Safety of Medicines and Medical Devices

Baroness Jolly Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Jolly (LD)]

My Lords, the safety of medicines and medical devices is a cause in which we are all invested. I join others in thanking the noble Lord, Lord O’Shaughnessy, for instigating this debate and for his excellent opening speech. I was particularly interested in his account of treatment of cancer in the brain in Birmingham—my brother-in-law is an in-patient there as we speak.

In a context where important pharmaceutical and technical advances are being made, ongoing work must be undertaken to ensure that patient safety is never compromised. I am encouraged by some steps that the Government are taking, such as the independent medicines and medical devices safety review.

There are two key ways to keep people safe. The Government must improve regulatory oversight, and must advocate listening to and responding promptly to patients experiencing adverse effects from unsafe medication or devices. Many noble Lords will have received correspondence about the devastation caused by sodium valproate and the awful effect it has had on babies, now disabled adults. Their mothers took the drug while pregnant. Will the Minister hold a briefing session for interested Peers to update us on progress with that—perhaps when we have finished all the health legislation currently coming down the track? That would be hugely helpful.

The impact of Brexit on medicines and medical device safety has already been covered well by other noble Lords, so I will not spend too much time on the topic. I am worried, however, by the expertise we have lost through the relocation of hundreds of staff of the European Medicines Agency to its new headquarters in Amsterdam.

I note that numerous drug safety reports, and reports of suspected adverse reactions to drugs, previously submitted at the EU level will instead be submitted to the MHRA. I echo the concern of the BMA, which has warned about skills gaps in pharmacovigilance. Can the Minister confirm that there is a recruitment drive to ensure that the MHRA is sufficiently staffed to consider the broad range of medicines and medical devices that require scrutiny in the UK? Moreover, what are the Government doing to ensure that the relationship between the EMA and the MHRA remains strong and convergent post Brexit? Will the Government make stronger assurances than the text of the political declaration that accompanied the withdrawal agreement, which states only that the UK and the EU will,

“explore the possibility of cooperation”,

after the transition period? That is simply not good enough. A weak relationship could harm patients and stifle progress. I look to the Minister for assurance that she is aware of this and taking action.

I am pleased to note the work of the independent medicines and medical devices safety review currently under way, looking into how concerns about surgical mesh were handled, and the devastating effects of Primodos and sodium valproate. A lot of insightful evidence has been submitted so far. The noble Baroness, Lady Cumberlege, is investigating whether the NHS harbours enough of a listening culture. The Epilepsy Society raised this issue in its evidence. In the case of surgical mesh, it seems that there was a degree of gender bias, meaning that women’s pain was not taken seriously. My right honourable friend Norman Lamb MP was vocal on the subject of mesh implants, highlighting the years of life-altering pain experienced by affected women, compounded by the emotional trauma of not being listened to and believed. On the back of all that, he set up the APPG. With the review now one year old, does the Minister know whether affected patients finally feel listened to? The review’s impact must be wide-ranging; it should complement work happening upstream to improve review processes.

Several organisations, including the Royal College of Surgeons, have called for tighter regulation and oversight of devices. Looking forward, new devices may be more complex than those of old but, contrarily, some devices may become simpler. Both require vigorous testing. More importantly, we must build ever more comprehensive mechanisms for both regulation and patient feedback. These systems must speak to each other to ensure that every new medicine and medical device is safe for patients. Technology has a role to play in linking patient experiences with unsafe medicines and medical devices in a clear pattern. Just as John Snow—not that Jon Snow—related the spread of cholera to a single water pump, so we see now, through work to analyse multiple databases on patient and drug experiences, that symptoms can be traced to an inappropriate medicine or a faulty medical device. This is an expanding area of work that must be monitored.

The noble Baroness, Lady Masham, mentioned sepsis. A few weeks ago, the noble Lord, Lord Grade of Yarmouth, told the House about the benefits of a national sepsis register. For medicine safety, the Royal College of General Practitioners has recommended a single system, with some similarities for reporting drug safety issues, which would be linked to GP notes. Will the Government consider this, while being mindful of data privacy? Perhaps it could be cross-referenced with the yellow card scheme, providing a stronger pool of data from which to draw conclusions. Multiple health sector experts, including pharmaceutical companies and health professionals, advocate strengthening knowledge of and access to the yellow card scheme.

Training health workers is a key way to keep patients safe—if the Government will provide funding. This could include broader “driving licence” training for the safe use of particular pieces of medical equipment, as well as the training of other health professionals. An obvious but important example is community pharmacists. We all agree that they play a key role in medical safety, for instance through medicine use reviews, new medicines services and keeping a look out for customers buying strong over-the-counter medications, or who appear to be suffering adverse side effects.

In conclusion, the debate has been excellent. I congratulate the noble Lord, Lord Carrington, on an outstanding maiden speech, and I thank the noble Lord, Lord O’Shaughnessy, for introducing the debate. I look forward to the Minister’s response.

Mental Capacity (Amendment) Bill [HL]

Baroness Jolly Excerpts

Tuesday 26th February 2019 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I offer my support to my noble friend’s amendment. All of us know—with due respect to the lawyers sitting among us today—that when you have more than a few lawyers, you get more than some factorial of opinions. My noble friend’s amendment was drawn up in consultation with both the care sector and human rights lawyers—hence we have more than one view. We believe that where we are is the right view.

