Medical Implants (EU and UK)

Debate between Sarah Newton and Jamie Reed

Wednesday 6th March 2013 Commons Chamber

[Mr Jamie Reed (Copeland) (Lab)]

The report of the Science and Technology Committee was produced under the chairmanship of my hon. Friend the Member for Ellesmere Port and Neston (Andrew Miller). I congratulate him on the work of the Committee and on an excellent report. He is known in this House for his diligence and attention to detail, and the report illustrates those instincts. It is also a pleasure to follow the hon. Members for Southport (John Pugh) and for Strangford (Jim Shannon), who have made telling and important contributions.

The House has demonstrated not only a shared understanding of the issues before us in this brief debate on medical implants, but a welcome unity of purpose. The House is at its best when it acts in such a fashion. Debates like this allow us to break through what actors call the “fourth wall”. I hope that anyone who is watching this debate can see that, as should always be the case, we are not making by-the-numbers political arguments, but are making a sincere effort to address the issues before us for the benefit of the people who send us here.

In health care regulatory systems, medical implants and devices hold a unique status. The synthesis of new medicines and other pharmaceutical products is done through highly precise chemical processes, whereas implants are developed largely through an iterative engineering process. As we can see from the Committee’s report, that presents unique challenges. The bulk of the regulatory framework for medical testing focuses on the side effects and efficacy of new drugs. Although the emphasis is on medicines, there need to be mechanisms for the effective regulation of safe medical implants, given the fundamental differences between implants and medicines.

As the Committee’s report highlighted, there are weaknesses in the current regulatory system. As Members have mentioned, those have been highlighted by the recent PIP breast implant scandal and by faulty metal-on-metal hip replacements. In looking at those high-profile scandals, we must recognise the role of criminal activity, especially in the PIP scandal. In that case, it quickly became apparent that the company that manufactured the implants was engaged in a clear case of fraud. There is no reasonable and workable system that could prevent such cases. That fact is recognised by many in the industry and, I am sure, by Members across the House.

Although the PIP scandal was caused by criminal activity, it presented the opportunity for us to take a deep look at our regulatory framework and to assess its strengths and weaknesses. The system is obviously not perfect, as I am sure Members across the House will agree, and improvements need to be made. The case of the DePuy metal-on-metal hip implants shows that faulty products have been certified under the current system.

There is a fine balance to strike when debating the regulatory framework of medical impacts because it is essential that all products are safe, and that they bring only benefits to patients and are not harmful. It is also necessary for access to products to be improved and expedited. The ideal is to bring safe medical implants to patients in an efficient and timely manner, and that is the sole purpose of a regulatory system in this context.

We must be increasingly aware of how the regulatory system can affect the entire health economy. To emphasise the importance of that let us consider a condition that poses enormous public health, policy and financial questions, as well as questions of patients’ rights and expectations: type 1 diabetes.

I declare an interest as a type 1 diabetic who was diagnosed through diabetic ketoacidosis just two weeks before the 2010 general election—ideal preparation, I must say. I raise the issue not to bore the House with my personal interests but because figures released this week by Diabetes UK show that the number of people in the UK who have been diagnosed with diabetes has reached 3 million for the first time. That is an increase of 132,000 over the last year and a further 850,000 people are now believed to suffer from undiagnosed type 2 diabetes. Each year an estimated 24,000 people die from diabetes-related medical conditions and the situation is expected to worsen—I know the Minister is aware of the figures. Barbara Young, the chief executive of Diabetes UK, has called the situation a “public health emergency”, and she is right.

It cannot be stated enough that type 1 and type 2 diabetes are different conditions and differ in many ways. Type 2 diabetes is often the result of lifestyle circumstances or choices, but type 1 diabetes is a genetic, sometimes hereditary auto-immune condition that is not related to the lifestyle of an individual. The latest breakdown of figures that I have comes from 2009. Research undertaken by the university of Birmingham and the National Institute for Health Research showed that at that time, 488,089 people in England and Wales had type 1 diabetes, some 15,000 of whom were children and young people between nought and 24 years of age. In 2009-10, 27,200 hospital admissions and 96,651 bed days were due to type 1 diabetes in England. To be blunt for a moment, apart from concerning ourselves with the needs of the patient, that is costing the NHS a fortune.

Also this week the US-based Diabetes Research Institute announced details of its research into what it describes as a “quantum leap” towards a biological cure for type 1 diabetes with the development of its BioHub—a bioengineered “mini-organ” that mimics the pancreas. It contains real insulin-producing cells that can sense blood sugar and release the precise amount of insulin needed in real time. In short, if successful, such a treatment could transform the lives of 500,000 people in England and Wales, save the NHS a fortune that could be spent elsewhere, and help begin to meet the challenge of the public health emergency we face. With that case study we see that the improvement of a system that expedites access and demonstrates the safety of medical implants for patients could not be clearer or more important.

