Health and Care Bill

Lord Russell of Liverpool Excerpts

Committee stage
Thursday 20th January 2022 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

My Lords, I will speak particularly to Amendments 54, 74 and 97 in this group. I warmly thank the noble Lords, Lord Patel and Lord Hunt, for lending their support to all three amendments, and the noble Lord, Lord Warner, for supporting Amendment 74. I pay particular tribute to the noble Lord, Lord Patel, and his historic work prior to the setting up of NICE; it was a great contribution that deserves to be recognised.

We are all aware of the procedure that, when a medicine is approved, it goes through two processes. First, it goes to the Medicines and Healthcare products Regulatory Agency, known as the MHRA, a body which checks whether a drug is safe and effectively does what it says on the tin. It then goes through a separate process run by the National Institute for Health and Care Excellence, known as NICE, which looks at cost-effectiveness and value for money. After those two hurdles have been passed, the medicines should, theoretically, be accessible to anyone. That is very clear in the NHS constitution, which explains that there is a legal right for people to have access to NHS NICE-approved drugs if it is right in their particular circumstances that they should. Indeed, the NICE guidelines say very clearly that there should be automatic adoption within 90 days of approval, if clinically appropriate and relevant.

For a drug then to be prescribed, it must not only have been approved by NICE but go on to the approved list of drugs in the local health authorities, called a formulary. The problem is that somebody must put the drug on the formulary and, currently, while in theory there is a system under the NHS NICE guidelines, this does not actually happen. Sadly, this results in a postcode lottery where some areas have the product on their formulary and others do not. Sometimes this is a process failure, but sometimes it is to avoid budget overspends. Therefore, I would say that it is at the patient’s expense that they are deprived of the drug.

To give an example of the problem, there is currently a drug for multiple sclerosis that patients are still waiting after 150 days to see go on to the formularies in around 25% of the local health systems across the country. There is a state-of-the-art flash monitor for type 1 diabetes, but the uptake across the country varies between 16% and 65%. What is most worrying is that those parts of the country with the greatest levels of deprivation have the lowest level of uptake.

I make a plea to the Minister: in my view, ICBs should be required to ensure that all NICE-approved medicines and devices are available and promoted to their population, because the cost of these drugs is covered by the VPAS reimbursement scheme agreed between the NHS and the pharmaceutical industry. If a treatment is unavailable in one ICB footprint, they should be required to commission the required treatment from another ICB. The Government should also promote uptake through the ICBs of NICE-approved medicines and report uptake of new medicines annually.

Amendment 54 would require an ICB to arrange for provision of a NICE-approved treatment to any patient whose NHS clinician has recommended it, even if that treatment is not otherwise available to patients in that ICB area. Amendment 74 would require ICBs to ensure that all NICE approvals are available and promoted to their population via a publicly accessible format, normally online, and to report on their uptake annually. Amendment 97 would mandate integrated care boards and healthcare providers, notably hospital trusts, to update their formularies to include all NICE-approved medicines or devices within 28 days of market authorisation, to ensure they are available for healthcare practitioners, through either their physician, for example, or prescribing pharmacist, to make available for suitable patients.

I thank those who submitted briefings to me while I was preparing for today, notably JDRF, which makes a number of recommendations on this issue, particularly in regard to type 1 diabetes. These aim to reduce inequalities, remove the postcode lotteries to which I referred and make sure that treatments, such as those for type 1 diabetes, are uniformly available across the piece. I also thank EMIG, a pharmaceutical trade association for small and medium-sized companies, for its briefing. It says that the uptake of NICE-approved medicines is critical for NHS patients to benefit from the latest and most promising innovations. Finally, I am grateful to Vertex Pharmaceuticals, which submitted a briefing that again supports the conclusions reached. Among the proposals it highlights is the introduction of a modifier to take account of the severity of a disease and efforts to more fairly consider uncertainty in the evidence for highly innovative and complex treatments for rare and severe diseases, including through greater use of real-world evidence.