The Minister stated that it was not always possible to use plain English in legislation. That is patently not the case. I point the Minister to the Care Act, another piece of legislation that affects the care of vulnerable adults. It was written from top to toe in plain English.

There is a call for this amendment to be clear. We have already heard today that the double negatives used in the government amendment are not easily understood. It does not read well; it is not comfortable. It needs to be clear, in positive rather than negative language, and able to be understood by a lay person or a carer. This amendment has the backing of the care and health sector bodies, and so we support it.

[Lord Hope of Craighead (CB)]

My Lords, this is a very difficult area. I agree with all the noble Baronesses who have spoken, in so far as they stress the problems of trying to identify what one means by “liberty” in this area, particularly regarding mental health. A number of cases have come before the courts, both in this House when it was sitting in its appellate capacity, and in the UK Supreme Court, where I sat and grappled with this problem myself. I support the government amendment which seems much more consistent with the way the Strasbourg court has interpreted Article 5.

There is a great deal of case law that has been developed over the years as to the meaning of “liberty” in its various contexts. The point that comes out very clearly from a case called HL v the United Kingdom—it went to Strasbourg following a decision in this House in a case called R v Bournewood Community and Mental Health NHS Trust—is that account has to be taken of a whole range of factors when you look at the word “liberty” for the purposes of the article. The court says that in the end it will always come down to a question of degree and intensity, regarding whether what has been going on really is a deprivation of liberty or merely a restriction. It is trying to devise a dividing line between these factors that one is searching for in looking for a definition.

The court said it decided not to try to define the world “liberty”, because it was so difficult to find a workable definition that would apply to all circumstances. What you tend to find is the approach that the government amendment takes, of saying what does not fall within the article in a given case, and what does. It is a safer way of proceeding, rather than trying to, as the amendment in the name of the noble Baroness does, lay down in clear terms what the “deprivation of liberty” amounts to. The problem is that if one looks at the way in which that amendment is framed, in future cases the courts are going to find it very difficult to see whether Article 5 is consistent with what is in the amendment. Then there is the problem of the court having to declare an incompatibility, which then has to be sorted out by some further amendment.

The safer and most useful route is to anchor the amendment to Article 5, as subsection (1) of the government amendment does; and then, for the guidance of those who have to deal with these difficult issues, set out some clearly defined areas where they are not at risk of it being said that they are in conflict with the article. I do not find the provisions set out in the subsections that follow difficult to understand.

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If the Government are not able to consider putting some kind of time limit within the main body of the Bill then, having pointed out that I am certainly not wedded to 72 hours, I feel that I will need to seek the opinion of the House. The backlog in the current system indicates what could happen under the Bill if we do not have some kind of clear time limit for information.

[Baroness Jolly]

My Lords, I shall speak briefly and I apologise to the House: I should have declared my interest at the beginning of this stage as a chair of an organisation caring for over 2,000 adults with learning disability or autism, or both. In Committee the noble Baroness, Lady Hollins, tabled an amendment on the provision of information for cared-for people, carers, family members and IMCAs. She is not in her place today but the noble Baroness, Lady Watkins of Tavistock, has produced a really elegant amendment and I shall support it.

On Report, I also explained why it is not sufficient to have this commitment in the code of practice. I shall not repeat that argument in detail now but it drew upon a Supreme Court ruling of earlier this year. The MCA code of practice not only misstated the legal situation but could not establish a duty where none had existed. If there is a need for a hard-edged duty or right, that needs to be put into legislation and not the code. We must have provisions in the Bill to provide the person with information about their situation and rights, along with clear statutory entitlements to copies of the relevant documentation for those supporting and representing them.

[Lord O'Shaughnessy]

My Lords, the rights to information are another good example of the positive change that this House made in the passage of the Bill. I pay tribute to the noble Baroness, Lady Watkins, and Baroness Hollis, for making that argument so persuasively. I am very grateful to my noble friend the Minister and my right honourable friend the Minister of State, Caroline Dinenage, for responding.

I completely understand the desire to create—if I can borrow a bit of terminology—a backstop for why these sorts of cases ought to be considered. It is very easy to see how in practice when perhaps a small institution is caring for people with complex needs, the definition of “practicable” could stretch over time because of urgent or important responsibilities. There is a risk that, without some kind of backstop or time limit, this is too vague. However, I have a big problem with having an arbitrary time limit. I know that the noble Baroness is not attached to any particular time, but any time is by definition arbitrary.

My concern is that if this is in primary legislation it could lead to rushed or poor record keeping if it is not, for example, possible to conclude the review, assemble all the relevant pieces of information and provide that in a readable form—bearing in mind that is not going to be just straight English language for everybody—to the appropriate person, the IMCA, and so on. We should particularly bear in mind that an appropriate person could be somebody appointed by the cared-for person who resides in another country. So there are complexities at the edge of these kinds of cases that mean that if an arbitrary limit—which any limit would be—is set out in primary legislation, it could mean that as institutions bump up against it, they just rush to get the job done rather than making sure that they take care to do the highest-quality piece of work. That is my fear, although maybe other noble Lords do not share it.

