Health: Brain Tumours
Baroness Jolly Excerpts(3 years, 3 months ago)
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Lord Bethell (Con)
My Lords, the noble Baroness is right that brain tumours and brain cancer are some of the most awful situations, particularly because they so frequently affect the young. That is why infrastructure spend on brain tumour research has increased. I am pleased to say that we received 62 applications for research funding between May 2018 and 2020, 10 of which have been funded so far, but more can be done in that area. Supporting families is, of course, part of the responsibility of the charities and trusts involved, and I wish the best to all those families who have been hit by this awful condition.
Baroness Jolly (LD) [V]
My Lords, when this issue was raised at Questions on 19 November last year, the Minister suggested that the quality of applications needed improving. He kindly offered to meet research charities working in this area to facilitate this. Can he tell the House which of these charities he has met or has an appointment to meet and how many applications have since been received?
Lord Bethell (Con)
My Lords, I have had three meetings, particularly with the Tessa Jowell Brain Cancer Mission, which has been extremely constructive and brought with it clinical expertise, patient groups and policymakers. Together we have worked on a plan, which I articulated in my opening remarks. It has emerged that it is not a question of the quality of the research applications. The quality of research in this area is fantastic. The problem is that we need to have better basic science at the very early stage of the pipeline in order to guide the later operable research suggestions. That is why we have organised the workshops, are feeding back to the applicants in the previous round of research and are actively engaged in this area.
Mental Health Act Reform
Baroness Jolly Excerpts(3 years, 3 months ago)
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Lord Bethell (Con)
The noble Lord is entirely right: when people experience a mental health crisis, they should be treated with consideration. Unfortunately, the police are sometimes at the front line of dealing with those with mental health difficulties. It is a stretch for them, and they should have the right training to be able to deal with a situation sensitively and they should have the right premises to be able to give people safe and secure environments. It is at the outer limits of their professional responsibilities, but we are doing as much as we can to put the training in place.
I remember from my own personal experience, when my father and my mother were sectioned, the consideration and thoughtfulness of those involved in both those processes. It is not all bad, but I take the noble Lord’s point.
Baroness Jolly (LD) [V]
My Lords, I welcome the White Paper and the commitment to deliver person-centred care. Many health and social care professionals will need to change the way they work, which is both necessary and welcome. What is the national budget for training over the next five years and how soon will those being treated for mental health conditions expect to notice a difference in their care?
Lord Bethell (Con)
My Lords, the noble Baroness is entirely right: the training is critical in this area; it could not be more important. We have invested £500 million in mental health services and support for the NHS workforce to address this. I cannot give her the precise number that she has asked for, but I shall write to her if I can track it down. However, we recognise the urgency of the situation and we hope that the impact of this money will be felt as quickly as possible.
Medicines and Medical Devices Bill
Baroness Jolly ExcerptsThursday 14th January 2021
(3 years, 3 months ago)
Lords ChamberRead 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 154-II(Rev) Revised second marshalled list for Report - (12 Jan 2021)
Lord Naseby (Con) [V]
My Lords, I declare an interest in that I am married to a retired general practitioner.
I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.
I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.
In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.
Baroness Jolly (LD) [V]
My Lords, I support this amendment to require
“the Secretary of State to publish a strategy for tackling antivaccination disinformation within one month of the Bill passing.”
The noble Baroness, Lady Thornton, has picked a fascinating, current topic, and the noble Baroness, Lady Bennett of Manor Castle, posed some pointed questions about the quality and effectiveness of the messages. I look forward to the Minister summing up on these points.
Misinformation is not new. I remember websites being used many years ago to persuade parents to ensure that their children had their childhood vaccinations at the appropriate time, and it is paramount that the Government take a robust stance against anti-vaccination disinformation. Research from Oxford University suggests that 12% of the UK population is “strongly hesitant” about taking the vaccine, with a further 16% unsure. Together, that makes 28%, a very significant proportion of the population—over a quarter. We are putting all our efforts into stopping the spread of this virus. This means that if the 28% avoid vaccination, they will run the real and severe risk of catching the virus; not only that, we will run the risk of catching it from them, so undoing all the benefits of the programme.
Lord Naseby (Con) [V]
It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?
Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.
Baroness Jolly (LD) [V]
These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.
Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.
The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.
Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.
Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.
Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.
These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.
Baroness Thornton (Lab) [V]
My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.
Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.
Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that
“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.
This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.
Amendment 21 would ensure that patient information
“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”
We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.
Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.
Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.
Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.
My question goes to the nub of Amendment 50—in which regard, if this is correct, Amendments 51 and others in this group will not be needed. Is it for the Secretary of State to decide what goes in the regulations on which presumably Parliament will be consulted under the affirmative procedure?
I can quite understand that the use of “may” appears to be discretionary, leaving open what should be included. Having got this far, it would be helpful to understand the thinking behind the use of “may” in Amendment 50, which indicates that this may be discretionary, whereas clearly it appears to be the will of the House that this is mandatory.
Baroness Jolly (LD) [V]
My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and the amendments in the name of the noble Baroness, Lady Thornton, in this group would require the Secretary of State to create the committee in Amendment 50, as the Government’s amendment states only that the Government “may” create the committee, not that they must.
