutical companies, and Queen’s university Belfast is one of them, at the forefront of the good work being done on new drugs for ailments including cancer, diabetes, and dementia and Alzheimer’s. Students come from all over the world to do research and to learn there. I commend the university, which has been able to source individual funding, and the many other UK universities doing similar work.
The campaign Empower: Access to Medicine, set up by a man suffering from motor neurone disease, recently caught my eye. The campaign calls for a review of the law and ethics on drug development, as it takes many years and billions of pounds to take a new drug to market from A to Z. The last drug licensed for motor neurone disease, which damages the nervous system, leaving muscles wasted and weak, was riluzole, which has been in use for 20 years. Can there have been no scientific advances since then? I do not believe that. Les Halpin has commented that
“to see primarily it’s the regulations that are slowing the whole process down, it just means we could be waiting an awful long time until a new drug is produced.”
I have a dear friend, whom I have known for many years, who has motor neurone disease. I have seen a healthy man go from being a fun person in the peak of health to someone wasting away in a chair. The drugs have given him a longer life, and perhaps a better quality of life latterly, but they cannot stop the onslaught of the disease. The finality of what will happen to him is clear.
Mr Gregory Campbell (East Londonderry) (DUP)
Does my hon. Friend agree that beyond the difficult and onerous issue of NICE approval of drugs that he and the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) outlined, and which needs to be resolved, is the cost of drugs, post-approval? We need more work to be done on dragging down the cost, to make them more accessible.
Jim Shannon
There are parts of the world where drugs can be made more cheaply, and they include India. The drugs in India are equal to those made in the USA, for example, but can be made more cheaply. Why do not we obtain those similar drugs, at a cheaper price, so that we can provide the relevant care, as my hon. Friend has suggested? We should take that on board.
The Parliamentary Under-Secretary of State for Health (Anna Soubry)
I hope that the hon. Gentleman will be interested to know that last week I went to India where I had that precise conversation with several organisations. We hope that a memorandum of understanding will emerge, involving the regulatory bodies with which I had meetings. The hon. Gentleman is right to point out that we can take advantage of the great work being done in India to produce medicines that are just as good as those made anywhere else, and often at a fraction of the price.
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?
John Pugh (Southport) (LD)
I thank the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) for introducing the debate and explaining this important issue so well. I also pay tribute to Les Halpin, whom I had the privilege to meet. I use the word “privilege” exactly, because it was a privilege to meet someone who is so afflicted and yet so thoroughly constructive.
I once had the opportunity to attend a session with the National Institute for Health and Clinical Excellence when it was investigating a particular drug for a complaint called ankylosing spondylitis—I have not written that in my notes, so Hansard is on its own. The session was robustly and impressively chaired, and the drug and issues concerning it were thoroughly examined. During my period in Parliament, NICE has come up again and again, and various complaints have been raised by Members of Parliament, the pharmaceutical industry and patient groups. One complaint is about the inordinate time it often takes to develop a drug, which certainly appears to be the case; the other complaint, made by big pharma, is the cost that NICE adds to the development of drugs.
The example of India has been cited, but I am not sure that that is a good parallel. I have been to India and spoken to pharmaceutical companies out there, and they seem to specialise not in developing the more esoteric lines of drugs but in developing and marketing lines of generic drugs or taking up drugs that are out of patent and producing them at less cost than their western counterparts.
NICE would genuinely acknowledge that it adds to the cost of development, but there is also a question about its rigorous but circumscribed methodology. There were many debates in this place a few years ago about Alzheimer’s drugs, and the issue appeared to be not that the drugs do not work, but that they do not work for everyone in a sufficiently predictable way for NICE to approve them; although I have met constituents who can genuinely testify to the benefit of a drug that NICE is not prepared to go with. Of course, there are similar cases in which people genuinely disagree with NICE’s decisions. Most Members of Parliament will, at some time during their career, write a letter on behalf of a constituent who simply cannot get a drug because a primary care trust is sheltering behind the mantra that NICE does not approve. All that set aside, NICE represents a model that has been emulated worldwide, because with NICE we end up with cost-effective, efficacious and safe drugs.
