Safety of Medicines and Medical Devices

Baroness Blackwood of North Oxford Excerpts

Thursday 28th February 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I congratulate my noble friend Lord O’Shaughnessy on securing this debate and on what I know was a very personal commitment to this subject when he was Minister. I also congratulate the noble Lord, Lord Carrington, on a truly excellent maiden speech. We all recognise the significant contribution to the United Kingdom’s public life by his father, the late Lord Carrington, but I do not think the current noble Lord, Lord Carrington, will have any trouble following in his footsteps.

Indeed, I thank all noble Lords who contributed today. It has been a thoughtful and sobering debate on a really important subject. We should be proud of the world-leading role that UK researchers, clinicians, industry and regulators play in medical discovery and innovative treatment. We are the first country to introduce whole-genome sequencing to routine clinical care, the first in the world to approve Kymriah and the first in Europe to approve CAR T-cell therapy. As the noble Baroness, Lady Masham, rightly said, that is so important for patients with rare or hard-to-treat conditions, because it raises the hope of earlier diagnosis and more targeted treatments. That is at the heart of many of the measures in the long-term plan and the life sciences strategy, which is directed at improving the capacity of our life sciences industry and the NHS to improve the quality of care for patients.

As many noble Lords eloquently pointed out, medical innovation flourishes only on a firm foundation of clear and effective regulation and informed consent. That is not only about patient safety but about giving certainty to researchers and innovations. The noble Baroness, Lady Finlay, and my noble friend Lord Bethell movingly reminded us that there is an innate tension in the need to drive forward the frontiers of medical innovation to offer hope to those with rare and hard-to-treat conditions—perhaps it is appropriate that today is Rare Disease Day. But there is also the need in a complex and universal system such as the NHS to have effective and agile safety and consent systems. However, in that context, it is never an excuse for a patient’s voice not to be heard loudly, quickly and effectively when things go wrong and we must never tolerate any form of gender bias, as the noble Baroness, Lady Jolly, said.

We heard today of some of the successes and strengths of our current systems of regulation for both medicines and medical devices, but we also heard about instances where our regulatory and wider systems could go further. I pay tribute to all those patients, some of whom are here today, who have shared their experiences and have gone on with a resolute determination to campaign for change for themselves and on behalf of others, including groups that my predecessor met and worked hard with, such as INFACT and Sling the Mesh. Many of them have met Ministers and Members of this House and have, with great bravery, told their stories, many of which are heartbreaking for them and their families. To them I say: thank you for your courage and dignity. Please know that your voices are heard not only here today but across government and across the system.

Noble Lords have already debated many aspects of the role of the MHRA to be responsible for the regulatory compliance of medicines and devices. As noble Lords will be aware, no medicine or medical device is entirely risk-free. The possibility of a patient suffering an adverse reaction or incident, although limited, can never be eliminated. That is why the MHRA has powers to take action, including removing products and devices from the market or resisting their use if the risk and benefit profile changes as new evidence emerges. We need to ensure that we are capturing that evidence most effectively.

Recent examples of where the MHRA has made use of those powers include recalling some sartan medicines for high blood pressure and issuing new temporary measures for the uterine fibroid drug Esmya. The MHRA also initiated EU action on valproate and will continue to consider what further restrictions are needed to ensure that valproate is not used in pregnancy. I will return to that in more detail a little later.

The noble Baroness, Lady Finlay, is absolutely right that the MHRA and NICE are indeed working more and more closely together on these matters. I have heard her and others’ points about the use of registries to capture evidence more effectively. We need to consider how that would interact with local care health records, however, and whether they are the most appropriate place to capture that information. I will take that point away and consider it carefully.

I particularly thank my noble friend Lord Bethell for his truly eloquent account. I appreciate his impatience for progress on this matter, so I would like to focus for a moment on the system for regulating devices. As the House is aware, medical devices are not brought to the market in the same way as medicines. The regulation of medical devices is instead governed by three EU directives as part of the pan-EU system of conformity assessment, a system that sets out standards for pre and post-market assessment of medical devices, including categories of device and the role of notified bodies and the MHRA.

However, there is no direct authorisation of devices for the UK or EU markets conducted by the MHRA. Medical devices and the wider medical technology sector form an area of very fast technological innovation, as the noble Baroness, Lady Thornton, pointed out. This means that devices are routinely improved and replaced as technology is developed, with a view to improving patient safety and experiences. It also means that there are comparative limitations on the amount of pre-market assessment that can be conducted for devices—unlike for medicines—given that the evidence of their actual use by patients is critical to the overall assessment of their efficacy. This is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance and vigilance to respond to information about the safety of devices when in use, and take appropriate regulatory action to improve them. This includes issuing medical device alerts to the healthcare service and the restricting and recalling of products. The publication of more data and patient feedback is an evolving process, as more experience is gained from the use of medical devices.

While the overall system seeks to establish a balance between continuous innovation in medical technologies and patient safety, I fully accept that it is not easy to achieve. By its nature, the regulation of innovative sectors must respond with continuous improvement, while the sectors’ systems and processes need to be continuously reviewed in the interests of patient safety. This is something that I know the MHRA and others take seriously, and to which I am personally committed. It is why the UK has played a role in arguing for change at European level in recent years, and why the Government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations, which my noble friend Lord Dundee mentioned. We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices.

This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence. My noble friend referenced a strong example of this: the Scan4Safety pilot, which was conducted in six trusts. We hope to roll that out across all acute trusts in England. I am a strong supporter of this, given that I announced the pilot in the first place.

