Medicines and Medical Devices Bill

Lord Alton of Liverpool Excerpts

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

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.

We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.

However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.

Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?

Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:

“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.


The end of the paragraph says that applications for marketing authorisation for a medicinal product must

“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”

For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.

That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.

Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,

“have two special objects in view with regard to disease, namely, to do good or to do no harm.”

The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.

[Lord Alton of Liverpool (CB)]

My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.

At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.

I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,

“the safety of human medicines as the overriding consideration”

the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.

Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”

The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.

As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.

I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was

“disjointed, siloed, unresponsive, and defensive.”

Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.

The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.

At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have

“lived a life wracked by guilt.”

Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.

--- Later in debate ---

I would like to end by saying thank you to STOPAIDS and its coalition partners for their tireless work on this issue, no doubt driven by their bitter experience during the HIV/AIDS pandemic—or global epidemic, whichever term you prefer. However you look at it, they more than most understand the urgency of putting safeguards on to the face of the only Bill we will see for some time on medicines and medical devices. No one in Britain should die needlessly while the NHS is held to ransom by unscrupulous pharmaceutical companies. I beg to move.

[Lord Alton of Liverpool (CB)]

My Lords, in her prescient, topical and important speech, the noble Baroness, Lady Sheehan, asked a number of important questions of the Minister. I look forward, as I know other Members of the Committee will, to his response later in his remarks. The noble Baroness was right to remind us of the importance of fair access to medicine and the role of pharmaceuticals. Any vaccination programme for Covid-19 should be equitable and fair. She referred in her remarks to some work done at Liverpool University, which I will return to a bit later in my remarks. In her amendment specifically, she draws our attention to the International Covenant on Economic, Social and Cultural Rights of 1966, and, as she has done in her remarks, reminds us of the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights—TRIPS.

Earlier this year, with other noble Lords who serve on the International Relations and Defence Committee, I participated in hearings which led to the publication on 10 July of our report entitled The UK and Sub-Saharan Africa: prosperity, peace and development co-operation. The inquiry was chaired by the noble Baroness, Lady Anelay of St Johns. We became acutely aware of the potentially catastrophic effect of Covid-19 on already fragile economies and societies. John Hopkins University suggests that across the continent of Africa, with its population of around 1 billion people, there have been about 37,000 deaths, compared with 230,000 in Europe. Indeed, there have been more deaths in the United Kingdom than in the whole of Africa. But we must treat the data with some caution and even scepticism. Reporting in many places is rudimentary, with Nigeria carrying out just 2.7 tests per 1,000 people, compared with 381 in the United Kingdom, so the data may have to be treated with caution.

Mercifully, the reported death rate—18,000 in South Africa, for instance—does seem to be lower than in some parts of the world, perhaps assisted by younger populations; few homes for the elderly; less common incidence of type-2 diabetes and obesity; more outdoor living and low travel; and experience of dealing with Ebola, malaria and AIDS. We should nevertheless be concerned that, as recently as last week, the World Health Organization said there had been a substantial rise in deaths and recognised that disparities in our health systems and economic power could still see an acceleration in infections and fatalities.

The smouldering pandemic in Africa has been held at bay by swift and significant lockdowns in many African countries, leading inevitably to significant loss of jobs. That cannot be sustained indefinitely. These fragile economies will see increases in destitution and chronic poverty if we are unable to ensure protection for all as and when a vaccine becomes available.

James Duddridge MP, the Africa Minister, told the inquiry that, as a consequence of Covid-19, the World Bank projected 40 million to 60 million additional individuals falling into extreme poverty, and it has been projected that the economy of sub-Saharan Africa will be between 2.1% and 5.1% smaller by the end of the year. The London School of Hygiene & Tropical Medicine told the inquiry that the region was likely to face particular contextual challenges from Covid-19, including

“economic, social and cultural inequalities, lack of personal protective equipment … and the additional health burden of communicable and non-communicable diseases”.

It cited three factors which could worsen the impact:

“overcrowding and large household sizes”,

which increases transmissibility, a

“high baseline prevalence of co-morbidities”

and

“lack of intensive care capacity”.

Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) Regulations 2020

Lord Alton of Liverpool Excerpts

Friday 25th September 2020 Lords Chamber

[Lord Alton of Liverpool (CB) [V]]

My Lords, I declare an interest as I live in the north-west of England, as do members of my family, one of whom is an A&E doctor working with Covid patients.

Greater Manchester’s mayor, Andy Burnham, has described the situation in the region as “chaotic”. Across the political divide, Bolton’s MP, Chris Green, laments a breakdown in the communication of decisions. Constantly changing messaging has been buttressed by muddle and confusion. Take my unanswered Written Questions about why grandparents are prohibited from helping frontline workers with their young grandchildren, while simultaneously, several separate adults have been able to go to a public house together. Others, urged to return to the office just weeks ago, are now told not to, unless it is essential.

We must be honest with the public about risks but let them judge for themselves. The priority must be to protect the vulnerable, remembering that there were nearly 30,000 extra care home deaths between 2 March and June 12 this year, compared with the same period in 2019. A new study in the Lancet of data from Salford found that between March and May, diagnoses of serious health conditions halved, with lethal consequences.

For the general population, clearer decisions should be decided more locally, as in Germany and South Korea, where decentralisation has been effective. An over-centralised “pushmi-pullyu”, stop-start approach destroys jobs and drives up unemployment. That in turn will have catastrophic consequences across the north-west every bit as destructive of health and well-being as Covid-19. Chaos and confusion undermine confidence in government, while an emasculated Parliament gives the illusion of accountability and scrutiny. Our loss of liberty under the cover of Covid-19, and the intolerable threat to use our Armed Forces to enforce decrees and edicts touching every aspect of our lives, is simply not acceptable, and Ministers need to understand that.

Medicines and Medical Devices Bill

Lord Alton of Liverpool Excerpts

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

[Lord Alton of Liverpool (CB)]

My Lords, I declare an interest as vice-chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests. I want to raise two issues: Primodos, which is part of the investigation conducted by the noble Baroness, Lady Cumberlege; and the violation of human rights in the trading and misuse of organs and human tissue, referred to earlier by the noble Lords, Lord Hunt of Kings Heath and Lord Collins, and the noble Baroness, Lady Northover.

The Minister knows how much I admire the noble Baroness, Lady Cumberlege, but I reiterate my whole hearted support for her report and recommendations, and I place again on record my admiration for the sensitive way in which she collected evidence, dealt with the many people who were affected by these scandals and brought forward these admirable recommendations. Parliament must now ensure that the report does not gather dust. The Royal College of Surgeons rightly draws attention to the review’s recommendation of a patient safety commissioner, as referred to earlier, and I look forward to hearing from the Minister what we are going to do about that.

It is over 10 years since I first questioned Ministers about Primodos after a man called Karl Murphy came to my university office and showed me the disabilities with which he has had to live all his life. Following the recent Sky TV documentary, he emailed me last week saying:

“the lies and deceit I have seen regarding this drug is an utter disgrace … I really do hope that the Government and Bayer have some respect and understanding of what these families are going through.”

The redoubtable Marie Lyon has refused over all these years to let this scandal be swept under the carpet, and I am glad that the Minister heard from her first-hand only yesterday. She made a telling point to me that in appointing Stephen Lightfoot, an ex-director of Bayer, as the new chair of the MHRA, they have clearly learned absolutely nothing about conflicts of interest and public perception and confidence. In the light of such appointments and reports of five scientists walking out of a task force for back pain after finding out that a briefing paper was funded by the drug company Grünenthal, perhaps the Minister will say what the Government will be doing to police conflicts of interest and the suppression or manipulation of data.

If Primodos teaches us anything, it is the importance of the independent assessment and scrutiny of all clinical trials. But, like others, I would like to see the Bill tackle the misuse of human tissue and organs. In the letter sent yesterday by the Minister, he says the

“government takes these allegations seriously and we continue to monitor all available evidence”,

but monitoring is simply not enough.