On this small group of amendments, I look forward to hearing what the noble Baroness, Lady Finlay, has to say in connection with her neat, simple amendment, which would strengthen what we are proposing to do here. I urge the Minister and the department to address these postcode lotteries and make sure that NICE does not just make the guidelines but ensures that treatments reach the formularies and ultimately the patient in question. I beg to move.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak now.

[Baroness Brinton (LD) [V]]

My Lords, I wish to speak in support of Amendments 54, 74 and 97, tabled by the noble Baroness, Lady McIntosh, and Amendment 163, tabled by the noble Baroness, Lady Finlay. I too pay tribute to the historic work of the noble Lord, Lord Patel, prior to the setting up of NICE.

While it is not an interest in the formal sense, I declare that I have autoimmune disease and have experience of being on the NICE rheumatoid arthritis care and treatment pathway for 19 years, which has been regularly updated by NICE over that time. Where it has been applied in full and from diagnosis, patients have found it very beneficial and, with new and more effective drugs being approved every few years, many are now in remission. I pay tribute to the consultants trying to do their best for their patients and the National Rheumatoid Arthritis Society and Versus Arthritis helplines which support RA patients in navigating their way through access to their NICE treatments when these have been blocked.

I thank the noble Baroness, Lady McIntosh, for her introduction to this group and for explaining the problem with the formulary list. She is right that this should be addressed formally. However, I want to focus on some of the commissioning practices on NICE-recommended treatments, including those on the formulary, in the current CCGs, because I believe these explain the need for the amendments in this group.

In May 2014, the High Court ruled that Thanet CCG could not disagree with NICE guidance merely because it disagreed with it, even when there is no statutory duty to provide that treatment. This specific case was about access to fertility treatments for a woman who was about to undergo bone marrow transplantation to put her severe form of Crohn’s disease into remission. NICE’s 2013 clinical guidance recommended that

“oocyte or embryo cryopreservation as appropriate”

should be offered

“to women of reproductive age … who are preparing for medical treatment for cancer that is likely to make them infertile”.

This was not cancer, and the CCG’s own policy was to not grant funding unless there were exceptional circumstances.

Health and Care Bill

Lord Russell of Liverpool Excerpts

Lords Hansard - Part 2 & Report stage
Wednesday 16th March 2022 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, we now come to the very real problem that relates to the power differential between a doctor and the parents of a sick child. I am most grateful to all who have met me and discussed the amendment, particularly some senior paediatricians and the charity Together for Short Lives, and for support from the Charlie Gard Foundation in redrafting this amendment.

The amendment has been carefully redrafted in the light of comments made on the earlier version. Everyone I have spoken to has recognised that problems sometimes arise. In its 2018-19 review, the Nuffield Council on Bioethics observed common themes behind disagreements—communication issues, differing perspectives on what kind of risks could justifiably be taken, feelings of powerlessness for both parents and staff, and delays in seeking resolution interventions. Among the recommendations is mandatory communications training, as in proposed new subsection (2)(a) in the amendment, and the timely use of effective resolution interventions such as mediation, as in proposed new subsection (2)(e). When parents, as most do, have looked up their child’s condition on the internet, they often come across suggested treatments on different websites or by talking to medical contacts that they have. Clinicians can feel threatened by that.

When parents are worried, they can come across as angry or difficult in their attempt to get information or get something done. All too often, they are labelled as overanxious. Yet, is it normal to be out of your mind with worry if your child, whom you adore, looks as if they might die.

