Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Patel

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.

The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.

However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.

We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.

I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.

Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.

For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.

In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.

I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.

This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?

We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.

[Lord Patel (CB) [V]]

My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.

Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.

There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain 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.

By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.

For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?

Care Bill [HL]

Debate between Baroness Wheeler and Lord Patel

Monday 21st October 2013 Lords Chamber

[Lord Patel]

My Lords, I rise to support the amendment in the name of the noble Lord, Lord Aberdare. He is extremely knowledgeable about issues relating to pancreatic cancer. While the principles of early diagnosis and related outcomes are important for all diseases, this is particularly so for cancers and especially for certain cancers, such as pancreatic cancer. I have spoken before in this House about how two members of my family—my mother and my mother-in-law—both died of pancreatic cancer. Emphasising the need for early diagnosis of any disease is important in the training of doctors and nurses.

[Baroness Wheeler (Lab)]

My Lords, we very much welcome this important group of amendments. If one reads back over the debates on the Bill in Committee, there can be little doubt that the provisions for HEE and LETBs have been considerably strengthened and improved by your Lordships’ detailed scrutiny and deliberations. These amendments consolidate that work.

We have also been encouraged by the progress that HEE has been making under the leadership of Sir Keith Pearson. The website demonstrates this, and the HEE leadership team has been highly visible at conferences and forums, setting out its proposed strategic priorities and consulting on the way forward. In particular, HEE seems to have taken up the key message that, in educating and training staff for NHS and public health, it must have a strategic understanding of the workforce requirements across the boundaries of health and social care and of the need for staff to work in an integrated way. This has been a major concern. I was pleased, for example, to hear the HEE medical director, Wendy Reid, emphasise this at a recent Westminster Health Forum workforce conference that I chaired.

These amendments strengthen the role of LETBs by emphasising that HEE duties under Clause 89 to ensure that quality improvement in education and training, promotion of research—as the Minister has stated—and the NHS Constitution all apply to LETBs. This is an important provision and reflects concerns expressed in Committee that LETBs must pay attention to the maintenance of standards and quality in education and training, as well as ensuring that sufficient numbers of staff are trained locally. This was a point made by my noble friend Lord Turnberg and which the Minister addressed earlier.

Amendments explicitly providing HEE with authority to delegate its functions to its committees, sub-committees, members or other persons are important in allowing HEE the flexibility that it needs to deliver its priorities and functions, and we strongly support them.

On HEE board and LETB representation, we join other noble Lords in expressing our relief at the government amendments, which ensure that people with clinical expertise are appointed to both bodies. This was a serious omission and its inclusion now greatly strengthens the Bill, as does the Government’s commitment that regulations will place a specific requirement on HEE and LETBs to include a nurse and a doctor. It is particularly important, as my noble friend Lord Hunt underlined in Committee, for the people in the driving seat on education and training requirements, standards and future needs at local level to be those who provide the services. HEE and LETBs must understand the pressures that the service is under in relation to staffing and to ensuring that education and training is flexible and responsive to the rapidly changing face and needs of health and social care. The implementation of the Francis recommendations for a lay patient representative on the HEE board and LETBs is also a key change to the Bill, which we strongly welcome and which will only enhance the work and effectiveness of those bodies.

Finally, as supportive of HEE as we are, it is hard to see in HEE work to date a clear strategy for developing the vital cadre of NHS managers that is needed to lead the NHS in the coming months and decades. There was a strong concern about this in Committee and the need for close working with HEE and the NHS Leadership Academy was acknowledged by the Minister. The Joint Committee wanted to see a statutory commitment for HEE to work in partnership with the academy, to ensure that managers in training work alongside their clinical colleagues and to increase the number of managers in the future who have clinical experience. Does the Minister not agree that this needs to be an explicit, upfront priority for HEE, which translates through to the work of LETBs? How will the Government ensure that this vital issue is addressed?

Health and Social Care Bill

Debate between Baroness Wheeler and Lord Patel

Tuesday 22nd November 2011 Lords Chamber

[Lord Patel]

My Lords, I apologise to the Minister and to the noble Baroness, Lady Northover. Yesterday afternoon I told them that I was degrouping these amendments to be taken at a later stage of the Committee. That was, however, before I got beaten up later in the day and lost my normal aggression. I had to retable them and I apologise for that. I hope that it is possible to take them today.