To go back to the case I witnessed in NICE headquarters many years ago, I was surprised that sufferers with that particular complaint were in the room and thoroughly involved in the process. As the process went on, however, I discovered that one of the people—the reference point, as it were, for the piece of research—had died during the project. That, perforce, will happen many times if one enlists people already diagnosed with a terminal illness; some people’s needs are more urgent, some have less to lose and in the case of terminally ill people, some are not classified in that way unless there is no available cure.
A reasonable case can be made for relaxing the rules, to have more trials and to get more innovation in such circumstances; patients, science, medicine and future patients would all benefit, provided, of course, that the patient was genuinely a volunteer and properly advised of the risks. Another proviso I have just thought of, as India was mentioned, is that the volunteer was afflicted with the particular complaint, because in no way would we be happy with a world where people were trialling drugs for reasons other than their own benefit.
The question is, should we have a more flexible system than the orthodox one that we have put in place through NICE? I was at a breakfast this morning about NHS research, and I was pleased to learn that over the past decade or so, the number of NHS patients featuring in research has increased appreciably. Apparently, a decade or so ago, only about 2% of cancer patients featured in a clinical trial or piece of research, whereas now the figure is some 20%, which is a significant improvement, so we must not kid ourselves that even in the orthodox setting of the NHS valuable pieces of research are not being conducted.
As I see it, there are still arguments against what Les is suggesting, and he must be acutely aware of the force of some of those arguments. The Minister is a lawyer and, even with a disclaimer in advance, it is difficult to avoid the spectre of litigation if a drug that has not been thoroughly stress-tested is in use; it is hard to assure oneself that it is not at least a possibility. Cost might still be an issue, if the drug is very expensive, and the NHS has to consider carefully whether to spend a lot of money, perhaps to no effect. There is always the possibility of an unsafe medicine or of one that has not been thoroughly tested having catastrophic effects and worsening someone’s decline. That can happen even when the drug is tested; everyone can recall that thalidomide was tested, quite thoroughly in some respects, but not to the nth degree, with disastrous consequences.
Such entirely valid considerations are not a case against a different regime in principle, they are a case against what might be regarded as a gung-ho approach. After all, as the hon. Gentleman said, all medicines have side effects. The worst thing someone can do when prescribed a medicine is to take out of its box the long sheet listing all the possible side effects; if they read it, they simply would not take the medicine, regarding themselves as safer by not taking it. Where a drug has no known side effects and there are genuine grounds for belief in its potential benefits, some sort of pre-approval system is genuinely arguable for terminally ill patients, rather than having to wait for full NICE approval—the full works. Flexibility is not a non-legitimate demand in any context. We have to bear in mind that although there are general rules, there will always have to be sensible provisos, exceptions and caveats about an application.
I am reminded of the forthcoming ban on the use of opiates when driving. I am obviously keen that people under the influence of methadone or heroin do not take those drugs and then get in a car. Some people, however, have long-term, chronic conditions and are taking an opiate, but they are well used to the symptoms provoked and could or should be safely allowed to drive a car. I am sure that they would drive the car with no difficulty at all. Whatever rules we have need to be flexible for such cases. Likewise, whatever rules we have about the safety of medicines need to recognise that for some people, the environment in which they are taking the medicines, their circumstances and the risks they face are quite different. We need flexibility, where the risks are limited and where the benefits to science and the individual are potentially massive. There has to be an intelligible response of some sort to the sincere request made by the hon. Gentleman and by Les Halpin.
Furthermore, I agree with the hon. Gentleman on another extremely important issue—I did not expect him to raise it, but he did. If we are looking at a more innovative, research-based NHS, it would help enormously if pharmaceutical companies signposted the dead ends they have been down, indicating where things had not worked. That would save enormous sums of money, possibly for their competitors but certainly for the health of the nation and the NHS. I congratulate the hon. Gentleman and reiterate my sincere tribute to Les Halpin. I hope that he is in good shape today and listening to the debate, and that we can get a result for him.
