Health and Care Bill

Lord Brougham and Vaux Excerpts

Lords Hansard - Part 1 & Committee stage
Wednesday 9th February 2022 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, Amendment 284 would implement one of the major recommendations of the Independent Medicines and Medical Devices Safety Review. I will say from the start that I so welcome the government amendments. I thank the Minister and the civil servants for crafting them in such a thorough way.

There is one glitch, however, about which I have given the Minister forewarning. All the government amendments say that the Secretary of State “may”—and of course that is a very sneaky word. What we want to see is a more robust word: the Secretary of State “shall.”

However, I do not want to detract in any way from the burden of my amendment, which is that relationships between the pharmaceutical and the medical device industries on the one hand, and the hospitals, medical research institutes and individual clinicians on the other, can be a huge force for good. Industry collaborating with doctors, researchers and scientists working in the NHS, academia or elsewhere has led to great breakthroughs and great treatments that we have been able to introduce. No one should want to stop that happening—but we do have a right to see where the money goes. Despite all the undoubted good that collaboration between industry and the rest of healthcare brings, we know that there are long-standing concerns about undue influence.

We need transparency so that trust can be rebuilt where it has been undermined in the past. Voluntary arrangements are all well and good, but they have a drawback: they are voluntary; they are not a requirement; they carry no teeth. So I am encouraged to see that the ABPI, which represents many pharmaceutical companies in the UK, agrees. It is supportive of moving to mandatory disclosure.

Amendment 284 would make it a requirement for payment by the industry to teaching hospitals, research bodies and individual clinicians to be published by the companies themselves. Such legislation exists and works very effectively in the United States. It is called the Physician Payments Sunshine Act, and it has been in existence since 2010. All the information is held on a public website. Americans can see at a glance which pharmaceutical or device companies have made payments to physicians or others: when, why and how much. It is not just the US which benefits from this level of transparency; various European countries have similar legislation in place, and we should not be the poorer cousin.

I of course welcome the Government’s own amendments that are grouped with mine and very much look forward to what the Minister has to say about them. I hope we can all agree that transparency, trust and good, safe care go hand in hand. That is why the amendments are so important.

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

My Lords, I invite the noble Baroness, Lady Brinton, to speak remotely now.

[Baroness Brinton (LD) [V]]

My Lords, this amendment is a companion piece to the previous amendment on declarations of interest that we believe should be made by doctors and other regulated healthcare staff, and ensures that any companies involved in the production, buying or selling of pharmaceutical products or medical devices must publish any payments made to teaching hospitals, research institutions or individual clinicians. Whether someone wants to know about a doctor working with a pharma company, or the other way around, we need a system that provides a golden thread of transparency and accountability.

Reporting payments or benefits in kind by the relevant organisations and individuals receiving them ensures that the links between donors, recipients and their respective interests are always visible. Although it is, we hope, rare, this is more than just transparency. As in any walk of life, occasionally there is malpractice and fraud, which needs to be prevented. A register such as this helps to remind all those concerned of the rules.

I echo the comments made by the noble Baroness, Lady Cumberlege, that “may” is not strong enough: “shall” is important here. The noble Baroness also referred to the USA Sunshine register; and, as I said on the last group of amendments, we definitely need the disinfection of sunlight. Can the Minister say whether any such regulations on industry reporting might be published and brought into force?

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

My Lords, I invite the noble Lord, Lord Howarth of Newport, to speak remotely now.

[Lord Howarth of Newport (Lab) [V]]

My Lords, I thank the noble Baroness, Lady Cumberlege, for tabling Amendment 284. If we are to avoid the risk of corruption and maintain full public confidence, it is vital that there should be full disclosure of payments by commercial interests to hospitals—I would have thought to all hospitals, not just teaching hospitals—research institutions and clinicians. It is a good maxim to follow the money and to be able to do so.

In regard to research, there has long been public concern about business interests suborning researchers whose judgments and pronouncements influence public understanding, sometimes with important implications for public health. Corrupt scientists certified that DDT and pesticides used in agriculture were not harmful to public health. Exposure of that by Rachel Carson in her book Silent Spring did not end the mischief. Bogus research evidence was paid for for decades by the tobacco industry in a rearguard action to persuade Governments and the public that tobacco was not harmful to human health.

