Medicines and Medical Devices Bill

Baroness Barker Excerpts

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

[Baroness Barker (LD)]

My Lords, Brexit poses many threats to the economy and well-being of UK citizens. Perhaps the greatest is the threat to our life sciences and pharmaceutical industries which, based on our scientific resources in universities and companies that have easy access to international talent and resources, have been truly world-leading. The impact of moving away from the existing collaborative approach between the UK and the EU will be substantial. The European market accounts for 25% of all world sales of medicines and has timely access to new medicines and devices. The UK, in comparison, accounts for only 3% of the total world market. It is against that backdrop that we have to consider this legislation, which is intended to mitigate threats to our industry.

We all agree that we need legislation, but not this thoroughly unsatisfactory Bill. It is a Bill that should not be accepted unless it is thoroughly revised, for three main reasons. The first is that alluded to by the Minister: it is built on the flawed assumption that the Secretary of State or an “appropriate authority” must take equal account of the safety of human medicines and medical devices, the availability of human medicines and medical devices, and the “attractiveness” of the relevant part of the UK as a place in which to conduct clinical trials, supply human medicines or develop medical devices.

The last two considerations depend on the paramountcy of the first. If we do not accept that in legislation, none of the rest will apply; we will simply be signalling to the world a willingness to move away from international standards. One of the most interesting and detailed points made in the briefings that we were given came from the Association of the British Pharmaceutical Industry, which pointed out that it wanted to encourage the UK to apply for full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. They are global organisations that produce harmonised regulatory guidance across nations. It was pointed out that previously the UK had represented the EU at meetings of those bodies and contributed to committees and regulatory thinking. Since 1 February 2020, we have had no direct recognised status as either a member or an observer. If we are willing to move away so swiftly from the international standard-setting bodies, we cannot do so on the basis of this unsatisfactory legislation.

The second reason for rejecting this Bill is that it is a Toom Tabard Bill, as we would say in Scotland; it is an empty cloak. The Minister put the best gloss possible on the reports from the Delegated Powers Committee and the Constitution Committee, whose comments were detailed, comprehensive and scathing—I have rarely seen reports of that nature.

On the delegated powers, Clauses 1, 8 and 12 allow Ministers by regulations to amend or supplement the whole regulatory regime for human medicines and clinical trials under important legislation such as the Human Medicines Regulations 2012. Those regulations alone contain 350 criminal offences which a Secretary of State could unilaterally or without any scrutiny change completely. It is something when the Constitution Committee says, as it has done:

“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


That is a very powerful reason.

Both the Delegated Powers Committee and the Constitution Committee were deeply critical of the way in which the Government have used this legislation, coming as it does at the time of the current pandemic, to confer emergency powers on Ministers to disapply existing health medicines regulations. They point out that there are no formal requirements to set out the form, publication or dissemination of protocols; Ministers can do that simply by publishing a document on a website. That is not taking back control; it is taking the mickey. It is time for us as a Parliament to stand up and say that this is not an acceptable way forward.

The third reason for rejecting this Bill is its potential to do harm. Many professionals in the pharmaceutical and medical devices industries have expressed the fear that by slightly and incrementally moving away from existing regulation from the EU we could very quickly put ourselves into sudden isolation. We should be fearful of that, not just because it could harm our ability to market into the European Union but because many other countries—African countries, for example— use EU approval as a short-cut mechanism for approving medicines which they do not have the capacity to trial themselves.

The report of the noble Baroness, Lady Cumberlege, is sobering. If we were to take just one thing from it, it would be the need for us to set up as soon as possible and as a matter of urgency not just databases but registries of medical devices. Those of your Lordships who have read the report will understand the difference that makes to traceability.

The Government are in trouble with the timescale that they have set for Brexit. This Bill demands detailed and lengthy scrutiny. For the health not just of our fellow citizens but of future generations, some forensic surgery needs to be done on it. It should not pass without receiving detailed attention from your Lordships’ House.

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

Baroness Barker Excerpts

Wednesday 29th July 2020 Lords Chamber

[Baroness Barker (LD) [V]]

My Lords, why did Public Health England take until 20 July to start supplying test data to local authorities on a daily, rather than weekly, basis? Why were local authorities told only then which households contained people who had tested positive?