Despite these changes, I know that there are still patients who feel that their concerns or experiences are not adequately heard or considered by the health system, and that the response has not been agile enough. It is an essential principle of patient safety that the regulatory environment gives sufficient voice to concerns reported by patients, families and campaigners, and that it works alongside them to respond in a rapid, open and compassionate way to resolve issues. I offer my firm assurance now that, as a department, we will be neither complacent in our success nor ignorant of the possible opportunities to improve. Just as the landscape of medicines and medical devices is ever-changing, so too must be the regulatory frameworks in which they are marketed, monitored and used within our healthcare system.

It is this commitment to evolve and ensure that the patient voice is central to our healthcare system that led to the Independent Medicines and Medical Devices Safety Review, chaired by my noble friend Lady Cumberlege and introduced by my noble friend Lord O’Shaughnessy. We have already heard much about it, so I will not go into detail. However, it will be critical to improving our understanding and action on listening to and consulting patients in the UK healthcare system to ensure that informed choices can be made. We expect the review to report later in 2019, with my noble friend Lady Cumberlege’s assistance. As we have heard, I know it has been consulting in a detailed and patient-oriented manner across the UK. I specifically thank my noble friend for her great sensitivity and dedication when listening to patient groups and individuals. I have met her and her team and heard first-hand how she has travelled the country to ensure that those who want their story to be heard have had an opportunity to speak in a sensitive and appropriate environment. She has handled her work with great tact and compassion, and I thank her for all her hard work and dedication.

[Noble Lords]

Hear, hear!

[Baroness Blackwood of North Oxford]

Without second-guessing her conclusions, we recognise that we need to look beyond regulation and take a system approach to patient experience, enhancing the culture of improvement and using data to identify and drive required change, as my noble friend Lord O’Shaughnessy and the noble Lord, Lord Hunt, rightly pointed out. As part of this, I note my noble friend’s reference to a new national office of patient safety. That will require much more detailed discussion and consideration in the light of the review’s recommendations, but even at this stage it has much to recommend it.

 I shall move on to some of the specific questions about surgical mesh. There has been a detailed debate about it, so I do not want to repeat what has been said. As the noble Lord, Lord Hunt, pointed out, in July 2018 my noble friend Lady Cumberlege recommended that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence. That was supported by the Chief Medical Officer and senior clinicians. It was implemented through a high-vigilance regime of restricted practice and communicated to NHS England trusts. I understand that a similar process is taking place in Wales. I understand the impatience for a full ban, but for some women this may still be the only option for treatment, so it was considered that, while awaiting the outcome of the review, it was the appropriate route to take. The current findings are that the pause has dramatically reduced the number of procedures while we await the findings of the inquiry by my noble friend Lady Cumberlege. This is being kept under very tight scrutiny.

With reference to my noble friend’s specific question on a properly funded and staffed national network of expert mesh removal centres, I can confirm that NHS England has consulted on a service specification. When it is in place, we expect the service specification will cover multidisciplinary team management and complex vaginal mesh removal surgery for women who have complex complications. We are taking extremely seriously the review’s wider interim recommendations and are taking appropriate action in response. We will fully consider the final recommendations on mesh that the review will make later this year. Our primary objective will be to prevent future recurrence of the pain and appalling distress that patients, such as those who have given evidence to the review, experienced. We want to ensure that lessons are learned from their experience that will help us to protect other patients from any further risk of harm.

 Turning to valproate, I have tremendous sympathy for the families affected by its use. The Government’s priority is to ensure that women are aware of the risks of this medicine. I therefore agree with my noble friend that the Government’s ambition should be to limit in-utero exposure to as close to zero as possible. Our current goal is rapidly to reduce and eliminate pregnancies being exposed to valproate. This is being supported by a formal pregnancy prevention programme and annual specialist review, as well as clear valproate labelling and packaging. There is also a communication and awareness campaign for healthcare professionals and patients. In response to the question asked by the noble Baroness, Lady Walmsley, all pharmacies have been provided with materials and there have been repeated communications. The General Pharmaceutical Council has written to all pharmacists to remind them of their professional responsibility in providing information to women, while the Royal Pharmaceutical Society and pharmacy bodies have been very active in communicating with their membership and in auditing practice. I recognise that there are still concerns about performance, but action is being taken. Patient input and engagement with members of the patient group, INFACT—who I know my noble friend has met many times—have been invaluable in the feedback process. It remains the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure that women are aware of the risks and are on a pregnancy prevention programme.

I note the questions posed by noble Lord, Lord Alton, regarding Primodos. They were quite detailed so, if he will allow, I will come back to him in writing.

I hope I have covered the majority of points raised by my noble friends and others in this House. This has been an important debate and I reassure all noble Lords that, as a Government, we are fully committed to a system of regulation for medicines and medical devices which intelligently provides access to new, innovative and world-leading products to improve the lives of millions of patients—especially those with diseases that are rare and hard to treat—while simultaneously protecting UK patients from harm, and ensuring that patient voices are heard loudly and clearly throughout the system if something does go wrong.

I finish by thanking my noble friend Lord O’Shaughnessy and all noble Lords who have participated in the debate this afternoon. It is clear that we are united in our dedication to learning from the experiences of those who have been courageous in speaking out, and in our commitment to protecting and improving the safety of patients who use medicines and medical devices in the UK. I am sure that, if we work together on this matter, we will see not only better medicines, better support and better care for patients but a safer NHS that is more responsive when it needs to be.