Today, firms in the food industry deploy spurious evidence and arguments about the damage certain foods do to human health. They have lobbied Government with considerable success to the terrible detriment of human health—it is good that the Bill limits the advertising of unhealthy foods. Scientists, paid by energy firms, have abetted those who deny that climate change is manmade.

Disclosure payments in regard to research will help, but more is needed. The noble Baroness might have considered—and may yet consider—tabling another amendment needed to underpin research ethics. The data on which research conclusions are based should be held independently. The Engineering and Physical Sciences Research Council rightly now requires researchers to deposit data connected to the research they have funded.

There is huge pressure, in a competitive environment, on scientists to publish research, and there have been notorious instances of fake science—scientific discoveries announced that were made up and whose results could not be replicated by other researchers. A paper entitled Fake Science and the Knowledge Crisis published by the Royal Society said,

“it is especially important that the scientific world as a whole upholds the highest standards of ethical behaviour, honesty and transparency, aiming to sustain the gold standards of research integrity and validated information.”

However, the authors go on:

“Sadly, a range of forces are working counter to this aspiration.”


It is good that the pharmaceutical industry in the United Kingdom supports the transparency that the amendment calls for. We should certainly match the best standards and practice in the USA and Europe.

The NHS holds huge budgets for drugs, medical equipment and hospital building; big commercial interests are at stake. There is scope for corruption if the system is weakly regulated. The scandal of PPE contracts has led to widespread anxieties about the integrity of procurement. The public want to believe that the NHS is free of corruption, and I am sure it mainly is, but reassurance is needed. As the noble Baroness, Lady Brinton, reminded us. in the old saying, sunlight is the best disinfectant. We need the transparency that the amendment would secure.

The government amendments are, certainly at first blush, welcome. But, as the noble Baroness, Lady Cumberlege, noted there is a conspicuous difference in language between her amendment, which says that companies “must” publish payments, and the Minister’s amendments, which say that the Secretary of State “may” require or regulate. That slide of language is liable to weaken public confidence. I hope the Minister will explain why he has used the word “may” and not “shall” or “must”.

The government amendments are as elaborate as the noble Baroness’s is simple, and they prompt some questions. In the Government’s Amendment 312B, subsection (6)(b) states:

“The regulations may … create exceptions from requirements to publish or provide information.”


What would those exceptions be? Subsection (8) states that the Secretary of State may,

“grant an exception … in a particular case.”

What sort of case? Earlier in Amendment 312B, subsection (1)(a) refers to “payments or other benefits”. I ask the Minister whether the disclosure requirements he envisages cover benefits in kind, including donations to political parties. whether made by big pharma or small local donors.

I do not want to be cynical. How can the Minister reassure those who are?

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[Baroness Chakrabarti (Lab)]

My Lords, Amendment 292 is in my name and that of my noble friends Lady Lawrence of Clarendon and Lord Boateng, and the noble Baroness, Lady Bennett of Manor Castle. I thank noble Lords from across the Committee and the People’s Vaccine Alliance—Saoirse Fitzpatrick of STOPAIDS, in particular—for their advice.

Last year, the Prime Minister lauded the successes of the UK’s vaccination programme as a result of “greed and capitalism”, but the virus-busting vaccines, treatments and tests were in no small part funded by taxpayers, supporting the work of scientists at universities, research institutions and small-scale biotech companies across the world. Over €93 billion of public money has gone into developing vaccines and therapeutics. The AstraZeneca vaccine developed at Oxford University was over 97% publicly funded.

Public investment at the beginning of the research process assumes the biggest risk at the point when there is no certainty that a product will be successful. It is only when effectiveness is clearer that big pharma swoops in and uses exclusive intellectual property rights to hold a monopoly over that product in the market. The risk is socialised but rewards are privatised and, crucially, monopolised. The NHS is paying twice for medicines: once for research and again through procurement.