On track and trace, when will the Government stop wasting resources on national call centres and—as we on the Liberal Democrat Benches have been advocating since March—put resources into local resilience forums working with directors of public health, health and safety officers and local police?

Matt Hancock stated in mid-May that he had

“tried to throw a protective ring around our care homes”

right from the start of the outbreak. Today, the Public Accounts Committee stated that discharging 25,000 patients in order to free up beds was an example of

“the Government’s slow, inconsistent and, at times, negligent approach”

to social care. The committee also said that advising hospitals to discharge thousands of patients into care homes without knowing if they had coronavirus was a “reckless” and “appalling” policy error. Will the Minister tell the House who was responsible for that decision?

There was no protection from central government. Will directors of social services now be empowered to challenge any similar decisions by NHS Providers and central government which jeopardise social care? Will local authorities currently in lockdown, such as Leicester, be resourced to share their experience and good practice with colleagues in areas at risk, such as Oldham? As the demographic profile of areas most likely to experience second waves becomes clearer, will local authorities be identified and given additional resources now to put prevention plans in place?

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

Baroness Barker Excerpts

Friday 24th July 2020 Lords Chamber

[Baroness Barker (LD) [V]]

My Lords, had these regulations been provided in April with proper consultation, they might have been credible, but today, with our “world-beating” track and trace system, which fails to notify 20% of contacts of people who have tested positive, and with Public Health England releasing data to local authorities only once a week and without patient identification, they are highly questionable. When will local authorities be given real-time data and the powers that they really need—for example, to instruct the opening of facilities such as toilets? When will the Government release the scientific basis for treating different businesses in inconsistent ways? Will they monitor the differential impact of these regulations on black and minority communities, and will they act swiftly to end such discrimination?

Pharmacies

Baroness Barker Excerpts

Monday 20th July 2020 Lords Chamber

[Lord Bethell [V]]

As the father of four small children, I completely endorse the noble Baroness’s point. Many a night have I been outside a hard-working pharmacist’s shop looking for advice, support and essential medicines. I pay tribute to the hard-working community pharmacy sector, whose pharmacists are often up until midnight helping their local communities and hard-hit fathers like me.

[Baroness Barker (LD) [V]]

What advice has the department had from local directors of public health about the resources that are necessary to ensure continuity for community pharmacies during local lockdowns?

[Lord Bethell [V]]

We are fully engaged with the sector. The National Pharmacy Association and the other stakeholder groups are in close communication with the department to ensure that they have the PPE, medicines and finances to keep going during the epidemic. The voice of the DPHs is involved in that stakeholder engagement.

Covid-19: Mental Health Services

Baroness Barker Excerpts

Thursday 2nd July 2020 Lords Chamber

Asked by

[Baroness Barker]

To ask Her Majesty’s Government what steps they are taking to ensure that mental health services are available in (1) acute, and (2) community, care settings (a) during, and (b) after, the COVID-19 pandemic.

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

My Lords, the mental health challenge of Covid is a serious matter, and I pay tribute to NHS mental health services in both acute and community care settings, which have remained opened for business throughout this time, including delivering support digitally, over the phone and, where possible, face to face. There are no plans to stand down that support after the peak of the pandemic and we remain committed to our NHS long-term plan ambitions for increasing mental health services in acute and community care settings.

[Baroness Barker (LD) [V]]

In July 2019, the Government committed £2.3 billion for services for 370,000 people with severe mental illness. Will the Minister give an undertaking that if, as expected, Covid-19 causes greater demand for mental health services, that money will be increased?

[Lord Bethell [V]]

My Lords, we are investigating the long-term implications on our services from Covid-19. We are engaging with counterparts across Whitehall and, if necessary, we will invest further money. However, the mental health impact of Covid is not clear yet, and we await the final implications of that.

Covid-19: Masks

Baroness Barker Excerpts

Thursday 11th June 2020 Lords Chamber

[Baroness Barker (LD) [V]]

My Lords, on 4 March, the government advice on face masks was that they do nothing, so do not wear them. On 17 April, the advice was that they do more harm than good, and on 11 May, it was that wearing one is an added precaution. As of 4 June, wearing them is to be compulsory. In that time, the science did not change but the death toll rose. Why have the Government failed to distinguish between PPE standards necessary in acute treatment settings and masks which are suitable for people using public transport? Why, given this record, should the public trust them during a second spike?

