Medicines and Medical Devices Bill

Baroness Ritchie of Downpatrick Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, like many noble Lords who have spoken today, I agree that the provision of high-quality healthcare in which its citizens can all have confidence defines any nation. That is why this Bill, with all its warts, is so important.

We must always ensure that our ethical practices are of the highest standard. Any medical product available in the UK, or indeed anywhere, must be rigorously tested, safe and effective. That is also particularly true of any future vaccine for Covid-19.

However, I want to focus today on one aspect of this Bill, that relating to medical devices. I have long campaigned on the issue of winning justice for pelvic mesh sufferers, who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve justice, and we must ensure that this sort of systemic failure never happens again.

The recent report by the noble Baroness, Lady Cumberlege, entitled First Do No Harm, on surgical mesh and other medical interventions was scathing in its assessment of the failures of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As someone who met victims of this appalling mismanagement when I was a Member in the other place and learned at first hand of the pain they had been forced to endure and its effect on their quality of life, I am pleased that this review was commissioned and am happy to support the noble Baroness in her proposals. I am pleased, too, that it was able to be so honest in its findings.

I am further pleased that the Minister, the noble Lord, Lord Bethell, provided an apology in your Lordships’ House on the 9 July to all the people who have suffered as a result not only of pelvic mesh issues but of certain medications. I am now going to ask the Minister a direct question. Will the recommendations of the noble Baroness, Lady Cumberlege, be reflected in this Bill through government amendments in Committee? I refer in particular to the implementation task force, which must be set up without delay to oversee progress. Like other noble Lords, I believe that that recommendation should be given statutory effect if the Government and Parliament are to take this report seriously. That goes also for the recommendation that a commissioner for patient safety be created.

In relation to Northern Ireland, there is also the issue of potential regulatory divergence. As medicines are a devolved power but medical devices are not, the Bill in its current form raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK. That matter requires clarification in relation to the report of the noble Baroness, Lady Cumberlege, and this Bill. Can the Minister provide that? There is no doubt that such assurances are very necessary, but they should not and will not close the door on the past.

Medicines and Medical Devices Bill

Baroness Ritchie of Downpatrick Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

The noble Baroness, Lady McIntosh of Pickering, has scratched from this group, so we move on to the noble Baroness, Lady Ritchie of Downpatrick.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, it is a great pleasure to follow the noble Lord, Lord Blunkett, on this group. I pay tribute to the noble Baroness, Lady Cumberlege, for her report and for introducing this proposed new clause, which I feel the Minister should accept.

I apologise for not participating on previous days but I was involved in debates in the Chamber, so I ask your Lordships to accept my apologies.

I fully accept the need for this new clause. At Second Reading, I indicated that the recommendation of an independent patient safety commissioner, on a statutory basis—one of the central recommendations in the report of the noble Baroness, Lady Cumberlege, and her team—should be given legislative effect. The provision of high-quality healthcare in which all citizens can have confidence defines any nation. For me, that is why this Bill is so important and why it should be amended to include this proposed new clause, among others. Our ethical practices are of the highest standard, and any medical product available in the UK, or indeed anywhere, must be rigorously tested and be shown to be safe and effective. That also goes for the Covid vaccines which are currently under investigation and awaiting licence.

I have long campaigned to get justice for pelvic mesh sufferers who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve better justice and we must ensure that this sort of systemic failure never happens again. I remember, as a Member of the other place, meeting many constituents —in the main, women—who had a pelvic mesh inserted and suffered immeasurable pain. They were trying their very best to have it removed.

The recent report by the noble Baroness, Lady Cumberlege, First Do No Harm, on surgical mesh and other medical interventions, was scathing in its assessment of the failure of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As I said, I met victims of this appalling mismanagement when I was a Member in the other place. I learned at first hand of the pain they had been forced to endure and the impact that it had on the quality of their lives and those of their families. Therefore, I am pleased that the report was commissioned and I am happy to support the recommendation for an independent patient safety commissioner, as per the proposed new clause. It should be placed on the face of the Bill. I believe that, if the Government are serious about that report and about the Bill, this recommendation should be given legislative effect, and I urge the Minister to accept the amendment.

It would be vital for the commissioner to lead with full patient group engagement, and be accountable to Parliament. Patient groups should also be involved in developing a set of better patient safety principles that would govern the way the commissioner fulfilled her or his remit.

As other noble Lords have referred to, we now have experience of the work of various commissioners. I can speak about those that exist in Northern Ireland. There is now a Veterans Commissioner, a Children’s Commissioner and a victims’ commissioner. They all do good work, acting as advocates for people in their specific fields, and bring forward recommendations to the devolved Administrations. In this particular instance, there is absolutely nothing to suggest that this commissioner, if established through this legislation, would not do likewise. They would be a listening ear and would seek to improve existing health service regulations and practice, particularly in the area of medical devices.

Therefore, I am very happy to support this proposed new clause, and I urge the Minister to accept it.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, I will speak to Amendment 120 and, again, I am very grateful to my friend the noble and learned Lord, Lord Mackay of Clashfern, for joining me on this amendment. I beg noble Lords’ indulgence because, when I read the legislation and the Bill related to this and then looked at the advice or guidance issued by MHRA, I got more and more confused about what the divergence is going to be, how much of it there will be and how clear the Bill is. I am sorry, but I will be labouring the point at length to get some answers.