This amendment tries to provide a route for everyone to communicate better, and for the temperature to be lowered. It applies where there is a difference of opinion between the parents and the responsible doctor when a child is thought to be nearing the end of life. When staff become aware of a difference of opinion, the clinicians need to listen to the parents, and others concerned with the child’s welfare, who may have important information to inform thinking. Parents who want to seek a second opinion want to know the results of tests, such as radiology, for example, and, at the moment, they must go through a complex and sometimes slow process to access the information. Sadly, some parents only find out what was in the clinical record after their child has died. Of course, if there is any suspicion of child abuse, subsection (2)(b) would not apply, as it would be outwith the “reasonable steps” criterion.

Where another clinician from a reputable centre is suggesting a treatment, they should be asked to explain it, and the evidence base behind the suggestion, to avoid distortion of messaging—hence, subsection (2)(d) of the amendment. Clinicians, in explaining why they oppose a proposal, need to be able to explain to the parents what the “significant harm” in the proposal is. When taking any clinical decision, harms and burdens are weighed up against potential benefit. If a child is going to be taken into care, the test is whether it is of “significant harm” to leave the child where they are, rather than be taken into care. In some ways, this is similar, because the clinicians are being asked to show that it is significantly harmful for the child to pursue the parents’ proposal, rather than continuing with the current management plan—when it often involves withdrawing treatment and is likely to lead to death.

Some hospitals have excellent ethics committees to involve early. The Nuffield Council report recognises that there are very real difficulties in the concept of best interest when deciding not to treat, as it is often not clear to the parents why abandoning the hope of improvement is in the interests of the child. In an overcrowded NHS, unconscious bias can skew towards wanting a service to clear beds, when prognosis looks poor. However, parents know that the child has no interests once they are dead. Nuffield recommends that the views of parents should be accorded considerable weight in decisions about their child.

When the two parties are unable to resolve their difference of opinion, such a case would now go to the court immediately. This amendment suggests that a

“mediation process, acceptable to both parties”

should be allowed when, and only when, earlier attempts at resolution have failed, as in subsection (2)(e). A mediation process would be between the parents and the senior doctor with overall clinical responsibility. It cannot be delegated to a junior in training or to one of the nurses on the ward. If mediation fails, then, as now, the case would proceed to court. The amendment is clear that no doctor or institution would be required to provide a treatment which they do not feel comfortable giving. This is the current law. The amendment is also clear that the overriding principle is the principle, as laid out in current law, of the

“best interests of the child”

being paramount. If the child is Gillick-competent, such an amendment would not apply.

Similarly, the views of others, such as a social worker or health visitor who knows the family may provide important information. As is the case now, that information must be listened to, as it may relate to some safeguarding issues or other information unknown to either the clinical team or the court. The early steps outlined in this amendment should improve the quality of communication between parents and the medical team, thereby decreasing the need to go to mediation. The mediation process is to try to decrease the number of cases going to court. I beg to move.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite the noble Baroness to speak.

[Baroness Brinton (LD) [V]]

My Lords, I have put my name to Amendment 172. I thank the noble Baroness, Lady Finlay of Llandaff, for tabling this improved amendment, with important changes since Committee, as she has very helpfully explained to your Lordships’ House. I believe that this helps to find a way to balance the views of the child’s parents and the child’s doctors, and it is reassuring that many of the stakeholders from different perspectives have come to agreement on this.

The amendment also makes it clear that nothing affects the principle of the best interests of the child. This means that no medical professional could ever be forced to provide a medical treatment that they do not believe is in the best interests of the child, and that any other provider of such medical treatment would have to provide evidence during the mediation that this would benefit the child.

Another key reason for the need for this amendment is that at the moment mediation provision across England is inconsistent. While there is certainly excellence, there are also some problem areas. Having in legislation an independent mediation process made available at the earliest stage possible can help facilitate less confrontational conversations while supporting both sides in the argument.

The issue of parent-doctor conflicts will continue to persist frequently unless the Government can consider this amendment, and I strongly urge them to do so. If the noble Baroness, Lady Finlay, were to call a Division, we would support her on this, but I hope that the Minister will be able to provide some positive news.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

My Lords, the noble Baroness, Lady Masham, is also taking part remotely. I invite the noble Baroness to speak.

