BRX0020 - Evidence on Brexit: the regulation of medicines, medical devices and substances of human origin

BRX0020

Written evidence from Professor Thomas Joyce, Professor of Orthopaedic Engineering, School of Engineering, Newcastle University

Respondent

I am a Professor of Orthopaedic Engineering with over 20 years’ experience specialising in the design, testing, analysis and evaluation of medical devices including artificial hip, knee, shoulder and finger joints. I work extensively with clinicians and industry in order to inform and improve future designs of implants for the ultimate benefit of patients. I currently supervise investigations of artificial hip and knee joint failure, as well as projects which test artificial joints in the laboratory to indicate how they will perform within patients. I engage with patients whose implants have failed inside them, to determine what went wrong with the medical device and then ask how future failures can be prevented. In 2012 I gave oral evidence to the Science and Technology Select Committee of the House of Commons in regard to their enquiry into medical implant regulation in the UK and EU [1, 2]. At an EU level, in 2014, I contributed to the investigation of the safety of metal-on-metal implants [3].

Scope

My submission to the Committee focuses on an area of recent controversy, that of failed medical devices, which intersects with my areas of expertise. My main area of expertise relates to failures in metal-on-metal hips. Working alongside orthopaedic colleagues, we have examined hundreds of retrieved metal-on-metal hips to determine why they failed in the body. Our peer-reviewed scientific papers have been highly cited and helped with understanding of what went wrong with these medical devices [4, 5]. We were the only research group in the world to publish critical data on the DePuy ASR metal-on-metal hip prior to its worldwide recall in August 2010 [6-8]. Almost 100,000 ASR hips were implanted worldwide in what has been described as ‘one of the biggest disasters in orthopaedic history’ [9] as well as a ‘public health nightmare’ and ‘a tragedy for many patients’ [10]. We have also investigated other designs of metal-on-metal hip which have been implanted in large numbers and not met NICE guidelines [11, 12], and have alerted the orthopaedic community to these failed medical devices [13-15]. From investigating how these medical devices have come to market I have gained knowledge of the regulatory process and critiqued it [16]. On this basis I have commented on issues with vaginal mesh implants [17] and continue to raise concerns with contemporary failures in medical devices [18].

Responses to the Consultation Questions

1. What are the key considerations that arise for companies, healthcare services and regulatory bodies in the UK as a result of the UK’s withdrawal from the EU? Focussing on patients and the public, what needs to be done to ensure that any adverse impact is minimised or eliminated, and that opportunities to enhance services are maximised?

My key concern is that the recent European Medical Device Regulation (MDR), which in large part was developed in response to medical device scandals, will not be applied following the UK’s withdrawal from the EU.

In my view the recent Medical Device Regulation (MDR 2017/745) [19], which will be applicable in full across the EU from May 2020, represents a positive step forward. For example there is planned to be a European Database for Medical Devices (Eudamed), and that EU-wide pre- and post-market data will be made available. This will provide key data as well as transparency [20], two things that have largely been missing in regard to assessing medical devices in the recent past. It should also be noted that these regulations represent years of work at a pan-European level and to reject them now would be an inappropriate and, in my opinion, dangerous decision.

My fear is that any future medical device legislation, post-Brexit, will be weakened in the name of ‘innovation’ and that patient safety will be even more compromised than it currently is.

2. Following the UK’s withdrawal from the EU, what alternative arrangements for the regulation of medicines, medical devices, medical products and substances of human origin could be introduced? What are the respective opportunities, risks and trade-offs involved?

I think the most straightforward solution is to implement the recent Medical Device Regulation 2017/745 (MDR) in full in the UK following the UK’s withdrawal from the EU. While all legislation can likely be improved, this legislation gives us, in my opinion, a solid base from which to build. Having weaker legislation will only compromise patient safety in regard to implanted medical devices. That we have had three major recent scandals involving medical implants (metal-on-metal hips, Poly Implant Prostheses (PIP) breast implants, and vaginal mesh implants) indicates to me that previous regulatory system has not worked. Together, these medical device failures have had a negative effect on hundreds of thousands of people around the world, bringing substantial additional costs to health services and resulting in expensive litigation.

3. How will withdrawal from the European Union affect the UK’s ability to influence international standards in life sciences?

I think withdrawal from the European Union will weaken the UK’s ability to influence international standards with respect to medical device legislation.

4. What are the implications for medical research and development, including for the timely patient access to new medicines, technologies and other relevant medical innovations developed within or outside the U.K? How can any adverse consequences be avoided or mitigated and any potential opportunities be enhanced?

I think that any potential opportunities can be advanced by going beyond MDR 2017/745, which is due to come into full effect from 2020.

I feel there needs to be a recognition that previous medical device regulation has not sufficiently prioritised patient safety. I made this view when giving evidence to the Science and Technology Select Committee of the House of Commons in 2012 [1] and I have the same opinion now in 2017. Indeed, even the US Food and Drug Administration (FDA) published a document in 2012 entitled ‘Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US’ [21].

Evidence shows that the Medicines and Healthcare products Regulatory Agency (MHRA) is currently, and has previously, failed to safeguard patients effectively [16, 22, 23]. Regarding issues with metal-on-metal hips and PiP implants the Lancet stated “these serious examples of device failures result from MHRA’s paralysis and inability to address the shortcomings of a badly flawed system” [24]. With current concerns over vaginal mesh, the ex-Scottish Health Secretary, Alex McNeil, MSP, said about the MHRA in September 2017: “I don't think they are a very professional organisation, I don't think they are a very caring organisation, I don't think they care at all about Scotland and I don't think they have got patient care as their number one priority” and in regard to their role that they had been “less than professional or helpful” [25].

