The Minister of State, Department of Health (Norman Lamb)
I thank the hon. Member for Ellesmere Port and Neston (Andrew Miller) for the clarity with which he presented the Committee’s findings, and I thank the Committee for its valuable work.
The shadow Minister, the hon. Member for Copeland (Mr Reed), made some interesting points about the challenge of diabetes. I note his diagnosis of type 1 diabetes and the impact it has had, particularly in the run-up to the general election. It beggars belief that he had to cope with that in the middle of a campaign. He made a point about the potential power of science and devices to make a difference to patients’ lives and to save the system money—a double win that we are all after.
Before I go on to talk about points raised in the Committee’s report, let me deal with the specific point about Northern Ireland, which was raised by the hon. Member for Strangford (Jim Shannon). Most issues relating to the regulation of medical devices are UK-wide, and the MHRA operates across the UK. Some issues are devolved if they relate to the operation of the health service, and officials at the MHRA work closely with their counterparts in all the devolved Administrations. I hope that reassures the hon. Gentleman.
I will set out briefly what is currently being done to improve the regulatory system for medical devices. In October 2012, the Government began negotiations with other EU member states to revise the regulatory framework for medical devices, including implants. That will mean completely overhauling the regulatory system that has been in place for more than 20 years. The changes will take effect in 2017 at the earliest. In the interim, member states and the Commission are tightening up the most critical aspects of the current legislation. On top of the legislative changes, member states are implementing a voluntary programme of action that takes on board the lessons learned from the PIP scandal, which was mentioned earlier. However, we are not merely relying on the EU. The UK is taking its own action, including putting in place the recommendations of Earl Howe’s report, which was published in May last year. In addition, Sir Bruce Keogh’s review of the regulation of cosmetic interventions is due to report later this month.
Let me now turn to the issues raised in the Committee’s report. First, I would like to talk about the requirements on clinical data for medical devices. There are legitimate concerns about the quality of manufacturers’ clinical evidence, as well as about how rigorously notified bodies then evaluate the evidence they are presented with. The Government’s response highlights how the Commission’s proposal will address those concerns. In particular, we consider that the requirement on notified bodies to have in-house clinical expertise will be a big and important step forward that will ensure that notified bodies really scrutinise and challenge manufacturers on the quality of their clinical evidence.
I am pleased that the draft legislation requires manufacturers to comply with clear rules on clinical evaluation. It is also much clearer on when manufacturers can use clinical data from an equivalent device when conducting their own investigation—one of the issues discussed during this debate. None the less, by the end of the negotiations, we should have legislation that goes even further to ensure that notified bodies have access to high-quality clinical expertise. We do not have any detailed proposals, at this stage, but one idea is to establish an approved list of clinical experts that notified bodies must consult when assessing clinical evidence.
In addition, clinical data must be transparent, so that the procurement of devices is based on solid evidence. The hon. Member for Ellesmere Port and Neston raised concerns about this point. Current practice in the NHS means that clinicians take into account several factors before using a device, including the clinical evidence provided and the track record of the manufacturer. In the light of issues identified with some brands of metal-on-metal hips, the chief medical officer and the NHS medical director wrote to all NHS trusts in England last March asking them to ensure that there was sound clinical governance of procurement decisions about joint implants—this is the important point I want to make in response to what he said. I would expect these principles for the procurement process to apply to all medical devices used in the NHS.
It is worth highlighting how the UK is taking action, over and above the requirements of EU legislation, to support the safe introduction of new hip and knee implants into the market. Manufacturers, including Johnson & Johnson, Stryker and Biomet, have applied to participate in a pilot scheme that will give surgeons earlier and more accurate data on how well new hip and knee implants performed. This project involves close co-operation with clinicians, the NHS and the UK’s national joint registry. The MHRA is currently considering how this pilot could add value to other categories of device.
Andrew Miller
Will the Minister confirm that it would be perfectly reasonable, as part of the regulatory process a device must go through, for a procurement officer to ask to be notified of any failed applications to other countries?
Norman Lamb
It would be absolutely in order for a procurement officer to do that. The more searching their inquiries, the better, given the importance of what we are trying to achieve. We welcome the hon. Gentleman’s opinions on this issue and will consider how the system can be further strengthened. He makes a valuable contribution to our considerations.
The Government agree with the Committee about the need to improve the environment for clinical trials in this country, and we are doing a lot of work on that already. Things such as the life sciences strategy are making it easier for patients to get involved in research, and we have also set up the Health Research Authority, which is simplifying the approval process for ethical research.
