Covid-19: Vaccines and Medical Equipment

Baroness Sheehan Excerpts

Wednesday 25th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, our forthcoming chairmanship of the G7, at the beginning of next year, is giving us a good opportunity to engage with our partners, including the United States, on issues such as the vaccine. We are grateful to Gavi, which is doing a terrific job at buying the vaccine; it is being characterised by what I would term commercial savviness. The spending review implications for ODA have yet to be published fully, but I reassure the noble Lord that funding the global response to the pandemic and the equitable distribution of vaccines, in particular, remains a massive commitment for the Government.

[Baroness Sheehan (LD)]

My Lords, notwithstanding the good use of UK aid via the WHO’s COVAX initiative, evidence shows that treatment providers and Governments have had to grapple with intellectual property barriers to essential products such as therapeutics, respirators and reagents for test kits. Do the Government maintain the position they held at the WTO TRIPS council meeting of 16 October that IP barriers to the Covid-19 response are hypothetical and will not stand in the way of scaling up vaccine manufacture?

[Lord Bethell (Con)]

My Lords, the question of vaccine intellectual property is a delicate one because, as was mentioned earlier, we rely on the private sector for a lot of funding and research, and for supplying the research. So, we are respectful of intellectual property as a principle. None the less, we are also grateful to vaccine manufacturers that have taken an open-source approach to vaccine intellectual property and have made local manufacturing available, so that there can be an extremely wide distribution of vaccines, including to those in the developing world who would otherwise struggle.

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Lord Bethell (Con)]

I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.

[Baroness Sheehan (LD) [V]]

My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.

I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.

At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.

The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.

My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.

I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?

I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.

On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.

In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.

Covid-19: Test Results

Baroness Sheehan Excerpts

Tuesday 27th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, on the app, the noble Baroness alludes to two separate issues. The first is the exposure notices, which are not sent by the NHS app but by the Apple telephone device. We have put in the new version of the NHS app a way of mitigating those exposure notices. She is entirely right that the app has no idea of your geography; that is the genius of the app and its commitment to privacy. It means that we cannot tell you where you were exposed, but also that your location and privacy are protected. On social care, we are investing in a large number of trials to try to speed up mass social care testing, including bulk testing and the use of wastewater, which we discussed earlier.

[Baroness Sheehan (LD) [V]]

My Lords, on 25 September, NHS England gave guidance specifically to implement pool testing to speed up testing times. Since then, what increase in pool testing has taken place?

[Lord Bethell (Con)]

My Lords, pool testing offers a huge opportunity to cover a large amount of ground very quickly, and there are some workplace testing champions for it, including Amazon. However, it has some restrictions, in particular not knowing the identity of the person who might have tested positive. That is why we are running a large number of pilots at the moment and investing heavily in trying to figure out this exciting but challenging technology. We will deploy it the moment we can find a model that works.

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

The implementation of the recommendations of the Cumberlege report would afford an opportunity for the Government to do, and be seen to do, the right thing by patients, particularly women whose avoidable suffering has been caused by medical mistreatment over decades—all too often because of what looks like inherent misogyny on the part of male medics and a consequent trivialisation of the pain, discomfort and longer-term harm which so many women have had to endure. Parliament now has the opportunity not only to put measures in place ensuring that voices are heard in the future but to insist that an independent taskforce is appointed to implement the recommendations of the Cumberlege review without further delay. It is also a chance to bury those who have told the noble Baroness that they intend to bury her report and its recommendations. I wish her amendments well.

[Baroness Sheehan (LD) [V]]

My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.

I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read

“the appropriate authority must act with a view to ensuring”.

This offers greater purpose of intent on the part of the Government of the day than the existing

“the appropriate authority must have regard to”.

It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.

It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.

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Moved by

[Baroness Sheehan]

19: Clause 1, page 1, line 12, at end insert—
“(d) citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966; (e) the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) which include but are not limited to—(i) the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted;(ii) the right to determine what constitutes a national emergency and circumstances of extreme urgency;(iii) the freedom to establish the regime of exhaustion of intellectual property rights.”

[Baroness Sheehan (LD) [V]]

My Lords, I metaphorically rise to move Amendment 19, which is in my name and that of my noble friends Lady Jolly and Lord Sharkey and the noble Lord, Lord Alton, whose support is always very welcome. I look forward to the contributions from other noble Lords who have signalled their intention to speak. It is a matter of deep frustration that a number of noble Lords who wished to contribute to this debate are instead committed to the equally important debate on the internal markets Bill, which is pitted directly against this Bill.

Amendment 19 has been tabled simply to ensure that fair access to medicines is a core aim of the Bill. It would root the Bill in the International Covenant on Economic, Social and Cultural Rights of 1966, which is a binding international human rights treaty that we in the UK ratified in 1976. The amendment would put into the Bill the fundamental right of every citizen

“to access medicines as part of the right to the highest attainable standard of physical and mental health.”