No Secretary of State should be above independent advice. Amendment 50 is no bad thing, and of course any advisory committee on a statutory footing should consist of patients as well as experts. I understand that there might be kickback on the amendments in the name of the noble Baroness, Lady Thornton, but a Secretary of State will rarely have expertise in medical devices, so an ad hoc independent committee to inform, advise and warn would be very valuable. A lot of thought will need to be given to working out its terms of reference. We therefore support Amendments 51 to 53. As the noble Lord, Lord Lansley, said, it will also be critical to ensure how this committee will work alongside the MHRA.
Lord Bethell (Con)
My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of travel, the step change and the commitment to patient safety that the MHRA will enshrine.
As has been noted, the committee already exists. It currently meets, and it has an impact and an effect, but these measures mean that it will be strengthened. This change is put forward not solely by the Government; it was a recommendation in the review authored by my noble friend Lady Cumberlege. It adds to the collective picture of improvements that we are making, from future regulation of devices to the medical devices information system. I reassure my noble friend Lord Lansley that we have a profound commitment to creating a regulator in the MHRA that has international influence. I say to the noble Lord, Lord Hunt, that patient representatives are already on the DEAC. As Dr June Raine made clear in her briefing to noble Lords, she and the MHRA are massively committed to the patient safety agenda and to mobilising the patient safety voice through instruments such as the DEAC but not solely through it.
It is a delegated power, but one that I hope noble Lords agree is contained. It will allow us to ensure that the structure and focus of the committee can be kept under review to make best use of its impact, and the regulations will be subject to public consultation and all the steps therein.
The noble Baroness, Lady Thornton, has tabled Amendments 51 to 53 to the government amendment, which would change the nature of the regulations such that they “must” rather than “may” be made. However, as I have set out, the committee already exists; it functions now. It will be strengthened by the regulations. We are committed to a more structured decision-making process that improves transparency. There is no equivocation or doubt; these regulations will be made.
The powers provided by Amendment 50 in my name will enable movement towards a more transparent, proactive, whole-life cycle approach to vigilance. Fundamentally, they will make a difference in the oversight of medical devices to the benefit of patients and patient safety.
I am grateful to noble Lords who have continued to shine a light on the importance of device safety. I hope that this additional tool in the arsenal demonstrates continued commitment and that I have provided sufficient reassurances for the noble Baroness to feel able to withdraw the amendment.
Lord Lansley (Con) [V]
My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.
I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.
In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.
What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.
What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.
Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.
Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.
There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.
We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.
Baroness Jolly (LD) [V]
My Lords, these amendments relate to NHS access to medical devices, and Amendment 46 from the noble Baroness, Lady Finlay, would ensure early access for NHS patients to medical devices and allow monitoring of safety and efficacy in real-time use. This amendment is pre-empted rather by the Government’s amendment, which removes the concept of attractiveness.
Amendment 66 from the noble Lord, Lord Hunt of Kings Heath, would require NICE to ensure that its recommendations support the NHS in the ways outlined in subsection (1) of the proposed new clause. This includes ensuring access to new medicines and medical devices for patients with rare diseases. Those of us who have been involved in rare diseases will be all too well aware of the problems of access to appropriate treatments for so few patients.
The interesting thing about this debate is that two of the House’s big health thinkers have been speaking, and both the noble Lord, Lord Hunt of Kings Heath, and the noble Lord, Lord Lansley, have given us a really good big-picture look which takes us slightly above legislation.
The noble Lord, Lord Lansley, spoke of social and innovation benefits and the need to value innovation, but with innovation does not always come success: we may have to try again. He spoke about the innovative medicines fund and the necessity for NICE and NHS England to work together. When it is put like that, it sounds very straightforward: why is that not normally happening? He talked about the importance of value-based pricing and getting the best value from the drugs budget—which, after all, is finite. He also talked about the health technology assessment, which is of course qualitative, not quantitative. I valued the contribution of this debate on the fourth group of amendments, and I will read it again with great interest.
Baroness Jolly (LD) [V]
This amendment from the noble Lord, Lord Hunt of Kings Heath, supported by the noble Baronesses, Lady Cumberlege and Lady Bennett, would require the Secretary of State to introduce proposals for a redress agency for those harmed by medicines and medical devices. As the noble Lord, Lord Hunt of Kings Heath, said, the concept of a redress agency for those harmed in such a manner has been around for many years but has not been realised. However, in the light of the Cumberlege report, which has been a great catalyst for innovation, the Government must see that now is the time. This is a really practical and common-sense move that would provide support and relief for patients while also avoiding the need for costly litigation on both sides, saving the NHS a considerable amount of money which could be better spent.
The NHS has a duty to give proper support to those in its care who have been harmed. As the noble Lord, Lord Lansley, said, there needs to be independent fact-finding, leading to a resolution process. He cited the NHS Redress Act 2006. I ask the Minister to reflect on this debate and to speak to his right honourable friend the Secretary of State, perhaps using his charm to persuade him to think again.
One advantage of being at home for this debate, in front of your own computer in your own study, is the opportunity quickly to look online to see how easy it is to find the relevant website. It took me a couple of searches before I came up with NHS Resolution, but it was not hugely helpful or intuitive. Therefore, would the Minister also feed that back to the Secretary of State and the people who manage these schemes?
Lord Bethell (Con)
My Lords, the noble Lord, Lord Hunt of Kings Heath, raises matters in Amendment 67 that he raised in Grand Committee. I completely recognise that they are of enormous concern right across the House. One could say that it is the £83 billion question. I know he is an advocate, as indeed are many noble Lords, of the conclusions of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, and I commend him and other former Health Ministers in this place.
