Medicines and Medical Devices Bill
Baroness Watkins of Tavistock ExcerptsWednesday 4th November 2020
(5 years, 4 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-IV(a) Amendment for Grand Committee (for Fifth Marshalled List) - (3 Nov 2020)
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
A participants list for today’s proceedings has been published by the Government Whips Office, as have lists of Members who have put their name down to the amendments or expressed an interest on each group. I will call Members to speak in the order listed, but ask noble Lords to note that both the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, have had to withdraw. Members are not permitted to intervene spontaneously. The Chair calls each speaker. Interventions before speeches or “Before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. Groupings are binding, and it will not be possible to degroup or amend for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Grand Committee Room only.
I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an Amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. The proceeding today will cease at 4.30 pm, earlier than originally planned. We will now resume debate on Amendment 27.
Baroness Penn (Con)
My Lords, I thank noble Lords for their patience in waiting a full week to hear the response to what was a very useful and detailed debate. By way of compensation, I hope my response today reassures them that my time has been put to good effect: I am sure they will let me know if that is not the case.
Amendment 27 was tabled by the noble Lords, Lord Patel and Lord Hunt of Kings Heath. I reassure both noble Lords that the Government and the MHRA remain committed to ongoing international collaboration for the benefit of patients and the life sciences sector in the UK. The noble Lord, Lord Patel, set out some of the work the MHRA is doing to deliver on this commitment after the end of the transition period in his opening remarks on this group. I am pleased that noble Lords had the opportunity to hear from and question the MHRA directly on this and other issues this week. The Government heard the request from noble Lords to ensure that this is part of an ongoing dialogue with the regulator and parliamentarians.
In response to the noble Lord, Lord Hunt, I am reluctant to revisit the debate on alignment with the EU, which we have already had in this Committee, as well as in many previous debates. However, I reassure him that the UK is seeking mutual recognition with the EU on a number of areas, including batch testing, good manufacturing practice and continuing co-operation on pharmacovigilance. Certain aspects of medicine regulations are also harmonised at an international level and we are committed to those international standards in all areas. Indeed, to further support the aim of continued international collaboration, we have tabled Amendment 48, which I will come to shortly.
Turning to Amendment 118, tabled by the noble Baroness, Lady Thornton, I reassure her that this amendment is unnecessary. The MHRA and the VMD are both recognised globally as leading regulators and will retain their regulatory sovereignty regardless of any trade deals agreed. This will include the MHRA’s duty to consider the safety and efficacy of human medicines placed on the UK market. We will ensure that our new FTAs provide flexibility for the Government to protect legitimate domestic priorities; we have made this clear in our published approach to trade negotiations with specific trading partners.
On the price the NHS pays for medicines, the Government have made clear that this is not on the table for negotiations. The prices of branded medicines will continue to be controlled through the 2019 voluntary scheme for branded medicines pricing and access—VPAS. To be absolutely clear, the powers in the Bill do not enable regulations to be made that relate to the pricing of medicines or medical devices. In relation to data, the UK has a strong system to protect health and care data, as set out in the Data Protection Act 2018 and covered by the common law duty of confidentiality. Our objectives for trade negotiations are explicit that we will maintain the UK’s high standards of data protection. Again, to be absolutely clear, it would not be within the scope of the powers in the Bill under Clauses 1, 8 and 12 to create exceptions to or modify the provisions of our data protection legislation.
I heard in last week’s debate that questions of safeguards and data protection were at the heart of noble Lords’ concerns about the government amendments in the name of my noble friend Lord Bethell, to which I will now turn. These amendments would allow us to share information regarding these areas with international regulators or networks where this is required to give effect to international agreements or arrangements. I reassure the noble Lord, Lord Clement-Jones, and others about the motivation behind these amendments, which have been identified as necessary as part of the work to support the future relationship with the European Union, and to protect and preserve existing work that the MHRA does. On his question about source codes and algorithms in medical devices, I make two points. The UK-Japan trade deal, as with the EU-Japan trade deal that came before it, provides for safeguards against IP infringement on the question of source code and algorithms. However, to protect patient safety, and for effective regulation, there remains provision for a regulator or conformity assessment body to request source code and algorithms as part of their regulatory responsibilities.