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.
The Parliamentary Under-Secretary of State for Health (Anna Soubry)
It is a pleasure, Mr Caton, to serve under your chairmanship. I congratulate my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown) on securing this debate on a subject of which he clearly has considerable knowledge. I thank other hon. Members who have spoken, and pay tribute to the work done by Empower: Access to Medicine, particularly that of Mr Les Halpin, who has been spoken about in glowing terms. I add my good wishes to him to those of my hon. Friends the Members for The Cotswolds and for Southport (John Pugh)—the latter is giving me a thumbs-up, as I remembered the correct name of his constituency. A great failing of mine is not to remember it. I hope that Mr Halpin is able to watch this debate, and I know that he and many others will want to read it.
If I may say so, the debate is a good example of Parliament at its absolute best. Yet again, there is a story in one of the papers criticising Members of Parliament for expenses properly incurred. If only the press, instead of printing another knocking story, would come along and listen to debates such as this when important issues are put into the public domain with care and considerable knowledge. As is often the case in such debates in Westminster Hall, there has been an outbreak of political unity. Political parties play no part in this issue, and Members properly ask the Government tough questions. I pay tribute again to my hon. Friend the Member for The Cotswolds because he is a pleasant thorn in the Government’s side, and properly so. He has raised and is championing an issue that a constituent brought to his attention, and is holding the Government to account.
I fear—well, I know—that I cannot answer all the questions that my hon. Friend and the hon. Member for Copeland (Mr Reed) have asked and, as is the usual rule, if I cannot do so, my excellent officials will provide written responses. The matter is not in my portfolio—I am not making excuses—so I am not particularly familiar with it, and I am grateful for the excellent briefing that has been provided by my officials. Perhaps I will be forgiven for reading out a large part of my speech, which I do not normally do because I like to look as though I understand everything I am speaking about, but the subject is important and technical.
I would like to take credit for the approval of Kalydeco, a drug for cystic fibrosis users, but it was the National Institute for Health and Clinical Excellence that gave approval for it to be prescribed. The only reason I know anything about it is because one of my constituents wrote to me. A cystic fibrosis campaigning group has quite properly been contacting Members of Parliament, urging them to make all the representations that they can about the benefits of the drug. A very small number of people will benefit, because it relates to those who have cystic fibrosis because of a particular genetic disorder, but it will undoubtedly revolutionise their lives. I was certainly pleased to see that it will now be available for prescription.
The development of new medicines is a long and expensive process, as we all agree. The Association of the British Pharmaceutical Industry estimates that only one in 5,000 researched new compounds receive regulatory authority approval, taking 10 to 12 years on average. That is the scale of the research and the difficulties, in many respects.
The life sciences industry is undergoing rapid change. The time and cost involved in developing new medicines is rising, and the old “big pharma” model of having thousands of highly paid researchers working on a pipeline of blockbuster drugs is declining. A new model of collaboration, about the outsourcing of research and early clinical trials on patients, has emerged. Many patients with serious or life-threatening illnesses, who understandably expect that they should be able to access the latest and most effective treatments, feel that regulatory procedures can hamper access.
Turning to life sciences strategy, this country has a strong history of drug discovery and development, and improving access to medicines has long been a Government priority. The “Strategy for UK Life Sciences” was launched in December 2011. Recognising the issues facing the life sciences, the 10-year strategy includes measures to support innovation and early-stage development. My right hon. Friend the Prime Minister published a progress report and refresh of the strategy only last month.
My hon. Friend talked about adaptive licensing, as did other hon. Members. I would like to set out the arrangements that we are putting in place for an adaptive licensing pilot programme, with the objective of advancing and maximising the potential of existing flexibilities in the drug licensing processes to improve public health and stimulate innovative drug development.
