(2 years, 10 months ago)
Lords ChamberMy Lords, I will speak particularly to Amendments 54, 74 and 97 in this group. I warmly thank the noble Lords, Lord Patel and Lord Hunt, for lending their support to all three amendments, and the noble Lord, Lord Warner, for supporting Amendment 74. I pay particular tribute to the noble Lord, Lord Patel, and his historic work prior to the setting up of NICE; it was a great contribution that deserves to be recognised.
We are all aware of the procedure that, when a medicine is approved, it goes through two processes. First, it goes to the Medicines and Healthcare products Regulatory Agency, known as the MHRA, a body which checks whether a drug is safe and effectively does what it says on the tin. It then goes through a separate process run by the National Institute for Health and Care Excellence, known as NICE, which looks at cost-effectiveness and value for money. After those two hurdles have been passed, the medicines should, theoretically, be accessible to anyone. That is very clear in the NHS constitution, which explains that there is a legal right for people to have access to NHS NICE-approved drugs if it is right in their particular circumstances that they should. Indeed, the NICE guidelines say very clearly that there should be automatic adoption within 90 days of approval, if clinically appropriate and relevant.
For a drug then to be prescribed, it must not only have been approved by NICE but go on to the approved list of drugs in the local health authorities, called a formulary. The problem is that somebody must put the drug on the formulary and, currently, while in theory there is a system under the NHS NICE guidelines, this does not actually happen. Sadly, this results in a postcode lottery where some areas have the product on their formulary and others do not. Sometimes this is a process failure, but sometimes it is to avoid budget overspends. Therefore, I would say that it is at the patient’s expense that they are deprived of the drug.
To give an example of the problem, there is currently a drug for multiple sclerosis that patients are still waiting after 150 days to see go on to the formularies in around 25% of the local health systems across the country. There is a state-of-the-art flash monitor for type 1 diabetes, but the uptake across the country varies between 16% and 65%. What is most worrying is that those parts of the country with the greatest levels of deprivation have the lowest level of uptake.
I make a plea to the Minister: in my view, ICBs should be required to ensure that all NICE-approved medicines and devices are available and promoted to their population, because the cost of these drugs is covered by the VPAS reimbursement scheme agreed between the NHS and the pharmaceutical industry. If a treatment is unavailable in one ICB footprint, they should be required to commission the required treatment from another ICB. The Government should also promote uptake through the ICBs of NICE-approved medicines and report uptake of new medicines annually.
Amendment 54 would require an ICB to arrange for provision of a NICE-approved treatment to any patient whose NHS clinician has recommended it, even if that treatment is not otherwise available to patients in that ICB area. Amendment 74 would require ICBs to ensure that all NICE approvals are available and promoted to their population via a publicly accessible format, normally online, and to report on their uptake annually. Amendment 97 would mandate integrated care boards and healthcare providers, notably hospital trusts, to update their formularies to include all NICE-approved medicines or devices within 28 days of market authorisation, to ensure they are available for healthcare practitioners, through either their physician, for example, or prescribing pharmacist, to make available for suitable patients.
I thank those who submitted briefings to me while I was preparing for today, notably JDRF, which makes a number of recommendations on this issue, particularly in regard to type 1 diabetes. These aim to reduce inequalities, remove the postcode lotteries to which I referred and make sure that treatments, such as those for type 1 diabetes, are uniformly available across the piece. I also thank EMIG, a pharmaceutical trade association for small and medium-sized companies, for its briefing. It says that the uptake of NICE-approved medicines is critical for NHS patients to benefit from the latest and most promising innovations. Finally, I am grateful to Vertex Pharmaceuticals, which submitted a briefing that again supports the conclusions reached. Among the proposals it highlights is the introduction of a modifier to take account of the severity of a disease and efforts to more fairly consider uncertainty in the evidence for highly innovative and complex treatments for rare and severe diseases, including through greater use of real-world evidence.
On this small group of amendments, I look forward to hearing what the noble Baroness, Lady Finlay, has to say in connection with her neat, simple amendment, which would strengthen what we are proposing to do here. I urge the Minister and the department to address these postcode lotteries and make sure that NICE does not just make the guidelines but ensures that treatments reach the formularies and ultimately the patient in question. I beg to move.
My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak now.
