Terminal Illness (Access to Medicines)

John Pugh Excerpts

Wednesday 23rd January 2013 Westminster Hall

[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.