The MHRA and the VMD presently share and receive intelligence from their counterparts through our membership of the European Union, which will come to an end. The MHRA and the VMD will be the UK’s independent, standalone regulators and require appropriate legal powers for their own reciprocal information-sharing arrangements with other nations and forums. Without this, the UK may not be able to comply with its information-sharing obligations under international agreements; nor would it be able to participate in international arrangements facilitating the mutual exchange of intelligence regarding medicines and medical devices. These exchanges of information are of vital interest to UK patient safety. For example, intelligence sourced from international regulators through the EU has ensured access to life-saving medical devices for UK patients during Covid and has enabled the MHRA to trace suppliers of non-compliant testing kits. This is vital and will continue to be so going forward.
Future reciprocal information-sharing agreements with international regulators will help the MHRA and VMD to take swift regulatory action on medicines and medical devices that pose a risk, removing them from the marketplace if necessary. I reassure noble Lords that this data is limited to the data that the MHRA holds. The MHRA will always anonymise patient data before it is shared internationally, under the powers in the Bill. For the purpose of pharmacovigilance, for example, the MHRA might need to share information received through adverse incident reports. However, the information would always be anonymised and is usually kept at a high level—for example, description of the safety signal, or a trend report to identify whether another country has also identified an issue with a particular product or manufacturer.
I appreciate that there has been some concern over the use of the word “person” in the drafting of the amendment. We used that word, rather than specifying particular organisations, because we anticipate that international agreements will require the UK to share information not only with overseas regulators but with other bodies, such as overseas Governments, international organisations such as the World Health Organization, and international networks such as the International Medical Device Regulators Forum.
The wording is necessary because it provides the breadth, for example, to share data with international networks that might not be formalised. If we were to list all the organisations, networks and relationships that might be involved, it would simply not be possible to keep that list live on the face of legislation. Debate has been categorical that the MHRA needs to be a front-footed international regulator, and to limit it to the relationships it has now, rather than being flexible with regard to new regulatory forums or relationships, would restrict that aim.
The noble Lord, Lord Patel, asked pertinent questions about the data protection provisions in the new clauses. I have to admit to noble Lords that I had the same reaction about their potentially circular nature when I first read them, and I hope that I shall be able to unpack their effect here. The GDPR sets out seven key principles for processing personal data, the first of which involves “lawfulness, fairness and transparency”. We are providing a lawful basis for processing personal data by inserting these powers. That does not remove the other protections under the Data Protection Act that apply to the sharing of information under these clauses.
Where personal data are sensitive personal data, which are now called special category data, the GDPR requires further conditions, under Article 9, to be met for the processing to be lawful. Patient health data are a type of special category data. Relevant conditions under the GDPR, of which there are 10 that could be relied on to disclose patient data under the clause, would include “explicit consent”, reasons of “substantial public interest”, health or social care reasons, or public health reasons.
The GDPR also sets out further requirements where personal data are to be shared internationally. There must be an adequacy decision in place confirming that the third country or international organisation ensures an adequate level of data protection. In the absence of an adequacy decision, appropriate safeguards must be put in place that provide enforceable data subject rights and effective legal remedies, which can take the form of a legally binding agreement or contracts between parties. In the absence of an appropriate safeguard, data could be transferred only if it were
“necessary in order to protect the vital interests of the data subject or another natural person where the data subject is … incapable of giving consent.”
Equivalent safeguards for personal data and commercially sensitive information are already in place in Clause 35 for information relating to medical devices. This is solely to facilitate the appropriate sharing of information to give effect to international agreements and arrangements. They are critical to ensuring we can regulate effectively and uphold high standards of patient safety and access.
Amendment 45, in the name of the noble Baroness, Lady Thornton, seeks to achieve what is already standard and long-standing practice. Existing arrangements already ensure that timeliness, openness and transparency are key to the fees regime, and they are published online and available on GOV.UK. We will ensure that the industry and any other interested stakeholders know about any future fee changes in good time. We have laid statutory instruments to implement changes at the end of the transition period, as the cost of providing some regulatory services has fallen, so the fees charged will need to be reduced.
On the basis of the reassurances I have provided on Amendments 27, 45 and 118, I hope the noble Lord, Lord Patel, feels able to withdraw Amendment 27, and that the noble Baroness, Lady Thornton, is similarly assured and will not move her amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock (CB)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I gave the Minister notice last week that I might well want to speak after her, and I am doing that, for two reasons. One is to remind the Committee that, although we will allow the government amendments to go through without any objection, we do not agree with them, and will probably seek to amend them at a later stage.