I will concentrate mainly on HealthWatch England. The purpose of this amendment is simple—to make both HealthWatch England and local healthwatch organisations independent bodies and, in doing so, to give patients and public a truly independent voice. It does not change the broad thrust of the policy in any way, nor does it have any more resource implications.

In the Government’s list of intentions for HealthWatch England, the Minister recognised the need for it to maintain independence; to set its own work programme; to publish its own annual report to Parliament; and to have independent membership. He also said that regulation would be brought forward by the Secretary of State in relation to this. It would also provide advice directly to the Secretary of State, the NHS Commissioning Board, Monitor and local authorities. At the same time, the list also suggests that HealthWatch England will be able to advise the Care Quality Commission on the views of people who use the service; that it will be a committee of the CQC; and that the CQC will respond in writing to HealthWatch England’s advice.

HealthWatch England’s operating plan, which was discussed by the CQC board, suggests that its main focus will be local; it will be small and strategic; its accounting officer will be the CEO of the CQC; its staff will be employed by the CQC; and service-level agreement on its functions will be put in place. The plan also suggests that HealthWatch England’s committee will be appointed by the CQC; that its chair will be subject to CQC board governance; and that conflicts of interest will be decided by the board. HealthWatch England will publish reports on a “no surprise” basis. This is quite contrary to the suggestion that HealthWatch England should be independent of the CQC. The CQC clearly sees itself having a close relationship with HealthWatch England, with the latter relying on it for significant analytical intelligence and other analytics and data. Joint data collection will not be appropriate for the diverse functions of the two organisations. The relationship between the two has not had a good start either, with LINks and others feeling that they have not been fully consulted by the CQC in developing the plan.

The proposed duties of HealthWatch England are intended to provide local healthwatch organisations with advice and assistance in relation to promoting and supporting the involvement of people in the commissioning, provision and scrutiny of local care services. Under the duties, people will be able to monitor local health and social care services; their views will be obtained on the standard of local services; and information will be gathered on local need for and experiences of care services. Recommendations will be made to commissioners and providers of services about how local care services could or should be improved.

The relationship between HealthWatch England and local healthwatch organisations is important. The Bill establishes HealthWatch England as a statutory committee. Ministers say that the relationship between HealthWatch England and local healthwatch organisations must be an open dialogue so that critical knowledge of the views and experiences of patients and local service users will have a real influence on the delivery of health and social care. The aspiration is that local healthwatch organisations and HealthWatch England will collaborate with local authorities and clinical commissioning groups. However, the Bill does not give local healthwatch organisations any specific role in relation to clinical commissioning groups. They have no direct role in influencing the commissioning arrangements of CCGs in relation to the needs of local people, nor do they have any say in it.

In my view, therefore, HealthWatch England should be established as an independent body outside the CQC; be the guarantor of an independent local community voice; have clear accountability to local healthwatch organisations; and have adequate resourcing—there are concerns that the CQC will not adequately fund HealthWatch England. It should provide an expert team that has the knowledge and experience to build HealthWatch; and support the transition of LINks into healthwatch organisations and the development of local healthwatch’s ability to carry out its five statutory functions. It should provide local healthwatch organisations with support, training, advice, resources and expertise on health and social care policy, legal processes and myriad other issues if local healthwatch is to take off quickly. On the basis of current and previous experiences, I feel that the CQC’s belief that local healthwatch can be built and become operational quickly is misplaced—that is the experience of LINks, too.

HealthWatch England should have a capacity to carry out research that is needed by local healthwatch organisations to support their work. HealthWatch England should support the development of local expertise to gather information and data from all sources—public, patients, complaints and serious incident investigations—so that it has a well developed and informed view of the state of local health and social care services. It should support the development of regional healthwatch organisations so that a powerful regional voice on services and commissioning can be developed. It should provide the capacity to elevate local and regional demands for better health and social care to the NHS Commissioning Board, the Secretary of State, Monitor and the CQC. It should support the co-ordination of major demands for changes to health and social care policy and commissioning, integrating local healthwatch.

