Health: Medical Innovation

Lord Willis of Knaresborough Excerpts

Wednesday 16th January 2013 Lords Chamber

[Lord Willis of Knaresborough]

My Lords, I begin my remarks by echoing the comments of the noble Lord, Lord Winston. I have been a parliamentarian in both Houses for some 16 years now and I do not think I have ever heard a more moving, considerate or emotive speech than that of my noble friend Lord Saatchi. I thank him for it. In so doing, I have to say that some of the issues that he and the noble Lord, Lord Winston, have raised—and that others will raise—are ones that the Minister, with his responsibilities, can begin to address. Last night, I was responsible for hosting a reception for Children with Cancer UK, an organisation that has been running for 25 years and which began because, 25 years ago, childhood leukaemia killed eight out of 10 children who suffered from it. Now, 80% of children survive it. That happened through innovation—through the very things that the noble Lord, Lord Winston, mentioned and which others will mention—so there is hope. I would want to give my noble friend that element of hope.

My frustration is with many of our scientists’ inclinations. The means to deliver novel or experimental treatments to patients earlier exists. It is not something that does not exist and, quite frankly, it does not require further legislation. With the support of government and an excellent UK life sciences strategy, we have the means to do exactly what my noble friend wants to see. We do not need more legislation; we need action. We need regulators and funders to recognise that, while their approaches are fine for established research pathways and large populations of patients, they are hopelessly inadequate for new and experimental treatments on small, stratified populations.

There is progress. Both the conditional approval scheme and the named patient scheme are important in the toolbox of clinicians who want to try novel and untried treatments but, frankly, they are rarely used. Indeed, perhaps the Minister, when summing up, can say how often they are used and for what purpose. Perhaps, too, he could tell us what progress is being made on the early access scheme, championed in the UK Life Sciences Strategy, which would allow access to drugs earlier than the current regime permits, especially where the compounds under consideration represent possible therapies where few alternatives are available. Currently, the Government’s ambition for this scheme is two to five drugs per year. Does the Minister really feel that that should be the height of this strategy’s ambition?

Perhaps offering more promise, as the Science and Technology Select Committee heard in relation to its regenerative medicine inquiry, is the issue of adaptive licensing, an initiative that also appeared in the UK life sciences strategy. Adaptive licensing offers a flexible approach whereby regulators, clinicians, patients, the research community and industry are jointly involved in assessing the risks of a given experimental treatment so that a proportionate level of regulation can be determined for the release of novel drugs to patient groups. This proportionate approach recognises, as we move to more targeted therapies for smaller populations where traditional clinical trials will be of limited use, that this approach offers an alternative, more appropriate assessment of patient risk and benefits; but, again, where is the urgency or ambition? The expert group that was set up by the MHRA to look at adaptive licences has met only once, in October 2012. Frankly, if that is the rate of progress, it will be years before we see this opportunity realised.

Finally, I come to regulation and regulators, a topic to which I know many noble Lords will return later. When the Academy of Medical Sciences produced its report in 2011, the Government promised simplified, more unified and smarter regulation. The setting up of the Health Research Authority would herald a new dawn for those who see the regulatory burden—particularly for scientists, clinicians and SMEs working at the edge of discovery—as an obstacle to progress. Far from achieving that aim, the HRA appears to have become a very expensive national ethics service. If anything, regulation has become more complex and more bewildering. Indeed, as one expert witness revealed yesterday to our committee, “It is only accessible if you know where to look”.

Clinicians hoping to use new therapies to save the lives of cancer patients do not have the time, and often do not have the resources, to meet the demands of well meaning regulators and their plethora of never-ending hurdles set up to ensure patient safety. That is the real challenge. Without a more agile, unified and flexible regulatory system, which puts patients at its heart, all attempts to move novel and often untried treatments into patients will fail. In that case, we will fail my noble friend in his cause.