The report covers four main points, and I will take each one in turn. First, I will discuss the system of pre-market approvals and the difficulties surrounding them, before looking at transparency in the regulatory system, post-market scrutiny of products and international co-operation. Pre-market scrutiny of medical products is the minimum prerequisite when it comes to health care products, whether medicines or implants, but there are fundamental reasons why there is no one-size-fits-all system for testing them. With medicines, doses can be reduced and increased to test for side effects and efficacy, but, as I am sure all Members will recognise, it is impossible to change the dosage of a hip replacement. Furthermore, once an implant has been placed, it is difficult to remove it.

Similar issues present themselves with clinical trialling procedures. Medicines pass through the body relatively quickly, meaning that medicinal trials can be conducted within a reasonable time frame. A hip implant is typically designed to last over 10 years, and to obtain reliable clinical data that can withstand proper scrutiny, trials on those implants would have to last a number of years, which in many cases is simply not practical. A system has therefore developed that uses different types of clinical evidence to assess safety and efficacy. Where possible and practical, clinical trials on products should take place, but for implants, regulatory bodies will take what are known as equivalence data as the basis for their decision making. That was mentioned by my hon. Friend the Member for Ellesmere Port and Neston and is covered extensively in the report. These are data obtained from similar products. As I have said previously, products are developed in an iterative process and these data can be from earlier iterations that may have been available to patients for a number of years.

There are a number of issues with this method. First, the British Medical Journal has argued that, owing to the progression of new products and advances in this field, regulators may have difficulty assessing which products, and therefore data, are equivalent. This difficulty is, to some extent, surmounted by the differing regulatory requirements of different classifications of medical devices. Most medical implants are categorised as class 2b and class 3. These are the higher risk categories and this ensures that extra safety checks are in place.

Class 2b manufacturers are subject to annual detailed assessments of their facilities, practices and staff training levels to ensure they are performing to a high standard. With class 3 products, notified regulatory bodies also have access to technical documentation to ensure safe practices. So the difficulties inherent in the pre-market assessment of medical implants mean that post-market scrutiny and surveillance of products are essential in maintaining standards in the industry and in improving future regulatory regimes.

The Medicines and Healthcare products Regulatory Agency and other groups agree that this is one of the most important tenets of a regulatory system. It is almost impossible, and certainly not accurate, to predict the medical performance of devices after a considerable number of years. Continued, randomised testing of devices should form part of the regulatory processes and should make a keen contribution to assessing the efficacy and safety of products.

Looking at the level of international co-operation when it comes to regulating medical devices, it is crucial to realise that this is now a global industry. The EU Commission has recommended greater co-operation between member states in this field. It recommends that there should be a European body responsible for dealing with notifications of devices prior to market entry. I understand the Committee’s report does not accept this recommendation as it would lead to another layer of bureaucracy and delay. However, greater harmonisation of practices to ensure high standards are met by manufacturers throughout the world is interesting, and this is an issue that needs to be looked at in greater detail.

[Sarah Newton]

Another important reason we decided it would not be in the national interest to support that recommendation is that we believe that it contained the potential for a race to the bottom. Other European countries do not regulate as well as we do, and effective regulation is really important. We felt that a lowering of standards in other European countries might mean that implants could get in through the back door.

[Mr Reed]

The hon. Lady makes an excellent point. The Committee’s thinking on that point is clearly justifiable and robust. It also raises another issue. We all need to ensure that the industries we are talking about have a predictable, stable and safe environment in which to operate so that they can innovate, attract investment and continue the advanced manufacturing processes we need to secure advances in treatment and more.

It is important, however, that the focus upon constant improvement should be one of the core underpinnings of any regulatory framework and this is sadly lacking in the system at present. The key to improving the regulatory framework—and in many ways the key theme of the Committee’s report—is transparency. The BMJ acknowledges that there are

“many vested interests that disincentivise manufacturers and clinicians from highlighting problems”.

Commercial confidentiality is another stumbling block. This need not be the case as a more open system, with more published information and greater access to assessments of products, will foster greater trust in the system, which will then translate into wider public trust of the industry and of manufacturers within it.

An article in The Lancet from June 2012 argues that patients and medical professionals should have a greater role in reporting adverse effects from their devices. Who could disagree? It should be clear to everyone that the fairest and safest way of assessing medical products is to allow experts access to as much information as possible. The Committee’s report makes it clear that the default position on information should be transparency and openness, and should be confidential only in extreme circumstances. It is right that the MHRA has a specialist committee to assess the safety of products: the committee on the safety of devices. What is totally wrong, however, is that it works in secret. The Select Committee expressed its disappointment at not being able to evaluate the work of the CSD, and it seems impossible to evaluate the system as a whole when such a key part of it appears to be shrouded in secrecy.

