Covid-19 Regulations: Assisted Deaths Abroad

Baroness Thornton Excerpts

Tuesday 10th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I think it is to be welcomed that the response to the Urgent Question last week was that travelling for the purposes of an assisted death would be exempt from lockdown travel restrictions. However, there are concerns that this Statement did not go into detail about whether family members could accompany people. Legal constraints mean that it is not clear whether the exemption applies to them. Presumably, they would have to demonstrate their reasons for travel and might, in the course of doing so, incriminate themselves for assisting a suicide. So can the Minister clarify that family members accompanying someone travelling for an assisted death will not be vulnerable in this way? If the Minister does not know the answer in detail to this important question, please would he seek to find out from the Ministry of Justice, write to me, and put the letter in the Library?

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

The noble Baroness is entirely right on the question of travelling abroad for the purpose of assisted dying. It would be regarded as a reasonable excuse, and therefore anyone who did would not be breaking the law. In answer to the noble Baroness’s question, under Section 2(1) of the Suicide Act 1961, a person does commit an offence if he or she

“does an act capable of encouraging or assisting the suicide or attempted suicide of another person”

and that act

“was intended to encourage or assist suicide or an attempt at suicide.”

The 1961 Act provides no exceptions to the prohibition on assisting suicide. The maximum penalty, as noble Lords may know, is 14 years, and there is nothing in the Coronavirus Act or any recent legislation that in any way changes that.

Covid-19: Dental Services

Baroness Thornton Excerpts

Tuesday 10th November 2020 Lords Chamber

[The Lord Speaker (Lord Fowler)]

I make the point that I say at the beginning of every Question Time that two points are the maximum that should be made.

[Baroness Thornton (Lab)]

In my view, the Government have offered little support to dentist practices: not exempting them from business rates, even though book- makers and vape shops are exempted, and not offering them key worker status, which has caused problems with childcare. Can the Minister commit to early access to Covid-19 vaccines for all high-street dentists who are NHS contractors, rather than employees? Can the Minister give them key worker status?

[Lord Bethell (Con)]

My Lords, one area where the Government have made a big commitment to dentists is in PPE. As of Wednesday 4 November, over 5,000 dental and orthodontic providers in England had registered with the PPE portal and over 36 million items of PPE had been delivered. In terms of the commitment to workers, I will have to come back to the noble Baroness.

Covid-19: Transparency and Accuracy of Statistics

Baroness Thornton Excerpts

Monday 9th November 2020 Lords Chamber

[Lord Bethell (Con)]

On the manner in which the information was delivered, I take the noble Baroness’s comments completely on board. While it is not my role to be in charge of the presentation of No. 10 presentations, I think a lot of people would agree with her that there were a lot of slides, which were very detailed and not all formatted for the TV screen. However, we are trying our hardest to share with the public as much of the insight and science as we possibly can, and we are trying to hit that balance between too little and too much information. We are trying to publish data as soon as it can be reasonably verified. There will be some scratchiness around the edges on that, and I take the noble Baroness’s points about last Saturday completely on board. However, the commitment to transparency and open debate on these issues is sincere.

[Baroness Thornton (Lab)]

When will the Government start sharing data and having meaningful discussions before decisions are taken? Given that public confidence in these decisions is crucial for them to work, will the Government start working with the opposition parties, which they expect to—and which have—supported the lockdowns and proposals, as Keir Starmer and others have been offering for months?

[Lord Bethell (Con)]

The noble Baroness is right to pinpoint the sharing of data as being very important, and we have been as open and transparent as we can be. We publish an enormous amount of data. Just before this debate, I tweeted three of the main portals to the data, which there is not only an unprecedented quantity of but which is more up to date than could reasonably have been expected a few months ago, when such data was not available. Some of these decisions are made extremely quickly because the data changes so quickly. Sometimes, one believes that we are on track for one thing, and then the virus changes course and we have to change our policies accordingly. That is simply a fact of the challenge of fighting this virus: speed is of the essence, and sometimes it has been extremely difficult to do the kinds of consultation that the noble Baroness quite reasonably describes.