I take the point that the noble Baroness, Lady Jolly, made about whether or not—in her view, not—the guidance is the place to do it. It seems to me that it is the right place to do it, because we had not defined “practicable” and “appropriate” before. We can now derive some examples of what that would and ought to look like in normal cases, but also in edge cases. I have listened very carefully to the argument—as noble Lords know, my attitude throughout has been to listen and make sure that we can improve this Bill. However, I have concerns about putting an arbitrary limit in, for the reasons that I have set out. I hope my noble friend, as she has been asked to do by my noble friend Lady Browning, will be able to explain things to us in a bit more detail—and give us a flavour of how the statutory guidance would provide that kind of detail—to provide reassurance to noble Lords that this is not just a boundless commitment that does not have some teeth.

GP Partnership Review

Baroness Jolly Excerpts

Thursday 21st February 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

I am not able to talk about other parts of the public sector, but we recognise that there are legitimate concerns here, and we are working with the BMA and NHSE as part of our work on the recruitment and retention of GPs and consultants, and considering what mitigations, if any, would be appropriate.

[Baroness Jolly (LD)]

My Lords, this was indeed a good and welcome report. The Royal College of General Practitioners welcomed the findings, but noted that the profession was concerned about red tape surrounding appraisals, CQC inspections and now GDPR, which are all getting in the way of patient care. Who is responsible for squaring the circle between improving patient care and GP regulation and accountability?

[Baroness Blackwood of North Oxford]

The noble Baroness is absolutely right: we want to free up GPs to do exactly what they have been trained to do, which is to care for patients. That is why, as part of the GP contract, we have included funding to ensure that they can claim for any additional costs that they may have under the GDPR. It is also why we put in the long-term plan that we want to recruit an extra 20,000 staff who can provide the other services, such as administrative services, that GPs are sometimes caught up doing when they should not be.

Healthcare (International Arrangements) Bill

Baroness Jolly Excerpts

Committee: 1st sitting (Hansard - continued): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Baroness Manzoor]

I fully understand the point made by the noble Baroness, Lady Brinton. I always believe in a simplified place, but those are the accounting rules that we have for government and therefore they remain. We have gone the additional mile by saying that we will place on record a ministerial Statement at the end of each financial year and that this will include the areas I have indicated.

[Baroness Jolly (LD)]

The Minister referred to arrangements being put into NHS organisations to make this happen—but what about GP practices? If you talk to GPs, they will tell you that they are in private partnerships. Presumably the Government are talking to the Royal College. The last time I had a conversation with GPs was five or six years ago, when they were totally averse to collecting money for their services. Can the Minister clarify whether things have changed?

[Baroness Manzoor]

I can clarify that NHS trusts are funded on the basis of existing agreements and will provide additional funding for any new agreements reached within the powers of the Bill. The same thing will apply to GPs where charges need to be made for people who are not entitled to that care and do not fall within the reciprocal arrangements that we have in place. The procedure would apply as it currently applies and such people would be charged as appropriate. If they are part of the reciprocal agreements that we have, whether bilaterally or multilaterally, such charges will not be incurred.

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[Lord Patel]

My Lords, I shall speak to Amendment 22, in my name and that of the noble Lord, Lord Kakkar, and Amendment 25, which is in my name. Both relate to personal data, and seek assurance from the Government that, whatever processes are put in place, they will respect the need for confidentiality and trust. While I absolutely recognise the value of transferring individual health data when the patient is receiving treatment, and the need to do so, it is also important that the Bill provides powers to protect personal and health data.

Access to personal health data should be limited to healthcare purposes. Currently, the General Data Protection Regulation imposes restrictions on the transfer of data, which we may not have after we leave the EU. A separate issue is the definition of “authorised persons”, which, when they gave evidence, both the BMA and the Academy of Medical Royal Colleges referred to as a concern.

I am also unhappy about the mechanisms that will operate for patients to consent to having their data transferred. Amendment 25 refers to Clause 4(6), relating to data processing. It says:

“In this section—‘authorised person’ means”.


Paragraphs (a) to (e) then define who the authorised people might be. Amendment 25, which I tabled only to get an explanation from the Minister, suggests that paragraph (e) should be deleted. It says that,

“any other person authorised, or falling within a description of persons authorised, by regulations made by the Secretary of State for the purposes of this section”.

That sounds too wide to me. In this country we have clear protocols and guidelines about who should be transferring patients’ data and to whom. It is not to anybody not clearly defined as an authorised person. I beg to move.

[Baroness Jolly]

My Lords, the NHS in England has a long history and a good record of data governance. In 1996, Fiona Caldicott was called in and asked to look at the whole issue of NHS data. It must be said that the data was not as digital then as it is now. Her review came up with a group of principles—I think there were seven—and that was then followed by Caldicott 2. More recently, there has been another look at NHS data and we are now down to three principles. It is not just the Caldicott guardians. When he was Secretary of State at DCMS, Matt Hancock announced the data ethics framework and then we had GDPR. There is a really rich background of caring for patients’ data.