The Medicines and Healthcare products Regulatory Agency—I shall refer to it as the MHRA, as opposed to its otherwise very long name—has convened an expert group on innovation in the regulation of health care and agreed to a tripartite programme to take that work forward. It includes work at EU level on how the existing flexibilities in EU regulation can be used to bring forward innovative products; work at national level exploring options to help companies maximise the potential of existing drug licensing processes; and work at arm’s length from the MHRA and Government. The co-ordination of some other activities required for the pilot will be undertaken by the Centre for the Advancement of Sustainable Medical Innovation, including the exploration of suitable candidate products. However, pharmaceutical companies must come forward and nominate candidates for adaptive licensing.
Last year, we consulted on an early access scheme to make certain new and promising medicines available to patients in the UK before they are formally licensed. The MHRA is currently assessing the consultation responses. If introduced, the early access scheme would be designed for promising new medicines that will treat, diagnose or prevent life-threatening, chronic or seriously debilitating conditions without licensed treatment options. It would provide a scientific opinion from the MHRA on the benefits and risks of a new medicine about a year before the licensing process was completed. That additional information would assist both clinicians and patients in making treatment decisions in areas of unmet need, such as those described earlier by my hon. Friend. Both programmes are in a very early stage of development, as I think we all appreciate, and we will have more to say on that in the near future.
Turning to stratified medicines and genomics—I cannot pronounce it, but I am sure that Hansard will correct me if I get the word wrong—ongoing work on stratified medicines will improve our understanding of why groups of people with particular diseases respond differently to treatments. That point was very well made by my hon. Friend the Member for Southport. Our initiative to sequence 100,000 whole genomes from NHS patients will provide valuable information for researchers to gather new insights into health and disease and to develop new diagnostic tools and treatments.
Rare diseases are classified as conditions affecting no more than five in 10,000 people in the EU. Patients with rare conditions deserve the same quality, safety and efficacy in medicines as those with more common conditions. Since the pharmaceutical industry has little interest, under normal market conditions, in developing medicines intended for small numbers of patients, the EU offers a range of incentives to encourage the development of what are called “orphan” medicines in order to address the unmet clinical need.
Applications for the designation of orphan medicines are reviewed by the European Medicines Agency’s Committee for Orphan Medicinal Products—in its short form, the COMP. Via the MHRA, the UK takes an active role in the decision-making processes at the COMP, ensuring that applications for orphan drug designation are appropriately recognised and encouraging companies to develop their products further. Taking that one step further, I join the hon. Member for Strangford (Jim Shannon) in paying tribute to the research being undertaken at Queen’s university Belfast, and I know that many other universities throughout the whole United Kingdom are doing research into that sort of medicinal pharmaceutical advancement. They do not have some of the constraints of pharmaceutical companies, or perhaps the desire that some of those companies have to make a profit, so it is often universities that are best placed to do some of that invaluable research and development.
Jim Shannon
The work that is done at Queen’s university could not happen without partnership with the pharmaceutical groups, and clearly, they can use the partnerships to their advantage in creating new medicines. Partnerships are what life is very much about. A partnership is how we can work together to make it better, and that is a partnership that can work.
Anna Soubry
I am grateful for that intervention and I completely agree. It is great when we see business working with our universities on research. It can be highly productive and undoubtedly mutually beneficial, including to the rest of society, and that collaborative approach is much to be welcomed. It is fair to say that many universities, at first, had a bit of resistance to working with business, seeing it somehow as sullying themselves. However, over time they have recognised the absolute mutual benefit to both and, of course, that includes, should it be successful, a benefit to society.
Mr Jamie Reed
I am grateful to the Minister for her contribution. It is clear that there is an emerging cross-party consensus—dare I say it, a coalition—which is a tremendous sight to behold for everyone who cares about this issue. She talks about the difficulties posed by the research and development sector when it comes to manufacturing medicines for orphan diseases, and the costs inherent in producing them because of the market basis on which they are produced—no argument there. However, could she explain how that might affect the commissioning choices of clinical commissioning groups when it comes to purchasing those very same medicines, given the inherently inflated costs?