Some estimates show the public paying for up to two-thirds of drug development, including research and clinical trials. Drugs are getting only more expensive, with estimates that the NHS procurement bill increased by nearly 10% over the last couple of years, to £20.9 billion. Yet there is still no guarantee of production at the volumes required to meet demand or that patients will be able to access health technologies at affordable prices, nor that scientists will be able to make use of the data, knowledge and technologies generated in the research process to develop improved follow-on products. Due to the opaqueness of the pharmaceutical industry, it is very difficult to track public funding. The terms of agreement, actual costs and prices charged—all these are kept behind closed doors.

The amendment seeks to change that for health technologies developed with public funding, as well as to define emergency procedures to expedite a sharing of research, data and intellectual property in the case of a pandemic. By adhering to the “public health condition”, the Secretary of State and all public authorities would ensure that

“a proportionate share of any intellectual property resulting from the public funding … is subject to Crown ownership and openly licensed … a proportionate share of any private profit from public funding is re-invested in further public health-related research, and … public funding is published and taken into account in … the setting of reasonable prices for the public procurement of medicines domestically and internationally.”

Open licensing would allow production in a competitive generic market, bringing down the price of medicines. A study published in the BMJ showed how the price of oncology drugs could decrease by between 75% and 90%. We saw this with ARVs for HIV/AIDS, and how crucial that was in fighting that pandemic by reducing costs from over $10,000 per person per year to under $100. Reinvesting a proportion of profits could ensure that they go towards health priorities rather than financialised practices or the development of me-too drugs—sufficiently different to obtain patent protection but without added therapeutic value, compared with existing products.

There is recent precedent for more transparency and conditionality around public funding in Italy and France, while the European Union is looking at how to track public funding and measure societal impact. Even our Government are beginning to think about public interest conditions for future pandemic tools to ensure access in low- and middle-income countries. This is a recommendation of the UK’s pandemic preparedness partnership’s 100 Days Mission report, published during the UK’s G7 presidency.

There are also circumstances where there has been no public funding but the price or volume restrictions of a product are preventing widespread access. In that case, the amendment calls for a recommitment to the use of pre-existing public health safeguards within the Trade-Related Aspects of Intellectual Property Rights—TRIPS—Agreement. These flexibilities include the use of compulsory licences when intellectual property monopolies prevent access to a medicine. They enable a Government to license another manufacturer to produce a generic or biosimilar version of a patented health technology at a much lower price. These can be used at any time by any WTO member; they have already been implemented more than 100 times between 2011 and 2016.

The need to use flexibilities has never been greater, with ever more drugs coming to market with a price tag of over £1 million per dose. For example, the NHS is currently paying a list price of £1.795 million for a single dose of Zolgensma to treat spinal muscular atrophy—SMA. It is the most expensive drug in the world, despite public and philanthropic funding. A Crown-use licence would permit the Government to allow a third-party manufacturer to make a biosimilar version at a discounted price.

We must also stand with other countries in the face of huge and unconscionable pressure from big pharma when TRIPS flexibilities are used. In 2007, we supported the Thai Government when they applied for a compulsory licence to produce a more affordable antiretroviral drug to treat HIV and were met with a threat from the pharmaceutical company AbbVie that they would lose access to all its other products. We could show leadership and solidarity again. Multinational corporations, whether tech, pharma or other corporations that noble Lords have considered in your Lordships’ House in recent times, warrant international democratic governance, regulation and restraint. Hence the last part of the amendment.

In future pandemics, we must not remake the continuing mistakes of this one. Monopolies which profiteer from poverty and sickness are bad enough at the best of times. But in a global emergency, when so many ordinary citizens, health workers and ethical businesses have sacrificed so much by way of livelihoods, liberties and lives, such conduct is totally amoral. Pharmaceutical companies’ refusal to share manufacturing know-how has led to grotesque vaccine inequity. Only 10% of people in low-income countries have received a single jab. So the amendment stipulates immediate action as soon as the World Health Organization declares a pandemic. The temporary—I stress, temporary —waiver of UK registered patents, industrial designs and other intellectual property rights relating to undisclosed information necessary for combating a pandemic, and emergency compulsory directions to enable domestic manufacturing, would mean that any company within the UK with the capacity could be making these products. It would allow products to be shipped internationally and allow companies across the world access to the critical data and rights to produce pandemic tools at scale for their own people.

