argyrotsipi/train-dataset huggingface dataset:
Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
Julia Frances Cumberlege (Conservative, Centre-right): My Lords, I will speak to government Amendments 11 and 47, and those that follow on from them, Amendments 12 and 48 from the noble Baroness, Lady Thornton. The first lot refer to medicines and the second to devices. But first I thank the Minister for his strong emphasis on safety in all the amendments. He certainly has listened to noble Lords. In Committee we stressed the objective of making sure that the Bill is a safety Bill. I believe that safety now permeates throughout the Bill, which is so encouraging, and I thank him and his colleagues for that Although I welcome the government amendments, I really do not envy a Secretary of State’s task in weighing up the risks versus the benefits. This will require the wisdom of Solomon. At least once the Bill is enacted we will have the data, which is all-important and has just been referred to. Our review’s report shone the light on our frustration of not knowing what was happening to whom, by whom, when and where. This will, of course, become apparent, which will be very useful once we have these processes in place But we are still left with weighing up the benefits versus the risks. Surely this depends on where the threshold is set concerning any medicine or medical device. For instance, if 99 people benefit from one of these products but one dies, what weight do we give to the 99—or, perhaps more importantly, to the one who died? Does the Minister see thresholds as important? If so, does he envisage the application of a threshold for an individual medicine or device, or would there be a threshold to cover a similar range of products, or indeed a more overriding policy? I am not quite sure how this will be tackled.
Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
James Bethell (Conservative, Centre-right): My Lords, I completely concur with the noble Baroness, Lady Jolly. This has been a fascinating debate but I will restrict my comments to a few specifics in answering some of the questions raised by noble Lords. I shall start by talking briefly about risks and benefits, which I hope will provide further reassurances to noble Lords regarding their questions on these points A regulatory change that, for example, makes changes similar to those made to ensure the smooth vaccination programme for Covid-19, will require different assessment to those that change the medical devices regulatory regime to step up scrutiny of medical devices. The noble Lords, Lord Patel and Lord Kakkar, spent some time in Committee speaking to the importance of medical device regulation, and I agree with them. The amendments that I have tabled are silent on whether the impact on safety must be negative or positive to have the "lock" kick in. It applies to both However, it will come down to what the change is in order to determine what constitutes a risk in that scenario versus a benefit. That is obvious in the case of the Covid vaccine rollout. There is greater benefit to a smooth rollout of the vaccine programme than the risk of increasing the number of healthcare professionals who can deliver it. Risks can be mitigated, and they should be. Changes can also be highly technical. They may affect the safety of medicines or medical devices in a minor way but not to the same degree or extent as other changes. It would be impracticable to develop criteria that apply in all circumstances to all regulatory changes In response to my noble friend Lord O’Shaughnessy, I should reassure him that it is not our intention to in any way water down or reduce standards in the life sciences area. Instead, it is our intention to use this legislation to champion the UK’s wonderful life sciences sector We have often spoken of safety—I thank the noble Baroness, Lady Thornton, for her words on that matter—and of the vital importance of the regulator putting this at the heart of its work. Our regulator is stuffed full of scientists and experts. They are able to support the Secretary of State in making that assessment, based on the evidence. Would this change impact the highly regulated safety considerations, and are they the right ones to make? We need to empower those experts to make those recommendations, in specific circumstances. I hope that noble Lords agree with me that the Bill is better for the changes that we have already sought to make, that the questions behind these further changes are answered, and that we have reached a point of conclusion.
Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
Joanna Penn (Conservative, Centre-right): On the first point—considering environmental impacts in terms of research—obviously safety is one of the things primarily considered when looking at research on medicines. There is then separate provision in legislation for the safe disposal of any medicines that are not used. So we look at the safety of their use in humans and, through separate legislation, address the safe disposal of any medicines via that route That is also relevant to the second point on how human medicines can enter the ecosystem. I will write to the noble Baroness with further detail on that, but veterinary medicines are in a slightly different position, since we look at veterinary medicines for their impacts on animals but also have to think about their wider impact on the environment in terms of their position in the food chain. The safety standards on human medicines are much higher, because we look at their impact on patients taking them directly.
Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
Joanna Penn (Conservative, Centre-right): My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.
Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
Bernard Francisco Ribeiro (Conservative, Centre-right): My Lords, like the noble Lords who have spoken before me, I thank the Minister and the Government for accepting our amendment. I believe it sends a powerful message, not only to China but to other countries such as Pakistan and India, to which I referred in my speech of 28 October in Committee. In discussion with the Foreign Office, through the noble Lord, Lord Ahmad, we were reassured that the diplomatic strategy would be to continue lobbying as many countries as possible on the issue of human rights and the immoral practice of forced organ harvesting. With the noble Baroness, Lady Finlay, we undertook to raise awareness with the British Medical Association and the surgical royal colleges It is worth noting the World Health Organization’s Guiding Principles on Human Cell, Tissue and Organ Transplantation. Any programme such as the kidney pairing exchange, which makes it possible to utilise kidneys that are biologically incompatible between patients and their genetically or emotionally related donors, must follow and respect the WHO’s Guiding Principles of practice, particularly principles 3 and 5, which are worth quoting Principle 3 says: "Live donations are acceptable when the donor’s informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized, and when selection criteria for donors are scrupulously applied and monitored. Live donors should be informed of the probable risks, benefits and consequences of donation in a complete and understandable fashion; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion." Principle 5 states: "Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned." In 2017, the World Health Assembly supported a concept of financial neutrality to protect vulnerable people from being exploited. That is the essence of what this amendment achieves, and I am grateful to the Government and to the noble Lord, Lord Bethell, and the noble Baroness, Lady Penn, for endorsing it. I hope that they will maintain their pressure on the WHO to end these practices.
Afghanistan — House of Lords, 2021-04-21
Topic: Defense
Annabel Goldie (Conservative, Centre-right): I thank the noble Lord for his tribute to our Armed Forces and particularly for his acknowledgement of those who have paid the ultimate sacrifice. I entirely endorse his welcome and kind remarks. In response to his question, the United Kingdom has regular conversations with US counterparts on a range of issues, and we consult closely. As the noble Lord is aware, this is a NATO mission in Afghanistan and we were always clear that we would proceed in concert with our NATO allies and partners, which we have done. Regarding the noble Lord’s apprehensions, our support of the NATO mission has brought Afghanistan to a much better place than it was in 2001.
Health Protection (Coronavirus, Restrictions) (Leicester) Regulations 2020 — House of Lords, 2020-07-29
Topic: Health
Roger John Liddle (Labour, Centre-left): My Lords, once again we are debating a measure long after the horse has bolted. We need a radical change in our procedures so that we do not face this situation of Executive diktat in the future I want to ask the Minister if we can have a mature reflection on the lessons learned in the Leicester lockdown. It is clear that we are making progress in terms of better information sharing between the national and local systems. This is very much to be welcomed. But there is still a fundamental confusion of responsibility. Who is taking the decisions? Is it the responsible local people or is it Ministers? The regulations divide responsibility between the two. Can we not get to a situation where Ministers trust local decision-makers and give them the power and resources to organise effective local action Finally, the noble Lord, Lord Robathan, made an excellent point about what is happening to tackle the problems of sweatshops and the social circumstances which propagate the disease. Is stronger action being taken by the inspectorates, and will the Minister let us know what that is?
Health Protection (Coronavirus, Restrictions) (Leicester) Regulations 2020 — House of Lords, 2020-07-29
Topic: Health
David George Clark (Labour, Centre-left): My Lords, we have all watched the progress in Leicester with the lockdown and I very much agreed with the noble Lord, Lord Liddle, when he emphasised the point about learning lessons. I feel that we probably have, because I perceive an evolution of approach. We have seen a different approach in Bradford, and in Oldham, again, there is more finessing—and I learned only today that the next borough in the north-west likely to suffer these problems is Stockport This raises an issue, because these are local authorities in their own right. But what will the Government do with problems that run across local authority boundaries? I have bored the House ad nauseam by talking about the Lake District National Park, where 40,000 of us residents welcome 19 million visitors a year, which puts immense strain on our already poor local health service. But the three authorities covered by the Morecambe Bay health authority have among the highest rates of infection across the UK. If we have a gross influx of visitors from the affected areas, which now seem to be around Manchester, will the Government, if there is a spike, take urgent action to stop the staycation happening in the Lake District National Park?