The second point is to do with the word “person”. I thank the Minister for going into some detail, but frankly, that alarmed me more than reassured me, so I think we may have to engage with this, and discuss how to remove that word. It would be much too dangerous and risky to have such an amorphous expression in the Bill. Perhaps the Bill team could find some expression that, although it does not list all the different things that the person is supposed to be, provides some protection to cover the range of bodies that need to be consulted. I accept that we do not want long definitions in the Bill, but I am concerned about our having such an open definition, and we may discuss this again at a later stage.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We now come to the group consisting of Amendment 28. I remind noble Lords that anybody wishing to speak after the Minister should email the clerk during the debate.
Amendment 28
Lord O'Shaughnessy (Con)
My Lords, I thank the noble Lord, Lord Patel, for moving this amendment. I also pay tribute to my noble friend Lord Lansley for laying the amendment and for creating the template for the innovative medicines fund—the Cancer Drugs Fund—in the first place. The noble Lord, Lord Patel, described the tens of thousands of patients who have benefited from that scheme. It has been a fantastic innovation and something I am sure we all want to build on.
It also seems entirely appropriate that I am following the noble Lord, Lord Hunt, who gave a powerful speech. When I was a Minister, he was unrelenting in pointing out the weaknesses in the PPRS when it came to supporting innovation. He was right then and he is right now. That is why I needed no persuading to support this idea and this amendment. It was something that I tried and failed to introduce in the VPAS when I was a Minister, but perhaps a seed was planted then. It was fantastic to see the commitment made in the Conservative party manifesto in 2019 to create an innovative medicines fund.
As the noble Lord, Lord Patel, said, there are many areas, particularly, but not exclusively, rare diseases—and I have a daughter with a rare genetic condition—where experimental drugs seem to offer great hope, whether that is cannabinoids for epilepsy in children, or gene therapies for children with spinal muscular atrophy, or the many other conditions where the promise seems huge but the data does not yet convince. It feels to me that if we accept circumstances in which it is right to give cancer patients access to those kinds of therapies, it should also be right to give all other patients access to those kinds of therapies too. That is really what the innovative medicines fund is about.
I think that we have seen the shape of the future innovative medicines fund and what it would look like. The VPAS allows for confidential, complex deals for the first time. We have seen CAR-T therapies come through that route. We have also seen a deal signed for Inclisiran—originally from the Medicines Company, now Novartis—with testing of that in a real-world situation following a very successful large-scale clinical trial that was largely focused in the UK. This provides a template for how we might go about doing business for common conditions, as well as for rare ones.
I am sure my noble friend the Minister will agree with everything she has heard today, so I want to ask her what the timetable is for introducing the scheme. Questions have been raised by the BIA and ABPI and others, and I very much agree with them that an ambitious definition of innovation is required. The noble Lord, Lord Hunt, made an excellent point when he forcefully said that we must make sure that the rebate is recycled into innovative medicines, rather than just going back to the Treasury—there does not need to be an additional expenditure control mechanism. I will be grateful for my noble friend’s guidance on that.
One other thing that has come up in our debate in Committee so far—and of course this is more difficult because it takes it outside medicines and into other areas—is the exciting potential in devices, digital and diagnostics. There is no rebate scheme or automatic source of third-party funding that could provide for that. Is the Minister prepared to entertain exploring the potential for expanding the innovative medicines fund into something broader, and beyond medicines, perhaps not in its first iteration but in the future? I look forward to hearing what she has to say.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I call the noble Baroness, Lady Finlay of Llandaff. Lady Finlay? I think we had better move on and we can come back. I call the noble Baroness, Lady Jolly.
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.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I have received a request to speak after the Minister from the noble Lord, Lord Hunt.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, before the noble Lord winds up, I want to thank the Minister. Clearly, the fund is welcome, but it will cover only a limited number of medicines. The debate goes wider than that.
I want to ask the Minister about the financial contribution that her department receives under the current voluntary agreement with pharma for sales of branded health service medicines. Does she not agree that it is a strange position we have reached where, if the cost to the NHS of those branded medicines goes above the agreed rate, her department receives a rebate? That is excellent, but why then does the NHS continue to treat drug costs almost as a pariah and hold down its investment in new medicines? Why cannot that rebate be used as a way to incentivise a switch by the NHS to new medicine?
I have debated this with the noble Lord, Lord O’Shaughnessy, and his predecessor. It is a real issue. The NHS itself believes drug costs to be a major problem, but the department has essentially solved the problem at a national level through the rebate scheme. Somehow, instead of a virtuous circle, we have got the very opposite.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I have also received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.