Two years ago, in August 2018, along with Professor Jo Martin, the president of the Royal College of Pathologists, I wrote to the Times after the NEC in Birmingham hosted the exhibition referred to by the noble Lord, Lord Collins. It was called “Real Bodies” and from the company Imagine Exhibitions. The exhibition consisted of human corpses and body parts. It advertised those exhibits as

“real human specimens that have been respectfully preserved”.

They were categorised as “unclaimed bodies”, with no relatives to identify them. As we heard, in advance of the American equivalent of that exhibition it was stated in a disclaimer —after a settlement with the New York State Attorney-General—that these human remains could be those of persons who were incarcerated in Chinese prisons. Imagine Exhibitions admitted that there was no documentation to prove the identities of the cadavers, yet they were permitted to enter the UK to be put on public display for commercial gain. Human tissue from abroad has no consent or traceability requirements to enter the UK, nor do we prohibit commercial gain. However, we should do and this Bill gives us the opportunity to do it.

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

Lord Alton of Liverpool Excerpts

Friday 24th July 2020 Lords Chamber

[Lord Alton of Liverpool (CB) [V]]

My Lords, the Minister referred to the situation in Leicester. There is concern here in the north-west about the situation in Blackburn. I hope he will refer in his reply to local restrictions.

I want to underline the concerns raised about scrutiny. Under the cover of Covid, we are in increasingly grave danger of legitimising these kinds of proceedings and putting a thin veneer of respectability on the actions of the Government. The Minister’s department should carefully study this week’s critical report by the Delegated Powers Committee on its approach to the new Medicines and Medical Devices Bill. By now he must surely be aware that parliamentarians are outraged by the failure to answer Parliamentary Questions, sometimes for months on end, as referred to by the noble Lord, Lord Harris.

These regulations, which significantly eased the lockdown from 4 July, have already been in effect for three weeks prior to this debate, so this is retrospective, simply going through the motions, with one-minute speeches that are inadequate to explore the implications for dissent and protest. The Commons has not even had that opportunity and has now risen for the Recess. This simply will not do.

Independent Medicines and Medical Devices Safety Review

Lord Alton of Liverpool Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord Bethell]

I completely endorse the comments of my noble friend. To embellish his point, it has been very interesting to see through Covid how patients have had to track their own symptoms, take advice on 111 for themselves and, in millions of cases, look after themselves at home, possibly with telemedicine to support them. This may an inflection point in the attitude of many people to their health. I certainly welcome a revolution of patient power and putting patients first in our healthcare system.

[Lord Alton of Liverpool (CB) [V]]

My Lords, families and dedicated campaigners such as Marie Lyon have told the All-Party Parliamentary Group on Hormone Pregnancy Tests, of which I am vice-chairman, that they have unequivocal admiration for the noble Baroness, Lady Cumberlege, for compassionately understanding their pain and suffering and allowing them, for the first time in more than 50 years, to have hope. Does the Minister agree with the report’s conclusion that, when the first comprehensive study, in 1967, identified a link between congenital abnormalities and HPTs, Primodos should have been removed from the market and that this regulatory failure has seen justice delayed and denied? Will there now be an independent re-examination of the contested conclusions of the report of the expert working group? In implementing the Cumberlege recommendations without delay, what practical help and redress will be provided for families whose lives were irreparably blighted by Primodos?

[Lord Bethell]

My Lords, I completely share the view of the noble Lord and of the patient groups who have unequivocal admiration for the noble Baroness, Lady Cumberlege, who has done the nation a great service with this report. As he knows, the Primodos case is subject to legal dispute, so I cannot comment on it from the Dispatch Box, but no one can read the report without feeling great disappointment that those hardships were suffered by those women. It is of enormous regret to us all.

Health Protection (Coronavirus, Restrictions) (England) Regulations 2020

Lord Alton of Liverpool Excerpts

Tuesday 12th May 2020 Lords Chamber

[Lord Alton of Liverpool (CB)]

My Lords, the justification for not providing Parliament with a draft of these regulations, as is usual, has been

“the serious and imminent threat to public health”.