Covid-19: Status Certification — House of Lords, 2021-04-29
Topic: Health
Nicholas True (Conservative, Centre-right): My Lords, we recognise the significant public and parliamentary interest in this important topic. That is why we are conducting a wide-ranging review, seeking input from clinicians, parliamentarians and businesses, and from specialists in areas such as ethics, equalities and privacy. The review is ongoing and no final decisions about the use of Covid status certification have been made. The Government will outline the findings of the review ahead of step 4 of the reopening road map.
Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2018 — House of Lords, 2018-12-04
Topic: Health
Christopher Rennard (Liberal Democrats, Centre to centre-left): My Lords, there are those—I am certainly not among them—who welcomed the idea of Brexit because they did not like the restrictions on the promotion of tobacco that we agreed across the EU. Contrary to the biased and selfish claims made on behalf of the tobacco industry, these regulations have been successful in reducing significantly the prevalence of tobacco smoking and its related diseases. We should never forget that tobacco products shorten the lives of half the people who smoke The tobacco lobbyists will be disappointed with the regulations because they show that they have lost the argument and there is now cross-party consensus on tackling tobacco-related problems. As the Minister said, even if we have the disastrous no-deal Brexit that some of those people want, the regulations will allow for a set of pictures, as currently used in Australia, to continue to appear on cigarette packs in the UK to warn smokers of the terrible damage done to their health by smoking As the Minister said, the regulations have the support of the excellent Action on Smoking and Health, of which I am a former director. Of course, they have my support too, but I would like to remind the Minister that the Tobacco and Related Products Regulations 2016 require the Secretary of State to review those regulations and publish a report before 20 May 2021. Some of the important points made by the noble Lord, Lord Hunt of Kings Heath, should be examined when that report is made. Some of us also feel passionately that e-cigarettes can and must be promoted effectively as an alternative to smoking tobacco, but in such a way as not to encourage people who have never smoked tobacco to take up an addiction to nicotine. I would like the Minister to confirm as well as he can that there will be no going back on our successful tobacco regulation policies, which are doing so much to improve the health and life expectancy of so many people. We should do nothing that reverses the excellent progress being made on this issue.
Covid-19: Status Certification — House of Lords, 2021-04-29
Topic: Health
Nicholas True (Conservative, Centre-right): I obviously agree with my noble friend that for international travel there have to be international discussions, and indeed there are. So far as his point on lockdown is concerned, lockdown is extremely hard. It is something that has been and is being done for the sake of the general good and has contributed to the situation we are now in. Of course, the Government never underestimate the mental health and other issues that arise and have arisen.
Covid-19: Status Certification — House of Lords, 2021-04-29
Topic: Health
Patrick Cormack (Conservative, Centre-right): My Lords, I raise a point I have raised many times before; I have had good answers from the noble Lord, Lord Bethell. A vulnerable area is the care home sector. It is absurd that care home workers are able to refuse to be vaccinated when they are attending to the most intimate needs of vulnerable, frail and often very old people.
Covid-19: Status Certification — House of Lords, 2021-04-29
Topic: Culture
Nicholas True (Conservative, Centre-right): Again, my Lords, as set out in the Statement and in my response, equality issues are considered and they are being considered in the scope of the review, as are the specific interests of the performing and arts sector. The noble Baroness will know that my right honourable friend the Chancellor of the Duchy of Lancaster and other members of the Government have met those in those sectors. We will of course reflect on the consideration that the noble Baroness puts forward.
