Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[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.

Coronavirus Vaccine

Debate between Baroness Wheeler and Baroness Jolly

Thursday 3rd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

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

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

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

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

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

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

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

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

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

[Baroness Jolly (LD) [V]]

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

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

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

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

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

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

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

Covid-19 Update

Debate between Baroness Wheeler and Baroness Jolly

Thursday 12th November 2020 Lords Chamber

[Baroness Wheeler (Lab)]

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

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

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


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

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

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

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

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

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

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

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

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

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

[Baroness Jolly (LD) [V]]

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

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

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

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

[Baroness Wheeler (Lab)]

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

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

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

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

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

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

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

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

[Baroness Jolly (LD) [V]]

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

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Baroness Jolly

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

[Baroness Jolly (LD) [V]]

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

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

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

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

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

[Baroness Wheeler (Lab)]

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

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

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

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

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

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

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

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

Gosport Independent Panel

Debate between Baroness Wheeler and Baroness Jolly

Thursday 22nd November 2018 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for reading out the Statement updating the House on government actions since this appalling tragedy was reported to the House in June. As the Statement says, the Gosport report was “truly shocking”, and once again our thoughts, sympathies and condolences go out to the families of the 456 patients whose lives were shortened. Those families campaigned for so many years to find out what happened. We also again pay tribute to these relatives for their courage, tenacity and persistence in seeking the truth, and to the panel, with particular thanks for the calm and compassionate leadership of the chair, Bishop James Jones, for its unstinting work in uncovering the injustice and for listening to and hearing the families’ concerns.

It is important to remind ourselves of the panel’s conclusions. First, there was a disregard for human life and a culture of shortening the lives of a large number of elderly patients. Secondly, there was an institutional regime of prescribing and administering “dangerous doses” of a hazardous combination of medication not clinically indicated or justified. Thirdly, relatives were constantly let down by those in authority in the hospital when they complained. Fourthly, senior management, the local constabulary and politicians, the coroner system, the CPS, the GMC and the NMC all failed to act in ways that would have better protected patients and relatives.

We welcome the commitment to strengthen protections for whistleblowers and for new legislation to compel NHS trusts to report annually on how concerns raised by staff have been addressed. Has a detailed programme of work for this been drawn up? When does the Minister envisage that legislation on these new powers will be introduced? However, much of the Statement today is about work in progress on the actions and measures that were announced when the report was published, and it is important that we receive regular updates in the future. In his June Statement, the Minister referred to the introduction next April of medical examiners to ensure that every death is scrutinised by either a coroner or a medical examiner, and yesterday’s Statement repeats this commitment. Can the Minister advise the House on progress on this? If they are to be employed by acute trusts, how will their independence be maintained and how will they link into the mortality reviews and the Learning from Deaths guidance? Has consideration been given to basing them in local authorities so that their remit can be extended to primary care, nursing homes and mental health and community trusts? What additional resources are being provided to fund these new posts?

When the report was published, the House welcomed the urgent establishment of a hotline and of counselling being made available to all those who had lost loved ones and were affected. Are these important provisions still available and will they continue to be provided? What further support is being provided? Also, in addition to the 456 patients given opiates without appropriate prescribing or as a result of the prescribing practices at the hospital, sadly, 200 more patients were referred to in the report whose clinical notes or medical records had gone missing. The panel considered that these patients had been similarly affected. What progress has been made by the workstream set up to further investigate this appalling situation? How many more cases have been substantiated as a result of this?

On the question of oversight of the use of opiates in the NHS, is the Minister satisfied that it is now tight enough to prevent incidents such as this happening again? We welcome the promise of a further review on how patient safety can be improved when prescribing and dispensing medicine, aimed at detecting inappropriate prescribing. Can the Minister give us further details of how this review is to be conducted, including the full remit and timescales?

In June, the Minister also promised a “fresh impetus” to moving forward on the need to streamline professional regulation following the report’s condemnation of the inadequacies of the GMC and NMC regulators who failed to act in ways that would have better protected patients and relatives. What progress has been made on this work?

Finally, we come back to the key issue of patient safety and the need to build a patient safety culture in the NHS. Does the Minister consider that additional legislation is needed to keep patients safe? Is a new independent body now required to pick up and take forward the remit of the former Patient Safety Agency, so unwisely abolished by the Government?