Notwithstanding that, the noble Lord, Lord Hunt of Kings Heath, is right to say that our duty is to ask awkward questions and to scrutinise. I will use my three short minutes to do that.

Confusingly, while these regulations impose restrictions and fines for members of the public breaking the lockdown, a Cabinet Minister has said of Covid-19, “let it run hot”. Our Minister, who replies for the whole Government, says that it was not his department that said this, but which of these strategies—carefully cautious or “let it rip”—is the Government’s position? When will he publish the scientific evidence behind the use of that phrase?

The Care Quality Commission is to investigate whether hospitals, some here in the north of England, might have broken the law by sending patients with Covid-19 back to care homes, where more than a quarter of Covid deaths have occurred. Managers and staff were not told that the patients being discharged were infected, triggering new fatal outbreaks among other residents. Will the Minister confirm that, in doing this, the law was indeed broken? When do the Government anticipate that the CQC will publish its report? Will the findings be presented to Parliament?

Will the Minister confirm that levels of coronavirus infection are probably at least five times higher among hospital and care home staff than in the wider population —I declare an interest in that one of my sons is an A&E doctor working in a hospital with Covid patients—and that coronavirus outbreaks in care homes are now leaking back into the community and driving the epidemic? Sir Ian Diamond, the head of the Office for National Statistics, says that the R number, referred to earlier by the noble Lord,

“is driven by the epidemic in care homes”.

Will these regulations be used to stop carers visiting multiple care facilities? If so, what thought is being given to the care needs of residents and ensuring that staff who are infected are properly isolated?

I have written to the Minister about the importance of giving public health officers and local councils greater control over tackling the outbreak in their communities. Sir David King, the former Chief Scientific Adviser, says this will be the only way to contain new peaks. Does the Minister agree? I also hope that the Minister agrees that the need for a national care service, locally administered but with central oversight, on a par with the National Health Service and with more than Cinderella status, is now self-evident and long overdue.

Covid-19: Social Care Services

Lord Alton of Liverpool Excerpts

Thursday 23rd April 2020 Lords Chamber

[Lord Alton of Liverpool (CB)]

My Lords, I too thank the noble Baroness, Lady Wheeler, for initiating today’s important debate.

Earlier this month I drew the Minister’s attention to the appalling death toll at Wavertree’s Oak Springs Care Home in Liverpool, where 16 people have died. For grieving loved ones and for the people who care for them, deaths in care homes are diminished when out of sight means out of mind. Even with a carer at your deathbed, it is a devastating and harrowing way to end your life in isolation. Surely more can be done to enable loved ones to visit and, where requested, to provide spiritual accompaniment, the sacraments and ministry, and for the skills of hospices and palliative care to be urgently made more widely available.

Carers have expressed concern to me—which I share—that the Government have said, in relation to the virus, “Let it run hot.” Is that still being said? Who authorised letters sent by GPs to care homes stating that their residents, including adults with learning disabilities, would be unlikely to be offered ventilation? It is impossible to say in advance that such treatment would not be appropriate or beneficial.

As we heard last week from the noble Baroness, Lady Warwick, deaths in care homes have quadrupled. The Financial Times yesterday estimated that some 10,000 have died of coronavirus in our care homes, while this morning the Daily Telegraph said it believed that the rate of attrition is about 400 every day. We have also learned that in Europe, half of all deaths have occurred in care homes. Meanwhile, only 25% of care workers have been able to access tests. Taking up a point made just a moment ago by the noble Baroness, Lady Barker, when will care homes be provided with adequate supplies of PPE and their staff routinely and regularly tested for the coronavirus? Without such tests, carers are having to self-isolate because they develop symptoms and do not want to risk killing the people they care for. No one can say that we did not know what we were facing.

Weeks ago, in Italy, it was said that the elderly in care were facing a massacre while from Spain there came deeply shocking reports of the corpses of elderly people being found in all but abandoned care homes. Given what we knew about this terrible unfolding tragedy, why were our care homes not locked down sooner, PPE not sent in immediately and tests not provided for all? Andrea Lyon, the manager of the Oak Springs Care Home, has said that the Government’s plans

“should have been ready to be actioned immediately, not three weeks down the line. I had to take care of my residents with less than 50% of my staff because the government didn’t have their action plan ready. It makes me very angry.”

