Puberty-blocker Drugs

Baroness Wheeler Excerpts

Thursday 10th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

My Lords, I salute the court’s thoughtful and lengthy judgment, which brought enormous clarity to an area which is very important but which has also caused concern and ambiguity. The court has made it clear that children under a certain age are not ordinarily able to make the kind of decisions that have previously been asked of them, but there are openings. No one under the age of 16 can now be referred on to puberty blockers unless a court rules that it is in the child’s best interest. These are helpful clarifications and we look forward to further work to clarify this area.

[Baroness Wheeler (Lab)]

My Lords, the mental health and well-being of young children and teenagers who present with gender dysphoria are paramount. Given the NHS England announcement on puberty blockers, what support are the Government giving to children and teenagers affected by the revised guidelines and their families and schools? On medical matters, will a young person under 16 concerned about gender dysphoria who approaches a GP continue to be covered by the duty of doctor-patient confidentiality?

[Lord Bethell (Con) [V]]

I reassure the noble Baroness that patient-doctor confidentiality remains paramount and is respected. To update her, the Tavistock has immediately suspended new referrals for puberty blockers and cross-sex hormones for under-16s. In future, they will be permitted only where a court specifically authorises it. I reassure the noble Baroness that those already on the programme will continue their medication until the review has been finalised.

Coronavirus Vaccine

Baroness Wheeler Excerpts

Thursday 3rd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for the Statement. Yesterday’s great news about the Pfizer/BioNTech vaccine and the MHRA’s clinical authorisation was the breakthrough that we all hoped for. We on these Benches join in with the heartfelt thanks to the dedicated scientists and those who have taken part in the trials, testing and validation process. Coming with the absolute assurance from the MHRA that no corners have been cut by it in the speeding-up of the vaccine, and that safety of the public has rightly remained paramount, the news is especially welcome.

Hospital trust staff will receive the vaccine first. This is a massive logistical challenge given the size of the workforce, the temperatures that this vaccine must be stored at and the two doses needed. We understand that 50 hospitals are already set up and waiting to receive the vaccine. How many NHS staff are expected to be vaccinated by January? When will mass-vaccination centres start opening in our communities?

On care homes, today we have the reality of the difficulty of ensuring that the vaccine can be delivered safely and quickly to them, in the light of its low temperature requirements and because of the fragmented social care system, involving thousands of predominantly small providers employing permanent and often frequently changing temporary staff. The Joint Committee on Vaccination and Immunisation’s Covid-19 priority lists advises that care homes residents and the staff who treat them should be first in line to be inoculated. We now understand that only care home staff will be among the first to be vaccinated, travelling to an NHS centre. While this and readiness in parts of the NHS to administer the vaccine are welcome, can the Minister update the House on how the Government will ensure that in the rollout of this essential vaccine, that hopefully will help to protect thousands of care home residents, they do not find themselves at the back of the queue once again? Care home managers are demanding clarity over this issue and have warned of confusion and raised expectations among vulnerable people.

Overall, we have historic strengths with vaccination, but in recent years we have lost our measles-free status, and we know that vaccination rates can often be lower in poorer and more vulnerable communities. While Covid-19 has affected everyone, the burden of the pandemic has disproportionately impacted the poorest, who are more likely to die than the richest. Can the Minister ensure that there is a health equality strategy, so that black and ethnic-minority groups, and the poorest and most vulnerable, do not miss out on this vaccine?

I also make a special plea for unpaid carers. Carers UK is deeply disappointed that carers are not on the priority list for the vaccine in England. Can the Minister explain the thinking behind this by the JCVI or the Government? They were prioritised for the flu vaccine, as it was recognised that if they get flu, the loved ones they care for are at risk and cannot be properly cared for. As a carer myself, I am in touch with many local carers, who play a vital role in keeping older, disabled and seriously ill people safe during the pandemic.

On the supply of vaccines, the UK has promised 40 million doses by spring, which is estimated as enough to give the required two jabs to health and care workers and everyone over 65. Nevertheless, in the first few weeks of winter, our ability to vaccinate could easily outstrip supply. Current figures are that there will be 800,000 doses in the country within days, with several million more to follow in weeks. I understand that the jabs are being manufactured in Belgium. What assessment have the Government made of the impact of Brexit on importation? Can the Minister reassure the House that supplies will not be disrupted, deal or no deal? We all understand that the restrictions will remain in place for some time but in the meantime, if someone is vaccinated, will they still have to isolate if contacted by test and trace, or are they now released from that obligation?

The Government’s document, Community Testing: A Guide for Local Delivery, suggests that local areas can use mass testing as a freedom pass. What does this mean in practice? How will local areas enforce rules if some people are able to follow different rules based on their testing status? In the Commons yesterday, the Prime Minister suggested that people may want to take advantage of mass testing ahead of visiting their families this Christmas, but what does this mean for people in areas that do not have access to lateral flow testing? Needless to say, despite the approval of a vaccine the restrictions will need to remain in place for some time, and test and trace will be key. Can the Minister confirm that mass testing will therefore be rolled out in all areas in time for Christmas? What are the consequences of the Christmas exemption period if not?

We must not forget that the Minister’s Statement also announced the welcome news that family visits can now take place in care homes, subject to visitors testing negative for Covid-19. However, the increase in staff and resident testing, alongside the introduction of visitor testing, must be backed up by additional resources to make this possible. What extra funding is being made available to care homes to meet the costs of additional testing, cleaning, PPE and visitor administrations that they will incur?

Today’s focus is on the vaccine and how it will be distributed. However, for the record, in response to the Secretary of State, Matt Hancock, claiming that the process of vaccine approval has been one of the early benefits of leaving the EU, the MHRA has today made it clear that the process for developing and authorising the vaccine has been undertaken under the terms of European law, which remain in force until the completion of the Brexit transition period at the end of the year. In other words, Matt Hancock’s assertion is simply not true.

[Baroness Jolly (LD) [V]]

No one can deny that the news about the Pfizer-BioNTech vaccine is just what we need as the days get shorter and Christmas still seems some way off. The technical achievement is enormous, and I am happy to congratulate all those involved in the creation of the vaccine, in the lightning regulation process and in its manufacture. The logistical challenge is next, and I feel sure that, again, the armed services will figure highly here.

Some time ago, I asked the Minister who might carry out the vaccinations. There are not enough NHS staff free to do it. Is there a plan to train others? The training is very short and needs no clinical background whatever. I seem to remember that student friends, when training to be doctors, would practise their technique by injecting oranges. I understand that it will be at least Easter before all the population has received the first round of the Pfizer vaccine and midsummer before we have all had the two jabs.