[Baroness Masham of Ilton (CB) [V]]

My Lords, I have my name to Amendment 172, and I congratulate my noble friend Lady Finlay of Llandaff on her persistence on this important matter of mediation. It is a proven way of dismantling conflicts before they reach the courts.

Over the years, there have been some tragic cases when relationships have broken down between doctors and family members. When this happens in a hospital environment, parents can feel backed into a corner, with no alternatives. Mediation gives the opportunity for the parents to give their views and to hear the doctors’ views too at the earliest stage.

Ending up in the courts costs parents, hospitals and the Government hundreds of thousands in legal fees and causes avoidable distress and concern to all those involved. The only people who win are the lawyers. Parents have to live with grief and the decisions which have been made for their child for the rest of their lives if the results are not good. They want to know that they tried everything possible to give their child the best chance.

I feel that there should be adequate training for doctors, nurses and social workers in the values of mediation so that there is a team approach to treating a child in a life-and-death situation. I hope the Minister understands the need for this amendment and will accept it.

--- Later in debate ---

[Lord Campbell-Savours (Lab) [V]]

My Lords, this is an important amendment. To me, it is the most important in the Bill. It concerns preservation of life in conditions of general pandemics. If you leave worldwide vaccine manufacturing programmes to the free market, you will never fully deliver. Profit will always trump the public good, unless the state intervenes in some regulatory form or another. This is basically why I am a Labour person.

With that in mind, it is clear that the more we are told that the current arrangements for licensing and manufacturing are necessary for reasons of quality control, the more I am convinced that this is not the only consideration in mind. There are other considerations—primarily the need to maximise profit. There is nothing wrong with profit if the justification is reasonable. It drives initiative and entrepreneurship. However, when there are wider issues involved, as in the case of a global pandemic which threatens the well-being of nations and the international economy, there must be a consideration of the wider public good and benefit. I am not convinced that, apart from the case of the AstraZeneca project, public benefit has been the driver.

In Committee, I set out in some detail a case wider than this amendment for worldwide licensing arrangements based on the original amendment of my noble friend Lady Chakrabarti. I remain confused by the Government’s position, which seems ever reliant on research and limited production at home, with volume production overseas. I would have thought that there are lessons to be learned about supply volatility from the case of oil from Russia. Equally, with both China and India leading the world in vaccine supply—at the same time as both countries remain reluctant to support us over certain areas of dispute and crisis in foreign policy—alarm bells should be ringing. I remain of the view that we in the United Kingdom should lead the world in this area of research, development, manufacturing, licensing and supply.

We are moving into an era of further pandemics as research-spawned accidental releases inevitably will reoccur, or perhaps they will not even be accidental in origin. There are huge foreign policy benefits to be gained arising out of being the world’s primary producer and licensee of these vaccines. When you help people, they remain indebted. That is the approach China is taking in many areas of its foreign policy.

I will give an example. The French Government funded my higher education in France 60 years ago. To this day, I remain indebted to France, with a lifetime feeling of obligation. This is often the case for foreign students. I believe that if we had been suppliers and licensees to the world over the recent period, in particular Africa and the third world, the payback would have been immeasurable, with huge implications for foreign policy.

I will exaggerate to make my case: suppose we had been supplier and licensee to China. Can noble Lords imagine what influence such beneficence would have had on Chinese public opinion and, perhaps ultimately, on Chinese foreign policy? A friend in need is a friend indeed—we should never forget that.

I appeal to the Government, even at this late stage in the current pandemic, to think long term, and create the vaccine supply, manufacturing and licensing programme that my noble friend Lady Chakrabarti is advocating. Her amendment seeks at least a temporary, time-agreed waiver. It is a start. I am using her amendment to argue a wider case, a new vision. Her excellent amendment puts in place a building block on which a longer-term strategy should be constructed. We should lead by helping others to help themselves. The rewards are inestimable.