The Committee’s report does not advocate widespread changes to the system, but it rightly recommends a significant improvement in the transparency of information available to medical professionals. In medicine, negative data, as the hon. Member for City of Chester (Stephen Mosley) said, are as crucial as positive data in assessing what is right for a patient. I assure the Minister that the Government will have the support of the Opposition if they wish to make quick progress on improving transparency in the system.

Regional Pay (NHS)

Debate between Sarah Newton and Jamie Reed

Wednesday 7th November 2012 Commons Chamber

[Mr Jamie Reed (Copeland) (Lab)]

NHS staff are among the most valued and respected members of any work force, public or private. Like so many public sector workers—the police, firefighters, teachers, social workers, and many more—they make a crucial and often critical difference every day to the real lives of ordinary people in communities throughout our country, wherever they may be and whatever their wealth. In so many ways, these universal services and the values that they both represent and live by are our national values. They support us, they strengthen us, and they bind us as one nation.

The values of the national health service were celebrated as an article of faith in what it means to be British by Danny Boyle during the opening ceremony of the Olympics. When the eyes of the world were upon us, we showed the world that the NHS and the values that underpin it are part of what makes us British—not Cornish, not Cumbrian, not Lancastrian, but British. It is little wonder that the new Secretary of State tried to have that tribute removed from the ceremony. He knew what it meant then, he knows what it means now, and his support for regional pay in the NHS—revealed at the Dispatch Box today—shows that he is determined to fragment the service.

Since the Government came to power, NHS staff have been marginalised, trivialised and ignored. Reorganisation was imposed upon them with no mandate, no support and no warning. Since then more than 6,000 nursing posts have been lost, and billions of pounds have been taken away from the NHS front line to pay for redundancies and a reorganisation that nobody wanted—a reorganisation that was hidden from the electorate before the election.

Despite all that, these people still achieve remarkable results in the most trying of circumstances every single day. They continue to succeed, despite the incompetence of the Prime Minister and his Health Ministers. NHS workers can surely be forgiven for having had enough of the Government being on their backs; but, not content with being on their backs, the Government now want to be in their pockets as well.

Regional pay is demotivating, demoralising and wrong. It will harm the NHS in the parts of our country that are most in need, not only in the NHS and not only in local NHS services, but in the local economies where those NHS services are located. The London Evening Standard’s city editor, Russell Lynch, wrote last week that the regions

“still account for more than three-quarters of the economy. And if I were in Middlesbrough, Manchester or Leeds right now, I’d be more worried about the mugging that’s on the way from the Chancellor over regional pay in the public sector.”

Of course he was right, and the fear is palpable. That is why this is so important. That is why the Government must intervene, stop regional pay taking hold, and uphold the principle of national pay agreements within the NHS.

As we have heard, 60 academics recently wrote to The Times damning the Government’s regional pay proposals. Let us examine why. The public sector wage bill last year was £162.5 billion for the employment of approximately 6 million people. The aim of the Prime Minister, the Chancellor and, I assume, the Health Secretary is to remove what they claim is an 8% disparity between the wages in the public and private sectors. As usual, that is a heavily disputed figure with no real basis, but let us assume that it is correct. If the Government succeed in removing the difference that they imagine exists, 6 million people will have a cumulative £13 billion less to spend. That is almost 1% of our total economy.

In an age of austerity, when the parts of our country that already rely heavily on public spending are feeling the cuts most acutely, what madness it is to take even more money away from those economies, those homes and those families. Talk about killing demand in the regions! This will not just hurt the public sector and damage local economies; it will bludgeon local private enterprise—those who work in partnership with the public sector, who have contracts with the public sector, who trade with the public sector, and who sell their products to local people paid by and working in the public sector. The insidious desire to divide and rule ignores the fact that one nation has one economy.

Let us consider what regional pay in the NHS could mean for the future of NHS services. The Government have encouraged privatisation to run amok in the NHS, deliberately and ideologically. Whereas we used the private sector in a targeted, limited and structured manner, the Conservatives want to let it run riot like the Bullingdon Club in a china shop. It is no wonder that private health care provides so many funds for the Conservative party.