Covid-19: Contracts and Mass Testing Programme

Baroness Thornton Excerpts

Wednesday 4th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, it seems to me that, however urgent the requirement for PPE and other services, transparency becomes even more important in those circumstances. The Minister will be fully aware that the Ministerial Code says that Ministers are responsible for ensuring that no conflict exists, or appears to exist, between their personal interests and their public duty. As the former chair of a procurement committee for MyCCG, I received extensive NHS training on conflicts of interest, which are defined as

“a set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”

Perception is as important as reality. Has the noble Lord declared the interests that arise out of the meetings that other noble Lords have mentioned today? Where are they recorded and published?

[Lord Bethell (Con)]

The noble Baroness is right that transparency is key. I take those principles extremely seriously, and that is why we are publishing the contracts. I encourage anyone who is interested in looking at them to look at my Twitter feed, where I published a link to the Contracts Finder service yesterday. I reassure her that, although some connections were made through networks, absolutely every contract had exactly the same technical assurance, exactly the same contract negotiation and exactly the same procurement scrutiny. Those were done by civil servants, and value for money for the taxpayer and the people was guaranteed by that process.

Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

Baroness Thornton Excerpts

Wednesday 4th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

Like the noble Baroness, Lady Jolly, I will actually be addressing the statutory instrument, the Minister will be pleased to hear. In a way, these Benches are probably the least of his problems tonight. I do not expect that he is thanking his clutch of colleagues who, for one reason or another, are trying to stop these important regulations or have regrets. Of course, most of the regrets are perfectly legitimate questions to be asked and concerns to be raised, which is actually the point of the debate. Putting down an amendment to the Motion to double your speaking time seems a bit iffy to me.

On behalf of these Benches, I will not be commenting further on the amendments to the Motion, which I think are based mostly on internal Conservative Party arguments. We will abstain if any of the five noble Lords move to a Division. As for the noble Lord, Lord Robathan, we know that he has form—possibly a quasi-herd immunity supporter, I wonder, who disregards the science which at present tells us that such abandonment of restrictions might mean many deaths until we have a cure or a vaccine. We know the noble Lord’s intemperate views are not those of his own Government. If he tests the opinion of the House tonight, we will vote against his amendment. Frankly, this is too important for the whole country to play games, like the noble Lord, Lord Robathan, and those who support him.

As my right honourable friend Sir Keir Starmer and my honourable friend Jon Ashworth have made clear in the past few days, these Benches have major concerns over the Government’s decision-making, communications and messaging, and it is of the greatest importance that we have far more clarity about what is to be done during lockdown II and its exit route, as my noble friend Lord Rooker said.

We have been offering to work with the Government for months. Indeed, yesterday in the House of Commons my honourable friend Rosena Allin-Khan MP asked the Minister Nadine Dorries five or six times about working together to deal with the mental health pandemic. She got a very rude brush-off from that Minister—not at all the kind of behaviour we would expect from our Minister.

This afternoon, the House is invited to endorse the Prime Minister’s decision to impose upon the whole country a deep, restrictive lockdown for which the exit strategy is still unclear. As the Chancellor of the Duchy of Lancaster confirmed on Sunday, it could stretch beyond four weeks. On these Benches, we have argued very strongly that the previous lockdown was the time when we could have got the vital systems, particularly test and trace, in place and rebuilt the vital local capacity that has been so foolishly run down by years of cuts and hostility to local government. This time we hope that the Government will not only recognise the crucial role of local knowledge and expertise but will fund local authorities as they have promised. We have at least to flag up that one day there will have to be a reckoning for the absurd way that contracts have been handed out to private organisations in a manner more reminiscent of a banana republic.

As Keir Starmer has made clear, Labour supports the introduction of national measures to slow down the spread of the virus. This is an approach that he made weeks ago on the emergence of evidence on 21 September, as my noble friends Lord Hunt and Lord Knight said, and for which he and the Labour Party received abuse from the Government and some of their supporters in the media. I think we are entitled to point out that the initial reaction of the Government was to do too little, too late; their shambolic press conference on Sunday was a graphic illustration of that. The cost of inaction is an inevitable harder lockdown now, as my noble friend Lady Andrews said.