[Lord Russell of Liverpool (CB)]

My Lords, I was happy to add my name to this amendment to give it a bit of cross-House balance. Like the noble Baroness, Lady Brinton, I am an officer of the all-party parliamentary group on coronavirus. In the last two years, we have had a bellyful of coronavirus; we have heard ad nauseum about the problems and the tragedies that it has created and encompassed, and that is partly what leads to this amendment.

It is self-evident that the United Kingdom, and most of the rest of the world, was unprepared. Countries that had experienced SARS, particularly in south-east Asia, had a better idea of what they were getting into. Frankly, however, for most of us in the West, it was the blind leading the blind. Looking in the mirror today—and accepting our failings, and the unease that we in the developed world should surely feel for largely having prioritised looking after our own—is for me, certainly, distinctly uncomfortable.

The aim of Amendment 174 is very simple: equitable access to affordable health technologies for all. One of the biggest challenges is how to deal with the exclusive intellectual property rights that exist in the healthcare sector. Only 7% of people in low-income countries have been double vaccinated. Only an additional 14% have had one dose.

Noble Lords should remember where the variants have come from. The exception, of course, is alpha, for which global Britain is responsible, so that is something that we can be proud of. Beta came from South Africa, gamma from Brazil, delta from India, and omicron is truly global because it started in about 10 countries simultaneously. The two countries that went it alone, rather proudly, in developing their own vaccines—China and Russia—have produced manifestly inferior vaccines, which have not been subject to proper, clinical peer scrutiny.

I give two examples of the problem we face. First, Pfizer’s new antiviral treatment excludes most Latin American countries, and generic versions—unless Pfizer does something about relaxing its intellectual property—may not be available in those countries until after 2041. Secondly, Tocilizumab, an antiviral manufactured by Roche, which is based on UK government-funded research, is unable to be manufactured in countries with established production capacity because Roche is enforcing its patents in these countries. There is a global shortage of this particular treatment.

Tackling the complex world of healthcare intellectual property is not easy. In my past career as a headhunter, I worked with clients that were large, complex, well-funded, international pharmaceutical companies, so I know full well the level of intellect and resource that they put into their intellectual property defences. We must apply ourselves in a disciplined and determined way at an international level; this is a chance for Great Britain to prove that it is indeed global. As an aside, during Oral Questions this morning, some of us on the Cross Benches were playing a game where, every time somebody from the Government Front Bench mentioned global Britain, another notional £10 clinked into the pockets of the Cross-Bench Christmas drinks fund; this afternoon, we had a particularly fruitful Oral Questions. As a mantra, it is meaningless unless it has real content behind it.

We need to develop a rapid response plan for the next pandemic. We will demonstrate that we have intellectual and moral myopia if we fail to do it. In a nod to Amendment 170, which we debated earlier, we should not show that we are content to let the less-developed world suffer from what I would describe as unassisted dying. That is unacceptable.

[Baroness Bennett of Manor Castle (GP)]

My Lords, I rise briefly to offer Green support for this amendment, which I would have signed had there been space.

The noble Baroness, Lady Chakrabarti, referred to today’s report that a watered-down version of the India-South Africa proposal for a TRIPS waiver looks likely to go through the WTO. I quote Max Lawson, co-chair of the People’s Vaccine Alliance:

“After almost 18 months of stalling and millions of deaths, the EU has climbed down and finally admitted that intellectual property rules and pharmaceutical monopolies are a barrier to vaccinating the world.”


Bouncing off the comments of the noble Lord, Lord Russell, I think that the Cross Benches might find an even larger drinks fund if they go for “world-leading” as the key phrase to identify. The comment from Mr Lawson shows that, collectively, the world has done very badly throughout the Covid pandemic and done very poorly by the global south. If the Government want to be world-leading, they could leap in right now and accept the noble Baroness’s amendment.