My proposed new clause would require the Secretary of State to report on

“regulatory divergence between Northern Ireland and the rest of the United Kingdom”.

This amendment would address the issues of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom. In relation to medicines and veterinary medicines, Northern Ireland is referred to separately from the rest of the UK. This means that, as set out in Clause 1(4)(b) and Clause 8(4)(b), the power to make regulations in respect of Northern Ireland lies with the Department of Health in Northern Ireland or both the department and the Secretary of State, when acting together.

Clause 40 limits the capacity of the Department of Health in Northern Ireland to act alone, only allowing it to do so when it would be

“within the legislative competence of the Assembly, and … would not require the consent of the Secretary of State.”

It is not clear in the Bill which areas would be in the sole competence of the Northern Ireland Assembly. Will the Minister clarify that?

Furthermore, while powers on medical devices are not reserved, the guidance most recently published by the MHRA paints a picture of two different systems—market authorisation and registration, among other issues—and distinguishes between the “Northern Ireland market” and the “Great Britain market”. This implies that regulation different from that in the rest of the UK may be intended for Northern Ireland in respect of medical devices.

The MHRA published guidance on medicines and medical devices based upon the potential situation at the end of the transition period, days before this House was due to sit for the Second Reading of the Bill. This advice implies that a dual system would be operating in respect of Northern Ireland for both medicines and medical devices due to the operation of the Northern Ireland protocol, to which the noble Baroness, Lady Wheeler, referred. This assumes that the Government will actually honour that agreement. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland.

The MHRA guidance makes a distinction between the EU market, the market of Great Britain and the market of Northern Ireland. It sets out that CE marks will cease to be recognised in the market of Great Britain from July 2023, unless the products in question are from manufacturers based in Northern Ireland. There are essentially two different baskets envisaged in the guidance for manufacturers that are based in Northern Ireland to bring a medicinal or medical product to the markets of Great Britain and Northern Ireland.

The first is to go through UK-based approved bodies for their assessments and market authorisations, which would be approval for the Great Britain or Great Britain and Northern Ireland markets, but it would not be recognised in the EU. The second is to submit their application to approval or notified bodies in the EEA, gaining a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market. Noble Lords will see how confusing the whole system sounds.

In contrast, manufacturers based in Great Britain would need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland but would need to undertake the separate task of getting an EU-based responsible person and applying separately for a CE mark in the EU if they were to bring their product to the EU market.

Further, from 30 June 2023, CE-marked devices originating from the EU market but not manufactured in Northern Ireland will no longer be able to flow to Great Britain. This regulatory set-up in Northern Ireland could therefore be an incentive for EU manufacturers to base their European operations in Northern Ireland to have unfettered access to both markets. Discussions about whether this constitutes state aid and would distort the EU single market are still ongoing.

On the face of the MHRA guidance, it appears that the recognition of the CE mark on medicines and devices coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. It certainly suggests a dual system applying between Northern Ireland and the UK, but the extent to which those systems will diverge in substance in future is not clear. It is not clear how systems of pharmacovigilance or the monitoring of medical devices will be co-ordinated for products available in the Great Britain market that are manufactured in Northern Ireland and subject to EU regulations and monitoring. If monitoring systems and databases are to be fit for purpose in the EU, surely it is essential that the UK has access to EU databases. In the absence of this access, how can the Government guarantee, or claim to be prioritising, the safety of patients?

What is clear, because the guidance states it, is that draft regulations with reference to medicines and medical devices exist but have not yet been introduced to Parliament. These draft regulations are what the guidance claims to be based on. If these regulations exist to the extent that the MHRA is publishing guidance based on them on issues of significant policy in these areas, why has this House not had sight of them? Why have they not been included as part of the substance of the Bill where they would receive proper scrutiny and provide much-needed clarity to all stakeholders for medicines and medical devices?

The situation regarding regulatory alignment or divergence between Northern Ireland and the rest of the UK is politically charged and should be dealt with explicitly. Given the potential for some aspects of medicine and veterinary medicine to be subject to the distinct competence of the Northern Ireland Assembly, there is potential for the requirement to have regard to “attractiveness” to have different interpretations in Northern Ireland and the rest of the UK. Further, the ambiguity surrounding the Northern Ireland protocol and its implications raises the potential for divergence, even where the United Kingdom Government have competence to regulate in respect of medical devices. For these reasons—I hope that I have made this point at length—the Government should clarify the position. This amendment would provide greater transparency about the potential regulatory divergence with a commitment to mitigate where possible.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.

During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.

In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?

I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.

There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.

There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.

[Baroness Penn (Con)]

My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.