Labour will support what the evidence required all along. Of course, here and in the other place, the details will be subject to scrutiny, which is our job. As the noble Baroness, Lady Jolly, said, we are at least debating these regulations four or five hours before the lockdown into comes into place, which is definite progress. We will join the Government in delivering the message that everyone has to play their part, abide by the rules and bring the rate of infection down. The Government are rightly saying that lockdown II may not end on 2 December but, like other noble Lords, I ask the Minister: what is the strategy for exiting this lockdown? Are we really going to go back to the three tiers that did not appear to work in the first place?

Above all, we have to have ready a proper world-class find, test, trace, isolate and support system. There have been so many months of unfulfilled promises on this, but it will have disastrous implications if we do not get it right. It is that case that our hospitals are filling up. Almost 11,000 people are now in hospital. Does the Minister feel that that will end if we bring the nationwide R rate to less than one?

I make a final plea for those who have people in care homes. Mistakes were made in the first wave of the pandemic. Families will be anxious to know that their loved ones in care homes will be protected as infections rise, but keeping care home residents safe should not mean locking residents up and keeping them away from the people who care about them, so can the Minister guarantee that families will be able to visit care homes during this lockdown and that they will be treated as key workers with access to regular testing so that they can visit their loved ones safely?

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock (CB)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I gave the Minister notice last week that I might well want to speak after her, and I am doing that, for two reasons. One is to remind the Committee that, although we will allow the government amendments to go through without any objection, we do not agree with them, and will probably seek to amend them at a later stage.

The second point is to do with the word “person”. I thank the Minister for going into some detail, but frankly, that alarmed me more than reassured me, so I think we may have to engage with this, and discuss how to remove that word. It would be much too dangerous and risky to have such an amorphous expression in the Bill. Perhaps the Bill team could find some expression that, although it does not list all the different things that the person is supposed to be, provides some protection to cover the range of bodies that need to be consulted. I accept that we do not want long definitions in the Bill, but I am concerned about our having such an open definition, and we may discuss this again at a later stage.

--- Later in debate ---

Moved by

[Baroness Thornton]

30: Clause 3, page 2, line 39, leave out “, for any purpose to do with human medicines,”
Member’s explanatory statement
This amendment tightens the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe.

[Baroness Thornton (Lab)]

This clause deals with falsified medicines and is a very important clause, and it is important therefore that we get this right. Amendment 30 would tighten the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe, and Amendment 33 would place a duty on the Secretary of State to act with a view to, rather than having regard to, the importance of ensuring that information is retained securely when exercising powers. The amendments in the name of the noble Lord, Lord Clement-Jones, whom I thank for supporting mine, are similarly concerned with the safety of information and accountability.

The MHRA said that the Falsified Medicines Directive will cease to apply in the case of a no-deal Brexit, because UK pharmacies will no longer have access to the database that holds false medicines data under the FMD. The noble Lord, Lord Clement-Jones, during Second Reading described the measures as “legislative creep” with regard to how any data could be used. He said that the clause

“considerably broadens the original data-collection provisions of the Falsified Medicines Directive”.—[Official Report, 2/9/20; col. 391.]

That is the whole point of these amendments. Indeed, the noble Baroness, Lady Masham, also said at Second Reading that the Company Chemists’ Association had raised concerns around the clause. Malcolm Harrison, the chief executive of the CCA, said he had grave concerns about the wording of Clause 3(1)(b), which relates to the development of a UK system to prevent the supply of falsified medicines. Jerome Bertin, general manager of SecurMed UK, said

“it is hard to determine if this would broaden the rights of access to such data, but the use of ‘for any purpose’ might suggest wider access rights, though for which stakeholders or regulators is unclear”.

Clearly, there needs not to be any ambiguity in this Bill. The wording of the clause therefore needs to be adjusted to ensure that there is no confusion and that there is a clear direction that data should not be used for any other purpose than ensuring that medicines are safe. Jerome Bertin also said that the Bill

“does not go anywhere near the detail of the EU directives (2001/83/EC superseded by 2011/62/EU) so it is hard to assess whether the FMD style protections would be diluted in a UK-only falsified medicines regulation”.