The Statement ends by underlining the cultural change that needs to be driven across the NHS to achieve openness, transparency and learning rather than blame and the cover-up of mistakes and incidents, and of course we agree with that. For all the awfulness of its findings, the Gosport panel report has managed to ensure that the carers and relatives of loved ones and staff have been listened to and heard. We on these Benches pledge our full support for the measures which will ensure that what happened at Gosport never happens again.

[Baroness Jolly (LD)]

My Lords, I join the noble Baroness, Lady Wheeler, in thanking the Minister for an update of this situation and I too pay tribute to the relatives and the whistleblowers in this awful scandal. I am sure that many noble Lords will remember how the Shipman scandal absolutely rocked the NHS back in the late 1990s. The learning which came out of that was meant to incorporate right across the NHS robust clinical governance structures. It is really quite ironic that the things which were put in place to deal with the Shipman case seem to have fallen apart completely as regards the particular issue of Gosport.

Whistleblowers need to be confident that there will be no danger of their being bullied. I am sure that other noble Lords will have had NHS employees ask to talk to them about whistleblowing issues. One of the saddest days I can remember was when I was sitting in the Royal Gallery talking to a very senior manager in an NHS trust who was trying to raise his concerns. In the end he resigned because he felt that he had been bullied into doing so. He was going to take his expertise elsewhere. There is learning that should come from that.

I welcome the Freedom to Speak Up initiative and the work from the National Guardian’s Office. What progress has been made in embedding the operation of that scheme? If it is still in train, when might it be embedded? What consideration has been given to a similar scheme for whistleblowers who work in the care sector? This has got the NHS sorted but, at the moment, there is no way that care workers who work in care homes or other care establishments can effectively blow the whistle.

Gosport Independent Panel: Publication of Report

Debate between Baroness Wheeler and Baroness Jolly

Wednesday 20th June 2018 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the noble Lord for reading out the Statement. I was able to hear only a little of the media coverage in anticipation of the report this morning, but I heard one of the relatives speaking about what she had been through over the past 20 years. It was heartrending. Our thoughts, sympathies and condolences go out to the families of those 450 patients whose lives were shortened and who have campaigned for so many years to find out what happened.

We also pay tribute to the relatives for their determination, tenacity and persistence, and to the parliamentarians and others who have played their part in helping to get the panel established or supporting the relatives who have lost loved ones. I include in this the organisation, Action against Medical Accidents, which helped the families to get inquests and to press for a full inquiry, as it has done on so many of these very difficult, awful occasions.

I finally place on record our thanks to all who served on the inquiry panel and offer particular thanks for the extraordinary dedication and calm, compassionate, relentless and determined leadership yet again of the former Bishop of Liverpool, James Jones, in uncovering injustice and revealing the truth about a shameful episode in our nation’s recent history. In its own words, the panel finally,

“listened and heard the families’ concerns”.

The four key conclusions of the panel were that there was disregard for human life and a culture of shortening lives of a large number of patients; that there was an institutional regime of prescribing and administering “dangerous doses” of a hazardous combination of medication not clinically indicated or justified; that relatives were constantly let down by those in authority in the hospital when they complained; and that senior management, Hampshire Constabulary, local politicians, the coroners system, the Crown Prosecution Service, the GMC and NMC all failed to act in ways that would have better protected patients and relatives.

As the panel comments, patients’ and relatives’ interests were,

“subordinated to the reputation of the hospital and the professions involved … a large number of patients and their relatives understood that their admission to the hospital was for either rehabilitation or respite … they were, in effect, put on a terminal care pathway”.

The report is a substantial, 400-page document published only this morning and it will take some time for us all fully to absorb each detail. I welcome the Government’s commitment to coming back to the House with a full response as quickly as possible. I also welcome the setting up of a hotline and making available counselling provision to those affected and who have lost loved ones, as well as the Secretary of State’s commitment to meeting the families, with Bishop James continuing to act as a link.

Perhaps I may raise five key issues at this stage. First, can any further action be taken in respect of the 200 additional patients whose clinical notes or medical records were missing and who the panel considered to have been affected in a way similar to that of the 450 patients given opiates without appropriate clinical direction or as a result of the prescribing and administering opioids that became the norm at the hospital?

