Medical Implants (EU and UK)

Debate between Norman Lamb and John Pugh

Wednesday 6th March 2013 Commons Chamber

[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.

NHS Commissioning Board

Debate between Norman Lamb and John Pugh

Tuesday 5th March 2013 Commons Chamber

[Norman Lamb]

The Leader of the House was absolutely correct in stating—[Interruption.] If the hon. Lady will listen to my answer, she may benefit from it. The Leader of the House made it absolutely clear in the House last week that the regulations would not introduce compulsory competitive tendering. We are amending them because there was legitimate and understandable concern about the impact of some of the provisions. We will make the position clear so that the policy intent of the Health and Social Care Act is implemented faithfully in these regulations.

[John Pugh (Southport) (LD)]

The Labour regulations are not perfect, and neither the regulations introduced by Labour nor those initially proposed by the coalition Government in section 75 will do in any sense. Do we not need regulations that embody the assurances given to peers and to GPs themselves during the passage of the Health and Social Care Bill, and not a charter for privatisation?

[Norman Lamb]

We will make absolutely sure that the amended regulations meet faithfully the commitments given in the Upper House during the passage of the Bill, and in the letter sent to clinical commissioning groups by the former Secretary of State following the legislation.

Winterbourne View

Debate between Norman Lamb and John Pugh

Monday 10th December 2012 Commons Chamber

[Norman Lamb]

I thank the right hon. Gentleman for his welcome for the broad thrust of my proposals, and for his questions. On standards of business in the sector, it strikes me that the levels of corporate accountability seem to be significantly lower in this sector than in many others. How bizarre is that, in a sector in which the protection of individuals is absolutely vital? In our response to Southern Cross and to this case, we will require owners to adopt a much more transparent approach and to disclose details of their financing arrangements. We are introducing that level of engagement and transparency as well as addressing the need for accountability. The right hon. Gentleman also asked about restraint, and we will certainly look at the appropriate methods of restraint. It should really be used only for the protection and safety of an individual or of others. It should not be used for chastisement or punishment, as appears to have been the case in some locations. That is completely unacceptable.

[John Pugh (Southport) (LD)]

One of the big problems is the fact that many local authorities house vulnerable people at a considerable distance from their families. What element of the proposals will constrain that unfortunate practice?

[Norman Lamb]

I thank my hon. Friend for that question. He is absolutely right that one thing uncovered, both at Winterbourne View and in the Care Quality Commission survey of similar institutions, was that people were sometimes placed hundreds of miles away from their families. That still continues; that is what we have to address. My hon. Friend asks about what in the proposals will address that and ensure that it does not happen. Every part of the system is signed up through the concordat to changing what has been an unacceptable practice. People will be held to account. I said in my statement that I will chair a programme board throughout this period of change, and we will publish regular updates so we can, in a sense, hold to account every primary care trust or clinical commissioning group and every local authority that fails to change in the way expected.

Mental Health (Approval Functions) Bill

Debate between Norman Lamb and John Pugh

Tuesday 30th October 2012 Commons Chamber

[Norman Lamb]

We are talking about the approval function. Subsection (2) mentions

“practitioners approved to give medical recommendations”,

so it clearly deals with practitioners who have already been authorised, but by the wrong body.

[John Pugh (Southport) (LD)]

I am genuinely trying to understand this point and ensure that the Bill is as foolproof as possible. As I understand the Government’s case, the clinical need of people with mental health problems—the Bill clearly would not apply to people who did not have mental health problems—is trumping the absence of proper process, so the Bill is not an abuse of human rights.

The difficulty that I have with that argument—perhaps I ought not to have it, and maybe I am being particularly thick—is that the clinical need in question was established through a process that is acknowledged as formerly having been flawed. The clinical need is apparent only when a case has been heard and processed. The concept of clinical need here is certainly—

--- Later in debate ---

[John Pugh]

My point is that the definition of clinical need ought to be good enough for a psychiatrist, but I am not convinced that in this context it is good enough for a lawyer.

[Norman Lamb]

All that is being regularised is the power to approve a doctor, not whether a doctor is clinically sound. Any patient who challenges a judgment to section them either now or in the past will retain all their rights in law. We have acted on the advice of both lawyers and clinicians to ensure that we deal with the problem that has emerged in a way that respects patients’ clinical interests and considers them with the utmost seriousness. To go through a full reauthorisation process in every case could be incredibly damaging to individuals in potentially vulnerable situations. The Bill is based on the best clinical and legal advice that we have received on how to deal with the problem.

Winterbourne View

Debate between Norman Lamb and John Pugh

Tuesday 30th October 2012 Commons Chamber

[Norman Lamb]

I share the hon. Lady’s view on what has happened. We must make absolutely certain that every commissioner is held to account. My understanding is that proper arrangements are in place for all those individuals, but I will continue to monitor the situation to ensure that that remains the case. We must be alert to the interests of the 48 residents who were in Winterbourne View, but we must also focus our minds on the 1,500 people who are in settings of that sort—assessment to treatment centres—often for years. The interests of all those individuals are important.

[John Pugh (Southport) (LD)]

To put it bluntly, after all this, is the Minister still confident in the CQC and does he believe that it is fit for purpose?

[Norman Lamb]

I tend to the view that we have had too many changes of regulator over a number of years, and that continuity would be a good thing. An assessment of the CQC earlier this year indicated that it was on the right track. I have met the new chief executive and am reassured by the plans he has in place. It is seductive to believe always that it is an attractive proposition to abolish an organisation and set up a new one, but is there any more chance that a new organisation will be better? Let us therefore make the CQC work properly.