Can the Minister clarify what sort of immunity someone would have if they failed to get the second jab? What is the timescale of the availability of the other vaccines that we know are in the pipeline? When do we expect all the population of the UK who are willing to be vaccinated to have received their vaccine, and does he have an indication of how many will refuse it?

Vaccine is not a magic bullet—yet. Those of us who will not get it for some time will have to be careful and adhere to the rules outlined by the Government. We might be surprised that not everyone is aware of the symptoms of the virus—the cough and the loss of taste and smell, along with flu-like symptoms. They have not been part of the messaging but, on prevention, we all know “hands, face, space”. Was there a reason that the messaging did not include symptoms? I appreciate that if you are an avid follower of the PM’s No. 10 virus briefings, all that information is at your fingertips, but for many these are not required viewing. How much is the department using Instagram, Facebook and Twitter to get these messages out? If it is not using them, why not? For months to come, people will be testing positive, and anyone who does will still be required to quarantine.

I would like to spend the rest of my time addressing some issues relating to self-isolation that have come from research by King’s College London, based on surveys carried out by the Department of Health and Social Care. Many of us who have been in this situation isolate, as that is doing our bit to prevent the spread of the virus. King’s found that intentions to isolate were high but, when it came to sticking to it, the numbers were low. It found that there were both practical and psychological barriers to an effective isolation system. Practically, there is the issue of finance. The evidence suggests that those of a lower socioeconomic status with dependent children or older relatives struggle financially or lose their pay if they self-isolate, and they choose to ignore the advice.

The £500 grant has not been available since the onset of the lockdowns, and £250 does not cover all the costs for a family for a week if you lose your wage. If a child has to go into quarantine, there is no eligibility for support, yet in all probability a parent will have to take time off work to care for the child. Not all employers continue paying a salary to those isolating or caring for someone who is isolating.

The data that I referred to came from a series of surveys carried out by the department. Is that data in the public domain? It would be really interesting to see the breakdown by geography and demography.

Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Baroness Wheeler Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

I thank the Minister for introducing the regulations, and other noble Lords for their contributions and key questions on these two important instruments. I also thank my noble friend Lord Blunkett for the speech he decided not to make. As noble Lords have said, it is timely to discuss these instruments now, as we take stock of the Medicines and Medical Devices Bill Committee discussions and outcomes, await Report dates and deliberations, and meanwhile continue the so far helpful discussions on a number of key issues taking place between the Minister, ourselves and other noble Lords involved with the Bill.

For the record, the Bill has changed substantially as a result of government amendments agreed in Committee —not by consensus among participants, as we normally would have expected, but by the Government’s insistence that it was necessary to agree the amendments in Committee to comply with the requirements and timescales for consultation on the Bill with the Department of Health in Northern Ireland and the Northern Ireland Assembly.



We are now working our way through the “new” Bill to assess the full impact of this departure from established procedure and, in particular, the response from the Government to the deep concerns of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee on the use of delegated powers across a range of provisions in the Bill. I note that the Government have not formally responded to these committees, as is also usual practice, other than broadly commenting in the course of their response on individual proposed amendments, or in general correspondence from the Minister in his letter to Peers of 13 October and to the noble Lord, Lord Lansley, of 18 October. Can the Minister tell the House if he plans to respond to the committees, explaining not only how their concerns have been addressed but by which specific government amendment? This information is pretty crucial to all involved as we continue to discuss the Bill with Ministers prior to Report.

The regulations today are confirmed through the affirmative procedure instruments. I would be grateful if the Minister can today confirm that the Government will use this procedure in all regulations on human medicines and medical devices, as also promised in his letter of 13 October.

We have had a good, if short, debate on these SIs, which are long, complex and technical, but which we recognise as a necessary step towards ensuring that people are kept safe when using medicines and medical devices after the end of the implementation period for exit from the EU. I will not repeat the content and purpose of the regulations, which have been well explained by the Minister and other noble Lords and also documented in the very helpful Explanatory Notes and Library briefing, and by the most helpful summary of all, in my view, the Commons Minister Edward Argar’s bullet-points letter of 20 October. In the main, the key issues are the ones we have closely examined in Committee, and which continue to be under discussion.

I want to reinforce and add to the questions raised by some noble Lords. First, on the landmark Cumberlege report, I referred earlier to the helpful discussions taking place on the implementation of this vital review, in particular the establishment of a patient safety commissioner. The Minister referred to these discussions, but he knows that a clear statement of commitment from the Government is needed on this and is long overdue. Can he update the House further on the progress of the discussions? The Minister in the Commons promised strengthened regulations to do more to protect patients, and to use the powers in the MMD Bill for this. He said that plans are in development which will take into consideration both international standards and global harmonisation in the establishment of our future system. I look forward to further information from the Minister about these budding plans and the timescale for when we can expect information and consultation on them.

My noble friend Lord Blunkett touched on the powers of the MHRA in relation to vaccines, and the powers generally in the Bill. There have been deep concerns about how the MHRA is to be staffed and resourced to meet the huge challenges of its future role as the UK regulator of all medicines coming into Great Britain and Northern Ireland. It is a much respected body, but its capacity and expertise will need to be hugely expanded to meet its new obligations and duties. The £13 million in additional funding from the Government up to the end of March 2021 will, I suspect, be just a pump-priming starter. Can the Minister tell the House the planned annual budget for the MHRA up to the end of year three of its operation under its extended remit?

The conformity assessment—the UKCA mark—will be available for industry to use for medical devices placed on the market in Great Britain from the end of the transition period. Is the Minister confident that manufacturers have been given sufficient time and guidance to prepare for the UKCA marking?

What assessment have the Government made of the impact these new regulations could have on the number of approved medical devices in the next few years? According to GlobalData’s pipeline products database, there are more than 17,000 active medical devices currently in the pipeline, with approximately 42% of these devices in the early stages of development. The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices—and, indeed, to the delays that noble Lords have talked about. Many companies are already struggling with the demands of the medical device regulations, including the increased costs. Does the Minister share my concern that this, coupled with the additional authorisation process required to reach the UK market, may lead to delays or deter companies from selling their products in the UK altogether?

Under these regulations, the UK will continue to recognise the CE marking on medical devices and in vitro diagnostic devices which have demonstrated their conformity with EU regulatory requirements, until July 2023. Will the UKCA marking be recognised by the EU? Can the Minister confirm whether the EU falsified medicines directive, referred to by the noble Baroness, Lady Bennett, will apply in the UK after Brexit? If not, packs of medicine intended for the UK that are not compliant with the directive may not be lawfully dispensed in Northern Ireland.