The provisions in the Bill authorising the sharing of data appear wide—that is probably the best way to put it. Clause 4(1) provides:

“An authorised person may process personal data held by the person in connection with any of the person’s functions where that person considers it necessary for the purposes of implementing”,


the Act. The words,

“that person considers it necessary”,

are a very wide formulation for the exercise of a function such as this. They seem designed to make a challenge in court almost impossible.

Among others defined as an authorised person is a “provider of healthcare”, so the authority extends beyond the NHS to all organisations that provide NHS care but might not be NHS organisations. So it would include commercial organisations as well as public authorities. Can the Minister confirm this and give an example, to better understand how wide the scope is?

Moreover, it is left to bodies such as the NHS to define for themselves the level of staff who should have this degree of authority. Will the Minister confirm how data is handled with devolved states and within the island of Ireland? How are we intending to communicate clinical data with organisations in the EU, and in the rest of the world, once the Bill has been enacted? Are there issues about shared datasets? We are fairly confident about sharing research data, but clinical data will be absolutely key here.

[Baroness Thornton]

My Lords, I have an amendment in this group. I support the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. Clause 4 of the Bill provides the legal basis for processing personal information and data about patients to facilitate patient information and payments for reciprocal healthcare after Brexit—whether as part of an agreement with the EU, an agreement with a country outside the EU or in connection with contingency plans arising from a no-deal scenario. It also seeks to ensure that the key safeguards which should always be at the heart of systems that use and exchange patients’ sensitive personal and medical data are in place. The noble Lord, Lord Patel, is right to press this issue. It was almost the first thing that he and I spoke about when we talked about the Bill, which made me look at and ask why he and other noble Lords, particularly those in the medical profession, were very concerned about this.

At Second Reading the Minister acknowledged that there were deep concerns raised by noble Lords on data processing provisions in Clause 4, and promised to address them—but unfortunately she ran out of time on that day. We look forward to her catching up with that. We know that the noble Baroness has special expertise and experience in this field, so I look forward to hearing her talk about how she envisages the necessary robust standards, security and safeguards applying in post-Brexit healthcare deals with the EU and the rest of the world, and how those will be achieved.

In the Commons, my colleagues pressed this matter with the Minister, Stephen Hammond. He gave an assurance that the powers to access personal data would be limited, and committed at the time to provide a briefing. I wanted to raise that with the Minister—my colleagues in the Commons certainly have not received that, but I thought that she might raise it with her colleague and see what the briefing might have said. I am sure that we too would be interested to receive it.

When I raised this issue at Second Reading, I mentioned that I had been in touch with the National Data Guardian for Health and Social Care, who, as we know, has a vital role in ensuring that confidential healthcare data is used and shared appropriately in protecting the high standard of confidentiality. Pursuing that question is whether the Minister has been in touch and sought her guidance on this matter.

[Lord O’Shaughnessy (Con)]

My Lords, this has been an important discussion on an area that is, of course, of growing concern not just for people in Parliament but for the general public. Noble Lords will also know about my interest in this issue; we have had many discussions over the last few years about it. It is critical that we get this right, to allay any fears—because there are fears that attend to the use and movement of data for various purposes.

The noble Baroness, Lady Jolly, makes the point in her amendment about the Caldicott principles and so on. I was pleased from the Government’s point of view to be able to bring the National Data Guardian on to a statutory footing, as well as other measures that we took to provide that level of reassurance. My understanding is that these are all part of the scaffolding around the Data Protection Act, which is the GDPR as put into our legislation. They are a way of translating the general provisions of that into healthcare purposes. I ask the Minister to confirm that, because the Bill clearly states that the Data Protection Act is the governing piece of legislation here, it therefore follows that things such as the NDG, the principles and other things apply. They, in effect, derive from that and apply to all aspects of healthcare, including reciprocal healthcare.

[Baroness Jolly]

We are talking about exchanging health datasets, but in this world we are talking about our EU partners, the EEA and whoever else in the world we make a healthcare arrangement with. Are there mechanisms—this is a question I do not know the answer to—whereby datasets can be standardised so that any method of recording healthcare information that we might use would be recognisable to somebody in the States, Canada or France?

[Lord O’Shaughnessy]

That is an incredibly important point and it goes to the question that I was about to ask my noble friend. My reading of it is that it will not be possible for us to make reciprocal healthcare arrangements that involve the flow of data with another country unless we deem that country to be adequately complying with the GDPR. That is absolutely right and it is a high bar. It does not just provide a degree of regulatory compliance and standardisation; there are also international healthcare codes that underpin it, as the noble Baroness will know. It would be useful if my noble friend could confirm that, because it is clearly a really important point that will, in a sense, allay some of the fears that have been raised tonight about just how the powers in the Bill, once they extend beyond the European Union, Switzerland, the EEA and so on, might be used.