Secondly, on GMC and NMC failures in this matter, does the Minister accept that this underlines the urgent need for legislation to streamline their professional regulatory procedures and responses? In this instance, despite GMC disciplinary action against the doctor involved resulting in her being found guilty of serious professional misconduct, it did not have the authority to overturn the decision of its disciplinary panel not to strike the doctor off the register. I understand that a White Paper on regulatory matters issued by the GMC this week emphasises that, as matters stand, the GMC is operating under a legislative framework that is 35 years old and simply not fit for purpose. A Bill has been sought by this and the other professional bodies and promised by the Government, but we still have had no sight of it. Is it not now vital that such legislation is forthcoming?

Thirdly, on the key question of patient safety, in light of this inquiry, what changes have been made, or will be made, to the oversight of how medicines, particularly opiates, are dispensed in our hospitals? Is the Minister satisfied that oversight of medicines in the NHS is now tight enough to prevent incidents like this happening again? What are the wider lessons for patient safety and the need to build the safety culture in the NHS, and is additional legislation required to keep patients safe? Do the Government now regret the abolition of the patient safety agency? Do they consider that a new independent body is urgently required to pick up and take forward the PSA remit, and will the Minister promise to review this issue? Is there a need for the scope of the draft patient safety investigations Bill to be widened to reflect the learning from these tragic events?

Fourthly, there is the issue of how a proper inquiry in such appalling situations is actually started when there are ongoing police investigations and coroners’ inquests to be held. Delay is built into the system from the outset. It is a key issue that we need to find a way through.

Finally, we have all welcomed the learning from deaths programme set up to build organisational learning on the sorts of failures that we are discussing today. How will the programme assist in helping learn the lessons in this report?

We will rightly acknowledge 70 years of the NHS and the great efforts of our NHS workers every day. On this occasion, however, the system has let so many down and we must all ask why.

[Baroness Jolly (LD)]

My Lords, I shall crave the indulgence of the House for a moment while I read out the first two points in the summary and conclusions of the report:

“In waiting patiently for the Panel’s Report, the families of those who died at Gosport War Memorial Hospital … will be asking: ‘Have you listened and heard our concerns, and has the validity of those concerns been demonstrated?’ … It is over 27 years since nurses at the hospital first voiced their concerns. It is at least 20 years since the families sought answers through proper investigation. In that time, the families have pleaded that ‘the truth must now come out’. They have witnessed from the outside many investigative processes. Some they have come to regard as ‘farce’ or ‘cover-up’. Sometimes they have discovered that experts who had found reason for concern had been ignored or disparaged. Sometimes long-awaited reports were not published”.


I commend my right honourable friend Norman Lamb for having a quiet word with the Secretary of State to ensure that this was moved forward.

This report makes for shocking reading. It hangs on a confusion of responsibilities between two organisations, the NHS and the police force, and there is a multitude of questions to be answered. I shall put only two questions to the Minister and hinge them on two points in the report. The first is paragraph 12.62. Health bodies felt prevented from taking action because police investigations were under way. The report points out:

“All concerned assumed not only that the police investigations took priority, but that they prevented any other investigations from proceeding”.


There is clearly a need to clarify lines of responsibility between the police and the NHS regulatory bodies when there are allegations of wrongdoing and systematic failings of this kind so that organisations simply do not pass the buck. Can the Minister assure me that this work will start?

Secondly, how will the Government take forward the call for action in paragraph 12.60? I welcome the Minister’s commitment to an independent inquiry in future in such circumstances to be carried out by the police force, but the report states that,

“the evidence … suggests that, faced with concerns amounting to allegations of unlawful killing in a hospital setting, there are clear difficulties for police investigation. It is not clear to the Panel how the police can best take forward such investigations, and how they are to know whose advice to seek from within the health service without compromising their enquiries. This is … significant if the problem concerns the practice on a ward where more than one member of a clinical team is involved. It is a need that calls for action across different authorities, rather than a matter for the police service in isolation”.

We cannot guarantee that something similar to this could not happen elsewhere—please God that it does not—but what action will be taken to ensure that there is not such a muddle and confusion in a resolution? What processes are either in place or being put in place within NHS settings and with police forces to make sure that this does not happen again?

Branded Health Service Medicines (Costs) Regulations 2018

Debate between Baroness Wheeler and Baroness Jolly

Wednesday 20th June 2018 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, for bringing this slightly interesting regret Motion.