In Committee, we had a very helpful, substantial and informative discussion on the concept and merits of a redress agency. I know that the noble Lord indicated that he would return to these matters if it seemed likely that we were unable to give an update on the way in which the department is responding to the review. I understand that he seeks further assurances and I shall attempt to give them.
As I set out in Committee, we are determined to ensure the safety of medicines and devices so that harm is less likely to happen in the first place, and, when things do go wrong, we are committed to fair redress arrangements that work for all. However, for the reasons that I set out in Committee, we do not believe it is necessary to create a new body for the purpose of providing redress for medicines and devices.
First, routes already exist if patients believe they were harmed by medicines or medical devices. They can bring a legal claim in the courts either against the manufacturer on the basis of product liability or against the actions of an NHS provider or clinician.
Secondly, the Government and manufacturers already have the ability to set up redress schemes when necessary, and in fact they have done so already, where appropriate, without ever establishing an additional agency. Setting up an overarching redress agency could become an unnecessary addition to an already complex landscape.
Thirdly, we do not believe that a redress agency in this country would necessarily make products safer or drive the right incentives for industries which are usually directed from a global level. It is a fact of life that any extra costs to firms could impact the attractiveness of the UK as a place to market and manufacture products —something that we are committed to supporting.
The noble Lord, Lord Hunt, asked what, in the absence of wholesale changes, we are doing to improve things. Since its strategy, Delivering Fair Resolution and Learning From Harm, was launched in 2017, NHS Resolution has successfully reduced the number of cases going to litigation. In its 2019-20 accounts, it reported that 71% of claims are now resolved without court hearings, which is extremely encouraging.
This has been accompanied by a significant increase in the use of ADR—alternative dispute resolution, referred to by my noble friend Lord Lansley—with over 1,000 mediations undertaken by 31 March 2020, with a success rate of around 80%. This is again encouraging. As a result of the strategies employed on ADR and early resolution, overall time to resolution of cases had reduced since the NAO report by an average of 26 days. The new early notification scheme for obstetric cerebral palsy has ensured that many early admissions of liability and interim payments can be made to families within months. In answer to my noble friend Lord Lansley, we keep the whole arrangement under review and assess options all the time.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a privilege to be able to support and put my name to the amendment in the name of my noble friend Lady Cumberlege. As has so often been the case in this Bill, where she leads, others follow, and I entirely endorse everything that she and the noble Baroness, Lady Bennett, have said. My reason for supporting the amendment is simple: as my noble friend made clear today, there are tens of thousands of women, men and their families who are suffering from the impact of licensed medicines and medical devices that have been wrongly used.
My noble friend’s landmark review gives voice to so many people who have been ignored for too long; that is what gives it such moral power and makes the force of its arguments so irresistible. Within the final report of her review is a clear recommendation for ex gratia redress schemes to be established for those affected by the HPT, mesh and valproate scandals. To my mind, this recommendation is neither radical nor extraordinary: such schemes have been set up in the past—for the victims of thalidomide and contaminated blood. Indeed, this is a common-sense proposal, and it is urgent—because the suffering of so many continues to this day, as my noble friend pointed out.
I have spoken in the past of two women—Janet Williams and Emma Murphy—whose lives, and whose children’s lives, have been changed for ever by in utero exposure to sodium valproate. They were interviewed as part of a recent Channel 4 documentary on the challenges they face in day-to-day life, the guilt they have been made to feel and their struggle to be heard. Janet and Emma’s honesty and tenacity have been an inspiration to me since I met them, and I defy anyone to watch that programme and not be moved to tears.
I was also contacted recently by another lady, who has been harmed by mesh. Her name is Susan Morgan, and, with her permission, I convey her story. She described to me being on,
“a hideous journey that was thrust upon me without consent”,
suffering grievous, painful and irreparable damage due to a mesh that can now never be removed. Sadly, she has lost nearly everything in dealing with the consequences of this terrible, avoidable injury, and she asks only that
“the burden of fear and worry be removed so that I can find some peace”.
Therefore, I ask my noble friend the Minister: are the redress schemes proposed in the review of the noble Baroness, Lady Cumberlege, under serious consideration, as my honourable friend Nadine Dorries said in the other place earlier this week? I hope so. If so, when will they be introduced? Only a robust answer will be enough to satisfy those supporting this amendment. I close by imploring my noble friend to move quickly: these victims cannot wait any longer—their pain is real, and their need is urgent. Of course, a redress scheme will not change or right every wrong that has been done to Susan, Janet, Emma and thousands like them, but perhaps it might bring them some peace.
Baroness Jolly (LD) [V]
Amendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State
“to create redress schemes for those who have already suffered avoidable harm”
related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.
I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.
Lord Hunt of Kings Heath (Lab) [V]
I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.
The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.
We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.
What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.
These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.
Baroness Jolly (LD) [V]
My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.
Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.
Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?
Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.
Baroness Penn (Con)
My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.
Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.
As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.
Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.
In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.
Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.
Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.
To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.
The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.
I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.
Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.
The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.
I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.