That is a legitimate question that needs to be answered.

There is no mention of this clause or this issue in the Explanatory Notes or the impact assessment for the Bill. With such a big issue regarding extremely sensitive data, there should be a more clearly outlined direction and a better thought-out way of introducing this clause for falsified medicines that also protects the extremely sensitive data that comes with it.

These amendments aim to ensure that data is protected and will not be used for any other purpose other than to ensure that medicines are safe. It is crucial that we get this right to avoid any unintended consequences, which could have grave repercussions. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

I very much support my noble friend in these amendments. As they have with her, a number of organisations have raised with me their concerns. The clause refers to the

“use, retention and disclosure, for any purpose to do with human medicines”,

which is very open-ended. In relation to information collected by such a system, it considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this. The noble Lord, Lord Clement-Jones, is not with us today but, when we debated it earlier, he referred to it as “legislative creep”—and, I must say, I agree with him.

In the Commons, the Health Minister Jo Churchill said in Committee:

“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 7.]


So it is very surprising to see this clause as currently drafted.

We have had briefings from the Company Chemists’ Association and ABPI, in addition to the ones that my noble friend mentioned. Because of the issue of commercially sensitive data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive. The principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.

The Minister’s department already has access to a wide range of data on medicines’ sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations, which we debated at some length a little while ago in your Lordships’ House. Of course, Ministers can request more detailed information if required. Given this access and the known sensitivities around falsified medicines data in general, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Why was such little reference made to it in the Explanatory Notes?

It is not unreasonable to ensure that the Bill is amended to enshrine at least a duty of full consultation with stakeholders before it goes through your Lordships’ House.

--- Later in debate ---

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

My Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.

We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.

I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.

Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.

We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.

The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.

We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.

I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.

I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.

[Baroness Thornton (Lab)]

I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.

The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.

Amendment 30 withdrawn.

--- Later in debate ---

[Baroness Jolly (LD) [V]]

My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.

[Baroness Thornton (Lab)]

My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.

[Lord Bethell (Con)]

My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.

I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.

I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.

It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.

The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.

I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.

Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Baroness Thornton Excerpts

Monday 2nd November 2020 Grand Committee

[Baroness Thornton (Lab)]

Like the noble Baroness, Lady Barker, and others in this Room, I have been involved in the legislation that is the subject of these regulations for, in my case, 20-odd years. I thank the Minister for his explanation of these regulations. If he looks back in the record to last year and the statutory instruments that we were discussing in Grand Committee—I think we might even be amending some of them today—he will see that his noble friend Lady Manzoor was given a particularly hard time by the Committee, because of course we were at the time putting on the statute book regulations just in case we crashed out of the European Union in March last year, and many of us resented the amount of legislative time that we wasted preparing for something which did not then happen.

It is of course important to acknowledge that these regulations are of vital and often life-saving importance, and concern literally matters of life and death.

The UK legislation for the safety and quality of blood, organs, tissue and cells, including reproductive cells, is of course based on European law. The European Union (Withdrawal) Act 2018 ensures that EU-derived domestic legislation will continue to have effect after the end of the transition period. In 2019, regulations were introduced to ensure that UK legislation in this area could function effectively after the transition period. However, Northern Ireland will remain subject to relevant EU laws as a result of the Ireland/Northern Ireland protocol. So today we are looking at four statutory instruments that would amend the 2019 regulations and enable Northern Ireland to continue to meet European law.

Like other noble Lords, I have two questions that flow from that. First, what effect will the United Kingdom Internal Market Bill have in this regard? Is it a complete waste of our time discussing these things? Secondly, as the noble Lord, Lord Lansley, and my noble friend Lord Hunt asked, what happens when there is divergence in the regulatory framework between the European Union and Great Britain?

As noble Lords have said, there is one blood establishment in Northern Ireland, and it will of course be able to continue receiving blood and blood components from Great Britain establishments. However, Northern Ireland establishments will treat Great Britain as a non-European Union member state—a third country—for this purpose. What does that mean? In practical language, will this delay or impede the use of blood products?