That anger will have its day during an inevitable public inquiry, but if any good is to come out of this rupture in our equilibrium, there will need to be radical and fundamental change in everything from our supply chain resilience to national self-sufficiency, inequality and social solidarity. What the deaths in our care homes have made abundantly clear is that, alongside our National Health Service, we need a national care service. If a national care service emerged from the wreckage of Covid-19, it would represent a gain among so much loss comparable to the gain of the National Health Service in 1945.

Wuhan Novel Coronavirus: UK Citizens

Lord Alton of Liverpool Excerpts

Thursday 30th January 2020 Lords Chamber

[Baroness Blackwood of North Oxford]

My noble friend has raised an important point. While the UK is one of the first countries outside China to have developed a prototype laboratory test for this novel disease, there is as yet no vaccine. The WHO is co-ordinating the research effort in this area and is producing an R&D road map. As a nation we are actively involved in this because we have particular capabilities here. We will be contributing to a co-ordinated global effort not only to improve the diagnostics but to develop vaccine capabilities.

[Lord Alton of Liverpool (CB)]

My Lords, has the Minister seen the report this morning from the AFP saying that Russia has closed its borders with China? Does that not add to the need for the World Health Organization to declare this a world health emergency? Are we in discussions with it about that?

[Baroness Blackwood of North Oxford]

I think I have already made the point that we are in constant dialogue with the World Health Organization regarding all aspects of the response to this outbreak. That dialogue includes the declaration of a PHEIC, which would include a number of different elements, and the organisation is meeting on that today.

Safety of Medicines and Medical Devices

Lord Alton of Liverpool Excerpts

Thursday 28th February 2019 Lords Chamber

[Lord Alton of Liverpool (CB)]

My Lords, I join others in congratulating my noble friend Lord Carrington on his very well-judged maiden speech today.

In this welcome debate, my remarks will centre on Primodos—an issue I raised with the noble Lord, Lord O’Shaughnessy, while he was a Minister. Like the noble Lord, I pay tribute to Marie Lyon, who chairs the Association for Children Damaged by Hormone Pregnancy Tests. Assiduously and tenaciously, she has fought for justice for those whom big pharmaceuticals have often treated with irresponsible contempt. She and her husband have travelled down from Wigan today and are watching our debate.

Marie Lyon wishes me to thank the noble Baroness, Lady Cumberlege, and the Independent Medicines and Medical Devices Safety Review for taking the campaigners seriously. She tells me:

“The sensitivity shown to our members by the”,


review,

“team is appreciated and commended. I really do feel that”,

they and,

“Baroness Cumberlege … are committed to discovering the truth about the failures of the Drug Company and the Government Regulators and have a genuine desire to ensure justice is served”.

I add my own thanks to the noble Lord, Lord O’Shaughnessy, for his role in encouraging the establishment of the independent review, and I wholly endorse what he said earlier about the desirability of creating a national office for patient safety.

My interest in Primodos began in 2010, when a gentleman born with severe birth defects asked to see me at my university office in Liverpool. He believed that his disabilities were attributable to Primodos, a hormone-based pregnancy test first marketed in the UK in 1959 and produced by Schering AG, which was subsequently taken over by Bayer AG. Withdrawn from sale in the United Kingdom in 1978, tellingly it was also used in South Korea to abort the child in the womb.

Dr Isabel Gal’s 1960 research at Queen Mary’s Hospital for Children demonstrated a link between the drug and severe birth defects, and a review by the Committee on Safety of Medicines concluded that pregnant women should not use it. However, subsequent court cases failed to provide a conclusive outcome, as did a 2014 review by the Medicines and Healthcare products Regulatory Agency.

On 26 October 2010, I asked the Government several Questions. One was about the dosage of the constituents of Primodos; one asked for any documents that the Government held about its dangers to be placed in the Library; one was about the nature of the disabilities; one was about the help given to those affected; and one requested Ministers to meet the Association for Children Damaged by Hormone Pregnancy Tests.

