Terminal Illness (Access to Medicines)

Jim Shannon Excerpts

Wednesday 23rd January 2013 Westminster Hall

[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.

--- Later in debate ---

[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?

--- Later in debate ---

[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.