The complexities businesses face are considerable and have been exacerbated by the Northern Ireland protocol, which requires companies seeking marketing authorisation to be able to sell a new medicine in the UK to continue to follow EU procedures in respect of Northern Ireland. Can the Minister confirm whether a single marketing authorisation will suffice or whether new companies will have to obtain a double “EU plus UK” marketing authorisation to sell throughout the UK?

For those of us deeply concerned about the risks of regulatory divergence on medicines and medical devices between Great Britain and Northern Ireland, can the Minister tell the House about the specific work that is being done, in response to the Bill and these regulations, to mitigate the adverse consequences of possible divergence in the medium and longer term? One has to look only at the timely and expert analysis of the noble Lord, Lord Patel, of the MHRA guidance on this issue in Committee to see that there are key issues that remain unclear and unresolved, and deep confusion around how the dual systems will work in the future.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

[Baroness Penn (Con)]

To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. Due to the break in the group since Tuesday, we have all had the advantage of being able to have a closer look in Hansard at the speeches made by the noble Lord, Lord Patel, and the noble Baroness, Lady Ritchie. If we had managed to squeeze in the Minister’s response, that would have been perfect; I could then have responded having read it all very closely.

Anyway, I thank the noble Lord, Lord Patel, both for his support of our amendment and his very detailed considerations and questions on the MHRA guidance on Northern Ireland-Great Britain regulatory diversion on medicines and medical devices. His speech was very much a tour de force on the whole situation, understating how confusing the situation is in relation to the distinction the MHRA guidance makes between the EU market, the GB market and the market for Northern Ireland. We will need to read Hansard carefully but, despite the Minister’s best endeavours, I cannot see that she has managed to clear up for us exactly how the whole confused system will work in the future.

Moreover, as the Minister and the noble Lord, Lord Patel, mentioned, we do have the draft regulations. My attention has been drawn to them only this week. I thought they were published on 13 November, not in October, but that may be just me not reading them properly. Both regulations deal with Northern Ireland and Great Britain regulatory diversion issues, so this debate will be paused until we have considered those regulations and come back to the main Bill, and while we see what outcome there will be on the adoption of the Northern Ireland protocol.

The noble Baroness, Lady Ritchie, underlined the need for monitoring, oversight and accountability on this issue, and the importance of reporting to Parliament, and we obviously strongly agree with that. I did not specifically hear a response to her question on what internal discussions there have been between the noble Lord, Lord Bethell, and the Minister in the Northern Ireland Executive with responsibility for the NI Department of Health. If the Minister could write to her and put a copy in the Library, so that we can see what progress the discussions have made so far, that would be really helpful.

On the issue of reporting to Parliament annually—as in the amendment in the name of the noble Lord, Lord Patel—and not every two years, as the amended legislation provides for, I think the annual report called for by the noble Lord will be very much needed as all the problems and issues underlined by him and others in this debate are being worked through.

The issue is vital, and many issues are still to be identified, considered, worked through and resolved, which will mitigate and minimise the potential for regulatory divergence in human medicines and medical devices between Northern Ireland and Great Britain. In that expectation, I beg leave to withdraw the amendment.

Amendment 119 withdrawn.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

Moved by

[Baroness Wheeler]

105: After Clause 16, insert the following new Clause—
“Requirement for consultation with devolved authorities
(1) Before making regulations under section 16 that contain provision which is within the legislative competence of a devolved legislature, the Secretary of State must consult the relevant devolved authority on that provision and have regard to the views of that devolved authority.(2) In this section—“devolved authority” means the Scottish Ministers, the Welsh Ministers, Northern Ireland ministers or a Northern Ireland department; and“devolved legislature” means the Scottish Parliament, Senedd Cymru or the Northern Ireland Assembly.(3) A provision is within the legislative competence of a devolved legislature if—(a) it would be within the legislative competence of the Scottish Parliament if it were contained in an Act of the Scottish Parliament;(b) it would be within the legislative competence of Senedd Cymru if it were contained in an Act of Senedd Cymru (including any provision that could only be made with the consent of a Minister of the Crown); or(c) the provision, if it were contained in an Act of the Northern Ireland Assembly—(i) would be within the legislative competence of the Assembly, and(ii) would not require the consent of the Secretary of State.”Member’s explanatory statement
This new Clause would require the Secretary of State to consult the devolved administrations before making regulations concerning UK-wide information systems.

[Baroness Wheeler (Lab)]

My Lords, I am moving Amendment 105 on behalf of my noble friend Lady Thornton; it leads the group of amendments following Clause 16, which provides the legal framework for the medical devices information system. I will also speak to our other amendments in this group—Amendments 128, 130 and 132—and on the remaining amendments, including government Amendment 126.

The number of amendments in this group shows the strength of feeling on this issue. Key issues raised last week and in debate on Clause 16 earlier today are also relevant here. As we have all stressed, First Do No Harm, the landmark report by the noble Baroness, Lady Cumberlege, very much places the importance of the MDIS system centre stage. The complete lack of safety data and record-keeping on pelvic mesh implants in thousands of women—including basic details about the patient’s name, medical history and health problems, and manufacture and supply information for these devices after implantation, which would have enabled patients to be traced and treated—reinforces the need for MDIS and its future role as both an information and tracing system.

Amendment 105 would add a new clause after Clause 16 to place a statutory requirement in the Bill that the devolved Administrations in Scotland, Wales and Northern Ireland must be consulted before regulations on the MDIS are laid and that the Secretary of State must have regard to the views of the devolved authority. Government Amendment 126 and Amendments 105, 127, 128, 129 and 132 all aim to strengthen consultation provisions, including public consultation before making regulations under any provision of Parts 1, 2 or 3 of the Bill or under Clause 16(1).

This focus on the importance of consultation and ensuring that NHS Digital—with its existing remit and expertise limited to England—fully engages in meaningful and active collaboration with the devolved authorities is absolutely crucial for the UK-wide development of MDIS. If the system is to be fit for purpose, the work to deliver it must be informed by and responsive to the local requirements and realities across the devolved Administrations. The devolved nations must be fully involved in the system’s design and modelling, have equal access to MDIS data analysis and sharing, have a governance structure for MDIS that includes representatives from all the devolved authorities’ institutions, and have parity of funding across the four nations.

I am very grateful for the helpful correspondence of 9 November from the Minister to the noble Baroness, Lady Finlay, regarding MDIS and working with the devolved Administrations. It was shared with Members, together with the 4 November letter from NHS Digital setting out its intended “collaborative approach”. These letters contain a number of assurances on both the current work being undertaken and how the future four-way relationship needs to be taken forward to develop the UK-wide system.

The remaining amendments in this group, including the government amendment, refer to the general duty under Clause 41 to consult before making regulations. Our Amendment 132 would insert a new clause on the duty to consult the devolved Administrations and “have regard” to their views. I hope the Minister will agree that that is not an unreasonable requirement.