It is clear that the issue at stake is the appropriate treatment of hypothyroidism. We have to trust clinicians to prescribe based on what they consider is best for their patients, as the noble Lord, Lord Turnberg, said. I have done an awful lot of reading about this over the last few days, and, although it depends on which article you read, it seems that a significant number of women have this condition: one figure I was given was 10%. In fact, for the last 25 years I have been diagnosed as hypothyroid. I take T4— levothyroxine—which is cheap as chips and costs the NHS about £1.30 every month. But of course, not everybody responds to that, and the alternative is the very much more expensive T3. Some 10% to 20% of patients diagnosed with hypothyroidism come into this category. It is therefore important that the patient receives the right drug. We have heard completely unacceptable tales of patients, as a result of decisions made by clinical commissioning groups, surfing the internet to see what they can get. I did exactly the same last night—having a look to see what I could get—and, again, the T3 was ridiculously expensive, whereas T4 was hardly worth buying online as you could get it very much more cheaply.

What is to be done about this? I was going to explain what it is like when you develop hypothyroidism, before you are diagnosed, and so I thank the noble Lord, Lord Borwick, because his description was lovely: “pathetic, befuddled and exhausted”. I went to see a doctor because my brain was in a fog. I explained it to him and he said, “What do you expect? You work full time and you have two toddlers”. So I was sent away. Curiously enough, at a family event—a lot of my family are doctors or nurses—my mother-in-law asked me, “How long have you had a thyroid problem?” and I said, “I didn’t know I had a thyroid problem”. I went to see my GP, who said, “No, you haven’t got a thyroid problem at all. Who said you had one? Gosh—what does a paediatrician know about it?” Eventually, I had to leave my practice and go to another one to get a diagnosis. I am sure that that is not normal, but it was quite an interesting experience for me. Since then, I have been as fit as a flea. The medication works like a magic charm; very quickly you feel normal and well again. So I cannot overstate to Members of your Lordships’ House how important that prescription was.

I emphasise to the Minister what other noble Lords have said today. We must use the purchasing power of the NHS to drive down the costs of T3 in order to make the argument go away. That might be done by effective negotiation, as the noble Lord, Lord Lucas, said, or in another way, but it is completely scandalous that patients have to buy their own drugs online, and CCGs should therefore review or rework their guidelines as a matter of urgency. Drug companies must not hold the NHS to ransom over the cost of medication that will make patients feel absolutely well again.

On the issue of the costs of medication, one of the non-medical side-effects of having a diagnosis of hypothyroidism was that any other drug I had became free. It is on a list of conditions which, if you have them, mean that any other medication you need becomes free. At that time I was in my early 30s and working. It was very nice to have free prescriptions; I tried to pay for them but they would not let me. However, it means that for the NHS, an awful lot of money is spent inappropriately. Can the Minister give an indication of whether the department has any indication of how much this costs the NHS? I am happy for the NHS to pay for my levothyroxine, but it should not have paid for all other medication I was in receipt of—although, now that I am old, it comes free anyway. How sustainable is this in the current climate, and when was the principle last reviewed?

My takeaway issue for all this is that, whatever happens, we should ensure that the cost of T3 is driven down. However, I would also like the Minister to take this other issue away and—not as a matter of huge urgency—come back to me with some answers.

[Baroness Wheeler (Lab)]

My Lords, I thank my noble friend for tabling this Motion and for his excellent speech setting out the concerns we all share about NHS patients getting access to the drugs they need and how a number of CCGs are in effect placing a ban on expensive branded medicines—in this case ignoring NHS England’s advice concerning T3 in the treatment of hypothyroidism. I look forward to the Minister’s response to the key questions put forward by noble Lords on this issue.

The Motion has the full support from these Benches. I also commend the work of the British Thyroid Association and Thyroid UK in highlighting this issue, and the very helpful information on their websites, as well as the expert explanation from my noble friend Lord Turnberg on hypothyroidism. The websites include case studies of patient voices which clearly show the impact and suffering of patients who are either denied T3 or who are taken off it because of a decision made by their CCG. It is especially upsetting when patients who have successfully taken the drug for a number of years suddenly have to go back on to a drug, mainly T4, which they already know does not provide them with the treatment they need or will make them ill again. The case studies refer to both the T4 drug and the natural desiccated thyroid—NDT—drug, which I understand is the treatment given before T4 came on to the market but which is not now available in the NHS as it has to go through the Food and Drug Administration process, and it is not known when the branded NDT products will be licensed.