Healthcare (International Arrangements) Bill

Baroness Jolly Excerpts

Committee: 1st sitting (Hansard): House of Lords
Tuesday 19th February 2019 Lords Chamber

Noble Lords have been very patient with me; I will try not to bang on any longer. If we had time and exit day was further away, I should propose that this Bill should be sent packing back to the Government to redraft it and produce a Bill that is constitutionally acceptable. That option is not open. The healthcare of our citizens in Europe, and EU citizens here, must continue and survive. I shall support the amendments proposed by the noble Baroness, Lady Thornton. This breath-takingly flawed Bill undoubtedly requires the further safeguard of a sunset clause. This would enable the Government the opportunity to rethink their legislation—instead of having it cast straight back on to the Minister’s desk—and come back to the House with fresh proposals before the end of March 2021, when there really should have been enough time to produce an acceptable Bill. Once the Brexit legislative crisis has diminished, Bills like this one should indeed be wrecked.

[Baroness Jolly (LD)]

My Lords, I thank the Minister for her letter, but I rather feel that it posed as many questions as it has answered. Much of what I was going to be talking about with this group of amendments has been said very elegantly by the noble and learned Lord, Lord Judge. However, I am supporting Amendments 1, 2, 12, 13, 45, 46 and 47. As has just been said, your Lordships’ House has many committees. The refrain of the Second Reading was the expression “breath-taking scope”. The 47th report of the Delegated Powers Committee continues in the same vein:

“Under the powers in clause 2(1)(a) and (b) of the Bill, the Secretary of State could fund the entire cost of mental health provision in, say, the state of Arizona as well as the cost of all hip replacements in, say, Australia. If this might appear fanciful, we assess powers by how they are capable of being used, not by how governments say that they propose to use them. The fact that the powers could be used in these ways suggests that they are too widely drawn”.


When I read the Bill, parts of it read very much like a trade Bill. We believe that reciprocal arrangements with other than EU states are better dealt with one-to-one, much like those with Australia and New Zealand, for example. I am not convinced that arrangements with other than EU states will all fit in the same pattern. If the Minister wishes to bring a subsequent Bill for worldwide minus EU, we would be happy to look at it. Will she confirm that the Bill before us has been drawn up to fit in with future trade agreements across the world? Would any further secondary legislation be required? What parliamentary scrutiny would there be and are there any red lines?

[Lord Brooke of Alverthorpe (Lab)]

My Lords, first, I apologise to the Committee for not having been able to speak at Second Reading. Secondly, I welcome the Minister to her new post and wish her well with it, although I am sorry, like the noble and learned Lord, Lord Judge, that she has been given a hospital pass on this one. I shall speak briefly in support of Amendment 1 in the name of the noble Baroness, Lady Thornton. I am sorry to hear that the clause stand part may not be pushed to a vote, but perhaps the way that the debate goes may necessitate that.

My interest goes back before the Minister came into the House. I asked a series of questions about the proposed trade agreement between the UK and the USA. I have been particularly concerned, as have many in the health industry, that this agreement will open up an opportunity for the USA to come in very strongly indeed. The health industry in America is a very big part of the economy, and one area in which it has not been able to make great movement is within the NHS. Some of us have been concerned that the trade agreement would open that up, and we have been seeking to have it taken off the agenda. I have tabled Questions asking for it not to be on the agenda, and the Government have so far not been prepared to give any such assurance. I have contemplated moving an amendment to this Bill to ensure that, while the Minister is saying that this has nothing to do with that, she could accept such an amendment and set my mind at rest very quickly.

I read very carefully what she said in response to similar criticisms of the Bill at Second Reading:

“The Government are completely committed to the guiding principles of the NHS—that it is universal and free at the point of need. Our position is definitive: the NHS is not and never will be for sale”.—[Official Report, 5/2/19; col. 1488.]


She was not saying anything there with which I would disagree, but one worries about trade agreements whereby people can effectively take over and, while not owning it, can run parts of a major utility such as the NHS. That is why some of us have been seeking an agreement that it would not be on the agenda at all and the NHS would be left as it is, free of any trade agreement, particularly with the United States. I would be grateful, therefore, if the Minister could reassure me that in no way would a trade agreement with the USA have the NHS as part of it. If not, I may have to go away and see whether I can bring back an amendment on this issue.

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[The Earl of Dundee]

My Lords, in this group, I support Amendments 18 and 19, which were addressed by the noble Lord, Lord Foulkes of Cumnock. As with a number of earlier amendments, here there are two specifications, each of which serves a clear and useful purpose: giving assurance without applying any onerous impositions.

In their forthcoming negotiations, the Government will clearly seek to protect current arrangements, in this case including those affecting travellers with long-term medical conditions as well as those for pensioners.

Be that as it may, incorporating these categories in the Bill would give much-needed comfort to direct participants as it would to others desirous of protecting them. If that is a positive effect, there is really no downside. That is avoided through Amendment 18, which states:

“It shall be the objective of Her Majesty’s Government”.


Post Brexit, those words will encourage the Government to replicate what already obtains without forcing that eventuality against insurmountable difficulties if any such should happen to intervene.

[Baroness Jolly]

My Lords, at Second Reading I spoke about Northern Ireland. All noble Lords will be aware that there is no Assembly in Northern Ireland, which makes for difficulties. Notwithstanding that, for the past 20 years there has been two-way traffic of patients across the Northern Ireland border. There is a raft of cross-border successes including radiotherapy, ENT, cardiology, ambulance services which operate north and south of the border and the common travel area. I do not need to underline to noble Lords that any barrier at the border would be detrimental to healthcare, especially to children and vulnerable patients.