Government Amendment 126 would amend Clause 41 to ensure consultation with the devolved authorities under Clause 16, headed “Information systems”. Although the inclusion of this statutory duty to consult as far as Clause 16 goes is a step forward, other key parts of the Bill have an impact on the devolved authorities. We want to see a general duty in Clause 41 to consult the devolved Administrations, as is common practice in a number of Bills—not just limited to consultation in relation to Clause 16. I hope that the Minister will undertake to review the Bill after Committee and consider this key point in relation to Clause 41.

In his 13 October letter to noble Lords, the Minister refers to the Government’s amendments as providing “certainty” that the Government will ensure that the devolved authorities’ views are heard throughout the development of the regulations and in their implementation. The certainty given, however, is in relation only to Clause 16 and not to the rest of the Bill, as we would like to see.

Amendment 130 is a probing amendment that would remove the permissive provision in Clause 41(3) that consultation carried out before the Act was passed could satisfy the duty to consult. This clause is very open-ended. Can the Minister provide details of the purpose and intended use of this provision? There is no explanation in the Explanatory Notes. Will there be a time limit on how up to date a consultation needs to be for it to be considered done and dusted?

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.

[Baroness Wheeler (Lab)]

I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.

[Lord Bethell (Con)]

On the question why the government amendment is being made to Clause 41 rather than Clause 16, which I think is what the noble Baroness is asking about, Clause 41 is concerned with consultation. It is important that consultation requirements are provided for in one place, as that assists with clarity and understanding. The legal effect is the same, irrespective of where in the Bill the obligation to consult the devolved Administrations when making regulations under Clause 16 is found.

--- Later in debate ---

[Baroness Wheeler (Lab)]

I thank the Minister for that and I beg leave to withdraw the amendment.

Amendment 105 withdrawn.

--- Later in debate ---

Moved by

[Baroness Wheeler]

119: After Clause 38, insert the following new Clause—
“Northern Ireland and regulatory divergence
(1) The Secretary of State must work together with the appropriate authority in Northern Ireland to minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices. (2) Where the Secretary of State has identified areas of regulatory divergence in relation to human medicines, veterinary medicines and medical devices between Northern Ireland and the rest of the UK, the Secretary of State must lay a report before both Houses of Parliament setting out how the divergence will impact—(a) the UK; and(b) Northern Ireland.(3) The report must set out the steps the appropriate authorities have taken to mitigate against such divergence.”Member’s explanatory statement
This Clause would require the Secretary of State to work with the appropriate authority in Northern Ireland to minimise the potential for regulatory divergence relating to medicines and devices, and report any areas of regulatory divergence to Parliament, including the impact they will have, and report on actions to mitigate against adverse consequences arising from divergence.

[Baroness Wheeler (Lab)]

My Lords, on behalf of my noble friend Lady Thornton, I am moving Amendment 119 on the important issue of regulatory divergence with Northern Ireland and reporting to Parliament. I am grateful for the support of the noble Baroness, Lady Ritchie, who raised this key issue at Second Reading, as did the noble Lord, Lord Patel, whose Amendment 120 is grouped with this amendment. I look forward to their contributions and to those of other noble Lords.

Amendment 119 would add a new clause to the Bill on the interpretation of Part 3, “Medical Devices”. It would require the Government to work with the appropriate authority in Northern Ireland to

“minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices.”

Where an area of divergence is identified, the Secretary of State would be required to lay a report before Parliament on the impact it will have and the steps being taken to mitigate it.

Human and veterinary medicines are transferred matters in Northern Ireland. For this reason, Clauses 1 and 8 lay out in black and white the possibility of regulatory divergence, as they give separate powers to Northern Ireland departments to make regulations relating to Northern Ireland. However, despite this being in the Bill, the rest of the legislation as drafted is completely silent on the implications this may have, or on any mechanism for dealing with them. This means Northern Ireland could end up passing different legislation.

As well as those powers in the Bill, there is the wider context of the Northern Ireland protocol, under which Northern Ireland will continue to apply certain European Union standards that will no longer automatically be part of the law governing Great Britain. For example, in the Government’s own guidance on regulating medical devices from 1 January 2021, it is stated that, unlike in Great Britain, the EU medical device regulations and the EU in vitro diagnostic medical device regulations will apply in Northern Ireland from May 2021 and May 2022 respectively.

The risks of divergence have been raised by Members in both Houses, including the risk that what may on the face of it seem to be only minor or technical differences could create a butterfly effect, leading to much larger legal and operational problems. The Bill does not itself create divergence and nor for that matter does the Northern Ireland protocol, but both permit it or create a situation in which it may arise. It is therefore vital that the implications of this are part of discussions on the Bill.

Covid-19 Update

Baroness Wheeler Excerpts

Thursday 12th November 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, this Statement was made in the Commons on Tuesday and, as we know, events move quickly where the coronavirus pandemic is concerned. Since Tuesday, further details about the welcome breakthrough in the development of a vaccine have been emerging and there is much scope for optimism. Also welcome is that the Government have, at last, agreed to a six-day travel window for students in England next month, after the end of lockdown, so that they can go home before Christmas and undertake periods of isolation, if needed, and be with their families. This requires mass testing on university campuses before students can leave, so can the Minister update the House on the plans and arrangements for this, please?

However, yesterday we also reached the grim milestone of Britain’s Covid-19 death toll passing 50,000—a sobering reminder of the severity of the crisis, as we struggle through the second wave. As Labour’s leader, Keir Starmer, said:

“Behind these numbers is a devastated family, one for every death, and they have to be uppermost in our mind.”


The announcement in Tuesday’s Statement of twice-weekly routine testing for front-line NHS staff is a very important development. It is vital not just for protecting staff, but for infection control in healthcare settings. We have been pressing for a systematic programme for this for months. Can the Minister please update the House on the progress and roll-out timescales to which the Government are now working?

On testing more broadly, the Government have announced plans for the mass distribution of lateral flow tests. I understand that local directors of public health have been asked to develop local strategies, but does the Minister agree that families with a loved one in a care home should be given priority access to these tests, so that they can see, and hold the hand of, that loved one? Will public health teams be put in charge of contract tracing from day one? At a Commons Select Committee this week, the noble Baroness, Lady Harding, who is in charge of test and trace, finally admitted what we have been saying all along: that people are not self-isolating

“because they find it very difficult … the need to keep earning and … feed your family is … fundamental”.

Does the Minister therefore accept that a better package of financial support is needed to ensure isolation is adhered to? Can the Minister also tell the House if it is the Government’s intention to reduce the isolation period? What assessment has been made of evidence that a negative PCR swab, seven days after exposure, could release someone from quarantine?