The provisions for importing blood or blood components from a non-EU member state are set out. The Northern Ireland blood establishment already has the required import authorisations in place, and GB blood establishments currently prepare blood and blood components to meet EU and UK standards, so Northern Ireland blood establishments can continue to receive blood or blood components from Great Britain. There are 10 hospital blood banks in Northern Ireland, which will not, I think, need to take any action as a result of this SI.

On organs for transplant, the NHS Blood and Transplant service will continue to be responsible for organ donation and retrieval in the UK. Between April 2019 and March 2020, as other noble Lords have said, 32 organs from deceased donors moved from Great Britain to Northern Ireland, and 126 organs moved from Northern Ireland to Great Britain. Organs will be able to continue moving from Great Britain to Northern Ireland. However, Northern Ireland-based establishments again will be treating Great Britain as a non-EU member state for these purposes. We are told that these are the same provisions that currently apply to organs moving within the UK, and so the changes made by the 2020 SI will make no difference. However, what of the future? What happens when and if the European Union changes the regulations in this area? How will this be impacted? For tissues and organs, as the noble Baroness, Lady Walmsley, said, time is absolutely of the essence in these matters.

The HFEA says on its website:

“As the regulator of the fertility sector we continue to support clinics during the transition period. We have been communicating regularly with clinics through our Clinic Focus publication and have developed an EU exit webpage for clinics. We believe that fertility clinics are minimising the possibility of disruption of patient treatment.”


Well, I wonder whether that is the case, actually, for fertility treatment between Ireland, Northern Ireland and Great Britain.

The Human Tissue Authority website says that

“establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) may require changes to their licence. This applies to establishments in the Human Application sector from 1 January 2021.”

So the HTA is saying that human tissue establishments will need to vary their licence in order to continue their activities post transition. This includes establishments that intend to import or export tissues and cells as the starting material for the manufacture of an advanced therapy medicinal product. That is extremely important. In what way will this take place? Will there be delays? How will it happen?

I will look briefly at sperm banks, and I asked this question last year. The UK currently imports sperm primarily from sperm banks in the USA and Denmark. How will that traffic in particular be affected by these new regulations and instruments? In the regime that we currently have, we will be a third country and no longer a member of the EEA. So I would like to have explained how that will affect the import of sperm from the sperm banks that we use in Denmark.

Covid-19: Charitably Funded Hospices

Baroness Thornton Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Bethell (Con)]

I assure the noble and learned Baroness that we understand absolutely the contribution of hospices, the value for money that they represent, the role that they play in communities and the incredible sensitivity with which they handle end-of-life and palliative care. I pay tribute to the contribution made by the noble and learned Baroness to the Living Well Dying Well charity and to Hospiscare. It is the contribution of people such as the noble and learned Baroness to the hospice care movement that has made it such a powerful and sensitive supporter of people at their time of most urgent need.

[Baroness Thornton (Lab)]

It will be quite clear to the Minister now that virtually every single Member of your Lordships’ House has a local hospice to which they are attached. Mine is St John’s Hospice in St John’s Wood, which has just launched an appeal to recoup a £1.3 million shortfall during the pandemic. Because hospices are being asked to take on more and more patients that they do not have the funding to cover, I hope that the important 4 November meeting will be based on an assessment of the need for continuing support for the sector for the remainder of 2020 and into 2021. Also, what plans do the Government have to ensure that everyone who needs quality palliative and end-of-life care will continue to receive it through and beyond the pandemic?

[Lord Bethell (Con)]

The noble Baroness will know through her work as a lay member of the NHS Camden Clinical Commissioning Group that hospices are much valued by the healthcare system. I assure her that the agenda for 4 November will include an assessment of the ongoing support that hospices will need through the winter.

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

[Baroness Barker (LD)]

I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.

My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.

I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.

I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.

I say this as someone who has had a long-standing interest in HIV. To see some patient groups in some parts of the world continue to become infected and, perhaps, have threats to their lives that would not occur if they had simply been born in another country is devastating. For example, in the world of HIV, very little work is being done on development of antiretroviral drugs for paediatrics because there is very little call for that in western developed nations, whereas there is a very big need for it in sub-Saharan Africa. Our involvement in these matters has a direct bearing on the lives of people across the world and on our standing not only as one of the major governmental funders through the different international funds but as a country in which research into new and emerging transmissible diseases is second to none because of our long-standing history.