In his reply at the time, the noble Earl, Lord Howe, said that the regulatory agency had no information on the number of children who are born with disabilities, nor did it have evidence. If there was no evidence, why did they ban the drug? As for meeting the victims:

“The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer”.—[Official Report, 26/10/10; col. WA 265.]


Despite further letters and Questions, a 2017 report of an expert working group of the UK Commission on Human Medicines continued to state that there was no causal association. Yet in that same year, Sky News broadcast “The Secret Drug Scandal”, which found that evidence of an association had been destroyed by a UK regulator in the 1970s. I asked the Government for their response and,

“whether they will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety”.

In another Question, I asked whether they would examine why,

“no toxicology or testing was undertaken prior to the drug Primodos being licensed”,

and whether they were aware that,

“Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and … that there may have been collusion between the drug manufacturer and the regulatory bodies”.

In another, I asked why Primodos had stayed on the market and no tests had been,

“ordered by the Committee for the Safety of Medicines under the Medicines Act 1971”.

In another, I asked them to,

“meet with Marie Lyon and representatives of the Primodos victims support group”,

and in another, asked why they were not funding research in Aberdeen and Cambridge examining the,

“likely effects on the child in the womb”.

Then, in February 2018, the right honourable Jeremy Hunt announced his welcome review to be led by the noble Baroness, Lady Cumberlege. I hope that when the Minister replies, she will tell us when it is likely to report and—perhaps more importantly—who will be responsible for taking forward its recommendations. Among other things, as we heard from the noble Baroness, the review will investigate any association between hormone pregnancy tests and their teratogenic effects, and whether the regulatory bodies could, and should, have acted on concerns sooner—and if they did not, why.

Meanwhile, a team at Oxford, led by Professor Carl Heneghan, the scientist responsible for identifying Thalidomide association, has discovered that pooled data show “a clear association” with several forms of malformation. Professor Neil Vargesson has carried out other work on zebrafish, which revealed anomalies that mirrored the adverse effects on victims of Primodos. Their studies were peer-reviewed and remain in the top percentile of scientific studies.

In the House of Commons, the Prime Minister said:

“Ministers are aware of the new study that has come out … and … that study will be looked at very carefully”.—[Official Report, Commons, 16/1/19; col. 1160.]


I welcome that. However, the raw data that Professor Heneghan needs to complete his review has not been made available. The All-Party Parliamentary Group on Hormone Pregnancy Tests, chaired by Yasmin Qureshi MP, and of which I am vice-chairman, has sent a freedom of information request for the data, but to date has not received a response.

Mrs Lyon has twice emailed the Medicines and Healthcare products Regulatory Agency, but has not received a response. I gave the Minister notice of my intention to raise this question today. This is tardy and unco-operative on the part of that body. I hope the Minister will be able tell us whether more can be done to take that forward.

Severely disabled children, cared for by family members now in their late 70s, are increasingly becoming the responsibility of their siblings. While their health deteriorates, many battle every day to support themselves. Some have died fighting to the very end to reveal the truth about the failures of the drugs company and the regulatory agencies. They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.

Health and Social Care Act 2012

Lord Alton of Liverpool Excerpts

Thursday 5th July 2018 Lords Chamber

[Lord O'Shaughnessy]

My noble friend makes a very important point, which is that as we move ahead, even with the funding settlement, it is essential that the NHS becomes more productive. That means looking at whether there are medicines or treatments that are no longer producing the outcomes it was suggested that they would and taking those out of service. It is very important to state that this has to be a clinically led process. We have already begun that with certain low-value prescriptions. NHS England is now leading that process—as I say, it is clinically led—to look at whether there are other treatments that could be discontinued.

[Lord Alton of Liverpool (CB)]

My Lords, what does the Minister make of the poll that showed that 66% of British people would be prepared to pay more for the provision of the National Health Service? What is his view on a hypothecated tax to meet those needs?

[Lord O'Shaughnessy]

I am sure that the Chancellor will have taken that view on board and he will reveal his decisions in the Budget.