The vaccine is a moment of great hope and optimism, in a bleak, dismal year that has shattered so many lives and families. The Government need to continue to be optimistic, but must be cautious to resist the urge to talk up and overpromise, and adopt their usual best-in-the-world rhetoric. As further details about the vaccine emerge, there will be many questions, and I am sure noble Lords will follow these up. We strongly support the priority list drawn up by the Joint Committee on Vaccination and Immunisation, under which care home residents and staff get the vaccine first, followed by the over-80s and other NHS and care staff. There will need to be widespread consultation with key stakeholders on the arrangements, timings, resources and logistics. Given past experience, can the Minister specifically reassure the House that the adult social care sector, and care homes in particular, will be fully involved in planning delivery of and administering the vaccine?

Just as important, how will the disproportionate impact of the virus on minority ethnic communities be taken into account, when drawing up the final priority list arrangements? What is the Government’s working assumption of what proportion of the population needs to be vaccinated to establish herd immunity and bring the R rate below one? Can the Minister outline the latest clinical thinking around vaccination of children?

I understand that each person will require two shots of the vaccine, three weeks apart, and that protection develops a month after the first shot. Details of the Government’s plan for what amounts to the biggest vaccine manufacture, campaign and distribution in history are beginning to emerge. We need to learn lessons from the failures of the rollout of test and trace, and the early procurement of PPE. None of us wants to see booking systems overloaded with people told to travel miles, as we have seen with testing, so when will we see the Government develop that plan and their overall strategy?

Are the Government working with international partners to ensure that there are enough raw materials, enzymes and bioreactors to guarantee the mass manufacturing needed? Will there be the cold chain for transport and storage in various parts of the country for the Pfizer vaccine, which needs to be kept at minus 70 degrees centigrade? Have arrangements begun for procurement of the appropriate storage equipment? Will liquid nitrogen and freezers be provided to health centres, doctors’ practices and care homes? How is the vaccine to be distributed and administered to ensure that it is kept at such low temperatures?

On safety, it is comforting that the Deputy CMO, Jonathan Van-Tam, has assured us that he would urge his elderly mother to be vaccinated and that safety will not be compromised, despite the speed of the programme. The regulator, the MRHA, has rightly promised that there is no chance that it will compromise on standards of safety or effectiveness. How do the Government plan to get that message across to the public?

We know that vaccine hesitancy and denial is a growing problem. Labour has offered to work with the Government on a cross-party basis to build public confidence in the vaccine, promote take-up and dispel anti-vax myths, many of which are not just fiction but malicious. I look forward to a positive response from the Minister.

[Baroness Jolly (LD) [V]]

I thank the Minister. I am going to address testing and tracing. He may not have answers but I should be grateful if he could write to me. There have been more than 10 million downloads of the NHS Covid-19 contact tracing app. There have also been many complaints of Bluetooth draining batteries. I second those. Will he confirm whether there is a solution in the pipeline for that issue? If people do as I do and just switch off Bluetooth, the system will not work. How many of these app users are active? If 10 million people are actively telling the world where they are and are checking in and out of where they have been, that is wonderful. But if they do not do so, it is not terribly helpful.

Critically, how many people have been triggered via the app to isolate? Of those, what proportion have had their isolation checked and by whom? Testing is quick and easy but the delay in response time is unhelpful. Swab processing time is not reducing due to the increase in the number of swabs, and labs are taking longer. Is there yet sufficient capacity, and how many staff are being trained weekly to take on the extra capacity? Can the Minister indicate the cost of taking a swab and getting the results back to the individual? Finally, will he confirm when he expects to move to lateral flow tests, which are much quicker and would transform the lives of the staff of care homes, their residents and visiting families?

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

Moved by

[Baroness Wheeler]

62: Clause 9, page 6, line 11, at end insert—
“(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”Member’s explanatory statement
This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a risk-based decision process where veterinarians can dispense different medicines to animals beyond the terms of authorisation.

[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.

The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.

I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.

The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.

In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?

Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.

So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.

Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.

[Baroness Jolly (LD) [V]]

The noble Baroness, Lady Wheeler, has given a really good description of the cascade and the way in which it works. It is a risk- based decision process whereby vets can dispense different medicines to animals beyond the term of authorisation. The BVA supports maintaining the cascade. Can the Minister confirm the arrangements if no suitable UK drugs are available? Can she also confirm that veterinary drugs will be part of trade deals with both the EU and the US?

--- Later in debate ---

[Baroness Penn (Con)]

My Lords, I am grateful to the noble Baroness, Lady Wheeler, for raising the important issue of the prescribing cascade, as put forward in Amendment 62. I recognise the desire to ensure that the use of the cascade continues to be regulated. It is an important tool for veterinary surgeons, as they can access a wider range of medicines to treat animals under their care and avoid unacceptable suffering. However, I reassure the noble Baroness that this amendment is not necessary. The Bill already confers discretionary powers that will allow the appropriate authority to decide, following public consultation, if and how the existing cascade provisions in the Veterinary Medicines Regulations 2013 should be amended.

The existing provisions for the prescribing cascade are well used and well understood by veterinary surgeons who are responsible for their prescribing decisions. The provisions were so well described by the noble Baroness that I shall not repeat them here.

The noble Baroness, Lady Wheeler, is right that the second option under the cascade is the use of human medicine authorisation in the UK or a veterinary medicine authorised in an EU member state. She and the noble Baroness, Lady Jolly, asked what will happen after the end of the transition period. On 1 January, the second option will be extended to encompass the importing of veterinary medicines from any other country, rather than only EU member states. This is being provided for through secondary legislation taken through last year, I believe.

The Veterinary Medicines Regulations 2013 also set out additional conditions that need to be met when a product is prescribed under the cascade for use in food-producing species. These conditions help protect the safety of consumers of produce from treated animals. The conditions state that the pharmacologically active substances contained in the medicines must have a maximum residue limit, an appropriate withdrawal period must be specified, and specified records must be kept. These conditions help protect the safety of consumers of produce from treated animals. We do not plan to significantly diverge from the current prescribing cascade for veterinary medicines.

The new EU regulation 2019/6 on veterinary medicinal products will apply in the EU from January 2022. This regulation introduces changes to the cascade, such as separate cascade structures for food producing and non-food producing animals. It includes provisions on the use of antimicrobial medicines under the cascade. For example, the European Commission may, by means of implementing Acts yet to be adopted by the EU, establish a list of antimicrobials which shall not be used under the cascade and a list of antimicrobials which shall be used, subject to certain conditions for cascade use. If it is in the best interests of the UK, we can make provision corresponding or similar to those in EU regulation under the powers in the Bill.

