My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.
The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.
I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.
I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.
By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.
However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.
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On medical devices, I start by saying that the practical reality of medical devices is quite different. There are an estimated 500,000 medical devices available on the UK market. The sector is constantly developing; new technologies appear at greater pace than they do in the pharmaceutical sector and the rate of innovation is accelerating. As a result, the conformity assessment procedure to place a device on the market is different. Medical devices undergo a range of testing requirements, commensurate with the risk they pose to patients, before they are placed on the market.
All custom-made devices, systems or procedure packs, and all in vitro diagnostic devices—known as class 1 —are registered with the MHRA. This is because some of these products do not benefit from the independent oversight of a notified body before they are placed on the market. I completely acknowledge the concerns about equivalence voiced by my noble friend Lady Cumberlege and the noble Lord, Lord Kakkar, and alluded to by others. This mandatory registration with the MHRA is required in the Medical Devices Regulations 2002 and provides a level of additional scrutiny on these products that otherwise would be absent. Higher-risk classification devices are checked for conformity against the regulatory standards by independent notified bodies prior to being placed on the market, giving an important additional level of scrutiny required.
I should flag that vaginal mesh was and remains overseen by a relevant notified body, but even that did not mean that counterindications were necessarily picked up immediately, partly because of the reasons described by the noble Lord, Lord Kakkar. However, the data provisions in Clause 16 will massively help this and are an important part of our response to the challenge described by noble Lords.
MHRA oversees the notified bodies, ensuring that all activities are carried out in accordance with the regulations. These organisations can specialise in certain areas; they add expertise and capacity as required, in a flexible way that would be challenging for public sector bodies to replicate. This range of expertise is required to reflect the volume and complexity of medical devices. This system ensures efficient, rapid undertaking of pre-market assessments, aiding patient access to innovation.
It is also very difficult to conduct wide-scale clinical investigations of medical devices. Clinical investigations for medical devices differ from clinical trials for human
medicines in that they may be smaller and less complex. Clinical trials can be less relevant, practical or measurable for medical devices, as alluded to by the noble Lord, Lord Patel, and others. Their effect is therefore less easy to measure. That is why the focus of medical device regulation is on stringent post-market assessment.
The Medical Devices Regulations 2002 require all manufacturers placing medical devices on the market to fulfil certain obligations, including conducting post-market surveillance for their products. The medical device vigilance guidance—MEDDEV 2.12-1—sets out detailed steps on how manufacturers should meet these post-market obligations. For example, the guidance covers reporting serious adverse events to their national competent authority and field safety notices.
For some medical devices placed on the market, the notified bodies will review the manufacturer’s post-market surveillance system as part of the conformity assessment procedure or during an audit. The MHRA also conducts market surveillance for devices placed on the UK market, which includes reviewing all medical device adverse events reported to the agency.
I completely take on board the comments from my noble friend Lady Cumberlege and others on the need for trials and their publication, and on the need for follow-up. Some medical devices do undergo clinical investigations under the Medical Devices Regulations 2002, and the MHRA is responsible for issuing approvals for, and is notified of, all clinical investigations that take place in the UK. Any adverse events relating to clinical investigations must be reported by the MHRA. Medical device manufacturers are required to demonstrate that they have the data to support the performance and safety of their device. For many devices this is through the conduct of a clinical investigation.
The objective of a conformity assessment is to ensure that medical devices placed on the market comply with the regulatory requirements as set out under the Medical Devices Regulations 2002. Depending on the type of device under review—for example, a high-risk medical device—the manufacturer may be required to submit clinical evidence to support the intended purpose of the device. This would be reviewed by the notified body. Amendments 84 and 89 are therefore unnecessary.
The Bill already provides for changes to be made to clinical investigations. Clause 13(1)(i) provides for regulations about the investigation into, or the evaluation of, the safety or performance of medical devices. Additionally, Clauses 14(1)(b) and (c) enable provisions about the recording of safety and performance information and that information being provided to the Secretary of State. This includes clinical effectiveness.
I say to the noble Lord, Lord Kakkar, that we intend Clause 13 to be used for the safety of medical devices in relation to manufacturers, not Clause 16. Both clauses provide for his amendment as drafted already, so it is not necessary. We recognise that the standards of safety applied to medical devices, while specific to their nature, can be strengthened. I acknowledge the comments of many noble Lords on the matter. While I do not necessarily agree a two-year, rapid provisional
licence is the right model, it is right that we review the regulations that apply to medical devices to improve safety standards.
I know the noble Lord, Lord Kakkar has concerns specifically about devices that can be modified or manufactured by an individual surgeon. In certain circumstances, it can be deemed necessary that a hospital trust manufacture a device or adapt a mass-produced one for specific patients within that trust. Under the current Medical Devices Regulations 2002, these devices are not subject to the registration requirements set out above because they are not placed on the market. Mass-produced devices that are adapted are not custom-made devices. In these circumstances, the onus is on the clinician and the trust, rather than the manufacturer, to ensure that the device performs as intended and is safe to be used. Should we decide to change this, these regulations give us the power to do so.
I know that the noble Baroness, Lady Cumberlege has concerns over what this invests in the clinician. I say to her and others that it is our intention to look at this issue in regulations made under the Bill. The design of the future regulations will be informed by a consultation that is open to the public and will take these areas of concern into account.
However, we cannot prescribe the outcome now for two important reasons. First, we have already provided for a two-and-a-half year period for medical devices with a CE mark to continue to be accepted on to the UK market to allow for new regulations to be developed. This has been done through the statutory instrument laid before Parliament on 15 October. Separately, we tabled a statutory instrument dealing with medicines on 20 October which provides for a two-year period. However, with devices we must also consider the impact of a very different regulatory system—one of pre-licensing—and what this would do to the availability of medical devices in the UK with such a significant departure from the other system. Before we are able to take that into consideration we cannot commit to the regulations as described.
I hope that I have demonstrated that these amendments are unnecessary, and I ask the noble Baroness to withdraw her amendment.