G8 Summit on Dementia

Debate between Sarah Newton and Andrew Miller

Thursday 28th November 2013 Commons Chamber

[Sarah Newton]

I am a member of the Science and Technology Committee, and I am delighted that my Chairman, the hon. Member for Ellesmere Port and Neston (Andrew Miller), is here and has intervened. I would like to draw the Minister’s attention to some excellent work that our Committee has been doing this year. I think that some of the reports we have published will help him to prepare for the summit. We undertook a very good investigation into clinical trials and also produced a report called “Bridging the valley of death”. Both reports highlighted a very significant issue facing research, not only in the UK but globally.

As Members will know, we have an absolutely world-class science base in our country. The main challenge facing it is to overcome regulatory environments, many of which are international, to enable it to take its first-class research across the valley of death and into the development of ways of diagnosing dementia and therapies for treating it. It is very important to learn the lessons from our very extensive inquiries to enable more of this research to be commercially developed in order to find its way into the marketplace.

[Andrew Miller]

Does the hon. Lady agree that it would be helpful if the Minister could revisit the Government’s response to our inquiry on clinical trials, because we could then be a world leader and show real leadership at the summit?

[Sarah Newton]

Only yesterday, we took evidence from Professor Collinge from University College London and Professor Ironside from Edinburgh, who are leaders in the field of degenerative brain disease. They provided us with even more compelling evidence of the increasing difficulties of getting from the research stage to being able to secure enough commitment from the pharmaceutical industry and other bodies that fund research into developing the science into diagnostic and therapeutic techniques. They reported that the pharmaceutical industry, which is a massive investor in research and its outcomes, is getting far more risk-averse and, as a result, is putting many more burdens on to the research of scientists in universities—burdens that they are not really capable of taking on board. The G8’s focus on getting the companies and clinicians, as well as researchers, around the table to look at the pathways from the science into scaleable, commercialised solutions is vital.

It is important that we do this not only in our own country but internationally, because most of the regulations are international. Where there is not international agreement, that in itself becomes a barrier to research and its commercialisation. The work done at the G8 will enable there to be much larger markets, meaning that very many more people will be helped and that money will flow into the research and make it more widely available.

The transcripts from our findings yesterday will be available in a couple of days’ time. That should give the Minister a good opportunity to look at the evidence we were given by those very eminent researchers, who are undertaking research into prions, as well as looking into developments on variant CJD, which is a form of dementia, and how that links to other types of dementia such as Alzheimer’s. We need that sort of joining up across the process to enable diagnostic and preventive procedures, and therapies, to be developed. All the various scientists—

Medical Implants (EU and UK)

Debate between Sarah Newton and Andrew Miller

Wednesday 6th March 2013 Commons Chamber

[Andrew Miller]

The hon. Gentleman, who works hard on the Select Committee, is absolutely right in what he says. I stress to the Minister that not only was this report unanimously endorsed by the Committee members, but we were angry at the lack of available information. That was no fault of the Minister or his predecessors; it resulted from a system that had grown, as the use of implants had grown, into a mechanism that was not fit for purpose. The Minister is rightly participating in the process of revising the directive, but some urgent requirements mean that he has to take a proactive approach and encourage—indeed, instruct, if he has that power—procurement offices of the NHS to set a new standard. They should simply require anyone tendering for a product in this category to provide, as part of the tendering process, totally transparent information about the process and the regulatory regime it has gone through.

[Sarah Newton (Truro and Falmouth) (Con)]

Perhaps the hon. Gentleman will elaborate on some of the positive examples that the Committee found, which included the groups of orthopaedic surgeons who voluntarily shared information on different hip replacement devices and could contextualise the outcomes. The implant itself is not always responsible for the outcome—that could result from other factors to do with the medical condition of the patient or all sorts of other circumstances—but these people were able to contextualise that information in large enough sample sizes to help other surgeons to come to the right decisions about the right implants for their patients.

[Andrew Miller]

The hon. Lady, another hard-working member of the Committee, is absolutely right and that could take us on to a much more complex debate about how we move from where we are in today’s medicine to future developments in stratified medicine and so on. The way in which our medical profession works in such a strong collegiate manner helps to maintain standards at the highest level. Lessons can be learned in that regard that underline the importance of the NHS as the lead body in this area.

Post-market surveillance is a crucial element of the regulatory system and is technically the responsibility of the manufacturers. However, the notified bodies also have some oversight through auditing. The Medicines and Healthcare products Regulatory Agency investigates adverse incidents once they have been reported. Again, we called for greater transparency by recommending that manufacturers publish the results of post-market surveillance studies. We proposed that a system such as the MHRA’s black triangle system, which flags up new medicines approved on limited clinical data, should be adopted for devices approved on equivalence alone. We found some evidence that clinicians under-report adverse incidents, so we wanted the Government to consider making reporting mandatory.

One place to keep post-market data is a registry. The National Joint Registry for England and Wales—meaning joints in the body, not joint between England and Wales—is a success story. It collects data on all joint replacements in the NHS and the private sector and is the biggest such register in the world. The NJR provided data on the DePuy metal-on-metal hip implant, which was then recalled worldwide in 2010.

Registries do not always succeed. Between 1996 and 2003, we had the national breast implant registry, but that failed, partly because of the unwillingness of patients to give follow-up information. Nevertheless, our colleagues on the Health Committee called for Sir Bruce Keogh to pursue the creation of a register of breast implants in his review of PIP implants. I hope that the Government will put in place measures to ensure that any new registry learns lessons from the NJR’s successes.

I recently went through a minor medical procedure and was asked to provide data as part of a broader clinical dataset and to allow them to be used. The form started off by saying how to opt out of providing that data, rather than explaining to me as the patient why it was beneficial for those data to be collected. When such registers are produced, I hope that the Minister will agree that the starting point should be that the authorisation form should not start with the negative procedure of how to opt out but start with positive information about why such data are beneficial to the individual and to society more broadly.