The MHRA has responded that patient safety is their highest priority [25]. However this does not appear to be the case, based on the examples of metal-on-metal hips, PiP breast implants and vaginal mesh implants. In each case, the regulator has suggested that negative side effects have not been proven to be widespread. This indicates that the systems for reporting adverse events with medical implants in the UK are not working; and the MHRA does not appear to consider the view that their systems are not capturing the true data.

Moreover, if patient safety is their highest priority, then why don’t they apply the precautionary principle? The precautionary principle says that if there is a chance of harm by an item then its use is stopped while the potential problem is investigated. We see this precautionary approach in cars and in aircraft with thousands of vehicles brought back to be checked and planes grounded while investigations are undertaken. Yet the same precautionary approach does not appear to happen when there are concerns with medical implants – the failure of which has ruined the lives of thousands of UK citizens [10, 26, 27]. In my view this should change. When major concerns exist, implantation of specific medical devices should stop and evidence be gathered and assessed so that an informed decision on benefits and risks can be made. Patient safety has to be prioritised.

Yet in July 2017, Dr Ian Hudson, the chief executive of the MHRA said ‘It is a priority of the Medicines and Healthcare products Agency (MHRA) to support innovation across industry, SMEs, academia and healthcare, providing help to develop novel medicines, devices and manufacturing processes, through mechanisms such as the Early Access to Medicines Scheme and the MHRA Innovation Office’ [28]. In October, when speaking to the Science and Technology Committee of the House of Lords he said ‘we don’t want to increase burdens on industry’ and the MHRA was working on ‘accelerating the review process, … building on the earlier access to medicines scheme’ [29].

It is possible to have both safe medical devices and effective medical devices. To achieve this we need transparency, data on how medical implants are performing within patients, and a willingness to apply the precautionary principle. On this basis we could have the best and safest medical device regulation in the world.

The top priority for regulators should be explicitly stated as patient safety. If that means regulators stopping medical devices being implanted while patient concerns are investigated, then so be it.

Secondly, there should be phased introduction of new medical implants only undertaken at specialist centres where all details of the implants and the procedures are fully tracked. Once the efficacy is shown after a certain amount of time, then the implant could be introduced more widely.

Thirdly, to provide the fullest possible information, all implants which are fitted inside patients should be recorded into an appropriate registry. This is currently proposed with Eudamed. Through this route their performance can be tracked and analysed. The best performing implants can be identified for the benefit of future patients. Vitally, it must be the case that if an implant appears to be performing poorly through the registry, then further implantations of that specific type of implant are halted so that an investigation can be made. For artificial hips and knees this implant registry already exists and is achieved at a cost of approximately £20 per implant. This is a relatively trivial amount for the crucial clinical data that can be obtained to help patients and medical professionals.

With these enhancements in place in the UK, alongside the benefits of MDR 2017/275, I think we would truly have the best regulations and safeguards in the world, which would both protect patients and provide key evidence of the most effective medical devices available.

References

[1] Joyce TJ, McCormack P. Regulation of medical implants. Submission: Commons Select: Science and Technology Committee. 2012. http://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/inquiries/parliament-2010/regulation-of-medical-implants1/

[2] House_of_Commons. Regulation of medical implants in the EU and UK. In: Science_and_Technology_Committee, editor. London2012. http://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/inquiries/parliament-2010/regulation-of-medical-implants1/

[3] Scientific_Committee_on_Emerging_Newly_Identified_Health_Risks_(SCENIHR). Final opinion on Metal-on-Metal joint replacements Brussels2014. https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_20_en

[4] Langton DJ, Sidaginamale R, Lord JK, Nargol AVF, Joyce TJ. Taper junction failure in large-diameter metal-on-metal bearings. Bone and Joint Research. 2012;1:56-63.

[5] Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AVF. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br. 2010;92-B:38-46.

[6] Langton DJ, Jameson SS, Joyce TJ, Webb J, Nargol AVF. The effect of component size and orientation on the concentrations of metal ions after resurfacing arthroplasty of the hip. J Bone Joint Surg Br. 2008;90-B:1143-51.

[7] Langton DJ, Sprowson AP, Joyce TJ, Reed M, Carluke I, Partington P, et al. Blood metal ion concentrations after hip resurfacing arthroplasty: A comparative study of Articular Surface Replacement and Birmingham Hip Resurfacing arthroplasties. J Bone Joint Surg Br. 2009;91-B:1287-95.

[8] Joyce TJ, Langton DJ, Jameson SS, Nargol AVF. Tribological analysis of failed resurfacing hip prostheses and comparison with clinical data. Proceedings of the Institution of Mechanical Engineers, Part J: Journal of Engineering Tribology. 2009;223:317-23.

[9] Cohen D. Out of joint: The story of the ASR. BMJ. 2011;342.

[10] Curfman GD, Redberg RF. Medical Devices - Balancing Regulation and Innovation. New England Journal of Medicine. 2011;365:975-7.

[11] National_Institute_for_Clinical_Excellence. Guidance on the Selection of Prostheses for Primary Total Hip Replacement. 2000. http://guidance.nice.org.uk/TA2/Guidance/pdf/English