Fair access to medicines is an issue at the forefront of concerns expressed by patients’ groups. There are regular reports in the media about price gouging by pharmaceutical companies. Furthermore, one of the key calls in the collated briefing of the Royal College of Physicians, the Faculty of Pharmaceutical Medicine and the British Association of Dermatologists is that:

“The Bill must include provisions which allow for review of processes for issuing sole manufacturing licenses and consider the use of price control mechanisms in relation to costs of production, to increase access to medicines at fair prices.”


Yet this issue was not brought up during the Bill’s passage through the other place, nor does it feature directly in any other amendment before the Committee. So I hope that your Lordships will forgive what will be a rather full presentation of the important issues raised in the amendment.

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

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

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.

[Baroness Sheehan (LD) [V]]

My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.

The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.

The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?

Medicines and Medical Devices Bill

Baroness Sheehan Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Sheehan (LD)]

My Lords, I will raise an issue that was not raised in the other place; I cannot hope to do it justice in four minutes. However, it is topical and urgent and, as confirmed by the Public Bill Office, within scope.

A safe and effective vaccine for Covid-19 is critical if we are to return to life as we knew it just a few short months ago. One does not yet exist. There are promising candidates out there, but we know from our experience in setting up an efficient testing regime that it is not easy to get from concept to delivery, however much of a world-beater a candidate may be. Bearing that in mind, thought and planning are necessary to help us beat this disease. Moreover—this point lies at the crux of my contribution today—we must act in unison with all countries of the world to ensure equitable access for all to any successful vaccines and treatments, because until everyone is safe, no one is safe.

Our experience here also shows that a small number of local cases can very soon become an outbreak and stringent restrictions have to be reimposed, Glasgow being the most recent example. It does not need a great leap of imagination to extrapolate this to the global stage. We really do all have to work together and co-ordinate action. Pharmaceutical companies have to play their part too.

Let us suppose that a safe and effective vaccine is found. The volumes of production required to inoculate the entire global population will be staggering and vastly outstrip the manufacturing capacity of individual companies. Holding exclusive licences over Covid-19 health technologies will not only affect pricing and hinder further research but prevent countries producing the volumes needed. Given that the UK, US, Japan and the EU countries have already secured over 1.8 billion of CEPI’s estimated 2 billion to 4 billion dose volume available until the end of 2021, the sharing of IP and know-how will be key to scaling up manufacturing capacity to meet global demand, in particular to ensure that low and middle-income countries can access a Covid-19 vaccine. To control the spread of Covid-19, it is crucial for all countries to be able to vaccinate the minimum 20% of their population necessary to protect key workers and vital health systems that, once lost, will take much time and money to reinstate.

Together with partners such as Gavi and CEPI, the WHO has been working to co-ordinate global action, resulting in myriad acronyms—the ACT accelerator, the AMC COVAX facility and CTAP, among many others. It is good that the Government have supported these initiatives, but—this is the huge part—they lack safeguards to ensure that vaccines and treatments, often resulting from huge investment from public purses, will be made available for all at a fair price.

I will give just a couple of examples of why these safeguards are so necessary. Gilead’s Remdesivir has been proven to reduce the need for mechanical ventilation for Covid-19 patients in hospital. However, with monopoly protection, Gilead was able to charge the US $2,340 per five-day treatment course of the drug, despite the substantial amount of public funding to develop the drug and researchers at the University of Liverpool calculating that the drug can be made for $9 at a reasonable profit. AstraZeneca has said it will supply the vaccine at cost to the UK Government during the pandemic phase, but what price will the NHS have to pay post pandemic? What happens to the money paid in advance if the vaccine is not approved? The contract between the UK Government and AstraZeneca has still not been published.

The Bill represents a timely opportunity to ensure that intellectual property rights support public health imperatives, as per the 2001 Doha declaration on trade-related aspects of intellectual property rights, TRIPS. The Government also have another tool in the issuance of Crown-use licences, similar to steps taken by countries such as Australia, Canada and Germany. In conclusion, will the Government take up the International Trade Select Committee’s recommendation to evaluate the case for measures to allow compulsory licensing, so that Covid-19 technologies are available as quickly, cheaply and widely as possible?

Health Protection (Coronavirus, Restrictions) (No. 2) (England) Regulations 2020

Baroness Sheehan Excerpts

Friday 24th July 2020 Lords Chamber

[Baroness Sheehan (LD) [V]]

My Lords, just this morning the Lords Science and Technology Committee published an open letter to the Prime Minister reflecting sobering evidence from lauded health and science professionals. Clearly, we must get ahead of the virus before a resurgence of Covid-19 and winter flu overwhelm a health service already on its knees. We have heard that symptomatic testing and its follow-through is inadequate. Granular data is still not reaching local authorities and no targeted regime for asymptomatic testing is in place. We have heard that it is essential that infection rates come down, but the latest ONS data tells us that the numbers testing positive in England have stopped coming down, and those figures do not include the impact of loosening lockdown from 4 July. Essentially, winter is coming and we are not ready. Trust in our leaders is fading fast.

This is no way to deal with a fast-moving killer pandemic. A minute’s speaking time—let alone a review of these regulations due the day after Parliament rises—makes a mockery of parliamentary scrutiny and the gravity of the situation.