My noble friend and other speakers described their concerns over current CCG decisions that go against NICE guidelines and the advice of NHS England, and the increasing rationing of key services, so I will not repeat them and will await the Minister’s response. The NHS England recommendation and guidance on T3 needs to be clear and unambiguous. I hope that the Minister will acknowledge the confusion and concerns, and will ensure that NHS England informs CCGs that they must both comply with their guidance and amend it to end the scope for CCG misinterpretation. I hope that he will also acknowledge that access to T3 on the NHS is a matter of urgency for many patients and that he will give serious consideration to the call from Thyroid UK and ITT for the procurement of T3 from outside the UK for NHS prescriptions until its UK cost comes down.

On the regulations, I note paragraph 4.7 of the Explanatory Memorandum, which deals with provisions of the Health Service Medical Supplies (Costs) Act 2017 that have been included. This includes the promise of the annual review of the operation and objectives of the statutory scheme which is to be published and put before Parliament. Can the Minister tell the House what the current thinking is in terms of the review process and timing, and say when he would expect the first review to be completed?

The impact assessment also states that the implementation of these regulations will generate a saving of £33 million to the NHS between April 2018 and March 2019. The Department of Health and Social Care says that this will enable the provision of additional treatments and services estimated to provide NHS patients with an additional 2,213 quality-adjusted life years, valued at £133 million. Can the Minister explain to the House exactly how the Government have calculated the savings, and can he give more details of how this money is to be spent in the NHS?

The Explanatory Memorandum also says that the regulations set out other instances when the Secretary of State can give a direction specifying the maximum price of drugs—for example, when there are supply issues with respect to a particular branded health service medicine and the Secretary of State is satisfied that a new temporary minimum price needs to be provided to help resolve the supply issue. Can the Minister explain to the House how the Secretary of State is to decide on the temporary minimum price?

Finally, in respect of the provisions in the regulations for manufacturers and suppliers to pay 7.8% of their net sales income to the Government, the impact assessment provides for those in the PPRS with annual NHS sales above £5 million to make percentage payments based on the difference between allowed percentage and actual percentage growth in NHS expenditure on branded medicines. Can the Minister provide more clarity on how this 7.8% figure has been reached?

Epilepsy: New Treatments

Debate between Baroness Wheeler and Baroness Jolly

Monday 2nd February 2015 Lords Chamber

[Baroness Jolly]

The noble Lord is absolutely right.

[Baroness Wheeler (Lab)]

My Lords, on commissioning, CCGs have a strategic influence and make key commissioning decisions that impact on the lives of nearly half a million people with epilepsy in England. Yet, last year’s Epilepsy Action report showed that only 10% of them had produced written needs assessments for people with epilepsy and that 70% reported that they did not have any plans to do so, either for this or for people with other neurological conditions. What are the Government doing to remedy this appalling situation?

[Baroness Jolly]

If the noble Baroness is referring to the joint strategic needs assessment, that is produced by the clinical commissioning groups working in conjunction with local authorities. It is up to them to make decisions about what they consider to be important.

NHS: GP Salaries

Debate between Baroness Wheeler and Baroness Jolly

Monday 26th January 2015 Lords Chamber

[Baroness Jolly]

My Lords, I am sorry, I missed the question in the whole of the tale.

[Baroness Wheeler (Lab)]

My Lords, I thank my noble friend Lord Reid for once again setting the record straight on this issue. Moreover, in Labour’s last year in office, 98% of patients were being seen by their GPs within four hours. Does the Minister agree that the key problems that need to be addressed were set out in the Nuffield Trust’s recent report—an emerging crisis in the GP workforce, not enough GPs being trained, more trainees now working part-time, more existing GPs planning to retire early, and the numbers just not keeping up with those of hospital doctors?

Medical Innovation Bill [HL]

Debate between Baroness Wheeler and Baroness Jolly

Friday 12th December 2014 Lords Chamber

[Baroness Wheeler]

This is a very important group dealing with patient safety. I shall briefly intervene in support of my noble friend Lord Turnberg’s Amendment 3, which refers to seeking the support of the appropriately qualified doctor rather than his or her views, and to support Amendment 7 from the noble Lord, Lord Saatchi, on recording the treatment and consultation on the patient’s notes.

Our firm preference was for the Bill to specify the need for the written consent of the appropriately qualified doctor, but we have heard senior medical doctors’ concerns about giving formal written consent to another doctor’s proposed course of treatment for the patient without knowing their full history and other circumstances.