(3 years, 4 months ago)
Lords ChamberI have received one request to speak after the Minister, from the noble Lord, Lord Randall of Uxbridge. Lord Randall? Uxbridge is offline. I call the mover of the amendment, Baroness McIntosh of Pickering.
I thank all noble Lords who have contributed to the debate, especially those who spoke in support of Amendment 188.
I pay tribute to my noble friend the Minister. It must be pleasing for him to see his work on the quality of life come to life. I commend a slightly shorter report that we did on bricks and water, which goes to the point of building regulations and minimum standards. I am pleased that he is committed not only to labelling but to the work being done with the Ministry of Housing, Communities and Local Government on minimum standards. As the noble Baroness, Lady Parminter, said, that is extremely important. I share the concern of the noble Baroness, Lady Jones of Whitchurch, that Clause 83 allows a potential weakening of the EU water framework directive. I hope this will not be the case and that, if anything, we might impose higher standards, which we would wish to meet.
(3 years, 4 months ago)
Grand CommitteeI will move Amendment 7 briefly. I have listened carefully to what my noble friend has said in response to other debates and I accept his request for flexibility, rather than having something set out prescriptively in statute. But I cannot think of another committee or Bill that has been set up without us having any indication, at all, of how long the periods of appointment will be and whether they will be renewable. Is he asking the committee to give the chairman complete carte blanche to make these appointments? I accept that he wishes to consult the chairman on them, and accept his confirmation that public appointments procedure will be followed. It would be surprising if he said anything different to that.
Clause 1(2) states that
“The members of the Committee are to be appointed by the Secretary of State”,
and no more than that. Can the Minister give an indication of the period of appointment and the reason why there is no consistency? Why is Clause 1 completely silent on whether it will be for three or five years, and whether it will be renewable?
Secondly, we should in mind that my noble friend Lord Caithness established earlier that there is no longer a rural affairs commission or committee. I do not think that was set up by statute, but was a creature appointed internally by the department. Perhaps my noble friend would be good enough to confirm that. But what is his estimate for the life of the animal sentience committee? Does he envisage that it will last for three or five years? If it is being set up by statute, will it then need to be disbanded by statute, if that is the wish of the Government? It might be a future Government down the line; it may not be this Government or the Minister in situ. What is his view of the life of the committee? Having been created by primary legislation, would we need another Bill to disband it in future?
The noble Lord, Lord Hamilton of Epsom, has withdrawn from this group, so I call the noble Lord, Lord Howard of Rising.
Just to be clear, it is not within my powers to strike anything from Hansard. I call the noble Baroness, Lady McIntosh of Pickering.
I am grateful to all who have spoken in this debate, particularly those who have expressed their support: my noble friends Lord Moylan and Lord Howard of Rising. My noble friend Lord Moylan is very brave to take on the noble Baroness, Lady Jones of Moulsecoomb—I call her my noble friend—and I am sure that we can all get together and make up afterwards.
I listened very carefully to what the noble Baroness, Lady Hayman, said about there being no appetite on her Benches to support the deletion of the existing Clause 1. My noble friend Lord Forsyth pre-empted what I was going to say. It is customary to invite my noble friend the Minister to come forward with government amendments at this stage—I say so because I fear that the overwhelming mood of the Committee this afternoon is that we stand prepared to do our work of scrutiny extremely carefully, and I do not think that we take kindly to the fact that this will be delegated to a body the complexion, remit and resources of which we are as yet unaware. I urge my noble friend to meet us and come forward with appropriate amendments before we reach the next stage—but I withdraw my opposition to Clause 1 at this stage.
(3 years, 9 months ago)
Grand CommitteeMy Lords, I find myself in some sympathy with the noble Baroness, Lady Bowles, on Amendment 5 because this is a grey area where small businesses are perhaps not well served. My noble friend Lord Howe claimed, in his full and comprehensive response to the last debate, that this was not the right time or place to look at the regulatory objectives, as this would better take place under the Government’s future regulatory framework review. I would argue, in support of the noble Baroness, Lady Bowles, that small businesses are not well served by the current provisions. If you look at some of the work of the Financial Ombudsman Service, which the Committee has referred to, I would not hold out much hope for a small business claiming redress and a decision under that agreement. I would be delighted if my noble friend were to prove me wrong in summing up this debate.
Amendment 5, in particular, has strengths to commend it and I would very much like to lend it my support. I look forward very much indeed to hearing what my noble friend will say and whether the Government might look favourably on it, a lacuna having been identified in the regulatory framework.