While international agreements are for the UK Government to agree, healthcare is a devolved matter, so as powers become repatriated from the EU after Brexit, the potential for overlapping competences will increase as well as the possibility for disagreement about how health issues should be managed. The Constitution Committee recommended that the Government set out how they intend to manage overlapping competences in relation to the Bill and other policy areas. Will the Minister clarify this? The amendment also outlines that the UK Government must ensure they use as a negotiating strategy continued access to healthcare in Northern Ireland and the Republic. There is also a danger that the Secretary of State will be able to overturn any Act of Parliament in history, including Northern Ireland legislation. This is theoretical, but the Bill should be judged on what it can do, not on what the Government of the day anticipate it will do.

I have a few questions for the Minister. Within the EU, we have had peace of mind knowing that our health needs are safeguarded if medical attention is required. Does the Minister agree that if a withdrawal agreement has not been ratified by exit day it is essential that UK citizens living in Northern Ireland can continue to access medical treatment in the Republic under a healthcare agreement so that this amendment is necessary? How is that best managed? The noble Baroness, Lady Thornton, talked about a strategy. Can the Minister confirm that in negotiations with the EU the common travel area is treated as a priority for healthcare in the island of Ireland? Is it intended to create a strategy or does one exist? With whom was it negotiated? Can Parliament see it?

Healthcare (International Arrangements) Bill

Baroness Jolly Excerpts

2nd reading (Hansard): House of Lords
Tuesday 5th February 2019 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I join other noble Lords in welcoming the noble Baroness, Lady Blackwood of North Oxford, to the Dispatch Box and in congratulating her on her very fine maiden speech. I hope she learns to love her brief. On these Benches we look forward to working with her, improving legislation and asking fairly regular questions.

One of the privileges of membership of the European Union is that, no matter where we are in the EU, our health needs are safeguarded when we need medical attention. Under EU agreements, the UK has participated in a variety of reciprocal healthcare arrangements with other countries, with the result that all citizens and visitors are protected. This Bill aims to allow the Government to implement new relationships with our EU neighbours, but it goes far further. It aims to give the Secretary of State powers to fund healthcare outside the UK and to give effect to healthcare arrangements between the UK and other countries. It gives data powers to the Secretary of State that exceed what one might think he or she should need.

We know how crucial it is that people’s health is protected after 29 March. In 2016, 91,000 British citizens used their EHICs while abroad in Spain. In Germany, 22,000 British citizens accessed medical help when they urgently needed it. Each year, thousands of older British people who have retired to the EU rely on reciprocal healthcare to access services as they age. Kidney Care UK has called for greater certainty for people living or travelling abroad with long-term health conditions and for those of us who have booked holidays for after Brexit. The BMA warns that care needs may not be met if many people are forced to return from abroad where their health needs are no longer covered. The BMA and the Nuffield Trust have estimated that in that scenario, an additional 900 beds might be needed. Of course, social care might also be affected.

A Bill of this kind is necessary if we are to leave the European Union. I do not believe that the extraordinary scope of the overall Bill has been adequately justified by the department, and I have several areas of concern. First, I am concerned by the extent of the powers called for. This issue has been raised several times today, but it is important to reiterate it. In November, the House’s Delegated Powers and Regulatory Reform Committee described the scope of Clause 2 as “breath-taking”. The committee noted that the clause covers everything from what kinds of healthcare can be funded to whom functions can be delegated to. That would appear to be everyone, everywhere. The Bill does not limit its scope just to Europe. It calls for worldwide powers to make healthcare agreements with any country, anywhere. Why is this necessary? Surely the focus of the Bill should be purely on building new agreements with the EU and EFTA countries.

Clause 4 makes any healthcare provider and anyone the Secretary of State decides an authorised person. Does this mean that confidential health records can be shared with private healthcare providers and anyone else the Secretary of State gives authority to, in the UK or abroad? I appreciate that data is important, but I wonder whether the Government are getting distracted from the key issue at hand.

In direct contradiction to the Government’s promises regarding the Bill, only last week a no-deal technical notice was published by the Department of Health and Social Care which recommended that British nationals living abroad should buy health insurance.

I am seriously concerned by the lack of comprehensive affirmative procedure in the Bill. Under this version of the Bill, regulations which do not contain provisions that make modifications to primary legislation are subject to the negative resolution procedure. Simply put, the Bill does not make provision for adequate parliamentary oversight, is too wide, and is unfocused in what it covers. As the DPRR Committee noted in paragraph 11 of its report, there is nothing that would prevent the theoretical funding of incongruous or excessive health procedures with the blessing of the Secretary of State. It is regrettable that these issues have been raised countless times since November, yet the Government have not fully explained why they request so much power and so much scope. Will the Minister, in her summing up, therefore justify in plain terms the reasons for the Bill being formulated in such a way?