Baroness Jolly
Baroness Jolly
“Super-affirmative procedure
(1) For the purposes of section 1(1), section 9(1), section 14(1) and section 18(1), the “super-affirmative procedure” is as follows.(2) The Secretary of State must lay before Parliament—(a) a draft of the regulations, and(b) a document which explains the draft regulations.(3) Where a draft of the regulations is laid before Parliament under subsection (2), no statutory instrument containing the regulations is to be laid before Parliament until after the expiry of the 30-day period. (4) The Secretary of State must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within the 30-day period.(5) In preparing a draft statutory instrument containing the regulations, the Secretary of State must take account of—(a) any representations,(b) any resolution of either House of Parliament, and(c) any recommendations of a committee under subsection (4), made within the 30-day period with regard to the draft regulations.(6) If, after the 30-day period, the Secretary of State wishes to make regulations in the terms of the draft or a revised draft, he or she must lay before Parliament a statement—(a) stating whether any representations, resolutions or recommendations were made under subsection (5);(b) giving details of any representations, resolutions or recommendations so made; and(c) explaining any changes made in any revised draft of the regulations.(7) The Secretary of State may make a statutory instrument containing the regulations (whether or not revised) if, after the laying of the statement required under subsection (6), a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.(8) In this section, reference to “the 30-day period” in relation to any draft regulations is to the period of 30 days beginning with the day on which the original draft regulations were laid before Parliament.(9) For the purposes of subsection (8) no account is to be taken of any time during which Parliament is dissolved or prorogued or during which either House is adjourned for more than four days.”
Covid-19: Vaccinations
Baroness Jolly Excerpts(3 years, 3 months ago)
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Lord Bethell (Con)
The noble Lord is entirely right. The advent of the new variant, with its extremely high transmissibility, means that we all have to rethink our approach to the pandemic. We must all adopt habits that are uncomfortable and frustrating, of which mask-wearing is one good example. I know that colleagues in government are looking at ways in which restrictions should be refined. The Government do not take a view on intervening with members of the public; it is the personal responsibility of individuals to make decisions for themselves. The police certainly have very clear guidance on what interventions they should make, and it is best to leave it to them.
Baroness Jolly (LD) [V]
My Lords, the scale of this rollout is truly impressive, and I join others in congratulating all those who have actually made it work in such a short time span. I live in a very rural area on the edge of Bodmin Moor. My local satellite surgery has closed because it cannot be made Covid secure, and the vaccination site is 18 miles away with no public transport connections. Would it be possible for older people who cannot get to the vaccination site to be vaccinated by a different practice, which is only five miles away by bus but in the other direction?
Lord Bethell (Con)
The short answer is yes, and absolutely. The noble Baroness makes a point that we understand vividly and extremely well. Many smaller GP surgeries simply are not physically capable of being Covid secure, as she rightly points out. We are taking a panoptic view of health records to ensure that the right GP surgeries which are open can offer the service to those who would not normally be reached.
Medicines and Medical Devices Bill
Baroness Jolly ExcerptsTuesday 12th January 2021
(3 years, 3 months ago)
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Baroness Jolly (LD) [V]
My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.
At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.
The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.
I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.
As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?
Baroness Thornton (Lab)
My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.
I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.
One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.
Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.
Baroness Jolly (LD) [V]
As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?
It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.
Lord Bethell (Con)
My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.
The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.
I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.
Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.
The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.
The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.
The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.
I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.
This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.
The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.
We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.
I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.
We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,
“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]
The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”
As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.
I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.
The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.
We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.
Baroness Jolly (LD) [V]
My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.
Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.
The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.
One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.
We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.
Baroness Thornton (Lab)
The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.
I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.
As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.
Baroness Jolly (LD) [V]
My Lords, this has been a fascinating debate. We all want the UK to be a manufacturing centre for pharmaceuticals and valuable medical devices. The amendments in this group relate largely to the overarching objective of regulations made under the Bill.
It was argued in Committee that the Government needed to be clearer about the intent of the regulations and what the guiding principles would be. I am pleased that they have accepted this, and a number of amendments in this group provide that the appropriate authority’s overarching objective in making regulations must be safeguarding public health.
The noble Baroness, Lady Thornton, and I put down an amendment to change “public health” in the government amendment to
“the health and safety of the public”.
That was not an “angels dancing on the head of a pin” moment. Public health could have a very narrow definition in a health and social care context—we think of local government and Public Health England. However, our wording describes the issue that we are discussing. It is much broader than the “public health” definition, which is too narrow. Health and safety should be at the centre of what is used in treatment. The abuse of this was illustrated by the noble Baroness, Lady Cumberlege, who gave us perfect examples in her report. Mesh is technically a device and sodium valproate was the medicine. They were both abused, and their use was inappropriate. They hurt and damaged a lot of people, predominantly women, for a very long time—some people, for ever.
Now we have a workable framework in which to put both medicines and medical devices in the context of the health of the public, and that is extremely welcome.
Baroness Jolly (LD) [V]
My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.
The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?
Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.
In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—
Lord Crisp (CB) [V]
My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.
This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.
Baroness Jolly (LD) [V]
My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?
On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.
Baroness Wheeler (Lab)
My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.
As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.
Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.
On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?
Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.
Baroness Jolly (LD) [V]
My Lords, this has been a detailed, depressing debate and I feel completely powerless. I pay tribute to the noble Lord, Lord Hunt of Kings Heath, for his phenomenal tenacity on this and to the noble Lord, Lord Alton, for his tireless work. I am sure others do just as much and I do not know about it.