For all those reasons, I very much support my noble friend Lady Sheehan, and I await with interest the answer to the question that my noble friend Lord Stunell put, which was the one I was going to ask, about proposed new paragraph (d) in my noble friend’s amendment.

[Baroness Thornton (Lab)]

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”


That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”


drugs

“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.

The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.

Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.

This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:

“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]


I could not have put it better myself.

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

My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.

I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.

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[Baroness Jolly (LD) [V]]

My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.

Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.

Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.

The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.

Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.

[Baroness Thornton (Lab)]

This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.

I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.

All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.

[Lord Bethell (Con)]

My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.

The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.

I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.

I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.

By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.

However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.

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[Baroness Jolly (LD) [V]]

My Lords, the noble Lord, Lord Patel, set the tone for this debate. I share the concerns of the noble Lord, Lord Hunt of Kings Heath; his concerns should concern us all. We are entering new territory. We have worked across an EU framework for a long time and are now going to be on our own. We need to work out policies and procedures to deal with this new landscape, which of course is what we are doing today. However, we will still have to work with Europe, if not within it.

I understand that we are to leave on 31 December, but we really must not bury our heads in the ground. Regulation will be key; mutual recognition is important. I think the Minister has referred to mutual recognition in the past. I wonder if he or the noble Baroness, Lady Penn—I am not sure who will be summing up—could clarify that issue. We need easy and ready access to new medicines, early-phase trials and the willingness of the NHS to take them up. There is also the role of NICE. We have not looked at mutual recognition of standards, but we need to share information with international partners. My noble friend Lord Clement-Jones asked a lot of pertinent questions. If the Minister does not have these issues in her brief, perhaps we might have either a letter or a meeting, because these are really meaty issues that we are discussing.

Amendment 27 would make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay so that the UK can get early access to new medicines. Amendment 45 would require the Secretary of State to publish their proposed regime for a list of fees in respect of human medicines. What is the timescale on that? It would be interesting to see this fees regime alongside the old regime that we will be leaving.

Government Amendments 48 and 66 relate to the disclosure of information in accordance with international agreements. My noble friend Lord Clement-Jones had something to say about that. Interestingly, although I am not absolutely clear, Labour’s Amendment 118 aims to protect medicines and medical devices regulations from any form of control from outside the UK in the event of a trade deal. This goes back to legislation that we dealt with, which I think we ended up renaming the international health Bill. We need to be clear, coming up to the end of the year, about what a trade deal might actually look like and what things would look like without a trade deal. Those are my reflections on the amendments.

[Baroness Thornton (Lab)]

This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.

I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.

I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:

“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”


The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.

One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.

Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.

The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.

[Baroness Penn (Con)]

My Lords, I am responding as a Whip, rather than as a Minister. I understand that this is not the ideal moment to break, but I believe that noble Lords would wish to hear a full response to the issues raised. I therefore beg to move that the debate on this amendment be adjourned.

Covid-19: Test Results

Baroness Thornton Excerpts

Tuesday 27th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I take my hat off to the London School of Hygiene & Tropical Medicine, which runs an extremely exciting trial. In fact, the Secretary of State is visiting this very afternoon in order to get an update on that trial. Dogs can be used as a way of screening crowds in such places as airports and high-density venues. The validation of that method has not been proven yet, but I am personally extremely hopeful and remain grateful to those involved in the pilot.

[Baroness Thornton (Lab)]

We move from dogs to the technical teething problems with the app. It seems that the NHS Test and Trace app sends out exposure warnings to people stating that they have to isolate and then a few hours later sends another alert saying that there is no issue and they do not have to isolate. That probably means it is working quite well, but it does not tell anybody where they might have been exposed, or, as I have experienced, it flashes at you that you have been near someone who has tested positive and then there is complete silence. When will we be able to trust the technology to help us as well as alarm us? Secondly, when will the care homes testing speed up? Care homes’ turnaround time for tests still seems to be stuck in three to five days on average.

[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.