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

Baroness Barker Excerpts

Monday 8th June 2020 Lords Chamber

[Baroness Barker (LD) [V]]

My Lords, these fees are a perfect encapsulation of the disparity between health and social care. Prior to the emergence of Covid, the social care sector was in crisis. Since 2010, local government finance has reduced by 50%, but statutory responsibilities have not. Local authorities have had staff reductions, to the point where there are senior directors, front-line staff and very few people in between.

On 25 February, the Department of Health and Social Care guidance told local authorities:

“It remains very unlikely that people receiving care in a care home or the community will become infected … There is no need to do anything differently in any care setting at present.”


On 14 May, the Health Secretary, Matt Hancock, stated that

“right from the start we have tried to throw a protective ring around our care homes.”

The public response was incredulity, because by that time there had been 10,000 deaths in care homes in England and Wales, according to the ONS—a quarter of all deaths. I repeat the statement from Martin Green, chief executive of Care England, who asked to

“see the evidence of what exactly the protective ring consists… and when exactly they instituted this protective ring”,

asked why

“we had our PPE distribution networks disrupted to send things to the NHS”

and

“why we had our primary care support withdrawn from many care homes?”

Why are they still waiting for it?

On 18 May, in their Covid recovery strategy, Our Plan to Rebuild, the Government pulled another fast trick. On clinical support, the strategy states that

“the Government is accelerating the introduction of a new service of enhanced health support in care homes from GPs and community health services, including making sure every care home has a named clinician to support the clinical needs of their residents by 15 May.”

But that should have been happening already under various pieces of legislation. In truth, the NHS abandoned care homes at their point of greatest need. Nevertheless, I ask the Minister: what progress has there been towards that 15 May deadline?

It is time for the Government to stop announcing new responsibilities for local government and start listening to local authorities about what they need central government and the NHS to do, so that there can be a joint strategy to manage Covid and its lasting impact on communities. Inadequate testing, little tracking and no isolation means that care homes will not be ready to withstand a second spike. They simply will not be able to provide what these older people desperately need.

Hospitals: Patient Safety

Baroness Barker Excerpts

Thursday 21st May 2020 Lords Chamber

[Lord Bethell]

My Lords, there was some interruption in hearing my noble friend’s question but, if I understood him correctly, the answer is that all patients are now tested on entry to hospital. Until their test result has arrived, they are treated as though they have Covid-19 and isolated wherever possible.

[Baroness Barker (LD)]

How will the Government enable hospitals to work on a regional basis, co-operatively, to optimise the use of surgical and radiological resources?

[Lord Bethell]

I am afraid that at the moment, I cannot give a precise and thorough answer to the perceptive and very detailed question asked by the noble Baroness, but I will be glad to.

Mental Health Services

Baroness Barker Excerpts

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

I recognise the insight of my noble friend Lady Newlove, who speaks from experience of these matters. I reassure her that the funding in place from the long-term plan for mental health has been substantial and will support a dramatic change in mental health services. We will be supporting mental health workers who, as my noble friend says, have delivered under difficult circumstances. Their creativity is demonstrated by the introduction of video and other technical facilities to keep mental health services going during the lockdown. I pay tribute to their inventiveness and creativity at this time.

[Baroness Barker (LD)]

My Lords, is data on mental health support, A&E presentations, referrals to community mental health services, crisis resolution callouts and detentions under the Mental Health Act being collected during this period—yes or no?

[Lord Bethell]

My Lords, I understand that it is a firm “yes”, but I will check that answer and revert to the noble Baroness if there is any different information.

Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020

Baroness Barker Excerpts

Monday 18th May 2020 Lords Chamber

[Baroness Barker (LD)]

My Lords, the United Kingdom has been a world leader in transplant research and reconstructive surgery since the 1940s, and we continue to be the home to world-leading developments in bioscience. Moreover, we have been the outstanding leader in the ethical regulation of cutting-edge medicine and medical technology, due in no small part to the work of your Lordships’ House and the work of Baroness Warnock.

