Medical Implants (EU and UK)

Sarah Newton Excerpts

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.

--- Later in debate ---

[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.