Lord O'Shaughnessy (Con)
I apologise for my email ineptitude.
I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.
I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock)
We now come to the group beginning with Amendment 30. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 3: Falsified medicines
Amendment 30
Lord Hunt of Kings Heath (Lab) [V]
I very much support my noble friend in these amendments. As they have with her, a number of organisations have raised with me their concerns. The clause refers to the
“use, retention and disclosure, for any purpose to do with human medicines”,
which is very open-ended. In relation to information collected by such a system, it considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this. The noble Lord, Lord Clement-Jones, is not with us today but, when we debated it earlier, he referred to it as “legislative creep”—and, I must say, I agree with him.
In the Commons, the Health Minister Jo Churchill said in Committee:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 7.]
So it is very surprising to see this clause as currently drafted.
We have had briefings from the Company Chemists’ Association and ABPI, in addition to the ones that my noble friend mentioned. Because of the issue of commercially sensitive data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive. The principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Minister’s department already has access to a wide range of data on medicines’ sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations, which we debated at some length a little while ago in your Lordships’ House. Of course, Ministers can request more detailed information if required. Given this access and the known sensitivities around falsified medicines data in general, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Why was such little reference made to it in the Explanatory Notes?
It is not unreasonable to ensure that the Bill is amended to enshrine at least a duty of full consultation with stakeholders before it goes through your Lordships’ House.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
The noble Lords, Lord O’Shaughnessy and Lord Clement-Jones, have withdrawn. I therefore call the noble Baroness, Lady Jolly.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We now come to the group consisting of Amendment 40. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 40
Medicines and Medical Devices Bill
Baroness Watkins of Tavistock ExcerptsMonday 26th October 2020
(5 years, 5 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Lord O'Shaughnessy (Con) [V]
My Lords, I have spent far too much time with patients harmed by medicines and medical devices going wrong—valproate, mesh and Primodos—and many people affected adversely by other treatments in which they had vested so much hope to be unconcerned about the issue of patient safety. I applaud all noble Lords who have tabled amendments on this topic, and especially pay tribute to my noble friend Lady Cumberlege, whose exemplary work on this issue through her review has given the issue, and the women—because it is mainly women who have been affected—the profile that they should always have had.
I certainly agree with all noble Lords that safety should be considered of greater importance than the attractiveness of the UK. There is and should be no trade-off necessary between attractiveness and high regulatory standards. I also agree with the point made by the noble Lord, Lord Hunt—that there is so much more to patient safety than the regulatory regime for medicines and devices that we are discussing today, but that is what we are discussing.
Having said all that, I have something nagging slightly at me about the topic, which I want to explore in my comments. I wonder whether there is some tension between availability of medicines and devices on the one hand and their safety on the other. As the Bill stands, it fails to elucidate this tension properly. The question that we need to solve is whether it is always right that safety should trump availability and access to medicines.
I start by looking at the purpose of our regulatory regime. The homepage of the MHRA says that it is to
“maintain the safety, quality and effectiveness of our medicines, devices and diagnostic tools”.
Of course, its reputation stands on its ability to make judgments against those criteria, which can sometimes be in tension: a drug can be safe but not efficacious, and it can be effective but not acceptably safe. If there are shortages, which sometimes happens, quality variation might be needed to access necessary medicines and devices. Striking a balance between all those factors and getting the right balance between risk and reward is where the hard task of regulating occurs.
We have heard many examples already on Second Reading and in Committee today of the tragedies that have happened when there have been regulatory and other failures of medicines and medical devices. However, it is also true that some of the greatest success stories in medicines have come about through a more pro-risk approach. I mentioned the HPV vaccine last time, which of course has been extended to boys, even though there continues to be some concern about the level of adverse events. The early access to medicines scheme allows patients to be treated with unlicensed medicines that have not yet had regulatory approval but where there might be a transformative opportunity for patients. Of course, in considering these issues, the words of the noble Lord, Lord Saatchi, and Baroness Jowell in the debate that they so wonderfully led, inspiring us all, also ring true. Creating more access to experimental therapies for ordinary patients can often be the right thing to do for them. It is not that we want unsafe medicines—of course not. But what matters ultimately is the safety of the patient, and sometimes that might mean—or their health and best interests might mean—better access to riskier medicines for some patients that would be unacceptably risky for most patients. Indeed, it is quite possible that the move to personalised medicine will make this more and more likely.