To return to a point made by the shadow Minister, we wholeheartedly agree on the importance of transparency, which brings numerous benefits. I have always strongly believed that it empowers patients, informs and liberates health care professionals and builds trust in industry, notified bodies and public authorities. The proposed new European regulations will increase transparency, giving the public, patients and clinicians access, first, to clear information on the safety and performance of devices; secondly, registration information on devices and the companies that make, distribute and use them; and thirdly, information on the electronic traceability system for devices.
Furthermore, the outcome of peer reviews between different national authorities—reports from each member state on how they have monitored their notified bodies and statements from notified bodies on their independence and impartiality—will also be made public. The hon. Member for Ellesmere Port—I apologise for abbreviating his constituency—drew attention to concerns about the quality of different authorities across the EU, so this is an important step. The UK is already pushing for improvements in transparency in negotiations with other member states. For example, as we highlighted in our response, we would like to see clinical data from post-market surveillance published, so that the available information on the safety and performance of devices always remains up to date. We can do more as well. The Government’s public consultation on the proposed regulation closed on 21 January. It provided us with a lot of useful ideas, which we are currently considering in detail.
Let me turn to the issue of notified bodies and pre-market assessment. Strengthening the quality of notified bodies is absolutely one of the most important ways to improve the regulatory system. The Government agree with the Committee’s recommendations in this area. We are pleased that the Commission’s proposal goes a long way towards addressing the current weaknesses in the system. Competent authorities will review each other and share ideas on how to improve the way in which they monitor notified bodies. The Commission can take action in response to a member state’s concern about a particular notified body. There is significantly more detail on the criteria that notified bodies must fulfil, and teams of experts from different competent authorities will audit notified bodies every three years. The Government agree with the Committee that a new layer of European bureaucracy is not the solution to problems with notified bodies. We need to focus not on who carries out pre-market assessment, but on how it is carried out.
Regardless of all that, we cannot just sit back and wait for the revised legislation to come into place—it is some way off yet. As I outlined previously, we are acting before then to ensure that notified bodies improve as soon as possible. Interim action is being taken across Europe. It includes, first, joint audits of notified bodies on a voluntary basis. The first of these took place in the UK in January and many more are planned for 2013. Secondly, all member states are auditing the quality of their notified bodies that assess high-risk devices. Thirdly, rules on notified bodies and how they audit manufacturers, including undertaking unannounced inspections, are being put together.
While we strengthen the pre-market assessment of devices, it is equally important that adequate post-market surveillance and vigilance procedures are put in place. My hon. Friend the Member for Southport (John Pugh) entertained us and educated us on some important issues. He drew attention to the complexity of identifying the cause of a problem and whether it is the equipment or how it is used. That is not always easy, and the court action he referred to very much drew attention to the complexity of these issues. I am afraid that I am unlikely to be able to satisfy him on the £1.2 billion, but I liked the effort on his part.
John Pugh
I hope the Minister did not think I was being awkward in any way, but the original purpose of estimates day was clearly not to discuss medical implants. However, I have now learnt not only that we do not talk about estimates on estimates day, but that we are not allowed to talk about them.
Norman Lamb
I am very grateful to my hon. Friend for that intervention. I have never known him to be awkward; it is not in his nature.
While we strengthen the pre-market assessment of devices, it is equally important that adequate post-market surveillance and vigilance procedures are put in place. The Committee recommended setting up a black triangle scheme for medical devices approved with equivalence data. I recognise the Committee’s rationale for that recommendation, but we do not think it is the best way forward. A national scheme would place potentially disproportionate costs on industry and risk a loss of competitiveness for the UK. The hon. Member for Strangford (Jim Shannon) correctly drew attention to the enormous potential we have in the UK for generating new business in this area and the importance of giving businesses every opportunity to start up and develop. We do not want to impose disproportionate costs on UK businesses and put that potential growth at risk. Instead, recognising the importance of the point made by the hon. Gentleman and the Committee, we are considering what we can do at the EU level. For example, notified bodies could require manufacturers to carry out post-market studies for certain devices.
Finally, the Committee recommended that the Government consider making the reporting of incidents by health care professionals mandatory. Increasing reporting is clearly critical to ensuring that the regulator has a full picture of emerging problems with devices. Mandatory reporting is an option that the Government are continuing to consider, although it cannot be the only solution. The MHRA is currently leading work to improve reporting and has been working closely with the General Medical Council and the medical royal colleges to consider how to strengthen professional responsibilities in this area.
In conclusion, the Government attach great importance to strengthening the regulatory system for medical implants. I am immensely grateful to the Committee for its work and recommendations, just as I am to everyone who has contributed to this debate or at some other time. I am confident that the work being undertaken now and to improve the European legislation will make a real difference to safety and transparency.