The UK Government and animal sectors have already shown their commitment to tackling antimicrobial resistance and the sectors have substantially reduced their use of antimicrobials in food-producing species—a 53% reduction in sales between 2014 and 2018. The Government will consult on proposed changes to the VMR, including changes implementing our priorities on antimicrobial resistance.

The amendment that the noble Baroness has proposed would obligate the Secretary of State to make changes to the regulations on the use of the cascade. I hope I have reassured her that the cascade remains of vital importance, and it is right that we have the option to amend the regulations when it is appropriate and necessary, subject to consultation, rather than being obliged to do so.

I will write to the noble Baroness, Lady Jolly, on her question about trade deals.

In the light of that response, I ask the noble Baroness, Lady Wheeler, to withdraw her amendment.

[Baroness Wheeler (Lab)]

I thank the noble Baroness, Lady Jolly, for her support and the Minister for her response. As I said, I have learned a great deal about this valuable procedure. I am grateful for the Minister’s reassurance on the Government’s continued support for and commitment to the cascade. I will certainly read her comments carefully. I did not hear any reference to the VICH, but if she would write to me on that that would be very helpful. With that, I withdraw the amendment.

Amendment 62 withdrawn.

--- Later in debate ---

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I put my name down to speak on this group primarily to speak to Amendment 106 in the name of the noble Baroness, Lady Thornton, but I will comment briefly on the excellent Amendment 67A from the noble Baroness, Lady Jolly. It seems to address an obvious lacuna in the Bill and I hope that the addition of veterinary devices would be a really simple procedure that the Government could take on board. I also commend Amendment 67B in the name of the noble Baroness, Lady Jolly, and associate myself with the remarks from the noble Lord, Lord Patel, on the concerns about the apparent weakness of government Amendment 131.

I wanted to speak to Amendment 106 because many of us who have been in different roles in politics over many years are used to receiving cries for help from people who feel as if medical systems have made them more ill, treated them badly and failed to live up to the oath of “first do no harm”. It is very hard for a person in your Lordships’ House or in politics to make a judgment call on what can be done and how people can be helped—on how systematic the issue really is and where this should be going. What we really need is a place where records are kept overall; it does not feel as if that is happening at the moment. The amendment lays down a way to address that. Of course, we have not heard yet from the noble Baroness, Lady Thornton, so I am interpreting what her amendment says.

There is also a broader point here, which we need to address throughout the Bill, and which I have been thinking about in the context of Covid-19. We really have a huge problem of trust, given the concern among significant parts of the public about how systems are working and whether decisions are being made in the right interests. One thing we need to do is to make sure that the whole system is transparent and open, and that records are there and accessible. We know of so many cases—the noble Baroness, Lady Cumberlege, set out some—where there tends to be a particular issue with the way that medicine has treated women.

There is also an issue in that the people who come to us and are able to make a fuss are often those who, in one way or another, have some form of social capital in their education, knowledge and ability to reach out and seek help. If we do not have regular systems of keeping records to see problems arising, it may be the most vulnerable who suffer without really knowing how to speak out and initiate action. I commend Amendment 106 to the Committee and look forward to hearing further discussion on it.

[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.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, this amendment would require the Secretary of State to establish the innovative medicines fund, as promised in the Conservative’s 2019 manifesto. It provides that it is funded from rebates paid to the Government under the terms of the pharmaceutical price regulation scheme.

The Cancer Drugs Fund was a Cameron initiative from the general election of 2010, and the 2019 general election saw a Johnson extension: the innovative medicines fund. He promised that

“doctors can use the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases.”

The promise was to increase the funding to £0.5 billion. Can the Minister confirm the figure and clarify how “innovative” will be defined? Importantly, how will the fund address the UK issue of combination pricing, where some new cancer treatments are not cost effective, even when the price is nothing?

There are questions about what drugs outside of cancer drugs could qualify to go into the new fund. Can the Minister help with a response here? There might be candidates from medicines selected for the early access to medicines fund, a pre-licensing indicator of promising innovation given by the MHRA. This would allow them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, which is a prerequisite for any drug to get a full, positive EAMS designation, there looks to be a good fit, and we support it.

[Baroness Wheeler (Lab)]

My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.

We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for

“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.

If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.

Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.

We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?

Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?

One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.

[Baroness Finlay of Llandaff (CB) [V]]

I thank the Committee for allowing me to come in a bit late; I apologise for that.

Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.

In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.

In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.

--- Later in debate ---

Moved by

[Baroness Wheeler]

46: Clause 6, page 4, line 12, leave out paragraph (b)
Member’s explanatory statement
This amendment removes provision for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by ministers, which is not subject to parliamentary scrutiny.

[Baroness Wheeler (Lab)]

I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.

We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.

The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:

“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,


and yet

“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.


As the DPRRC commented at paragraphs 39 and 42:

“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”


The Constitution Committee concurred and recommended that

“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”

Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.

It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:

“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.

--- Later in debate ---

[Lord Bethell (Con)]

I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.

[Baroness Wheeler (Lab)]

I thank noble Lords for their contributions in supporting the amendment—the noble Lord, Lord Hunt, reinforced by the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. I was particularly interested to hear the quote from the Leader of the House on this matter, and I am glad that that has now gone on record. I certainly echo the comments by the noble Lord, Lord Patel, about what he calls smokescreens, and his underlining of the powers the Government already have for dealing with such situations.

I thank the Minister for the very detailed explanation he offered on this issue, and for telling us why the Government feel that they do not need to address the DPRR Committee’s concern and table amendments. He also talked about protocols being a last resort, and I was grateful for that—and also for the fact that they would be time limited. I note those two things. This is a complex issue, not least for me. I need to look carefully at the Minister’s response, and, if necessary, come back to this issue on Report. I beg leave to withdraw the amendment.

Amendment 46 withdrawn.

Social Care

Baroness Wheeler Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Bethell (Con)]

The noble and right reverend Lord is entirely right. There has been a large number of reports on social care, but they have not in themselves brought us closer to a new deal. That is why the Government’s commitment is not necessarily to launch new reviews but to engage in consensus building across the political parties. That consensus building has been lacking in the past and has continually proved to be the stumbling block to reform. The commitment of both the Government and other Benches to those talks is the essential building block of any major reform. I completely pay tribute to the Leader of the Opposition and the Prime Minister for their commitment to those talks.

[Baroness Wheeler (Lab)]

My Lords, the CQC’s report, The State of Health Care and Adult Social Care in England, was published earlier this month. Last year’s report described social care as being at a “tipping point”, and this year’s makes it clear that Covid has not only exposed but exacerbated existing social care problems and thrown into stark relief the long-standing need for reform, investment and workforce planning, including a new deal for care staff. The CQC stresses that the legacy of Covid for social care must be that these crucial issues are tackled now. Why can this not be a priority for the Government and why can we not have at least a timetable for the publication of the social care reform proposals that the Government keep promising but failing to deliver on?