I am strongly supportive of the patient safety agenda, and encourage my noble friend the Minister to commit the Government to taking forward the recommendations made in my noble friend Lady Cumberlege’s review. However, I am a little worried, perhaps wrongly, about the potential impact of these amendments on patients’ ability to access experimental medicines and devices, or even the availability of standard medicines that are experiencing a shortage that might improve people’s lives. In a spirit of this being Committee, though not quite as iterative as it usually is, I wondered whether a different approach would be to amend the Bill so that Clause 1(2)(a) instead reads,
“the safety, quality and effectiveness of human medicines”,
which could then unambiguously be made the overarching priority of the legislation, involving as it would recognition of the trade-offs and tensions in the standard to which regulators are currently held, then applying this approach to medical devices. Whether this is the right way forward is up to noble Lords, but I hope that my noble friend the Minister is open minded on this issue and will consider very carefully the various arguments being made.
Baroness Watkins of Tavistock (CB) [V]
My Lords, it is a pleasure to follow other noble Lords, the majority of whom I completely agree with. I put my name down to speak to this group as I wish strongly to support the amendments tabled by the noble Baroness, Lady Cumberlege, Amendments 10, 12, 74 and 75.
Last year, I was on the pre-legislative scrutiny committee for the Health Service Safety Investigations Bill, which did not proceed as a result of the election. Therefore, I believe that putting patient safety at the heart of this Bill and making it a safety Bill as other noble Lords have outlined makes complete sense. It would protect our population and make our country far more attractive for medical research, because we would be seen internationally as a leader in safety in that work and in any licences we gave to medicines and medical devices.
As well as medical devices inserted in the way that was so eloquently outlined by the noble Baroness, Lady Cumberlege, and my noble friend Lord Patel, there are other pieces of equipment used regularly in intensive care and other care settings, including the community settings, where safety is paramount, particularly for the safe delivery of very small amounts of medication. Engineers in our country are developing far safer equipment for that kind of healthcare, which is largely delivered by nurses and other community health- care workers. Therefore, if we can make these issues clear in the Bill, we will be an extremely attractive country to sell such pieces of equipment internationally. For that reason, the priority of the Bill must be for patient safety, because it will result in much-increased attractiveness for us as an exporting nation in this field.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I understand that the noble and learned Lord, Lord Woolf, who was due to speak next, is not with us this afternoon. I am saying this very slowly in case he is, but I do not think so. In that case, I call the next speaker.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I support Amendment 20 in the name of the noble Baroness, Lady Thornton, to which I have added my name. Its purpose, together with Amendment 21 in the name of my noble friend Lord Patel, who has just spoken so eloquently in favour of it, are to provide a definition of attractiveness for clarity and the primacy of safety, while maintaining an environment that promotes the UK as a centre for global life science research and innovative working with academic partners in all continents across the globe. In addition, Amendment 20 should ensure that the UK population has prompt access to new medicines once they have been approved in line with Her Majesty’s Government’s philosophy for the future.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
That was commendably brief. I call the next speaker.
Health Protection (Coronavirus, Local COVID-19 Alert Level) (Very High) (England) Regulations 2020
Baroness Watkins of Tavistock Excerpts(5 years, 5 months ago)
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Baroness Watkins of Tavistock (CB) [V]
My Lords, it is a pleasure to welcome the noble Lord, Lord Moylan. I draw attention to my interests as listed in the register.
I support the principles informing this statutory instrument, yet citizens need to be aware of how compliance will enable restrictions to be downgraded from very high to high and medium, and vice versa. The public need to understand the criteria which are used, and will be used in the future, to inform a change in tier levels. Knowledge is vital to gain buy-in to the measures to protect lives and livelihoods. For example, will indicators be considered in addition to those that we have just been informed of, including rising levels of local unemployment and mental health crisis referrals, to inform local and national discussions regarding the application of tier-level restrictions by area? The SI’s associated guidance for visitor access to residential care homes is far from transparent. It simply states:
“Closed to external visitors other than in exceptional circumstances.”