Covid-19 Update

Baroness Sheehan Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

The noble Lord is right that the R figure is important, but in many ways, at this stage of the epidemic, the prevalence figure—the total number of people who carry the disease—is more meaningful. A higher R on a smaller prevalence is less worrying than a smaller R on a higher prevalence. As to having regional Rs, the data to date has not been strong enough for that to be a reliable figure. However, we are working towards that situation and I can envisage a moment when it would happen.

[Baroness Sheehan (LD) [V]]

Can the Minister say categorically that there will be enough properly equipped staff and support staff across all departments in local hospitals in Leicester to cope with the upcoming spike in admissions? What are the plans if local hospital capacity is breached? Will the Minister categorically assure the House that there will be no transfers from hospitals into care homes as a consequence of the projected spike in admissions?

[Lord Bethell]

I pay tribute to the NHS in the Leicester area, which has done magnificently. I understand that the facilities there are extremely resilient. In Leicester, as in many other places, a major source of concern is the spread of the disease among younger, working-age people, particularly those in their 20s and 30s, many of whom are not showing symptoms—are not touched negatively by the disease and may be socialising—but become infectious to their parents and grandparents. That is the cycle that we have seen in places such as Texas where, after the Easter break, young people led to a large outbreak of the disease. At this stage, hospitals are not facing the pressure, but we are leaning into the disease to prevent the cycle from heading that way.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2020

Baroness Sheehan Excerpts

Monday 8th June 2020 Lords Chamber

[Baroness Sheehan (LD) [V]]

My Lords, I add my thanks to the noble Lord, Lord Hunt of Kings Heath, for tabling this regret Motion. It gives me an opportunity to give heartfelt thanks to staff in care homes, who have gone above and beyond the call of duty to care for the vulnerable elderly, often at risk to their own lives, and many of them are from BAME communities.

I will confine my remarks to the role of the private sector since the 1980s, when the responsibility for social care was moved from local authorities to private providers and others. Money was then readily available from banks for a business model that had government money behind it, and a growing clientele from an ageing population. Unsurprisingly, global private equity, sovereign wealth and hedge funds piled into the sector. However, what role has this corporate debt business model played in the growing social care crisis over the last three decades, the tragic culmination of which we see today, with the unacceptably high death toll in care homes? Is this a suitable model for businesses with huge social responsibilities? Does it lend itself to putting a protective ring around vulnerable people when they need it? I suggest not. Does the Minister agree that servicing debt from taxpayers’ money and from people funding their own care is not a good look, especially when the people who suffer when things go wrong are the elderly and infirm?

This pandemic has shown that, given that public money is contributing to public care, we need better scrutiny of the industry’s finances, as well as public accountability of private equity-owned care homes. Looking at the example of the Four Seasons debacle, in 2016, even as it hurtled towards insolvency, its directors were paid a total of £2.71 million, of which the highest paid received over £1.5 million. In 2019, the firm went into receivership. Who asks the questions when something like this happens in the care sector? Who are the individuals profiting, who take the money and run—leaving it to taxpayers to pick up the tab—and how do we do identify them when they hide behind complex financial structures, many of which are listed offshore? Does the Minister agree that a Government bailout for such businesses would be unacceptable?

The sector desperately needs urgent reform, and I hope that the Government will do what they have promised: bring forward a plan—this time with proper public oversight—based on open and good governance, one that really does provide care from the cradle to the grave.

Covid-19: Extent of Infection

Baroness Sheehan Excerpts

Wednesday 22nd April 2020 Lords Chamber

Asked by

[Baroness Sheehan]

To ask Her Majesty’s Government what proportion of people in the United Kingdom have been found to have had COVID-19; and what assessment they have made of the impact of that figure on their policies towards lifting the restrictions in place as a result of the pandemic.

The Question was considered in a Virtual Proceeding via video call.

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[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

As of 21 April, 129,044 people have tested positive for Covid-19. This represents less than 0.02% of the population. When the evidence demonstrates that it is safe to do so, we will adjust the lockdown arrangements. We have set out the five conditions that need to be met before lockdown measures are adjusted. These include having reliable data from SAGE showing that the rate of infections is decreasing to manageable levels across the board.

[Baroness Sheehan (LD)]

My Lords, it is very clear that testing is the way out of this. First, there is the immediate urgency of testing front-line health and care workers exposed to high viral loads through lack of proper PPE, and we could do this now if the Government would give the go-ahead to local private research labs with the necessary level-2 clearance, which would not take resources from Public Health England’s needs. Secondly, there is the urgent need for mass testing. Why are the Government forgoing the first in favour of a gold-standard testing regime that they can control from the centre to deliver the second? Can they not do both?

[Lord Bethell]

I thank the noble Baroness, Lady Sheehan, for a very clear Question. I can reassure her on three points. First, front-line staff in the NHS and in care homes are eligible for test on request and we will be opening lines so that they can phone and book their own testing shortly. Secondly, I commend and thank those private research labs already contributing enormously to our testing regime. Thirdly, mass testing is one of the options that we are looking at: the Cabinet Office is devising plans for the medium term and will be publishing them shortly.