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

Moved by

[Baroness Wheeler]

23: Clause 2, page 2, line 8, leave out paragraph (c)
Member’s explanatory statement
This is a probing amendment that would omit the Secretary of State’s power to make changes to wholesale dealing, including hub and spoke models.

[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 23, in the name of my noble friend Lady Thornton, and to support Amendment 29, in the name of the noble Lord, Lord Clement-Jones.

Our amendment is a probing amendment, which has two aims. First, it provides us with the opportunity to hear from the Minister why the Government consider that the extensive delegated powers on the hub and spoke model for pharmacies are needed at this present time under the Bill, rather than ensuring that any such proposals are instead contained in future planned and well-thought-out primary legislation—properly consulted on and worked through—that amends existing legislation and regulations.

Secondly, we understand that there has been some discussion with key stakeholders in the pharmacy industry since the Government’s intentions were revealed in the nine short paragraphs on dispensing medicines in the impact assessment for the Bill—as we know, hub and spoke dispensing centres are not referred to on the face of the Bill. Today is an opportunity for the Minister to update us on the Government’s response to the concerns and issues raised by MPs in the Commons and by noble Lords during the Bill’s Second Reading, and in representations from leading industry organisations, including the National Pharmacy Association and the Pharmaceutical Services Negotiating Committee.

We need far greater clarity on what exactly is proposed, how the Government intend to take all this forward and how the very limited proposals that we have heard so far fit into the NHS long-term plan vision for the transformation of community pharmacy as an integral part of local primary care. How will pharmacists’ enhanced role in the future limit the number of people who will not have to see their GPs, in the way that the Government envisage?

Amendment 23 would amend Clause 2, on the “Manufacture, marketing and supply” of human medicines, and would delete the Secretary of State’s power to make provision for the distribution of human medicines by wholesale dealing, as is proposed for hub and spoke dispensing in the delegated powers proposed in the Bill. I have deep concern about the extensive range of delegated powers proposed under the Bill, and I support the decisive views of both the Delegated Powers Committee and the Constitution Committee on this matter, which have been made crystal clear by my noble friend Lady Thornton at all stages of the Bill. Major changes such as those envisaged for the community pharmacy sector through the extension of hub and spoke dispensing should be on the face of the Bill, with appropriate safeguards on their development, including a full public consultation.

The impact assessment tells us that

“dispensing needs to become more efficient to free up pharmacists’ time for other activities”

and that this will be achieved if all pharmacies have access to more efficient hub and spoke dispensing. We strongly support the aim of freeing up pharmacists’ time, better use of the skill mix in pharmacies, extending prescribing duties for pharmacists and a greater role in clinical service delivery. We also fully acknowledge the work, expertise and development of the hub and spoke models, including automated prescription assembly facilities—PAS facilities—operated by the large pharmacists, such as Lloyds Pharmacy, within their community retail pharmacy operations.

The impact assessment acknowledges the scale, substantial up-front and running costs and slow timetables of setting up and then operating hub and spokes efficiently and effectively, which are in reality way beyond local groups of pharmacies not part of nationwide businesses to fund and operate. In a moment of understated frankness, the IA admits:

“The costs and benefits remain uncertain, as do some details around the policy design, and the changes would be provided for by regulations made under the Bill.”


The Minister will know that the NPA has serious doubts about the suggested economic efficiency of the hub and spoke model, particularly in light of the impact assessment’s uncertainty. Under the five-year community pharmacy contractual framework agreement, the PSNC is tasked with the role of agreeing hub and spoke models which will allow the sector to benefit fairly. Can the Minister explain to the Committee how it is envisaged that hub and spoke models will be able to operate to ensure that the arrangements are fair to all pharmacies?

The NPA has stressed that, without a level playing field, competition and choice in the pharmaceutical wholesale market could be reduced by the pressure to set up or join hub and spoke arrangements. The resilience of the medicines supply system could be impacted, and medicine prices could rise as a result. As the NPA says, huge barriers will need to be overcome to make any model fair and appropriate for independents, including the risk of introducing new process errors, lack of clarity on the ownership of problems between the hub and spoke, longer lead-in times and impact on procurement margins—essentially, a reduction in system resilience and problems caused by restrictive distribution arrangements.

The impact assessment stresses that the proposed regulatory change is intended to be entirely permissive, with pharmacy businesses developing hub and spoke arrangements only where they deemed it would be

“beneficial for them to do so”.

Paragraph 255 sets out three types of hub and spoke arrangement that could be entered into, underlying the complexity of the range of models and reinforcing the need for greater consideration and thought to be given as to how further hub and spoke models could be introduced.

The Company Chemists’ Association, the trade body for large community pharmacy operations, which include Boots, Lloyds, Asda, Morrisons, Tesco and Superdrug, has expressed particular concern at hub and spoke models being introduced through secondary legislation and stressed the importance of extensive consultation with the industry—in fact, the consultation on the future of the industry began in 2016 but has yet to be concluded. When and how will consultation on this vital matter, which sees the most significant changes to pharmacy in decades, commence?

The Minister has rightly praised the contribution of independent pharmacies, particularly during the Covid pandemic. However, we know that, before Covid, more than half reported operating at a loss, a situation greatly exacerbated by Covid and extra costs, which led to their income decreasing while their role in the community became more important than ever, working long hours with often reduced staffing numbers, providing advice and support and supplying medicines. In rural areas, such pharmacies have always played a key role as often the only source of information and advice as well as of prescriptions and medical equipment. During Covid, in many areas they were and are the only primary healthcare professionals that patients can still see in person. What progress has been made in the discussions with the sector about additional funding on Covid costs? The £370 million provided in July was an advance payment to an already struggling industry rather than new money. Can the Minister place on record how much additional funding has been provided? My noble friend Lord Hunt will expand on this issue of funding community pharmacies and the wider pharmaceutical industry in relation to the price regulation scheme.

I want briefly to express support for Amendment 29 in the name of the noble Lord, Lord Clement-Jones, which would place a duty on the Secretary of State to consult the pharmaceutical, wholesale and pharmacy sectors and their regulators on an agreed framework for the safe transfer of patient data, prescription information and dispensed products between separate hubs and spokes. This and other provisions in the amendment would provide some vital safeguards if hub and spoke models are developed in future secondary legislation. We strongly support the noble Lord’s approach.