I welcome the announcement of testing healthcare students on clinical placements, particularly as they often work with vulnerable, frail residents in care homes. The test and trace system has limited resources, yet surely it is time to include essential visitors for each care home resident. In evidence to the Health and Social Care Committee, Helen Whately, Minister for Care, acknowledged the challenges associated with the restriction of visitors to care homes. Can the Minister assure the House that testing of at least two regular visitors per resident will be organised this winter? It is a basic human right to see, touch and reassure a loved one. We must learn to live with Covid and promote the health and happiness not only of care residents but of their families and loved ones if we are to remain a compassionate society during this pandemic.
Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020
Baroness Watkins of Tavistock Excerpts(5 years, 5 months ago)
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Baroness Watkins of Tavistock (CB) [V]
My Lords, I declare my interests as outlined in the register. I thank the noble Baroness, Lady Morrissey, for her important contribution to this debate; I agree with much of it.
When I put my name down to speak, it was to express my concern that Parliament appeared to be managing rises in Covid-19 rates in different areas of the country through myriad secondary legislation instruments—at least 18, I believe. As a member of the committee that considers SIs in this House, I and other members were becoming concerned that it was increasingly difficult to understand the evidence base on which individual SIs were being developed. In addition, it has become crystal clear over the weekend that the public and local authority elected representatives, particularly in the north-east, Liverpool and Manchester, have begun to lose trust in the way in which we are dealing with local restrictions.
Fortunately, the Prime Minister and his Cabinet accept that we must adopt a more strategic approach to legislation, associated with changes in the number of infections per 100,000 of the population. Currently, different parts of the country have significantly different rates, estimated at between 16 cases per 100,000 where I live, here on Dartmoor, and 600 in Nottingham. However, any three-tier system to manage the virus should be applied in a uniform manner associated with virus increases, and hopefully decreases, over time. The three-tier system that the Prime Minister is expected to announce should be passed into law and applied across England equitably as the virus ebbs and flows. Any legislation should clearly indicate when an area will be enabled to move up or down a tier, associated with the ratio of virus cases to the population. This will ensure that the public can clearly understand the core reason for proposed restrictions.
At the core of managing increases in infections are the test and trace system and the public’s buy-in to restrictions of liberty, be this closing licensed premises or requests to reduce travel and meeting friends and family. In March, care homes were largely closed down in terms of relatives’ and friends’ visits; we know that this caused considerable distress in many cases. Careful consideration must be given to trying to ensure that we avoid transmitting the virus from the community to care homes, but we must also weigh up the devastating effects to people of not being visited by ones they love. What approach do the Government intend to take on this issue?
When Governments reduce their populations’ liberties, even for good reason, it is vital that they counterbalance the restrictions with effective leadership. In particular, did the breakdown in recording over 15,000 positive coronavirus tests 10 days ago contribute to the rapid increase in cases in certain parts of the north-west and north-east of England? By this I mean: did a high proportion of those 15,000 cases, where contacts were not traced quickly, occur in this area?
Will the Minister assure the House that, if hospitals in any area of England become overloaded, the Government will ensure that additional test and trace facilities, PPE and other resources required to manage the virus will be made rapidly available from other parts of the country?
Finally, I welcome the honours given this weekend to nurses and other health and social care workers who contributed in the first wave of the pandemic. However, the Government’s recent press conferences have focused heavily on scientific evidence, with little reference to applied, evidence-based public health interventions, which nurses are often involved with. Yet nursing is reportedly the profession that is most trusted by the UK public. Nurses should play an important role in the public health messages we are trying to get across. They can encourage the take-up and delivery of vaccinations, including for flu and tuberculosis, and the mass vaccination for Covid-19 as and when it is developed. Does the Minister agree that now is the right time to more effectively use the voice of nurses, including the Chief Nursing Officer for England, Ruth May, and locally based community, hospital and school nurses, to explain to the public how best to reduce the spread of the virus?
Social Care Workers
Baroness Watkins of Tavistock Excerpts(5 years, 5 months ago)
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Lord Bethell (Con)
My Lords, the recruitment of nurses is extremely encouraging. We have had an enormous response, with more than 10,000 nurses already recruited and recruitment rates to universities for nursing qualifications also up. We have an enormous marketing campaign supported by broadcast and social media. However, more needs to be done and we are very focused on this area. The use of agencies provides some surge capacity for hospitals—it has a role—but I completely acknowledge my noble friend’s point that agency support needs to be used in a considered, thoughtful and commercially intelligent way.
