Medicines and Medical Devices Bill

Lord Kakkar Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Finally, I am also concerned about equivalence. We heard much during our review about medical devices. These devices were able to claim equivalence to an existing product and thus gain, in effect, automatic authorisation without any approval process. The equivalence arrangement is rather like a chain reaction. If a second product successfully claims equivalence to the original product, it may well be slightly different in composition or intended for a somewhat different use, yet it gains the ability to be marketed for the same purposes as the first product. A third product then comes along and is somewhat similar to the second, so it gains equivalence status, yet its composition or intended use is further removed from that of the original authorised product. So it can go on, and the products claiming equivalence can bear little relation to the original product. This can give rise to serious safety concerns. With that in mind, I ask my noble friend the Minister: how do the Government intend to approach the matter of equivalence in the field of medical devices once the Bill is enacted? I have given him notice of my question.

[Lord Kakkar (CB) [V]]

My Lords, I shall speak to Amendment 97 in my name and that of my noble friend Lord Patel. In so doing, I of course recognise the important points the noble Baroness, Lady Cumberlege, made. I will answer some of her questions in a moment.

The particular purpose of Amendment 97 is to extend the reach of Clause 16, which already gives powers to establish information systems for assessing

“the safety and performance … of medical devices that are placed on the market”,

to include provision for the establishment of an information system for the safety and performance of medical devices before they are placed on the market via a form of provisional licence. It would provide for the Secretary of State to require, under certain circumstances, that new devices would in the first instance be given a limited approval based on clinical evidence and clinical trials. However, it recognises that further information would be required and that a provisional licence, or formal marketing authorisation, would therefore be given only for information gathering purposes. This would ensure that the level of evidence provided prior to broad unfettered use of a device would be much greater than is currently available.

This approach is both important and practical. It is important, as we have seen in the report from the noble Baroness, Lady Cumberlege, because implanted devices can have serious, harmful effects for patients. Not all devices have the capacity to be harmful, but where there is concern, where there are limited data or where the argument is based on equivalence using the kinds of arguments that the noble Baroness has made, the introduction of a device into routine clinical practice would be limited by a provisional licence, with the need for careful, pre-specified monitoring and evaluation, both for efficacy and for safety. This will protect the patient. It will protect innovation and it will ensure that we continue to facilitate innovation but in a responsible way.

Arguments are made about the practicality of such an approach. During this debate, we have heard that there are differences between the standards required for the authorisation for marketing a medicinal product compared with a medical device. The reality is that medical devices have profound implications for the management of patients. Implantable devices, in particular, also have profound implications for patient safety. The approach is practical because successive Governments have emphasised and prioritised the ability of the National Health Service to collect data and to develop its digital capacity.

We have seen the benefit of these investments and this emphasis during the Covid-19 national research effort. The regulator working, for example, with NHS Digital could devise integrated data-acquisition platforms and clinical research methodologies, potentially applied in specialist clinical centres. Data might then be collected prospectively to a high level and a high quality on the devices selected for such a provisional licensing process. These devices would also be used under appropriate and informed clinical supervision by experts before widespread adoption across the entire health system was allowed.

Rather than stifling innovation, which is a concern, I believe such an approach would ensure that our country could secure a position of leadership in the increasingly important field of medical devices development. These are going to play an increasingly important role in the delivery of healthcare. We would provide a fully facilitated environment for the appropriate clinical evaluation of medical devices, both their efficacy and their safety. In much the same way that the establishment of NICE and the Scottish Medicines Consortium, of which my noble friend Lord Patel was a founding leader, helped establish our country at the forefront of the evaluation of medicine and the responsible adoption of innovative medicines, the proposals included in this group of amendments and the proposal for provisional licensing outlined in Amendment 97 would allow us to develop unique leadership in the development, evaluation and responsible advocacy for the use of medical devices in a way that is clearly not available currently.

The noble Baroness, Lady Cumberlege, made an important point about devices that are designed for implantation in a patient and whose removal is dangerous or practically impossible. What must be demanded here is a much higher level of evaluation in development and research—she made the clear point that equivalence is not an appropriate approach in those or any circumstances. Moreover, offering the opportunity after appropriate clinical evaluation for such devices to be introduced in a limited fashion—still in routine clinical practice but with careful, pre-specified evaluation and monitoring—ensures, as she said, that if there are early reports of adverse events, those might be identified quickly prior to any opportunity for such devices to be provided across the entire healthcare system, where reporting on their implantation and follow-up may be less rigorous. In a provisional system, data acquisition and reporting would be pre-specified, using platforms provided by the regulator and the NHS. With the remarkable capacity we now have for data acquisition and analysis in the NHS, such methodologies, applied in a routine fashion in appropriate circumstances, would provide the greatest opportunity to protect patient safety while driving forward innovation and making use of all the opportunities that the NHS provides in this regard.

[Lord O'Shaughnessy (Con) [V]]

My Lords, it is a pleasure to follow that excellent exposition of his and other amendments by the noble Lord, Lord Kakkar. I want particularly to speak in support of amendments aimed at putting post-marketing reporting requirements for medical devices on a par with those for medicines.

My noble friend Lady Cumberlege has again given a powerful and moving testimony of the reports that she uncovered in her review of the dangers for some patients of pelvic mesh, but severe problems have emerged in other medical devices, be that metal-on-metal hip replacements, PIP breast implants or elsewhere. They have shown how potentially dangerous medical devices, particularly, as other noble Lords have pointed out, those implanted into body tissue, are simply not regulated enough.

The regulatory regime for licensing medical devices distinguishes between different categories of risk. Higher-risk devices of course have to clear a higher bar, and the UK’s notified bodies are renowned for taking on such work—prior to Brexit, they carried out more higher-risk assessments than any other notified body in the EMA family. We therefore have potential strength in this area. However, these tragedies demonstrate that even this strong regulatory regime does not go far enough. We need a broader definition of risk which takes account of the nature of the device, the therapeutic ways in which it can be used and the places in a patient in which it can be put, as well as much better post-market surveillance and wider use of registries, including coverage of the independent sector, which is where some of the most acute problems arose.

It goes without saying that these are recommendations from my noble friend Lady Cumberlege’s report. Like other noble Lords, I strongly urge my noble friend the Minister and the Government more broadly to adopt them and reduce the unacceptable gap between the safety regimes for medicines and medical devices.

Having expressed my concerns the other day about access to experimental medicines, I applaud the intention behind the idea of provisional two-year licences, but we obviously have a job of work to do to reconcile these two sometimes competing imperatives—the noble Lord, Lord Kakkar, explained how he thinks that can be achieved. It may be stealing the thunder of a future group of amendments that we hope to deal with tonight, but I wonder whether a better answer would be the expansion promised in the Conservative manifesto of the Cancer Drugs Fund into an innovative medicines fund more broadly, as well as continuing and early access to compassionate-use schemes for medicines post Brexit.

Both the noble Lords, Lord Hunt and Lord Kakkar, raised the idea of these conditional licences being applied to devices, and my noble friend Lady Cumberlege mentioned safety concerns which might apply. I wonder whether the right approach would be to open the innovative medicines fund up to devices, digital and diagnostics. It would mean a name change, but that presumably would not be a problem. They could then qualify as well as medicines, so the kind of early access possible under these two-year conditional licences could take place in that specific, heavily monitored and controlled environment that has already demonstrated huge value when looking at transformative cancer drugs before they have achieved their full licence. Within these ideas is the right approach to balancing these two risks, and in fact merging them and getting something stronger as a result. I look forward to hearing from the Minister how the Government intend to move forward on these issues.