It was pointed out to the CQC that a research capability was essential for HealthWatch to function. If a potential service problem is suspected, it is necessary to check how widespread it is. Beyond this, the organisation must be able to carry out original research on consumer needs in order to improve services. No research capability had been placed in the plan that the CQC develops. It appeared in meetings with LINks that the CQC might commission research, but we know from examples that research at a local level is important—staff being the classic example.

Diverse and inclusive healthwatch organisations could substantially increase the power and influence of local people to monitor services more effectively, improve safety, influence commissioning and provide a voice that will be heard in the local, regional and national development of health and care policies. To be effective, HealthWatch, nationally and locally, must be fully independent and democratic. Others with experience have informed me that the dependent relationship that HealthWatch is intended to have in relation to local authorities is deeply flawed. They believe the proposed system will be expensive and difficult to establish. The decision not to ring-fence funding will make these bodies weak and vulnerable.

The way forward is for HealthWatch England to be an independent body helping the local healthwatch organisations, which should also be independent of the local authority. If the Government are serious about what they say—that the Bill is about putting patients and the public at the centre and the slogan, “no decision about me without me”,is what they wish to follow—then the way to create public confidence is to have HealthWatch England as an independent body. I beg to move.

[Baroness Wheeler]

My Lords, I start by saying that I was not one of the ones who beat up the noble Lord, Lord Patel, over grouping issues, although it was extremely frustrating to have them appear and disappear all the time. Anyway, we now have our list and I am speaking to that.

I am pleased to support the amendments in the group, which have two important aims: first, to ensure that HealthWatch England and local healthwatch organisations are truly involved and consulted where decisions are made about the development and planning of commissioning services and on reconfiguration or changes to services; secondly, to ensure that it is an independent statutory body and not a subcommittee of the Care Quality Commission.

The Government’s far-reaching proposed changes to the NHS, with the emphasis on competition and regulation, make the need for HealthWatch England to be given robust and independent scrutiny powers even more important. Amendment 305 from my noble friend Lord Harris and myself is a probing amendment with the intention of ensuring that HealthWatch England and local healthwatch organisations have the strengthened power and functions they need. It establishes HealthWatch England as an independent body responsible for providing the Secretary of State, the NHS Commissioning Board, the Care Quality Commission, Monitor and local authorities with information and advice on the views, needs and experiences of users of health and social services, and the views of local healthwatch organisations on care standards and how they can be improved.

Under Amendment 305, HealthWatch England is responsible for providing local healthwatch organisations with resources, advice and assistance. The amendments of my noble friend Lord Whitty, Amendments 318C and 318D, set out similar and additional powers and functions for HealthWatch England to those proposed in Amendment 305. We fully support these, which include powers of investigation into complaints and powers to seek disclosure of information from health and social care providers, the NHS Commissioning Board, CQC and others. Important functions also include information, research and representation functions.

The independence of HealthWatch England from the Care Quality Commission is vital if it is to be the national service users watchdog and champion. It must be able to hold regulators in the whole of the health and social care system to account and be the independent guarantor of the rights, duties and independence of local healthwatch organisations. Given the uncertainties still surrounding how Monitor and the CQC will work together, and the current trials and tribulations facing the CQC, how realistic is it to expect the CQC to undertake this role or for HealthWatch England to function properly as a CQC committee?

Does the Minister acknowledge these problems? Will he—or she—consider working with NLAM and other interested stakeholders to produce an alternative model for HealthWatch England that will secure the Government’s stated policy for a powerful and independent system of public involvement in health and social care? To be effective, local healthwatch must be able to scrutinise how consortia and health and well-being boards undertake public engagement and transparency and are ensuing that the public voice is embedded in the care pathway design. They should also be given the right to comment on tenders and commissioning contracts before release.

LINks organisations currently have significant powers to enter and view the premises of all health and social care providers regulated by the CQC—another potential conflict of interest if the CQC relationship is not changed. These powers are often little used by local LINks organisations and we hope that their retention in the Bill and robust guidance to local healthwatch organisations on how they can be applied to the benefit of improved patient care and treatment will lead to these important powers being more frequently used. I would welcome the Minister's endorsement of that.