Amendment 13, led by the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover and the Minister, would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines. The amendment pushes the Government to respond to the horrifying practice of forced organ harvesting that evidence suggests is taking place in China. The account of organ banks by the noble Baroness, Lady Finlay of Llandaff, was chilling. Liberal Democrats, among others, have been vocal about the appalling human rights violations faced by the Uighurs. The amendment would be an important step in the right direction, and we urge the Government to do all they can to put an end to this practice.
It is most unusual for a Minister on a Bill to be included as a signatory to an amendment. It should send a real signal that our Government do not support this appalling treatment of minorities, and I commend him on this stance. I would be grateful if the Minister, in summing up, could tell us whether there is anything we could practically do on this matter.
Lord Collins of Highbury (Lab)
My Lords, I too thank all noble Lords who put their names to this amendment. It truly reflects the cross-party concern on this issue. I pay particular thanks to my noble friend Lord Hunt and the noble Lord, Lord Alton, who have been absolutely persistent in raising this at every level. We have debated this not only on this Bill but in other debates in this House.
I thank the noble Lord the Minister and particularly the noble Baroness, Lady Penn, for the regular meetings she has had with noble Lords to listen to our concerns. The fact that they have both listened and acted is a reflection of the good work this House can do in not acting in a partisan way. We have put the issue first and delivered on it. I am also grateful to the noble Baroness for the way she has gone to the limit of this Bill’s scope. I recognise that the Bill’s scope has placed limitations on us, but it does not stop us speaking about and delivering on the political issue that my noble friend and the noble Lord, Lord Alton, have raised. I am particularly pleased to thank everyone concerned.
I will pick up a couple of points. One of the big political issues that started my noble friend’s concern was the exhibitions we saw. The idea that consent could be given by dead or dying prisoners in China is absolutely ridiculous. We should never accept it and should continue to ensure that we strengthen regulation in that regard. It will be ongoing work.
I also pick up a point that both my noble friend Lord Hunt and the noble Lord, Lord Alton, raised in Committee; in fact, we raised it at Second Reading. We named two companies involved in supplying organ-preserving devices to mainland China. This could explain how organs are being transported around China, supporting this obnoxious practice of harvesting organs.
I was pleased to read the statement made by Dominic Raab in his announcement that the Government will conduct an urgent review of export controls, specifically as they apply to the situation in the Xinjiang Province, to, as he said,
“make sure that we are doing everything that we can to prevent the export of any goods that could directly or indirectly contribute to human rights violations in that region.”
We have heard in our debates in this House that that is potentially going on, and I hope that the Minister will be able to respond that she will work with both the FCDO and the International Trade Department to ensure that the concerns raised today will be reflected the review that Dominic Raab has promised. I hope she will take that up and, as raised by both the noble Baroness, Lady Northover and my noble friend Lord Hunt, the China tribunal’s conclusions about the nature of the practice that has been going on and the fact that the Uighurs and Falun Gong practitioners are its main victims.
As we have said in many debates, the Communist Party of China and the Government of the People’s Republic have denied all claims about this, despite the evidence of the tribunal, and have relied on the WHO clearing them of wrongdoing. Of course, we know that that is because the WHO does not have an independent expert compliance assessment mechanism: it relies on the Government of China and the Chinese Communist Party simply saying that it does not happen. I know that the noble Lord, Lord Ahmad, has been consistent and persistent in raising this issue and it has been raised with the WHO, but I hope the Minister will be able to respond today that we will continue to raise it through the organ of the WHO.
In conclusion, I repeat what has been said by all noble Lords. The importance of this amendment is not simply the specific points of law that it will address. The most important thing the amendment and this debate tonight does is send a very clear message that we will not tolerate such appalling acts against humanity and will deliver for the people of China, not for the Communist Party of China.
Baroness Jolly (LD) [V]
My Lords, this amendment, led by my noble friend Lord Clement-Jones, would narrow the use of data in relation to falsified medicines to that which ensures patient safety. The use of patient data is a really delicate issue. As currently drafted, Clause 3 allows for regulations to be made about
“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”
The Minister has said that we want to explore creative uses of information. I am not quite sure what the general public would think of that statement. I am not quite sure what I think of that statement. As my noble friend Lord Clement-Jones has said, this is an incredibly wide remit granted to the Government. Restricting it to information that ensures patient safety, as in the amendment, will help protect patients’ information. In his summing up I would like the Minister to outline how this amendment will work in practice, and we will consider whether this might be brought back at Third Reading.
Baroness Thornton (Lab)
I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.
When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.
I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.
Baroness Jolly (LD) [V]
My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.
The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.
Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.
Baroness Thornton (Lab)
The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”
“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.
So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.
Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020
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Baroness Jolly (LD) [V]
My Lords, all the measures covered in the SIs we are debating will amount to nothing if we fail to defend our borders. I will address the points made by the noble Lords, Lord Reid and Lord Winston, about international travellers.
We have a proposed test-to-release scheme that allows passengers to shorten their required isolation period to five days if they take a private Covid-19 test five days after their arrival and receive a negative result. Information provided to the Secondary Legislation Scrutiny Committee by the department stated that
“the protective effect of testing to release international arrivals after 5 days of self-isolation is only marginally less effective than 14 days of self-isolation”.
Public Health England modelling says that the effectiveness of testing after five days is 85%, after eight days 96% and after 10 days 98%—13% more effectiveness if testing is postponed to 10 days after arrival.