Baroness Watkins of Tavistock (CB) [V]
My Lords, the introduction of living allowances for nursing students has improved recruitment this autumn. Stable funding for social care purchasers and providers in both care homes and domiciliary-based service is necessary to ensure dignity in care for the vulnerable in our society. It is essential that careers in social care are attractive and that staff are supported to deliver high-quality personalised care to clients. What plans do Her Majesty’s Government have to support local authorities, further education colleges and social care providers to train and retrain social care staff? Central funding is necessary. Incentives are needed to demonstrate that those joining the social care workforce are as valued by government and society as those working in the NHS.
Lord Bethell (Con)
The noble Baroness makes her point extremely well. We want social care to be a profession that people seek out, where they seek professional development and where they can find a fulfilling lifetime career. That will not be true for everyone, but we need a backbone of people who are committed to social care. That is why we have massively increased the funding to local authorities so that they can address the challenge of social care, and why we have published the adult social care coronavirus winter plan in order to provide short-term support for local authorities to achieve exactly what the noble Baroness has spelled out.
Covid-19 Update
Baroness Watkins of Tavistock Excerpts(5 years, 6 months ago)
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Baroness Watkins of Tavistock (CB)
My Lords, I thank the Minister for coming to take questions on this Statement. I will ask about two issues. If he cannot answer me now, could he kindly write with information? My main concern is people who are still going to work and caring for people who are Covid positive. Based on the highest prediction of need, how many days’ worth of PPE stock does the UK currently have in store for the NHS and voluntary and independent-sector providers of health and social care, including care homes and domiciliary services? How rapidly can stocks be replenished? What proportion is produced and manufactured in the UK? Have we tested the distribution systems and are they satisfactory?
My second question is in relation to vaccination. Vaccination will obviously be really important, but what are we doing now to support the Prime Minister’s approach, declared in August 2019, that we will increase MMR vaccination rates, among other needs, so that all people are protected as far as possible against other infections during the rise of Covid?
Lord Bethell (Con)
My Lords, the noble Baroness asked about PPE, which is naturally a concern as we go into winter. I assure her that the NHS has 15-day, 45-day and 90-day plans for the supply of PPE to the NHS and the independent sector. Roughly half of that comes from British sources. The distribution mechanisms have been radically overhauled and tested, and have proved to be utterly modernised.
We are working extremely hard on the deployment of a Covid vaccination. She rightly mentions other vaccinations. I assure her that we have 30 million doses of the flu vaccination. As she rightly points out, there appears to be a strong link between having flu today, Covid tomorrow and problems with a combination of both at a later date.
Childhood Obesity
Baroness Watkins of Tavistock Excerpts(5 years, 7 months ago)
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Lord Bethell (Con)
My Lords, I pay tribute to the noble Baroness, Lady Chisholm, for her expertise in this matter. She is entirely right that decisions made by families together are more powerful than those made by individuals. The obesity campaign launched in July seeks to achieve exactly that by having a campaign on better health targeted at the whole population. I also emphasise the Healthy Start vouchers, a scheme to provide a nutritional safety net to hundreds of thousands of pregnant women and families with children aged under four, which is one way of bringing families together around healthy food.
Baroness Watkins of Tavistock (CB)
School nurses play important roles in dietary education for new parents and school pupils. With the anticipated changes to Public Health England, how will the Government ensure, without structured plans, that these services are strengthened to promote healthy eating and exercise to prevent early childhood obesity?
Lord Bethell (Con)
The noble Baroness is entirely right that these nurses play an absolutely pivotal role. The reorganisation around PHE is due to start in April. We are seeking the best possible advice on where that work could be best sited. The National Institute for Health Protection is one potential home, but I reassure the Chamber that a safe and important home for those nurses is a priority for the Government.
Medicines and Medical Devices Bill
Baroness Watkins of Tavistock ExcerptsWednesday 2nd September 2020
(5 years, 7 months ago)
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Baroness Watkins of Tavistock (CB)
My Lords, I feel that I have drawn the short straw, speaking at this point.
Like other noble Lords, I broadly welcome and support this relatively short, important and necessary Bill. To promote patient safety, the meaning of
“the attractiveness of the … United Kingdom”
environment for medical research in future, particularly in relation to clinical trials, requires clarification. We see the global race to produce safe vaccines for Covid-19 that must, despite their urgency to protect populations, be tested for safety as well as efficacy. The UK currently adheres to the EU protocols that apply to ensure the safety of such products before licences are given for mass use. Can the Minister explain if there are any plans to relax our adherence to current EU legislation on clinical trials?