Medicines and Medical Devices Bill

Baroness Ritchie of Downpatrick Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

It is the same with the issue of independence. The noble Baroness, Lady Cumberlege, was a Minister in the Department of Health and she has said that the department does not like independence, and I can confirm that as a former Minister. But to have credibility, you have to have an independent approach. The task force is one example, and the patient safety commissioner is another. At heart, we want to hear from the Minister, before the Bill reaches the end of its stages in the House of Lords, what the government response is. I am afraid that we are not going to get it, which of course then leads us to push amendments at Report. But I hope that the Minister, with his colleagues, will reconsider their approach and, before we reach Report, set out what they will do with the noble Baroness’s recommendations.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Lord, Lord Hunt of Kings Heath, and support the noble Baroness, Lady Cumberlege, in her amendment, to which I have added my name.

The report that the Government commissioned and appointed the noble Baroness, Lady Cumberlege, to do on these issues of medicines and medical devices made nine very clear recommendations in July. One central recommendation in that report, First Do No Harm, was the need for a task force to oversee the implementation of the recommendations from the report —hence this amendment today.

If the Government, the Minister and his colleagues, are serious about the recommendations and recognise that there is an issue and a problem in relation to certain medicines and medical devices, they should see fit to implement all nine recommendations. I think back to when I was doing some research on this. An eminent QC, Lauren Sutherland, said that the Government should not ignore these recommendations—they should implement them.

I made the request, along with many other noble Lords, for the implementation of the task force during Second Reading in early September. I said that it should be set up without delay to oversee progress, and I believe that, if the Government are to take this report seriously and ensure that such failures do not happen again, that needs to happen. What better way to have an implementation group than by the task force that is already in existence, because it was independent of government, has worked on these issues for two years and is fully acquainted with all the matters, problems and challenges met by many people, who have suffered indignity and immeasurable pain as a result of the imprecision in relation to medical devices? To ensure proper implementation and oversight of the recommendations, a task force is a necessary prerequisite and needs to be placed in the Bill. The first remit or task of such a task force should be to set a timeline for its work and delivery of the review’s recommendations. The only way for that to work is if the implementation task force is put in the Bill.

As the report states, the task force should be made up of representatives of the various arms of the healthcare system that have a recognisable role to play in delivering patient safety—in other words, people acquainted with the issues and who have knowledge and expertise. Those responsible for implementation need to know that their work and progress will be monitored and they will be accountable. Supporting the implementation process should be a reference group made up of a range of patient interests going far wider than the groups the report members dealt with. Yet again, such a reference group would consist of people with direct experience, and ongoing daily experience, of the impact of such medicines that have been specified, as well as other types of medicines, where there have been side effects, and the medical devices that have caused so many problems to so many women and men.

We need a system and task force that listens, hears and acts with speed, compassion and with proportionality to prevent further avoidable harm—hence my support for the amendment in the name of the noble Baroness, Lady Cumberlege, to establish such an implementation task force without delay in the Bill.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.

In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.

Medicines and Medical Devices Bill

Baroness Ritchie of Downpatrick Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Baroness, Lady Bennett of Manor Castle.

At this stage, let me congratulate the noble Baroness, Lady Cumberlege, on her thought-provoking report, First Do No Harm, which really led to the position we are in today. I also thank the Minister—the noble Lord, Lord Bethell—for bringing forward on Report this amendment regarding the patient safety commissioner and putting it on a statutory basis. Led by the noble Baronesses, Lady Cumberlege and Lady Thornton, we have had several meetings with the Minister on this particular issue. He gave commitments in this respect, for which I, for one, am particularly grateful.

Naturally, as with everything, I have some questions, to which I and others would like some answers. On the nature of the patient safety commissioner’s appointment, how independent will they be? They will be accountable to the Secretary of State for Health and the department, but what does that level of accountability mean? What will the nature of the regulations circumscribing the appointment be? When will the appointment actually take place? What is the timeframe? Will there be adequate resources on an ongoing annual basis to fund this position, to ensure that the patient safety commissioner can act as an advocate on behalf of patients?

We have heard what the Minister had to say: that patient safety is the golden thread holding this Bill together. That is particularly important, but the patient safety commissioner will be the person who will have to provide direction and leadership. This was one of the principal aims and outcomes of the report by the noble Baroness, Lady Cumberlege, First Do No Harm. Patients who have been unwell and feel that they have been slighted or undermined in their dealings with medical practitioners want to feel safe and have confidence that they are being listened to. I hope that, whenever the regulations are published and enacted, this appointment can take place at very short notice. And, of course, the commissioner must be someone who commands respect and is a person of standing.

It is vital that the commissioner leads, with full patient group engagement and involvement, on the development of a set of principles for better patient safety that governs the way the commissioner fulfils his or her remit. I am delighted to support the government amendment. It goes without saying that I also support Amendment 65 in the name of the noble Baroness, Lady Cumberlege. There are issues with who the person is accountable to—the Department of Health, in this instance. I know that the noble Baroness was looking for the Cabinet Office, but that is just a detail. We have arrived at an important stage today, and I welcome that.

Finally, I have been talking to the Minister at the meetings organised by the department with the noble Baroness, Lady Cumberlege, to give an update on Northern Ireland, where there are several ongoing inquiries. The Minister and his officials were very helpful and are having discussions with the Minister for Health in Northern Ireland. Maybe today the Minister could provide me and your Lordships’ House with an update on the position within the Northern Ireland Executive and Department of Health.