Wednesday 11th November 2020
(4 years ago)
Grand CommitteeMedicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Amendment Paper: HL Bill 116-V Fifth marshalled list for Grand Committee - (6 Nov 2020)
Lord Bethell
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—(a) the health and welfare of animals;(b) the health and safety of the public;(c) the protection of the environment.”Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 8 if satisfied that they would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Lord Bethell
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 8 in considering whether regulations under subsection (1) would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection after subsection (1) of Clause 8.
Lord Bethell
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 10.
Lord Bethell
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with veterinary medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of veterinary medicines.(3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority— (a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Agriculture, Environment and Rural Affairs in Northern Ireland in connection with veterinary medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
Baroness Wheeler (Lab)
My Lords, our Amendment 106, which I am speaking to on behalf of my noble friend Lady Thornton, is in this group on reporting requirements under the Bill. Specifically, it would add a new clause providing for an annual report to Parliament on medical devices information systems established by NHS Digital under the powers conferred by Clause 16. I am grateful to the noble Baroness, Lady Bennett, for her support for this amendment.
Clause 16(1) gives the Secretary of State the power by regulations to make provision for NHS Digital to establish and operate
“one or more information systems”
for medical devices. Under the Bill, these relate to the safety, performance and
“clinical effectiveness, of medical devices … placed on the market; … the safety of individuals who receive or are treated with a medical device”,
or who have one implanted in them, and
“the improvement of medical device safety and performance through advances in technology”.
The annual report proposed in our amendment would provide for the operation of these information systems to include information on the overall data in relation to
“the number of patients who receive or are treated with a medical device, or into whom a medical device is implanted; … any safety concerns received; and … any regulatory action taken.”
Finally, the amendment would ensure that the Secretary of State provided a copy of the report from the information centre on these related areas to the devolved Administrations in Scotland, Wales and Northern Ireland.
The Government’s own Amendment 131, providing a new clause after Clause 41 on consultation provisions and requirements, limits itself to the provision of a biennial report to Parliament starting:
“As soon as reasonably practicable after”
the Bill has passed on the operation of regulations laid on human medicines, veterinary devices and medical devices. The amendment is part of the Government’s response to the Delegated Powers and Regulatory Reform Committee. It also provides for regulations to be subject to public consultation before they can be made and requires the Secretary of State to include in the biennial report, as part of a consultation process, a summary of the concerns expressed or proposals put forward and, in consulting, to set out how the key issues of safety, availability and attractiveness have been taken into account.
The Minister’s letter to Peers of 13 October, which, as my noble friend Lady Thornton has already pointed out, we did not receive until after the amendments had been laid, underlines the importance of the Government’s amendments in providing a reporting obligation on the Secretary of State which
“will inform Parliament of the outcome of consultations on regulation made under Clauses 1, 8 and 12 during the two-year period under consideration, and provide a look ahead to expected regulatory change in the future”.
While consultation before the preparation of the report and information on the consultation, concerns and proposals are welcome, we do not accept that Amendment 131 fully meets the concerns of the DPRRC. We consider that an annual report to Parliament is essential, given the vital importance of the scrutiny and accountability that Parliament must be able to exercise.
We also consider that the government amendment should make a specific commitment to consultation with the devolved Administrations in Scotland, Wales and Northern Ireland, and not just to the Secretary of State consulting such persons as he/she considers appropriate. We will take up the key issue of consultation with the devolved Administrations in our later amendment and I look forward to the Minister’s response to the question of the noble Lord, Lord Patel, on these areas.
Finally, I strongly support Amendments 67A and 67B from the noble Baroness, Lady Jolly, which call for reviews to be laid before Parliament of the regulation of veterinary devices and the Bill’s impact on veterinary medicines after the Act is passed. The noble Baroness made a pretty convincing case for these amendments. The delegated powers in Part 2 of the Bill to amend the Veterinary Medicines Regulations 2013 are wide-ranging. Close scrutiny of the impact on animal welfare, human safety and the environment, together with full consultation with key stakeholders and recommendations on the need for further regulation, will be crucial. Similarly, the review of the Act’s impact on veterinary medicines, to be published one year after it is passed; on safety in relation to animals, humans and the environment; on availability in the UK; and on the UK’s participation in the development and supply of veterinary medicines would ensure full scrutiny of how the provisions in Clauses 9 and 10 were working in respect of these key issues.
I have two further points. During the Commons Committee on the Bill, we raised the importance of the availability of veterinary medicine services, as well as medicines across the country, and of ensuring that they are available in rural and urban settings. This would ensure that we do not have a two-tier system whereby there is better access to veterinary medicines and services in certain communities. We also called for a full assessment of the capacity of the veterinary industry to meet the regulatory and other requirements set out in the Bill. These are key issues which the review process set out in the amendments of the noble Baroness, Lady Jolly, would address. Can the Minister tell the Committee what work is being undertaken with veterinary sector stake- holders, including the British Veterinary Association and the Royal College of Veterinary Surgeons, on these issues —particularly to ensure that, post Brexit, we have the sustainable, diverse and modernised UK veterinary infrastructure and skilled workforce that we need to ensure a safe environment for humans and animals?
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, Amendment 67A, put forward by the noble Baroness, Lady Jolly, relates to veterinary devices. This is a proposed new clause seeking to ensure that the Secretary of State sets up a working group to review the regulation of veterinary devices within six months of this Act passing.