The Bill refers to regulations relating to medical devices and the fact that Ministers will be given delegated powers in relation to their approval. Do the Government intend to adopt the EU regulation on medical devices 2017/745, which is not due to come into force until after the end of the transition period? Will the Government ensure that, as well as approving new devices in future, any maintenance of devices necessary to keep them safe in operating terms will also be included in the provision of granting such licences? We know that patients have occasionally been put at risk due to inadequate and/or irregular maintenance of devices—for example, with smart infusion pumps used to deliver medication. What onus will the Government put on purchasers of approved devices not only for safe maintenance but for adequate training for people to use the new devices to protect patients? This does not seem to be mentioned at all in the legislation as drafted.
I too fully support the excellent report and recommendations produced by the noble Baroness, Lady Cumberlege, and the way it uses plain English to describe the horror that some patients and their families have suffered. I am reminded of trying to find out, when I was training as a nurse, what “iatrogenic complications” meant. I think it is stark that the noble Baroness uses modern language that we can all understand. That is so important.
Will the Bill be used to incorporate some of the principles of the Health Service Safety Investigations Bill, which reached a Second Reading in this House, or is it the intention that that Bill will not be timetabled for completion and therefore the medical devices Bill will need to take up many of those issues at the same time?
Without doubt, I fully support the concept of a patient safety commissioner being appointed.
Covid-19: Response
Baroness Watkins of Tavistock Excerpts(5 years, 8 months ago)
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Lord Bethell [V]
My Lords, that is not in the current guidelines. The noble Lord is entirely right that it is incredibly time-consuming and not currently practicable. For the reasons I outlined in answer to an earlier question, a test today does not guarantee that someone will not be infectious either tomorrow or the next day. That is why we have not focused on testing at ports, but we remain open to suggestions. We assess a large number of options and, as evidence and trials emerge that may demonstrate the efficacy of different policies, we will of course consider them and remain open-minded.
Baroness Watkins of Tavistock (CB)
My Lords, the Statement is clear that the intention is to mass-vaccinate the population once we have a vaccine that is safe and effective. Can the Minister inform us of Her Majesty’s Government’s plans to achieve this, in the light of concerns among general practitioners that they will be overwhelmed, and given that as many as one in six people in a recent survey said that they would not take up the vaccine if it was available? Do the Government intend, for example, to deploy the many nurses and doctors who volunteered to assist earlier this year to deliver vaccinations for both flu and Covid-19? Will they engage faith leaders in encouraging the uptake of vaccinations through proper explanation of the benefits to individuals and to society as a whole of so doing?
Lord Bethell [V]
The noble Baroness raises an incredibly important issue and I pay tribute to Kate Bingham, who is running the Vaccine Taskforce. She is tackling exactly the issue that the noble Baroness raised. GPs are right to be concerned about capacity, which is why we are looking at ways of massively increasing the capacity to deliver such a vaccine. We will definitely look at resources such as returnees, pharmacists and other sources of people power to deliver the vaccine into the arms of the nation. On the anti-vaxxer groups, the fake news and wrong stories around vaccines are an area of deep concern. We are working with faith groups and other civic leaders to put right the arguments for a vaccine because, at the end of the day, any vaccine requires the participation of a large proportion of the country in order for it to be truly effective. It will cause huge disruption and personal suffering if trust is not maintained in the efficacy of such a vaccine.
Independent Medicines and Medical Devices Safety Review
Baroness Watkins of Tavistock Excerpts(5 years, 8 months ago)
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Lord Bethell
My noble friend Lady Cumberlege has put it incredibly well and I endorse her testimony about the courage and expertise of the patient groups who informed this report. I am only sad that they cannot be here to share this important moment. I pay tribute to the work of my noble friend and her team working on this. Patient safety is uppermost now in the mind of health carers. She is absolutely cutting with the groove. The words of Jeremy Hunt are very well made, and we are utterly committed to looking seriously at these recommendations.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I add my apologies to the patients and their families and acknowledge the superb work done by the noble Baroness, Lady Cumberlege, and her team. The report makes very salutary reading. Are we going to make sure that we keep central records relating to any type of implant in future, including mesh used in hernias, so that we can follow up individual cases as appropriate? Will the Government consider returning to the Health Service Safety Investigations Bill, which was delayed and abandoned as a result of the recent general election?
Lord Bethell
Health records are absolutely key—that is why we have tabled an amendment on them. That amendment enjoys the support of the Government and of me personally.