I will spend some of my time considering the issue of devolution. I was glad to catch up with the noble Baroness at a recent meeting before she became Minister, when we were able to share ways of working—probably the nicest way to put it—which could be useful. I was pleased to hear that the Bill team has been working closely with Scotland, Wales and Northern Ireland, as the Bill will affect their NHS systems too. Scotland and Wales have already voiced their support for the Bill, but I will draw attention to some reservations. The Senedd noted that,

“given the significant impact on devolved areas it is crucial that Welsh interests are appropriately considered in the development of reciprocal health arrangements and that mechanisms are in place to ensure that the Welsh Government contributes to the making of decisions that affect Wales”.

If the Bill passes, will the Government commit to consulting the devolved nations when new reciprocal healthcare relationships are negotiated?

Northern Ireland, as has already been stated, faces a particularly tricky set of issues with regards to healthcare post Brexit. For example, children regularly travel from Northern Ireland for cardiac surgery in Dublin, and there is a radiology unit in Derry that is a cross-border initiative available equally to patients on either side of the border. It is co-staffed and co-funded, and ambulance routes cross the border many times a day. While we are on Northern Ireland, could the Minister consider this scenario of a citizen of the Republic of Ireland living in France and returning to live in London? How do they stand with regard to the Bill? I am pleased that the Minister has confirmed that close work is going on between Westminster and relevant officials in Northern Ireland and the Republic to ensure that no individual reliant on cross-border services faces disruption in the case of a no-deal situation.

I am also concerned by the provisions for data sharing in the Bill. The noble Lord, Lord Kakkar, referred to that issue in his speech, and we will come to it in quite a lot of detail in Committee. Clause 4 provides a legal basis for “authorised people” to process personal data for reciprocal healthcare after the UK leaves the EU. This could be as part of an agreement with the EU, an agreement with a non-EU country, or in connection with no-deal plans. Clause 4 clarifies that this data sharing must be in accordance with data protection legislation. But how do we guarantee our data safety once it is exchanged with bilateral partners? Health data, by its detailed nature, proves particularly sensitive in this regard even when it is made anonymous.

In the NHS, the Caldicott principles were developed in 1997 to consider how patient information is handled across the system. Principle 4 states that access to personal confidential data should be on a strict need-to-know basis. Clause 4 does not adequately safeguard this need-to-know principle. The purpose of this clause appears to be so that we can know how many citizens of other countries are using the NHS, and vice versa. The noble Lord, Lord Thurlow, made the point earlier that it is important that we should know that, but it is not contained in this part of the legislation. In practice, we all know that this is very tricky data to collect. NHS England and the devolved NHSs all use different data management systems. This NHS England data will be in the purview of the Minister; I wish her the best of luck with it, because it needs a strong hand.

A core value of our NHS is that it is free at the point of need. We know already that our hospitals and surgeries are not set up to process treatment charges, let alone to feed this information back into a complex system to be adequately anonymised and passed to the relevant country. We heard about dummy bills; I lived in the Middle East for some years in the 1990s, and in the country where I was living healthcare was free. You went to see the doctor and were given a prescription, you had a conversation and might be referred on, and you were given a dummy bill so that you understood what the value of your care was. That was quite an eye-opener. I am sure that it would be quite difficult to implement here—they were starting with an almost brand-new health service—but it brought you up short and made you think. Have the Government fully considered the practicalities of implementing some aspects of Clause 4?

I fail to understand why the Bill is of global scope when it is brought in in order to mitigate the damaging effects of Brexit. The Bill should refer to future reciprocal health arrangements with EU and EFTA members only. I am also worried by the extent to which data protection and devolution issues have been considered. These are key areas where the Government can achieve their objectives to guarantee reciprocal healthcare without reaching for such powers. It seems that the Bill embraces a somewhat laissez-faire approach to our future international healthcare arrangements. By asking for far-reaching powers, the Government neglect thinking critically about what they will truly need to negotiate future agreements.

I am sure that we will explore these issues in more depth in Committee, when I hope that the Minister will listen to and act upon the concerns that are expressed by this House. Parliament should not, and I am sure will not, lightly hand such sweeping powers to the Executive to do as they please. Parliament has the right to say no. If the Government do not listen to this House and do not act to limit the powers in the Bill, we will have no choice but to vote against its passing at Third Reading.

Health: Pancreatic Cancer Treatment

Baroness Jolly Excerpts

Wednesday 19th December 2018 Lords Chamber

[Lord O’Shaughnessy]

I am grateful to the noble Baroness for that question. Obviously, rapid diagnosis is important, but she is quite right that it needs to progress to treatment. The main way we are trying to address that issue is to increase the cancer workforce at every level—nurses, radiologists, endoscopists, oncological doctors, and others. Unless there are the staff to carry out those procedures, we will not get the outcomes that we want.

[Baroness Jolly (LD)]

My Lords, as speed is of the essence, will the Minister tell the House what work has been done to ensure that the public and GPs do not ignore often innocuous symptoms? Is he confident that there are sufficient centres of excellence across England and that they are adequately staffed to start treatment as a matter of urgency?

[Lord O’Shaughnessy]

The noble Baroness makes a very important point. I am sure that she is aware of the 14 Be Clear on Cancer campaigns that have been run over the last eight years, which are absolutely about raising the salience of these issues and making sure that people know the signs they should be looking for and can come to GPs earlier. We are seeing fewer people presenting with cancer diagnosis through emergency departments, which have the worst outcomes, and more coming through GPs. Of course, as I said, we are investing in these rapid diagnostic centres as well.

