Westminster Hall is an alternative Chamber for MPs to hold debates, named after the adjoining Westminster Hall.
Each debate is chaired by an MP from the Panel of Chairs, rather than the Speaker or Deputy Speaker. A Government Minister will give the final speech, and no votes may be called on the debate topic.
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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?
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.