As I stressed earlier, the nine paragraphs of the impact assessment do not represent a strong or coherent case for moving forward at this time under the secondary legislation enabled by the Bill. Instead, they demonstrate the need for more thought, analysis and development of proposals for the future delivery and transformation of pharmacy services, with full involvement of and consultation with the industry, including on extending hub and spoke models. That would ensure a fair and level playing field and the survival of the independent local community pharmacies so valued by patients and their families and carers. I beg to move.

[Lord Clement-Jones (LD)]

My Lords, I want to speak to Amendment 29 in my name and those of the noble Lord, Lord Hunt, and my noble friend Lady Jolly. I thank the noble Baroness, Lady Wheeler, for her support and comprehensive exposition of the issues involved with regulation in respect of hub and spoke.

Like the noble Baroness’s amendment, mine is an attempt to flesh out concerns about the lack of detail in the regulation-making powers under Clause 2(1)(c) as regards authorising hub and spoke arrangements and the process by which new regulations will be agreed. For the record, I should say that “hub and spoke” describes how prescriptions are sent from a community pharmacy “spoke” to a central premise, or “hub”, for assembly, often using automated technology. The assembled medicines are then distributed back to the community pharmacy “spokes” for collection by patients. By removing elements of the existing workload in pharmacies, centralised automated assembly can give the pharmacist and their team more time to deliver healthcare services and advice and to support patients who have urgent and acute needs. This is not the same as an online-only pharmacy or a delivery system. It is not a means to enable home delivery of prescription items. There are significant costs of both setting up and running hub and spoke facilities, but it frees up capacity.

It is not blindingly clear on the face of it but, as a result of powers given under the Medicines and Medical Devices Bill, the Government intend to enable medicines assembly through hub and spoke models across legal entities, which is not allowed under current legislation. It is important that this technology is harnessed for the benefit of patients and the NHS within an agreed framework.

Over the past decade, many pharmacists have invested significantly in hub and spoke technology and use it to release capacity in their community pharmacy branches. It is hoped that, if wider use of the hub and spoke model can be permitted, this capacity can be used to enable community pharmacy teams to provide more clinical services to patients.

Noble Lords participating in Committee will be only too aware that community pharmacy is already helping the NHS in providing services and wants to deliver more. At a recent meeting with pharmacists I heard how, through freeing up capacity, hub and spoke arrangements support the delivery of essential and more advanced pharmacy services such as medicines use reviews, diabetes control, support during taking new medicines, minor ailments and vaccinations. NHS England, likewise, wants to open up the market to new technologies and enable greater efficiencies to be found in medicines supply, but the major pharmacy players believe that this can happen only if other barriers to automation are addressed through the community pharmacy contractual framework at the same time.

The noble Baroness, Lady Wheeler, mentioned the impact assessment and the need for much greater clarity on how the Government will deal with the barriers on the way to realising the efficiency benefits of hub and spoke. These barriers, over and above those mentioned by the noble Baroness, include, first, original pack dispensing. Very often, the quantities prescribed by doctors do not match the amount of medicines in the packs produced by the manufacturers. Pharmacy teams in England and Wales manually “snip” the plastic strips of pills to either add or take away from the manufactured quantity. Snipping is a time-consuming and expensive manual intervention that cannot be automated or delivered at scale.

A second barrier is the need for government support for infrastructure investment. Despite its potential, less than 10% of prescription items are currently dispensed using hub and spoke technology. The industry has already invested tens of millions of pounds in this technology. Government capital investment is needed for it to expand further.

A further barrier relates to fair community pharmacy funding, mentioned by the noble Baroness. The level of remuneration for pharmacy has been a challenge for some time. It needs to be addressed to help the sector to deliver the urgent care and services that the NHS badly needs, especially in the current Covid environment. This is even more important if pharmacy capacity is increased and there is a real prospect of enhancing pharmacy services to fill it.

The noble Baroness has explained the concerns over secondary legislation. I hope that the Minister will address some of these issues in her response and explain how she sees the extension of the hub and spoke dispensing model taking place and how consultation and agreement on a framework will take place.

--- Later in debate ---

[Baroness Penn (Con)]

My Lords, the commitment on the consultation is that it would be a public one, in line with the government amendment on what type of consultation we need to undertake for regulations made under the Bill. That would therefore include patient groups. On the content of the consultation, I understand that when it first took place it was very open, to hear from the sector how it would want to make use of the powers. My understanding is that we have heard the need to have a more structured conversation on the framework for how these powers could deliver the benefits which people think they could. Maybe I could undertake to write to the noble Lord with some more detail on that.

[Baroness Wheeler (Lab)]

Some of the points I was going to come back on have been raised pertinently by the noble Lord, Lord Clement-Jones, and my noble friend Lord Hunt. I too thank the Minister for her full and comprehensive response, and I thank all noble Lords for their contributions. Between us, we have covered a pretty comprehensive range of the issues and concerns around this. However, the Minister has not really made the case that warrants the use of the delegated powers contained in the Bill, nor met the criteria of the DPRR Committee—in particular, that the use of secondary legislation needs to be justified. The words of the DPRR were that the department should “acknowledge the breadth” and depth of the powers proposed and justify them. I do not think that has yet been done.

My noble friend Lord Hunt raised the complex issues on funding, as have other noble Lords. There is much to be achieved in putting funding on a stable footing for community pharmacists. The Minister was unable to answer the specific questions on the £370 million that my noble friend raised, but there needs to be recognition of extra costs. That point has been made forcefully in the House, in questions to the Minister, and I hope that the Government will make that response.

Overall, the Minister has not fully answered the key question of how these proposals fit into the longer-term NHS plan for transforming pharmacy as an integral part of primary care. There are a number of issues around that, which is why we particularly wanted to see a comprehensive plan going forward. Where is the overall strategy and plan for this?

The noble Lord, Lord Clement-Jones, raised a number of issues about how we want to take the development of pharmacists forward. The prescribing powers set out in the Bill are obviously the road to that, but I still do not have a comprehensive picture of how all this fits together. It comes back to the fairness of hub and spoke. Yes, of course the legislation is permissive, and community pharmacies will not have to join hub and spoke arrangements if they do not want to, but the complexity of some of the models proposed and the power of the large-scale providers really make the level playing-field so important—and important to the survival of community pharmacists—that we need to be much clearer about how it is going to work out.

I certainly welcome the commitment on consultation. That is so vital and, as everybody has said, the 2016 consultation was never really completed. As the Minister explained, there was neither the time nor the follow-through for it. I hope that this one will be comprehensive. I would have liked to have heard some kind of timescale but that is obviously yet to come. Much remains unanswered, which we may need to come back to on Report. We will look carefully at Hansard, but meanwhile, I beg leave to withdraw my amendment.

Amendment 23 withdrawn.