The Indian and South African proposal to temporarily waive the TRIPS agreement is supported by more than 100 countries. It is only opposed by the European Union, Switzerland and our own Government. The waiver could allow the 100-plus potential mRNA producers across Latin America, Asia and Africa access to critical clinical data and manufacturing know-how required to make mRNA vaccines, without fear of litigation in the worldwide race to beat variants of the virus.

New treatments are in high demand, and high-income countries have already brought up the lion’s share. We will be facing a treatment apartheid on top of a vaccine one if the United Kingdom and others do not shift their position urgently. Just last week, it was reported that the director-general of the WTO, Ngozi Okonjo-Iweala, was hopeful of a breakthrough in the long-standing waiver discussions. However, it is incredibly important that any compromise is not overly restrictive geographically or in terms of products or types of intellectual property.

The UK Government must stop saying that a waiver will take too long to implement while simultaneously blocking its agreement. They should end their group hug with the EU, Switzerland and big pharma and start embracing and empowering the global south and wider world. The line that temporarily waiving TRIPS will stifle future innovation ignores the public money that funded the riskiest parts of developing vaccines and treatments, and how innovation works. Sharing research data and clinical trials results with great minds around the world creates the conditions for competitive collaboration, vying to have the best results but also sharing lessons learned and supporting each other. This is how we have made great leaps in the past, as with the human genome project, where public funding supported a global collaboration which has changed modern science.

This is about improving access to affordable, life-saving health technologies for our NHS and the world to combat pandemics and improve health. It is about ensuring that we get the best from our biomedical innovation, especially when we are investing so much money and expertise and putting human beings through clinical trials. In a global health emergency, not sharing life-saving knowledge is as wicked as blocking access to emergency exits from a crowded building in a raging fire. I beg to move.

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

My Lords, I call the noble Baroness, Lady Brinton, who is taking part remotely.

[Baroness Brinton (LD) [V]]

My Lords, I am a former trustee of UNICEF UK and, before that, Christian Blind Mission, a global disability charity. I have seen first hand the two-tier system of access to global vaccines and medications. It is a pleasure to hear the noble Baroness, Lady Chakrabarti, set out how, through her Amendment 292, the UK can fulfil its global public health responsibilities for investment in research into vaccines and other health technologies and how, in an emergency, companies developing these goods would also be required to help. She has introduced it in her usual effective and persuasive way. I suspect I am not alone in valuing her contributions to your Lordships’ House.

Throughout this pandemic, the Government have rightly congratulated themselves on their investment in research on the range of vaccines developed in rapid time and also the extensive, rapid clinical trials assuring their safety prior to approval. However, less satisfactory has been the UK Government’s view about their international moral responsibilities as a member of the OECD and one of the high-income countries with access to much-respected vaccination and pharmaceutical research. The World Health Organization has said right from the start of the pandemic that no country is safe until all are safe, but low and middle-income countries have not just not had the advantage we have; we have reneged on our promises to them over the last two years.

The UK Government repeatedly tell us that they have donated cash to Gavi and COVAX, but the reality is that we need to help those countries now to become able to manufacture their own medicines and vaccines in the light of emergencies such as future pandemics. The old adage of “Give a child a fish, feed them for a day. Teach a child to fish, feed him for ever” is so true. Here, the fishing rod is the skills to manufacture and sell medications in a future pandemic.

The TRIPS waiver, or intellectual property waiver, is supported by the World Health Organization and many large charities and countries, including the USA and others. However, as we have heard, the EU, the UK and Switzerland are not in that bracket. Its intention is to increase vaccine production in developing countries by sharing intellectual property for vaccines publicly for the period of that pandemic. It is needed because the data for November 2021, nearly a year from the first vaccine being delivered, showed that just 4.2% of people in low-income countries had received their first Covid vaccine. Across Africa, 6.3% are now fully vaccinated. COVAX has shipped just one-third of what it had expected would be available by the end of October—those expectations were based on promises from high-income countries. Export bans, manufacturing delays and bets on vaccines that have not received regulatory approval have also held up deliveries. Worse, we know that in this country we have thrown away vaccines rather than redirect them if we chose not to use them at a particular time.