As my noble friend Lord Turnberg said, there is something of an irony in a Bill designed to address doctors’ fears of litigation running the risk of opening up the fear of litigation from the supporting doctor. We consider “support” to be preferable to the doctor’s “views” and I hope that the noble Lord, Lord Saatchi, can respond positively to this as a way of reassuring patients and their carers and relatives and enhancing patient safety.

My noble friend Lord Winston’s Amendment 2 seeks additional safeguards for patient safety by reference to excluding treatment where a,

“body of responsible medical opinion”,

considers that the treatment is likely seriously or unreasonably to compromise patient safety. He has raised some very important issues here, particularly in response to cancer treatment, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister.

The clarification the noble Lord, Lord Saatchi, provides in Amendment 7 concerning the issues to be recorded in the patient’s notes provides welcome safeguards. It does not include the full range of issues, covered under Clause 1(3), which noble Lords have been concerned to see recorded in the patient’s notes, but it goes some way to providing the greater transparency and accountability that we all wish to see, particularly in recording the doctor’s decision to depart from the existing range of accepted medical treatments for the patient’s condition and the explanation of the proposed treatment.

Finally, we have considerable sympathy with Amendment 13 for the reasons ably put forward by my noble friends Lord Winston and Lord Turnberg, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister on this issue.

[Baroness Jolly]

My Lords, I shall start my remarks by addressing Amendment 13. This amendment seeks to exclude from the Bill treatments that involve the insertion or injection of cells, tissues or other biologically derived material into the body of a patient. The Government do not consider this amendment to be necessary. The use of human tissue and cells is a heavily regulated area of practice. It is regulated by the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Medicines and Healthcare products Regulatory Agency. As part of making a responsible decision to innovate, the Bill requires that a doctor must consider not only the risks and benefits of the proposed treatment but how they would compare with other treatments and with not carrying out any treatment. This requirement provides a robust objective test of whether an innovative treatment should be used.

Clause 1(5) makes clear that the requirements in the law relating to best interests continue to apply in that nothing in the Bill permits a doctor to carry out treatment for any purpose other than the best interests of the patient. Further to this, the amended Bill requires doctors to act responsibly, including taking full account, in a responsible way, of the views of other appropriately qualified doctors. This clause provides a critical safeguard in ensuring that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.

The Bill provides safeguards for patients while ensuring that doctors can use their clinical judgment and be flexible to individual patients’ circumstances.

I now move to Amendments 2, 3 and 7. It is essential that any legislation is safe for patients. That is why the Government are pleased that the package of amendments devised with advice from Sir Bruce Keogh, the medical director of NHS England, to make the Bill safe for patients was accepted in Committee in this House on 24 October. The noble Lord, Lord Winston, has tabled an amendment that seeks to ensure that a doctor cannot rely on the Bill where a body of responsible medical opinion considers the treatment to compromise patient safety. He referred to the recent debate in the other place where my honourable friend George Freeman, the Minister, asserted that the Government are dedicated to patient safety and evidence-based medicine. I should like to reassure noble Lords that the Bill does not remove any of the current safeguards in place to protect patient safety. If the innovative treatment was considered likely to compromise patient safety, it is extremely unlikely that it would be considered a responsible decision under the Bill when later judged in court. A doctor who innovated in such circumstances is highly likely to be aware that his or her decision would not be considered responsible.

The noble Lord, Lord Winston, raised a couple of points. One was about quack doctors and the other was about stem cell injection. The Bill does not remove any safeguards for patients. There is no escape for negligent doctors under the Bill. They still need to demonstrate that they have acted responsibly. Nothing in the Bill allows doctors to bypass any processes and requirements set by their trust in relation to undertaking innovative treatments in the NHS. This would include ensuring that the commissioners would fund any treatment if it is to be provided within the NHS. Individual innovation is incredibly important, but it is not a substitute for medical research, which usually tests the efficacy of treatments in a systematic way. Successful individual innovations are likely to lead to systematic research projects as evidence builds around a particular speciality. As part of their professional development, doctors should contribute to research as well as look for innovative ways to treat their patients. Noble Lords will be pleased to note that we will emphasise the importance of research in accompanying guidance to doctors on the use of the Bill.