The proposal was examined by the committee, which was told that the new approach mirrored that taken by close partners, but no mention was made of the fact that infection rates have been much lower in those countries than in the UK. The committee was also told that our Border Force will be issuing more people with fines if they have not completed the passenger locator forms, the PLFs. However, if they have not completed the form how are they able to be contacted in order to levy the fine? By comparison, all passengers arriving in Australia, whether citizens or travellers from elsewhere, are required to isolate in a hotel, chosen by Australian immigration, for two weeks at their own expense.
We know that the virus has mutated. That is what viruses do, which makes the situation more uncomfortable. We need to be more ready and defend our borders. We cannot take risks. Will the Minister commit to reviewing the evidence and the department’s decision in these matters?
Obesity
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Lord Bethell (Con)
The noble Lord rightly alluded to the Better Health campaign, and I remind him that we did relaunch it yesterday. That went extremely well and got a lot of coverage. But there is only so much that government advertising can do; I do not think that we can advertise our way out of this problem. It is up to individuals to make their own decisions, it is up to GPs to give the support that people need and it is up to us as a society to accept that the health of the nation is important to its resilience and to its long-term health. Until those decisions are made, we struggle to make progress in this area.
Baroness Jolly (LD) [V]
My Lords, what works in rural Cornwall may not work in metropolitan Camden. Could the Minister tell the House whether there is a plan to require local integrated care systems to develop a local obesity prevention and treatment strategy for their population, strengthening existing services and sharing good practice across the national network?
Lord Bethell (Con)
Yes, I am glad to be able to reassure the noble Baroness that ICSs will be instructed to take obesity as part of one of their primary framework objectives. In fact, that is a very good example of how ICSs will make a big impact on complex issues such as obesity and how that impact will be felt in far-flung communities such as those in Cornwall.
Covid-19 Update
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Baroness Thornton (Lab)
My Lords, I thank the Minister for the debate today. A total of 34 million people will be living under tier 3 Covid rules from midnight tonight after London, parts of Essex and Hertfordshire were placed under the most severe level of restrictions. My first question for the Minister is: what have been the criteria for deciding these tiers, and will the Government commit to publishing the rationale for their decisions?
It was noticeable during the Statement yesterday that the Secretary of State spoke with firmness and confidence when he announced the new restrictions and why he was making them, and spoke about the worrying new strain of the virus. It was only when he was pressed on the effect of, and scientific story behind, the Christmas relaxation that he became less sure. One has to ask why that might be the case.
Talk of acting decisively and boldly seemed to go out of the window. In its place came fudge and obfuscation, dither and blather. Professor Chris Whitty, when commenting on the Christmas rules, said:
“This is, in a sense, a limited relaxation which will have some impact on the upward pressure on the coronavirus.”
Well, yes. The Government’s answer seems to be to fall back on the idea that this is all about “personal responsibility”—about the public taking a minimalist interpretation of the rules, not a maximalist one. The Health Secretary eventually gave a vague bit of concrete advice on Christmas, coming close to saying that we should self-isolate for a few days before meeting grandparents.
“The best thing you can do if you want to see elderly relatives at Christmas is to be extremely careful now about who you see”
was how he put it.
I therefore have to ask the Minister whether the Christmas relaxation is being reconsidered. What is the Secretary of State’s plan to keep people safe through Christmas and avoid huge pressures on the NHS in January? What is his plan to support an exhausted, underfunded and understaffed NHS through January to deliver the care that patients will need? Is he confident that our NHS will not be so overwhelmed in January that it impacts on the vaccination programme? Will the Government publish an impact assessment on their decision to allow a temporary relaxation that will allow three households to mix over the festive period?
This is a virus that, without adequate restrictions in place, spreads with ferocity. Case rates are increasing again, hospital admissions are climbing and the R is edging up. Last week, the England-wide rate was 159 per 100,000; now it is 188 per 100,000. That is a 20% increase. Across London, cases have increased by 30% and across the east of England by 36%. None of us is therefore surprised at the action that the Secretary of State took yesterday. Indeed, he was warned that tier 2 would not be enough to contain the spread of the virus in many places. It looks as though in some areas, such as Kent, tier 3 is not enough to contain the spread there.
Elsewhere in the country, tier 3 appears to be forcing the virus to flatline. Indeed, in the north-west it is trending down. However, overall, cases in the increasing areas are rising faster than those in the decreasing areas are falling. As things stand, we are heading into the Christmas easing with diminishing headroom. As my honourable friend Jon Ashworth said yesterday:
“The buffer zone that the tiers were supposed to provide is getting much thinner.”—[Official Report, Commons, 14/12/20; col. 25.]
London, like other parts of the country, will now suffer dreadfully from these further restrictions, which we support, but we think there are some serious problems. Businesses and livelihoods will suffer and there will be a cost to mental health and our NHS. The Minister has often praised Liverpool, but is not the biggest lesson to draw from Liverpool that people still struggle to isolate if they do not have the financial means to do so? The eligibility criteria for the £500 payment are still too tightly drawn: people need decent sick pay, people in some circumstances need alternative accommodation and people need help with their shopping and medicines. Surely, some of the £22 billion spent on test and trace could be reallocated to offer people adequate isolation support—as has happened elsewhere in Europe and the world?
Why is there still not a plan to make lockdown easy for people to do? Will the Government address the wide gaps that exist in economic support for the self-employed, for example? The IFS has noted that many would
“fall through the gaps completely”
and estimated that nearly two in five people with some self-employed income were excluded from the Government’s support schemes—this is not adequate.