I call the next speaker, the noble Baroness, Lady Bennett of Manor Castle. Baroness Bennett? We appear to have lost the noble Baroness, so if—
(4 years ago)
Lords ChamberThe noble Lord, Lord German, is not taking part in this group, so I call the next speaker, the noble Baroness, Lady McIntosh of Pickering.
I will speak briefly to several amendments in this group. Regarding Amendment 70, again I raise the question of substantial change, and whether that means a “significant amendment”. I am seeking clarification on the part of the Bill to which this refers.
Amendment 81 would delete “of no effect”, as would Amendment 84. Can the Minister say what that means when replying? It is very unclear. I am again grateful to the Law Society of Scotland for its help in putting forward and drafting these amendments.
In Amendment 92, what is meant by “less attractive”? In my view, to put a service provider at a disadvantage is a serious matter in a Bill such as this. Using a phrase such as “less attractive” as part of the assessment of disadvantage is subjective and lacks clarity. I would be very grateful if, when summing up, the Minister could just clarify what his understanding of “less attractive” is.
I turn to my Amendments 103 and 103A. Amendment 103, which would take out “mainly” and insert “substantially”, is a probing amendment to understand the meaning of “mainly” in connection with the gathering of experience—for example, in relation to Clause 23(7). In my view, Clause (23)(7)(b) requires further definition. How should “mainly” be measured? Will it be by the time spent as a proportion of the whole qualifying experience or by some other measure? How will this experience be recorded and verified?
The same questions arise in regard to that aspect of the experience obtained elsewhere than in the UK. The purpose of my Amendment 103A is to ask whether we are excluding all other experience than that obtained in the UK. I pray in aid my own experience, where I practised law in Brussels in two different situations. Would that experience, and the experience of others as well, qualify for the purposes of the Bill? I am grateful for the opportunity to move these probing amendments and I look forward to the Minister’s clarification of these points.
My Lords, I want to speak to this group of amendments for two simple reasons. First, services are incredibly important to the UK and to all four nations within it. As I said on Amendment 4, they are vital to the success of our economy, making up more than 80% of GDP. They range from financial services, mentioned by the noble Baroness, Lady Hayter, which I believe now provide more jobs outside London than in the City, to arts and entertainment of every kind. Invisibles, including legal and accountancy services where we have world-leading expertise, represent more export value than goods.
Secondly, I am mystified by the clauses on services, which are the subject of these amendments. The arrangements seem to work well currently. No doubt some protection is provided by the carryover of EU rules under the withdrawal Acts, which are relatively light touch because attempts to align local rules within the EU on services were also light touch.
We are forcing on to the service industries apparently new rules and new exemptions linked to the principles of mutual recognition and non-discrimination. There could potentially be a whole load of bureaucracy and regulation associated with this activity, which business, the service sector and regulators will need to understand. Lobbyists may try to secure new rules that benefit narrow interests, as they do in Brussels now. Moreover, as someone who takes a morbid and forensic interest in these things, I find the impact assessment—welcome though it is in principle—extremely disappointing. These are usually very helpful to Committee discussions, but the assessment asserts on page 2 that
“the cost savings to businesses, consumers and the wider UK economy would be expected to significantly offset any costs imposed by this legislation, translating into a net benefit to the UK economy.”
The small and micro business assessment on page 37, a section to which I always pay the greatest attention as small business is the lifeblood of this country and key to its dynamism, says:
“Due to a lack of historical need, there is a shortage of data on businesses trading between different parts of the UK. It has therefore not been possible to identify the volume of such businesses who operate across borders, nor the extent to which they benefit because of the hypothetical nature of the future regulatory regimes.”
So we have no evidence to justify the new powers, nor an assessment of their consequences. We almost seem to be creating borders for services where none existed before, which is surely the opposite of what we want.
We need to understand better how this part of the Bill will work, but the material presented so far has stumped me, as a business operator who has worked in various industries across the UK and the world. In that connection, let me ask a simple question on marketing activity, which is not listed in the schedules: would I be permitted to discriminate in favour of a company that was Welsh to help with the marketing of Welsh products or would I have to take time to listen to pitches from English-owned—or, indeed, US or Canadian-owned—companies?
In response to a number of understandable probing amendments in this group, can my noble friend the Minister kindly justify the provisions simply, with some good worked examples relating to significant service sectors, and assuage my fears? I must say, at this point in time, I am confused and therefore concerned.