On stem cell injection damaging patient safety, there is no reason for the Bill to damage patient safety. The decision to innovate under the Bill has to be responsible and the doctor would be negligent if he did not innovate responsibly. The Bill gives no extra leeway in respect of stem cell injection, as he suggested. Any decision to inject stem cells would have to comply with all existing safeguards and be responsible. The alarming examples given by the noble Lord are extremely unlikely to have been responsible. Quack treatments would simply not pass the hurdles of responsible decisions required by the Bill.

The amended Bill requires doctors to act responsibly, taking full account of the views of other appropriately qualified doctors. This clause provides a critical safeguard in ensuring that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.

Unpaid Carers

Debate between Baroness Wheeler and Baroness Jolly

Monday 8th December 2014 Lords Chamber

[Baroness Jolly]

I do not have figures that split out blood relatives from other carers. I shall find out whether such figures are available and let the noble Lord have them.

[Baroness Wheeler (Lab)]

My Lords, does the Minister agree that providing good quality home care and respite care is crucial to enabling carers to take up work and remain in jobs and not to descend into poverty or debt? Good care means dignity, respect and a better life for the person carers care for. What steps are the Government taking to ensure that health and social care commissioners recognise this point and provide for and pay for decent care?

[Baroness Jolly]

It is critical that carers have lives outside that of caring for the individual. The Government are therefore working very hard to ensure that carers can remain in employment or get employment but also have a social life outside their caring duties. Anyone who wants to return to work can get support from Jobcentre Plus and, as of 30 June this year, carers can request flexible working from their employers.

Carers Strategy

Debate between Baroness Wheeler and Baroness Jolly

Thursday 3rd July 2014 Lords Chamber

[Baroness Jolly]

Yes. That issue came up throughout the passage of the Care Bill. There was a lot of anxiety on behalf of local authorities. The impact assessment has committed extra money for carers’ rights and an additional £69.4 million for 2015-16 through the Better Care Fund, rising to £192.6 million by 2020.

[Baroness Wheeler (Lab)]

My Lords, on the issue of benefits, Carers UK figures show that by 2018 the Government will have cut carers’ benefits by an estimated £1 billion through the reduction in support with council tax, housing costs, the overall numbers receiving the carer’s allowance and the benefits cap. With their carers and disabled people losing support from the benefits system in this way, what assessment have the Government made of the very serious knock-on impact on social care and families’ abilities to provide care?

[Baroness Jolly]

That assessment will come as a result of the work being done on the report that was referred to earlier. However, I can tell the noble Baroness that the carer’s allowance will increase faster than wages and in line with inflation this year, from £59.75 to £61.35. A household will be exempt from the benefit cap where someone is receiving carer’s allowance and also there is someone within the household in receipt of a qualifying disability benefit, such as PIP, DLA housing benefit or attendance allowance.

Food Poisoning

Debate between Baroness Wheeler and Baroness Jolly

Tuesday 24th June 2014 Lords Chamber

[Baroness Jolly]

I have no information in my brief to that effect. However, it should be said that this scheme has been adopted by all but two local authorities in England, the two exceptions being the Royal Borough of Greenwich, which is ready to implement it, and Rutland, which is somewhat anxious about the success of businesses.

[Baroness Wheeler (Lab)]

Do the Government agree with Professor Chris Elliott, whom they commissioned to review food safety in the wake of the horsemeat scandal, that the Food Standards Agency should be given new powers to tackle fraud through a food crime unit?

[Baroness Jolly]

I regret that I shall have to write to the noble Baroness on that issue.

NHS: Hospital Medication

Debate between Baroness Wheeler and Baroness Jolly

Wednesday 9th April 2014 Lords Chamber

[Baroness Jolly]

Certainly those technologies exist. I have seen some of them in action, and they are really impressive. Local hospitals are responsible for their own IT systems, and some are very much further ahead than others, but I am sure others are aiming to catch up.

[Baroness Wheeler (Lab)]

My Lords, the Minister referred to the guidance on the reconciliation of medicines drawn up by NICE and the National Patient Safety Agency in 2007. However, since the Government abolished the NPSA two years ago and transferred the work to NHS England, information about the agency’s work and how it is being carried out and taken forward is very hard to come by. Will the Minister reassure the House that monitoring, keeping the guidelines under review and updating them to ensure patient safety are priorities for NHS England and the Government?