I turn to the vaccine. Can the Minister update us on how many people have received the vaccine? Can he set out exactly when unpaid carers will be given the vaccine, given that they spend their time caring for extremely vulnerable people and could pass on the virus? I echo what my honourable friend Jon Ashworth said in the other place yesterday, when he asked whether priority could be given to those who are terminally ill to get the vaccine as soon as possible.
Can the Minister also explain what guidance is being put in place for autistic people, for example, in in-patient settings to go home for Christmas? Autism charities have warned that autistic people in residential care will have to isolate for 14 days when they come back from visiting their families—that is not fair on those who need routine and support. The Government must make their guidance autism-friendly.
The PHE report last month found that people with learning disabilities had a death rate 4.1 times higher than the general population, and this could be 6.3 times higher—what steps are being taken to protect them as infections rise? In November, the Minister in the other place said she was asking SAGE to review this report and make further recommendations; what is the outcome of that?
Baroness Jolly (LD) [V]
I support the points made by the noble Baroness, Lady Thornton, on lockdown; she and I have repeated them regularly in these debates, and yet there is no change. My points will be around vaccines, acute hospitals and their staffing, and Christmas. I thank the Minister for repeating the Statement and join him in welcoming the news about vaccines. Anyone in need of a real feelgood story should watch last night’s “Panorama” programme about the development of the Oxford team’s AstraZeneca vaccine.
How confident is the Minister of 100% vaccine coverage, for those that are entitled, by Easter 2021? This is a lot of people, and we are not certain of all vaccines being available by that time. Could he explain to the House what determines who receives the AstraZeneca vaccine and who the Pfizer—or indeed any other vaccine that may come along? Is he confident that the new vaccines will be effective against the new variant that is emerging?
Can the Minister give us a statement about acute hospitals in tier 3 areas? At the moment, it looks as though the rise in cases in the London area and the south-east is almost matched by the rise in hospital admissions—they are just a percentage point apart. Are the Government confident in London’s hospital capacity? We know that, in some areas, there are Nightingale hospitals; is the NHS intending to bring them into use if necessary? Are there the clinical and other staff to run them?
For many of us, an in-person Christmas may not be possible. We need to look at the impacts that Thanksgiving had on the US Covid-19 figures and assess our risk. Many of my contemporaries have decided not to travel to celebrate with friends and family, and our children have told us that this is what we are going to do as well, so it looks as if many will be resorting to whatever is their favourite conferencing software to catch up with family.
Finally, will the Minister outline the Government’s communication strategy for Christmas? Clear messaging is imperative but many of the public who have been interviewed are unclear. Will ads be used in newspapers, broadcasts and online social media? Christmas is 10 days away, and people would appreciate a clear steer from the Government. This needs urgent and professional communications attention.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con) [V]
My Lords, I am extremely grateful for the clear and thoughtful questioning from the noble Baronesses, Lady Thornton and Lady Jolly. Both of them are right: we are seeing a sharp rise in south Wales, London and parts of the east and south-east of England, which is making us rethink some of our approach to Christmas. We have seen a sharp rise in the virus across London, Kent, parts of Essex and Hertfordshire, and reports of a new variant. We saw the evidence of this starting in the 15 to 19 year-old age group and we have taken swift and decisive action but, unfortunately, more may be necessary. We know that this rise will be mirrored in hospital admissions, and it takes only a few doubling times to put pressure on the NHS. The noble Baroness, Lady Jolly, is absolutely right to question whether we have the resources in place to see such doubling take place over time. This is a trend we are seeing all over Europe, in countries such as Sweden, where nearly all the intensive care in Stockholm is currently in use, and even in Germany, where tougher new restrictions were announced over the weekend.
It is entirely natural that we look very closely at the Christmas relaxation, but I am not in a position to share any update on that this evening. The noble Baroness, Lady Thornton, asked: what is the Secretary of State’s plan to keep us safe? We have plans, and I will be glad to share them with noble Lords. However, may I just say a word about personal responsibility? The noble Baroness, Lady Thornton, put it well: it is up to each and every one of us to decide whether we will take a minimalist or maximalist interpretation of the rules. At the end of the day, it is a personal decision on what kind of risk approach one will take to Christmas. The SAGE advice has been published and it is clear. It does not make very comfortable reading for those of us with elderly relations who have been looking forward to seeing us, but it clearly states that we should be looking to spend time at Christmas with as few people as possible for as short a time as possible and, wherever possible, outside instead of inside. I am afraid to say that that will be what a responsible Christmas looks like for everyone. It is not something that the Secretary of State can ordain; it is, unfortunately, what the spread of the virus requires.
I acknowledge—the noble Baroness, Lady Thornton alluded to this—that the tier 3 regimes, particularly in the north of England, have had a profound impact. The behaviours of people in the tier 3 areas have been considerably amended, and that has seen a sharp reduction in the infection rates in those areas. It demonstrates that restraint works, and I take a moment to applaud all those who have played a role in that achievement.
On the vaccine, I will be very happy to provide an update on the special cases that the noble Baronesses alluded to. Both the case for unpaid carers and the case for the terminally ill are powerful, and we are listening carefully to them as they are made. However, the JCVI has put in its priority decision and that is what we are working to at the moment. Any further complications or refinements to that create profound operational challenges, but we are listening very sensitively to the case being made for the special cases.