(4 years, 1 month ago)
Lords ChamberThe following Members in the Chamber have indicated that they wish to speak: the noble Baroness, Lady McIntosh of Pickering, the noble Earl, Lord Caithness, and the noble Lords, Lord Carrington and Lord Krebs. I will call them in that order. I call the noble Baroness, Lady McIntosh of Pickering.
I wish to speak briefly on Amendments 1, 11A, 17 and 17B. I have a question for the Minister on Amendment 1, to which the Commons has disagreed. In Committee and on Report, I stressed that it is extremely helpful to have some guidance on what the environmental objectives are going to be, particularly as I understand we only heard very late in the day what the interim arrangements will be from January 2021. This gives farmers quite short notice as to what the new objectives are going to be for claiming
“financial assistance during the plan period.”
Therefore, if my noble friend is not minded to support the amendment to which the Commons has disagreed, it would be very helpful if he would set out what benchmarks farmers are being asked to observe in the new payments scheme, which will be until such time as the new ELM scheme comes into effect.
I still have the difficulties that I rehearsed at earlier stages about Amendment 11B, and I hope my noble friend will clarify matters in summing up. My understanding is that all new and existing pesticides are very heavily regulated, but this amendment does not have regard to the fact that railways and many other transport systems rely heavily on the use of pesticides, which do not come close to being dangerous to human or public health. If adopted, this amendment would prevent them being used as they are. My noble friend referred to this in summing up the debate on the original amendment to insert after Clause 34 the new clause on pesticides. It would be very helpful to understand that.
The problem I have with Amendment 17B—I know that the noble Baroness, Lady Jones, has gone to great lengths with it—is the underlying assumption, also inherent to her introductory remarks, that it is farmers who are causing the problem. I would like to have much more regard held for, and tribute paid to, farmers because they are part of the solution, not part of the problem, as I think Amendment 17B indicates.
I emphasise the role that farmers and landowners can play, in a very big way, in sinking carbon under the new financial assistance schemes by rolling out projects such as the Pickering Slowing the Flow scheme. That will, I hope, have private funding from water companies as well as farmers, landowners, the Environment Agency, Defra and other bodies. I am quite excited about these new possibilities and a little conscious that this amendment seems to blame farmers rather than recognising the positive role that they play.
The following Members in the Chamber have indicated that they wish to speak: the noble Baroness, Lady McIntosh of Pickering and the noble Earl, Lord Caithness.
My Lords, I congratulate the noble Lord, Lord Krebs, on bringing forward a shorter amendment—I am always in favour of shorter amendments, as they leave less scope for interpretation. The noble Lord calls for a national food strategy within 18 months. I would like to see a response to the Dimbleby report before then and want to take this opportunity to urge my noble friend to produce such a response, even if it is informal.
Part 1 of the Dimbleby report has been extremely helpful in preparing for this Bill and the Trade Bill. It would be incumbent on the Government, even if it were just two departments—the Minister’s department of Defra and the Department for International Trade—to respond to the Dimbleby report in so far as it relates to obesity and the food strategy that Henry Dimbleby and his team, including the noble Baroness, Lady Boycott, who has played a sterling role in this regard, have set out. It would be important to hear from those two departments before this Bill and the Trade Bill left this place. I wonder whether there is any opportunity for my noble friend, even by way of a letter, to respond to the helpful conclusions of Henry Dimbleby.
I am slightly confused, because the reason that the Commons gave for disagreeing with the original Lords Amendment 9 is that
“it is inappropriate to impose a duty to publish a National Food Strategy.”
I thought that, in about 2010, the incoming coalition Government published something along the lines of a national food strategy—I forget what it was called—that was extremely well received and helpful. Is it not timely to have another stab at this within 10 years of the original?
I finish with a plea: that we do not wait 18 months from the day of passing this Bill before the national food strategy is presented. I commend the work of my noble friend’s department, Defra, in this regard; I commend the work of Henry Dimbleby. We owe it to Dimbleby and his team to come out with an interim acknowledgement of and response to his proposals.
Before I call the noble Baroness, Lady McIntosh of Pickering, I remind noble Lords that, if they wish to intervene, they should follow the usual channels and let the clerk know.