[Baroness Jolly]

Patient safety is indeed critical. After Mid Staffs and the Francis report, safety, openness and accountability are key, along with the duty of candour. “Sign up to Safety” is to be announced later this week to ensure that efforts are reported. That will help local hospitals and care homes understand where mistakes are being made and make patients feel more comfortable by owning up to problems.

Care Bill [HL]

Debate between Baroness Wheeler and Baroness Jolly

Monday 10th June 2013 Lords Chamber

[Baroness Jolly]

My Lords, I thank the noble Lords, Lord Turnberg and Lord Patel, for helping me with these amendments. The noble Lord, Lord Willis of Knaresborough, is unwell and may not be returning to us in time to help with the Bill. His twin passions are training and research, and Amendments 37 and 39 to Clause 90, which are all about the functions of LETBs, completely underpin that. I would be doing him a disservice if I did not ask the Minister to explore these areas when he sums up.

It is critical not only at a national level, with HEE, but at a local level, with the LETBs, that this area is not forgotten. Staff must understand not only the implications but all aspects of research. That must be plugged in at HEE and, with these amendments to Clause 90, at the LETB level.

[Baroness Wheeler]

I strongly support this group of amendments, the case for which has been ably made by my noble friend Lord Turnberg, the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly.

The importance to the NHS of research and innovation has come under close scrutiny and debate in the House in recent times, under the Health and Social Care Bill, in the powerful debate of the noble Lord, Lord Saatchi, earlier this year, and in the debate that we almost had in the name of the noble Lord, Lord Kakkar, on the life sciences industry’s important contribution to healthcare and to our economy.

Under the Health and Social Care Act, Labour fully supported placing duties on the Secretary of State, the NCB and CCGs to promote research. Indeed, my noble friends Lady Thornton and Lord Hunt proposed amendments to that Bill reinforcing the importance of research, and we were pleased to work with noble Lords across the House in strengthening these provisions. That is why amendments to Clause 86, which deals with quality improvement in education and training, are so important.

Amendment 17 deletes the current reference to HEE needing to promote,

“the use in those activities of evidence obtained from the research”,

and replaces it with a proactive reference to using this,

“evidence to ensure the rapid uptake of innovations into practice”.

Amendment 20 underlines the need for HEE,

“to secure that research and innovation are incorporated into education and training”.

This was a recommendation of the Joint Committee, which we fully support. All NHS staff should be equipped with the tools to understand and support research and to assess and use evidence to inform their decisions when caring for patients or supporting clinical staff. They also need to be able to make use of research throughout their careers—a point that my noble friend Lord Turnberg made strongly—and be familiar with the NHS research infrastructure, which can provide further help and support.

The recent survey by the Association of Medical Research Charities showed the challenges to be phased in in this regard. Some 91% of staff surveyed, including doctors and nurses, identified the barriers that they had experienced to taking part in research. Lack of time was the predominant reason given by respondents. Other reasons included funding, practical support and difficulties in navigating regulation. GPs are an important gateway for getting patients involved in research, but although a majority of GPs believes that it is important for the NHS to support research into treatments for their patients, only 32% felt that it was important for them personally to be involved. As AMRC emphasises, we still have a long way to go if the Government’s goal of every clinician being a researcher and every willing patient a research participant is to be achieved.

Amendment 32 to Clause 87 adds promoting innovation and research in clinical practice to the matters that the HEE should have regard to—a logical and crucial next step in our support for innovation and research under HEE’s national functions. Amendment 37 on the local functions that LETBs exercise on behalf of HEE makes the important cross-reference between Clause 90 and Clause 86, rather than Clause 84, on the issue of ensuring that there are sufficient skilled healthcare workers promoting research and the use of research evidence in the health service. We believe that if LETBs are performing other duties of behalf of HEE under Clause 90, there is no reason why they should not also promote research, obviously within the LETB area. Amendment 39 would confirm in legislation that HEE’s research duty applies to LETBs as a main function, and we strongly support that.

Throughout the debates on innovation and research, we heard continued concerns and frustrations at the often painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. There was frustration, too, that existing processes and pathways, such as conditional approval in the named patient schemes and the opportunities under existing legislation, are not being fully used. In the January debate, the Minister reminded us that it took an estimated 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. That is why these amendments to ensure that HEE actively promotes innovation and research and carries that through in the education and training of healthcare workers needs to be supported by the Government. I look forward to the Minister’s response.