There is currently no specific legislation for veterinary medical devices. The market is small and manufacturers may choose to market their products for dual use—for humans and animals. The medical devices regulations are intended only for human devices. However, we consider that the regulatory framework is also suitable for ensuring the quality and safety of equipment for veterinary use. The Bill allows us only to amend or supplement the existing veterinary regulations in the manner described in Clauses 9 and 10. Those clauses do not provide authority for regulations to introduce substantial new standalone requirements for veterinary medical devices. If a medical device is packaged with a veterinary medicine, the marketing authorisation application would need to set out relevant information on that device. The device would therefore be assessed together with the veterinary medicine before a marketing authorisation is granted. Therefore, this type of medical device falls under the regulation of veterinary medicines.
Lord Patel (CB) [V]
I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?
Lord Bethell (Con)
I will get to back to the noble Lord with the specific answer to that question, if I may.
Baroness Jolly (LD) [V]
My Lords, I shall not detain the Committee for very long. I thank the Minister for his comments. I feel inclined at the moment not to withdraw my amendment, but I would like to read Hansard, consult and decide whether to return with these amendments, or something like them, on Report. I beg leave to withdraw the amendment.
Lord Bethell
“(1A) The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.” Member’s explanatory statement
This amendment provides that the Secretary of State may only make regulations under subsection (1) of Clause 12 if satisfied that they would promote the health and safety of the public.
Lord Bethell
Member’s explanatory statement
This amendment requires the Secretary of State to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 12 in considering whether regulations under subsection (1) would promote the health and safety of the public.
Lord Bethell
“(c) the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 12(2)(c) in the Bill as brought from the House of Commons.
Baroness Thornton (Lab)
My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.
Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.
The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.
Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.
The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.
In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.
Lord Bethell (Con)
My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.
Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.
The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.
Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.
While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.
Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.
A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.
Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.
My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.
My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.
Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.
In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.
The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.
This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.
Baroness Thornton (Lab)
Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.
Lord Bethell (Con)
I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.
Baroness Finlay of Llandaff (CB)[V]
I am incredibly grateful to all noble Lords who have spoken in this debate. It has been very important and illuminating. We will all need to read the Minister’s words with care because there was an awful lot in them. I am most grateful to the noble Lord, Lord Ribeiro, for asking about the private sector, because if procedures are done in the private sector for patients who pay for themselves and those procedures are outsourced more and more, it will be important to make sure that this safety data is collected.
I am surprised that the word “must” is not being picked up. A supermarket will know how many tubs of mayonnaise it has ordered and which factory they came from. If there is glass in jam, a supermarket can track it back to the factory where the glass was. If we do not have complete data collection systems, we will find that all the places that are functioning above average will do really well. They will collect the data properly, and so on. But 50% of places are below the average line—that is the nature of an average. All patients need to be protected and standards need to be driven up. I was grateful to the noble Baronesses, Lady Walmsley, Lady Redfern and Lady Jolly, for elaborating on aspects of points that I have made, and particularly grateful to the noble Baroness, Lady Thornton, for giving us the history of the amendment and asking again how this would work in practice.
Consent is critical. Patients going into a hospital expect all the equipment to be safe and to be known about. They expect the fire alarms to work and that the oxygen pipes to anaesthetic machines are correctly positioned and known about, and that full servicing data is available. It is important. Here I should declare that I was a very junior doctor in a hospital, but on the periphery, when an anaesthetic accident happened many years ago. It was critical that things could be traced back urgently. Unfortunately, there are tragedies, even when it is possible to do that.
We need to be able to look right across the whole system. There is the safety aspect—the tracking and quality control—that goes along with all the routine procedures. If something faulty is used in 15 hospitals around the country, that needs to be known rapidly and safely. I, too, worry about relying on clinicians to report if there is a problem, and I rather felt that the Minister’s answer underlined the call for a distinct commissioner for safety. The noble Baroness, Lady Cumberlege, has been calling for that because we need somebody who can interrogate and analyse the data, and look at it carefully. She explained consent for patient details extremely well. The Montgomery test of consent is that you should be given the information that other reasonable people would expect. It is almost the Clapham omnibus test of what patients should be told.
This is not about what the clinicians want or do not want to tell patients. They might feel it unnecessary to tell them something, but most patients would want to know about it and therefore it should be disclosed to patients. A doctor might say, “This can happen, but it has never happened to me”, but they still have a duty to disclose. Linked to that consent, I would like us to have routine processes in clinical practice for consent data to be entered into a registry. Patients could opt out and say that they did not want it to be entered, so that box would not be ticked; their scanned-in data would then not be sent on with the additional information.
This debate has been incredibly important. It gets right to the nub of patient safety. I hope that the Minister will meet me and the noble Baroness, Lady Cumberlege. I have to say to the Committee that I am pretty convinced that we will return to this on Report because there is a lot more to do. However, we have another group of amendments to move on to, and that debate will be interesting and informative, so I beg leave to withdraw the amendment.
Baroness Thornton (Lab)
This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.
In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.
Lord Bethell (Con)
My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.
The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.
Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.
Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.
That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.
As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.
The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.
NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.
Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.
I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.
The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I will happily share with him. I shall highlight one. Cytosponge had a 19-year journey from when it was thought of to when it was adopted. It is estimated that it saves 7,190 QALYs having now gone through NICE. Companies do not feel incentivised to develop low-cost devices in this country.
Another example is the CoMICs study on conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery, which compared two types of bypass machines. The difficulties there resulted in most of the study going abroad and being conducted elsewhere. Our development of robotics has been impressive, but we have huge competition from the US market, in particular in device development.
So I suggest that we need to look at a way of making sure that we can develop devices. I accept that this amendment as worded may not be right for this Bill at this time, but I hope that we will not lose sight of the need to innovate. I would like to come back on Report to the concept of provisional licensing as a way of getting new and innovative devices through the system rapidly, possibly without burdening the NHS with the financial bureaucracy that this amendment might cause. I beg leave to withdraw the amendment.