Terminal Illness (Access to Medicines)

Jamie Reed Excerpts

Wednesday 23rd January 2013 Westminster Hall

[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.

--- Later in debate ---

[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.