What we have today is a public policy settlement under which research scientists and medical practitioners develop pioneering research. That takes place within a framework of legal principles which is subject to parliamentary scrutiny and is regularly updated as the science advances. I pay tribute to the then Prime Minister, Gordon Brown, for setting up the Organ Donation Taskforce, which in 2008 published the Organs for Transplants report. The report provided a series of recommendations to help us to increase our organ donor rate by 2013. That 2008 strategy did indeed manage to increase the rate of donations by 50% from deceased donors and by 30% from living donors. However, that is still not enough; we need more organs, because people are dying. In 2013, NHS Blood and Transplant published its report, Taking Organ Transplantation to 2020, which set out a more detailed plan.

I congratulate the noble Baroness, Lady Finlay, and others who worked very hard to secure the Organ Donation (Deemed Consent) Act 2019, which amended the practice of the 2004 Act but not its principles by moving to an opt-out principle for routine donations. That was necessary, because many of the most suitable organ donors are people who have been involved in accidents or who have sudden life-threatening illnesses and have not given prior consent. At the point of such an emergency, they and their families are unable to give the consent that they may have wanted to do.

These are decisions that ideally are taken in advance after long and detailed consideration, but which often arise in an emergency medicine setting. I suggest to noble Lords that they go back and look at the contribution made in another debate by the noble Baroness, Lady Tonge, who comes from a family of medics. All her family members had discussed the matter and decided that they were all in favour of organ donation. However, when her daughter died in a very tragic accident, not only did nobody raise the matter with them, but they did not think about it either. That has always been a matter of regret to her.

The policy intent has always been to exclude novel and rare transplants, including situations in which cells are retrieved from organs that could be used to create an advanced therapeutic medicinal product, as other noble Lords have said. Although some people who wish to do so can leave their bodies to medical research, that research is regulated separately by the Human Tissue Authority, so there really should be no confusion between medical research and transplantation. However, the Minister stated that if a transplant that is currently considered to be rare or novel were to become common, the process of amending the law would be the one that we are following now: discussion, consultation and proposals brought forward by law. My question is this: what would be the trigger for proposing such a change in the law? As other noble Lords have said, looking back over the past 17 years, should we not be looking at a periodic review of transplant law—say, every five to seven years?

I have spoken about black and minority-ethnic communities in your Lordships’ House before. In 2003 my friends Joe and Grace Desa lost their 13 year-old only child Daryl to a brain haemorrhage. Grace and Joe showed remarkable dignity during that unimaginable tragedy. One of the things that comforted them was that many people benefited from organs and tissues donated by Daryl. In 2018, when we looked at the figures again, we saw that people from black and minority communities were still waiting longer than others and that there was comparatively low organ donation from people from the same ethnic groups. It is really important that we make these groups the focus of particular awareness campaigns. I know that my friends Joe and Grace took part in them to try to increase donations from people from south Asian communities.

I welcome the emphasis in this new code of practice on taking into account family and religious beliefs, but I go back to the point made by the noble Baroness, Lady Deech. Is the intention of the code of practice to ensure that a family’s religious belief can take precedence, but not where an individual who has mental capacity has made a deliberate decision that they wish to be a donor? Can the Minister clarify that point? What good practice guides will be given to make sure that specialist nurses who work in organ donation work to clear guidance?

I too hope that the Government set up an independent inquiry into the effects of Covid on black and minority-ethnic populations. I hope that it will not just be about the emergency process that we have been under for the last two months but will look over the longer term at what Covid has done to affect health inequalities in Britain, including transplants.

My final point has not been mentioned by other speakers in this debate. The Human Tissue Authority operates under the EU organ donation directive and the EU tissues and cells directive. If there is no deal, the EU organ donation and tissues and cells directives would no longer apply in the UK. The Government have previously said that in the event of no deal, organisations and authorities in the United Kingdom will continue to work to the high practice standards they do now, but if we are no longer under those same directives as the rest of Europe, people in this country who need organ donations will no longer be treated on the same basis as those in other European countries. The UK would be treated as a third country. Will the Government confirm that if there is a no-deal Brexit, people requiring tissues and transplants of organs from other countries will be at a disadvantage? Will they issue updated guidance on this? The guidance they produced back in 2018 no longer stands.

We all want better and quicker availability of life-saving transplants for people who need them. We broadly support these regulations, and I hope the Government will make sure that in these difficult times there are the resources to make them happen in practice.