My Lords, I think I was in touch with one of the clerks, but I do not know whether I was in touch with the right clerk. It may help my noble friend if I indicate—I know he follows these matters very closely—that I have two amendments specifically on this point. I am proposing a new international trade commission, following on from the work of our government adviser Henry Dimbleby and the fact that a shadow trade commission is already meeting. So it will be extremely important that we have clarification on what budget has been allocated to the existing trade and agriculture commission before we reach the time when Amendments 54 and 55 will be discussed.
(4 years, 2 months ago)
Lords ChamberI call the next speaker, the noble Baroness, Lady Bennett of Manor Castle. The noble Baroness is not here, so I call the next speaker, the noble Baroness, Lady McIntosh of Pickering.
My Lords, I am most grateful to the noble Lord, Lord Wigley, and my noble friend the Duke of Montrose, for introducing their respective amendments. These two amendments refer back to comments that I made earlier about the status of the common framework agreements. It is very clear at this time that this is a fuzzy area and it is not quite clear what the status of the common framework agreements is—and yet, in the very specific circumstances that both noble Lords speaking to Amendments 68 and 68A referred to, time is pressing on and we need to know how the different Administrations across the United Kingdom will administer this part of the Bill.
My question to the Minister is: what is the status of the common frameworks at this time? I understand that they have been reduced to 21, but obviously the process is ongoing. It would be helpful to know whether this level of detail has been reached in the current negotiations and how circumstances referred to in Amendments 68 and 68A can be avoided if at all possible.
(4 years, 2 months ago)
Grand CommitteeI welcome this opportunity and congratulate my noble friend the Minister on introducing the changes today. As these are technical changes, I hope I am permitted to ask some general questions about how the INSPIRE regulations have been working to date and what changes might flow from the end of the transition period. My question is not dissimilar to that of my noble friend Lord Naseby. Does the Minister know the costs for district councils, county authorities and unitary authorities, for example, to provide this information? It may seem an odd question, but who looks at this data? It seems an extraordinary amount of data is being collected and for anyone interested in the environment, as I am, it is immensely interesting, but do we know how widespread its use is? Is it mostly used by other public bodies, universities and official bodies such as the Commission itself? What is the purpose of collating all this data?
I notice that it says that charging arrangements are in place. Does my noble friend know roughly the average charge for accessing this data? If there is no right to appeal, how does my noble friend know that the charge that is being levied is fair? I would be particularly interested to know whether the charge relates, for example, to the mapping that is being done for flooding. I congratulate successive Governments and the Minister’s department for the mapping that has been done. Ideally, if one looks at the mapping that is available to a district council, this is much more detailed and it would be of enormous benefit to the householder to know to whether and to what extent, particularly in terms of surface water flooding, which is a relatively recent phenomenon—we have only really recognised it since 2007—they are likely to be specifically at risk of such flooding. The reason I ask this is that I understand that district councils are reluctant—this may have changed—to provide this level of detail, because it could have adverse implications for the householder’s insurance. Presumably the whole point of accessing this information is that the Environment Agency is giving more global mapping, but it would be extremely interesting to get hold of what the district and county councils are setting out. It would be helpful to know that.
How will any complaint be made about the way in which the data is accessed or how the cost of accessing such data is levied? It would also be helpful to know that. Also, is the Minister confident that public bodies have the resources, particularly looking at the fact that resources available to councils—to local authorities—is extremely tight? We have seen this in things such as environmental health and trading standards being potentially compromised. Is the Minister confident going forward that these public bodies have the resources available to fulfil their obligations under the regulations?
Finally—I am sorry not to use up all my time but my noble friend might well be relieved about that—can my noble friend confirm that this information is also provided to the European authorities, such as the European Commission, the European Environment Agency and others? Will that continue to be the case? Obviously, in terms of the European environmental directives such as the water framework directive and the waste water directive, this type of information is extremely useful for seeing whether patterns are emerging, particularly in terms of climate change.
Sorry, I did say “finally” but it was very inadvertent. Does my noble friend have plans to look, for example, at data that is currently being collected by water companies through their normal daily work? That could show at a very early stage that Covid may be present in a particular community—perhaps not narrowing it down to a household but to a community. Do the Government have access to that information, which will be extremely important in preventing and controlling community outbreaks?
I am grateful to my noble friend for bringing these regulations before us in the form of a statutory instrument.
I understand that the sound issues have now been sorted out, so I again call the noble Lord, Lord Bhatia.