Botulinum Toxin and Cosmetic Fillers (Children) Bill — House of Lords, 2021-04-16
Topic: Health
Andrew Lansley (Conservative, Centre-right): My Lords, I congratulate my noble friend on bringing this Bill forward and on her excellent presentation, which set out very clearly its purposes and justification. I very much support it My noble friend will know, and the House may well recall, that the Bill is in line with one of the recommendations from the Review of the Regulation of Cosmetic Interventions led by Sir Bruce Keogh and published in April 2013. Of course, as Secretary of State, I asked him to lead that review back in January 2012, following the PIP breast implant scandal disclosed the previous month. It is fixed in the memory of Health Ministers across the globe—the problems were disclosed by the French Government the day before Christmas Eve, so we all lost our Christmas in 2011. One of the consequences was that the many issues and problems associated with cosmetic interventions and medical devices were exposed. Indeed, the Keogh review did a great deal to help to bring that forward. I think this Bill will be extremely welcome While I have this moment, I would mention the Cosmetic Surgery (Standards) Bill in my name, which is way down in the Lords list of Private Members’ Bills. It is not going to have the benefit of the House’s attention in this parliamentary Session; I hope it may in a future one, perhaps even with the benefit of support from the Government at some point. It also follows up one of Bruce Keogh’s recommendations. It was very good that our honourable friend the Member for Sevenoaks was able skilfully to bring this Bill through. I know how difficult it is in another place to get a Private Member’s Bill through, even if one is fortunate to get a place in the ballot I briefly mention two other things. First, Kevan Jones, who also supports my Bill, spoke in the other place about the issues associated with advertising cosmetic interventions, increasingly on social media these days, and he was right to do so. That is an issue raised in the review that needs to be followed up. I also hope that, in line with my Bill, the Government will encourage the General Medical Council, regardless of legislation or otherwise, to use the Royal College of Surgeons interspecialty committee’s work on certification for cosmetic surgery to try to ensure that it is indicated on the medical register, so that people can identify who is properly certified and qualified to provide cosmetic interventions Bruce Keogh’s review said—I think I quote correctly—that, in "our view … dermal fillers are a crisis waiting to happen." It is not a crisis in respect of which young people should be the victims. I am very glad that my noble friend has brought the Bill forward, and I hope that we will be able to pass it into law before the end of this Session.
Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 4) Regulations 2020 — House of Lords, 2020-10-06
Topic: Health
Philip Alexander Hunt (Labour, Centre-left): My Lords, it is a great pleasure to follow the noble Lord, Lord Lamont, and surely he is right. It is one thing to publish and enact regulations, which, from the Government’s view, are simple, but there has to be some rationality behind them. I hope the Minister will answer the question. He said there was no science at all behind the plucking out of the figure of six; can he confirm that that is so? Also, I do not understand why the Government did not exempt young children in England. What on earth is the reason for that? Does he not agree that Government would carry more credibility if there was some confidence in the overall direction we are going in? As the noble Lord, Lord Lamont, has pointed out, different Ministers have been saying different things today about the endgame It is not surprising: we have seen a litany of failures, such as the original behaviour by Mr Cummings, which was so damaging to public confidence, and the contrast between the "world-beating" test and trace system and the shambles we have seen week after week. Watching Mr Johnson on "The Andrew Marr Show" on Sunday, when he spoke of the tension between the interests of the economy and public health, which, of course, we understand, he came across as indecisive, late to act and failing to find a way to steer between these two options. The result is that we have failed in both. Public confidence is very important, and so too is parliamentary scrutiny. Mr Speaker intervened last week. Mr Hancock agreed that, where possible, the Commons would have a vote on national regulations in the future. What opportunity will this House have? In all the talk about new rationalisation of local lock- down regulations into three tiers, can we be assured that Parliament will debate this before they are introduced?
Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 4) Regulations 2020 — House of Lords, 2020-10-06
Topic: Health
Rita Donaghy (Labour, Centre-left): My Lords, we are caught between the Scylla and Charybdis of the so-called libertarians in the Conservative Party and the well-meaning, but not very competent, government action to deal with the pandemic. The regret Motion in the name of the noble Lord, Lord Lamont, is really a fundamental challenge to the Government’s strategy and should not be supported. However, those of us who want the Government to succeed in saving more lives need more clarity and consistency and, in particular, actual delivery of an effective test and trace system, with care homes and health staff given priority for testing and receiving results in good time It is very easy to mock with regard to funerals and weddings and to give examples of inconsistency. What is not easy is delivering effective policies that we all want to unite behind. Please could the Government do better?