One of the more flimsy Treasury claims about regional pay is that it would stop private firms being crowded out by the public sector, but how is this applicable to the NHS? Is the real purpose of the NHS regional pay proposals to allow the Government to facilitate faster privatisation of NHS services by hollowing out NHS terms and conditions? Unless the Government intervene —as they should—to halt this development, it will appear that part of the agenda underpinning regional pay is, indeed, to enable the easier privatisation of NHS services. Instead of seeing NHS staff for what they are—the best partners any Government committed to improving the NHS could ever have—this Government see them as surplus to requirements in too many parts of the country, with terms and conditions that the Government see as acting as a roadblock to further privatisation.

[Sarah Newton]

Will the hon. Gentleman give way?

[Mr Reed]

I am afraid I do not have enough time.

Let us concentrate on the impact of regional pay proposals in the south-west. Because the Government have given their clear approval through their submission to the NHS Pay Review Body, 20 trusts across the south-west have already each committed £10,000 to form a consortium—a cartel—designed to reduce staff pay and to break away from the established NHS terms and conditions. That is money that should be spent on patient care. Is the Secretary of State satisfied with that state of affairs? Some £200,000 is being spent in an effort to reduce the pay and conditions of NHS staff in the south-west—one of the lowest paid areas in England—against the backdrop of almost 1,000 nursing posts being lost in the south-west since this Government came to office.

It is barely credible that this Government should use the south-west as a laboratory in which to experiment with regional pay. It is a Liberal Democrat stronghold. The Liberal Democrat leader has said that regional pay will not happen, yet it is happening. It may call itself a coalition, but this is a Conservative Government in all but name, and with NHS regional pay they are treating south-west England in the same way that the last Tory Government treated Scotland with the poll tax. I know Members from the south-west see that, and I hope that they will vote with us to stop this gruesome experiment in its tracks.

Regional NHS pay is not being introduced only in the south-west, however. It is also being proposed by a series of trusts across the north-east, which is another region that cannot afford to let this Government pick its pocket. NHS trusts in Oxford, Birmingham, Cheshire and Manchester are also threatening to break away from the national pay agreements established under “Agenda for Change”.

This Government have lost financial control of the NHS, unless it is to cut it. They are now refusing even to try to control the demoralisation of NHS staff as their terms and conditions are denigrated. That is shameful. Why is this happening?

All roads lead back to the Government’s hated Health and Social Care Act 2012, with a £3 billion reorganisation at a time of an already unprecedented financial savings challenge. As trusts are plunged into financial turmoil, they are forced to look at opting out of national pay structures. And that is not all. The Treasury’s own figures show that real-terms NHS spending has been reduced under this Prime Minister year on year, as broken promise follows broken promise.

Regional pay in the NHS is opposed by the Royal College of Nursing, the Royal College of Midwives, NHS Employers, the British Medical Association and more. More importantly—[Interruption.] All Members would do well to listen to this point. Surveys show that 2 in 3 voters across the political spectrum believe that regional pay should be dropped: over 70% of Labour and Liberal Democrat voters and just over 50% of Conservative voters believe that.

That opposition is mirrored across this House. The Deputy Prime Minister claims to be against it—we will see—but Liberal Democrat MPs for Manchester, Withington, for Southport, for Torbay, for St Austell and Newquay, for St Ives and for North Cornwall are against it, and Conservative MPs for areas such as Torridge and West Devon, Hexham, and Brigg and Goole have also spoken out against these ruinous proposals. I commend the argument put forward by the hon. Member for Hexham (Guy Opperman). He has said:

“Our current pay system, which sets a base pay rate, already allows for adjustments in high cost areas like London”,

and

“I do not believe reducing public sector pay will help stimulate private economic growth.”

He added:

“I am very concerned that regional pay would lead to a reduction in the pay packets of some public sector workers in the North East.”

I share that view entirely, and the same can be said for communities across England.

Let none of us forget the disproportionate effects of regional pay on women, because this is also a gender issue. Not for the first time, working women around the country will be asking themselves just what this Prime Minister has against them. Do they all have to lend him a horse before he offers them some protection? Women make up 65% of the public sector work force and they account for more than 80% of NHS staff covered by “Agenda for Change”. Regional pay will hit women disproportionately. That is not right or fair. It is being done knowingly, and the Prime Minister will pay a heavy price if these proposals are not stopped.

We again find ourselves in the midst of a slow-moving disaster that the NHS can do without. We find ourselves having to deal with a Government who command no trust on the NHS, whether from the public or from health professionals. It is a disaster of the Government’s own making. As usual, the areas that can least afford to, and, most importantly, NHS patients, will end up paying the price for this ineptitude. The Secretary of State knows that regional pay will damage the NHS, he knows that the country is opposed to it, and he knows that he should intervene to stop it. A refusal to do so will demonstrate a failure to understand the values, principles and purpose of a truly national health service, and will illustrate his desire to undermine those very values. I commend the motion to the House.