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?
Anna Soubry
I am very grateful to my hon. Friend for raising those points. As he will understand, I cannot give a commitment either way on them, but they are very important points—points that I took not only out of his speech, but out of the speech of my hon. Friend the Member for Southport, who referred to me as a lawyer. I am a criminal lawyer, but I am not trying to take any responsibility for this, because it is a long time since I studied negligence and strict liability. However, I absolutely accept that there is a very strong argument to be made that the current state of the law does not help. Equally, there is a strong argument, as has been advanced, about people with a terminal illness being able to be prescribed medicines on a provisional basis, in precisely the sorts of conditions that my hon. Friend the Member for The Cotswolds described.
The hon. Member for Strangford, in particular, raised end-of-life care. That is a very difficult issue. It is the subject of almost endless debate in this place, or at least it should be. For what it is worth, my personal view is that often these matters should be the subject of discussion between a patient and their GP. Although it was many years ago that my father faced a terminal illness, he spoke at length, before the final stages of his illness, with our then general practitioner, who was utterly brilliant, about his death and how that death could be in some way planned for, if it is ever possible to do such a thing. Sometimes that can be done. There is sometimes a certain amount of flexibility to be able to plan a death and to say what one does and does not want. These are intensely personal matters. I sometimes think that there is a danger of over-regulation and almost too much transparency, if there can ever be too much transparency. Sometimes it prevents what should be very private discussions.
The other thing to say is that families, too, often feel excluded from many of these decisions. It is important that families are involved as much as possible, especially when the person is quite elderly. We all know the sorts of case that exist. Perhaps this is an old-fashioned view, but I think that the unique and very special relationship between a patient and their GP—perhaps their nurse as well—is incredibly important, and there should almost be an acceptance that it is between the two of them in the final stages.
Like many Members, I suspect, as a constituency MP I have received letters from constituents who have spoken with real distress about their hopes for the final stages of a loved one’s life just not being recognised. I think that it was the hon. Member for Strangford, or perhaps it was my hon. Friend the Member for The Cotswolds, who talked about the number of people who wanted to die at home but were not able to do so. [Interruption.] It was my hon. Friend, but I am sure that the hon. Gentleman would take up the point as well. As I said, a number of my constituents have spoken very movingly about this. I am thinking of one particular case in which a woman described how she had sat and talked with her late husband about the desire for him to die at home. They were sensible people who had thought these things through, but as it happened, because of a failing in palliative care—we have not got it all right, by any means—that did not happen. That is terribly sad and, frankly, in many cases there are no excuses for it. I am digressing, Mr Caton—forgive me—but I think that we should be able to have a more open and honest debate, which would then bring up the very issues that my hon. Friend has raised.
I have almost concluded my remarks, but I want to touch on a very important point raised by my hon. Friend the Member for Southport about India. I think that I am right in saying that he said that, in his opinion, India did not have a particular history of innovation in creating new drugs. But my view is that it does have a remarkable capacity to look at existing drugs and produce them considerably more cheaply than other countries, including ourselves.
When I went to India last week, one of the things that I came away with was that what drives the Indians is affordability. As might be imagined with a population of 1.2 billion, there are excruciatingly high levels of poverty and deprivation, but there is also an emerging health care system. I know that there is a great deal of research, which is being led by the desire of doctors to improve clinical outcomes. The doctors often go to great research institutions and say, “How can you help us to develop this?” or “How can we solve this problem?” There is therefore innovation in India but my hon. Friend’s point was a good one.
I understand that the development of new drugs for rare and life-threatening diseases is vital, and it is important to the coalition Government. I hope that I have been able to illustrate the breadth of the work that the Government are undertaking to improve access to new and existing medicines for NHS patients and to encourage the development of important new drugs to treat life-threatening diseases. I can assure my hon. Friend the Member for The Cotswolds and others that the Government’s priority is to ensure that NHS patients are able to access the most appropriate treatments to treat and manage their conditions.