It is time that the UK took a leading role in fulfilling the World Health Organization’s call. Now is the time to make all countries safe, not just for Covid but in preparation for whatever future pandemics may occur, and make sure every country is safe in the future.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

The noble Lord, Lord Howarth of Newport, is also taking part remotely. I invite the noble Lord to speak.

[Lord Howarth of Newport (Lab) [V]]

My Lords, this amendment raises major issues which warrant full debate outside the confines of the Health and Care Bill, but I am most grateful to my noble friend Lady Chakrabarti for providing us with this opportunity to consider them. I support the principle of the public health condition, as articulated in the amendment and as she described it.

The inflexible application of the intellectual property regime during the pandemic has been unconscionable. Huge numbers of people have died unnecessarily in low-income countries. Rich countries not only pre-empted and hoarded supplies beyond their reasonable needs but refused to relax the intellectual property regime to enable free manufacture of vaccines in low-income countries. South Africa and India led the appeal, on behalf of low-income countries, to the World Trade Organization to waive IP protections—patents, copyright, trade secrets. That appeal was rejected contemptuously and cruelly. The UK is among the culprits; the US and France support the waiver, but we do not.

The statement by the United Kingdom Government to the TRIPS council on 16 October 2020 is a piece of Mandarin cant: amoral, inhuman and disconnected from the realities of life and death for billions of people. Let me quote from it:

“Beyond hypotheticals, we have not identified clear ways in which IP has acted as a barrier to accessing vaccines, treatments, or technologies in the global response to COVID-19.”


The Covid crisis is not hypothetical. The refusal to support the free production of vaccines in low-income countries has had catastrophic consequences, yet still government Ministers repeat this theme.

The Government also said in their statement:

“A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address an unproven problem.”


The pandemic is an extreme situation and the problem is staring at us—howling at us. At least 350 million cases of Covid have been confirmed globally, and estimates of the number of deaths from Covid range from 5.75 million to much higher figures.

The Government stated that:

“Multiple factors need to be considered … These include increasing manufacturing and distribution capacity”.


Indeed. But the response to this challenge by our Government was to cut aid funding massively, from 0.7% of GDP to 0.5% of a declining GDP.

The Government then said:

“The world urgently needs access for all to … vaccines … which is why a strong and robust … IP system … is vital.”


That is a non sequitur to end all non sequiturs.

The last quote I will give from the Government’s statement to the TRIPS council is this:

“The UK has played a leading role in … ensuring no-one is left behind”.


Do the Government really believe that? It seems to me to be beyond satire.

If we refer to Our World in Data, a website from the University of Oxford, for up-to-date figures, we find that in low-income countries 10% of people have had at least one dose of vaccine, while in high-income countries the figure is 78%. Africa has been most wretchedly left behind: on the continent of Africa 15.2% of people have had one dose and only 28% are fully vaccinated, whereas in the United Kingdom 78% of people have had one dose and 73% are fully vaccinated. It is not surprising that African leaders have complained bitterly of vaccine apartheid. How does the Minister refute that charge?

I feel profound shame at the behaviour of our Government; not only have they been morally purblind but they have been recklessly imprudent. Consider the economic consequences. The IMF has downgraded African economic prospects. Do we gain from the impoverishment of Africa? Think only of the implications for migration. Consider the diplomatic consequences. Africa has turned to China. How does our vaccine nationalism assist post-Brexit Britain to develop relationships around the world? Consider the health and economic consequences for ourselves. If we do not tackle Covid globally, we risk continuing damage to our economy, and our physical and mental health, as we reel in and out of lockdowns and restrictions. Consider the consequences for the world. Professor Sarah Gilbert has warned that the biggest threat is Covid spreading and mutating uninhibited in unvaccinated countries. No one is safe until we are all safe. Dr Hans Kluge, the World Health Organization regional director for Europe, last week demanded a drastic and uncompromising increase in vaccine sharing across borders. He stated:

“We cannot accept vaccine inequity for one more day—vaccines must be for everyone”.


The United Kingdom has not paid its fair share of funding to the WHO accelerator programme. The UK committed to donating 100 million doses through COVAX, but what we have actually done falls far short of that; at the end of 2021, the figure was 30 million doses. Does the Minister accept that our Government have acted appallingly? Will he accept Amendment 292 and will the Government incorporate its principles, wherever relevant, in policy and legislation?