I share the tribute of the noble Baroness, Lady Jolly, to the AstraZeneca team. The “Panorama” programme last night was a tonic for the soul during these difficult times, and I would recommend it to everyone.
As to the new variant to which the noble Baroness, Lady Jolly, alluded, the preliminary scientific judgment is that it does not at the moment show any evidence that it will escape either the vaccine or any other therapeutics that are targeted at Covid. That is always the natural concern in these circumstances; we are studying it very carefully indeed and will, of course, update the House if any changes do emerge. However, the new variant, which has been correlated with higher levels of transmissibility in Kent, does remind us that the threat of Covid is undiminished and we must remain committed to the restrictions in place to contain this horrible virus.
Care Quality Commission Report
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The Lord Speaker (Lord Fowler)
Can we speed up a little, please? I call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, the noble Baroness, Lady Wheeler, is right to flag that this is not the first time that we have heard this catalogue of appalling treatment. The shame is that in some places local authorities and the NHS use a one-size-fits-all approach to commissioning services. We have to put the individual in care at the centre and treat them and their needs. When did a Minister last issue commissioning guidance to local authorities and the NHS in this matter, as the partners that have to commission the process? What family involvement is recommended in those conversations?
Lord Bethell (Con) [V]
I cannot go into details of commissioning guidance in this short Question, but I reassure the noble Baroness that, when it comes to family involvement, new guidance has been issued in response to the Joint Committee on Human Rights, which puts family involvement in any seclusion or restraint decision. That is an immediate development since the report in October.
Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020
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Baroness Jolly (LD) [V]
My Lords, I welcome the Government’s move to introduce this legislation, which simplifies and standardises the regulation of private sector testing for Covid-19. The Minister’s introduction was most helpful and I hope that he manages to avoid the virus. For the asymptomatic who require a test and can afford it, making tests accessible and of a high standard is extremely important.
We have two pieces of legislation before us today. I turn first to the health protection regulations. This instrument is to ensure that all private providers offering Covid-19 testing services on a commercial basis in England provide services that are of a sufficiently high standard. It is designed to simplify the complex regulatory environment for Covid-19 testing. Under the proposal, the United Kingdom Accreditation Service would provide a national accreditation service on the wider aspects of testing, including the processing, analysing and reporting of tests. The SI imposes an obligation on providers to make an application to a three-stage scheme to ensure consistency of standards; to offer assurance to the public about the quality of private tests through UKAS; and to ensure that the testing organisation would get accreditation from UKAS.
The second SI removes all coronavirus testing from the CQC regulatory environment, as I outlined above. But let us be clear: when anyone has Covid-19 symptoms, or has been asked to take a test by the local council, there are no problems. They can go the testing station or apply for the testing kit and there will be no cost. The free testing service is not for proof of freedom from Covid for travel or other purposes, such as being sure that you are safe to mix with friends and family at Christmas.
These tests have to be purchased privately and I wonder what their margin is. According to Which? last week, the going rate for a private test from a high street pharmacy is about £120. If a negative test is a prerequisite for a flight or something you feel you should do to make a family Christmas safe, the private sector is your only option, but for many, of course, that is not financially possible and so risks may be taken. Certainly, when our children were small, there was no way we could have afforded the equivalent of nearly £500; likewise if you had hoped to get away over the Christmas holidays for some sun. I note that the CMO has said that he is anticipating a surge in cases after Christmas. Testing might be nice to have, but masks will be essential.
It looks as though one of the beneficiaries of these SIs could be pharmacies. I have two points that I would like clarification on from the Minister. First, the Health Secretary has noted that 25% of individuals taking NHS tests were not eligible. This legislation seeks to enable private testing to complement government testing and reduce pressure on test and trace. Could the Minister please provide more detail on this? Specifically, how does increasing the accessibility of private sector testing allow the Government to shift to a wider testing strategy and, crucially, the testing of asymptomatic individuals?
Secondly, someone who cannot afford a private test from a high street pharmacy and cannot access NHS testing will be left in isolation, often without appropriate financial support. In general, we will always be limited by capacity to some extent, but it is vital that we move away from the current model of testing only those with symptoms. Mass testing in Liverpool showed that testing those without symptoms can help us to interrupt the flow of transmission. I would like reassurance from the Minister that encouraging private sector testing will not create or exacerbate inequalities.
A well-off asymptomatic individual may be able to end a period of isolation and return to work or travel by paying for a private test. As with all areas involving communication with the public, we have to be aware that an Anglo-Saxon approach is probably not ideal. This is a contributing factor to the low isolation compliance—a huge challenge in controlling the virus. What is the wider strategy to ensure that the NHS and Lighthouse Labs work in harmony so that those who most need tests can access them free of charge?
Of course, I appreciate that working with the private sector is vital in this pandemic and making the pathway to test provision simpler may increase competition and reduce prices. This would: allow providers to enter the market more quickly and at lower cost; provide more comprehensive oversight of the entire market; and ensure quality of testing standards. In addition,
“novel, non-clinical testing technologies and methods”
would not need to be individually exempted from regulation.
I will finish where I started: for those who are asymptomatic who require a test and can afford it, making tests accessible and of a high standard is extremely important. However, we must be wary of exacerbating inequalities through access to testing. How do the Government intend to prevent this? I look forward to the Minister’s comments.