NHS: Waiting Times

Baroness Jolly Excerpts

Tuesday 18th December 2018 Lords Chamber

[Lord O'Shaughnessy]

With respect to the noble Baroness, I think I did answer the noble Lord’s Question because there are two different issues. One is the offering of private healthcare services and the second is the use of private providers to carry out NHS-funded provision—something that has been going on in the NHS for a long time and was accelerated under the last Labour Government. Of course, if private or independent providers are used to reduce waiting lists under the NHS, the NHS pays and the patient does not pay anything.

[Baroness Jolly (LD)]

My Lords, there is also a problem with the pipeline. Hospital beds are not clearing as patients recovering from surgery wait to get home or to less intensive settings. Had the Government’s Green Paper been published when it was due two years ago, NHS treatment might be available for those requiring surgery, so how long after its publication does the Minister expect the ideas in it to be fully implemented, so helping this situation to go away?

[Lord O'Shaughnessy]

Is the noble Baroness talking about delayed transfers of care? Of course, it is a major issue. We know that there needs to be better integration between health and social care. The better care fund provides that. We have seen some improvement in delayed transfers of care and the Government made an investment for further beds to come on stream this winter, to ensure that there are more beds for people and that we discharge people faster from them.

NHS: Specialist Services in Remote Areas

Baroness Jolly Excerpts

Tuesday 11th December 2018 Lords Chamber

[Lord O'Shaughnessy]

The noble Baroness is quite right. There is an urgent need to recruit more GPs. We continue to be committed to that. I am sure she will be pleased to hear there are more GPs in training than there ever have been. We are also providing a £20,000 salary supplement to GPs who go and practise in rural areas.

[Baroness Jolly (LD)]

As the noble Baroness said, there are occasions when a patient needs to see a specialist, but travelling to access specialist services is especially difficult for those on low incomes. What is NHS England doing to advertise the healthcare travel costs scheme to patients in rural areas? Do the Government hold information on how many eligible patients are claiming?

[Lord O'Shaughnessy]

There are a number of schemes, as the noble Baroness points out. As well as the travel costs scheme, there is the low-income scheme. They are designed to help people with those kinds of costs. I do not have the specific numbers about take-up, but I shall certainly write to her with those.

Mental Capacity (Amendment) Bill [HL]

Baroness Jolly Excerpts

3rd reading (Hansard): House of Lords
Tuesday 11th December 2018 Lords Chamber

[Baroness Murphy (CB)]

My Lords, I support this amendment. It is well thought through and I am glad that the Government have brought it forward. However, like my noble friends Lady Hollins and Lady Meacher, I have some very serious doubts about the continuance of this Bill as it goes to the Commons. We have already raised our anxieties about how it fits in with the Wessely review, and we have come to the end of our deliberations—when the noble Baroness, Lady Thornton, and the noble Lord, Lord O’Shaughnessy, normally congratulate each other on the process that we have gone through—but in fact we are leaving this Bill with the very same problems with which it came to this House.

The Bill came before Parliament because of the totally unviable nature of the current legislation. However, we do not have a statutory definition of deprivation of liberty for the purposes of this legislation and we now intend, as the Bill goes to the Commons, still to intrude on people living in their own homes. We are talking about a Bill that affects about 1 million people. It is currently projected to cost £2 billion a year but, with our amendments that introduce some improvements, it will cost considerably more.

Will the Commons really tackle the key issues? We have not seen the wood for the trees—that is the problem. We have tackled some really important minor issues but not the major issues that will make the legislation implementable in the care system. Can the Minister tell us what will happen next?

[Baroness Jolly (LD)]

My Lords, I welcome the amendment and declare my interests as set out in the register.

I too would like to talk about the application to adults with learning disabilities, autism or dementia who also have a mental health diagnosis, and I would also like to talk about what other noble Lords have mentioned—the interface between the Mental Health Act and the Mental Capacity Act. As the Minister will have seen, Sir Simon’s review redraws the dividing line between when a person should be detained under the Mental Health Act and when they might fall under the Mental Capacity Act.

Given that the proposed new dividing line is “objection” —in other words, those not objecting fall under the Mental Capacity Act—the role of the advocate in articulating the wishes of the individual becomes paramount in ensuring that the individual is treated under the appropriate legislation. With that in mind, I have a couple of questions for the Minister. Does he agree that advocates will need to receive sufficient support and training to understand this new dividing line, as and when it comes into being? Can he also clarify who will be responsible for ensuring that the training takes place and from whose budget the funding for it will come?

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the Government for adopting the principle of the amendment that we put forward on Report and for recognising its importance. I am glad to see that this will be in pre-authorisation reviews and to hear the assurances that it will act as a trigger for all types of reviews and will be put into the Bill when it goes to the other place.

I also recognise that the Minister has touched on staff induction, which will need to include training on liberty protection safeguards and cover when the review should trigger further action. However, I seek a categoric assurance from the Minister that the code of practice will state that staff will have the full protection of whistleblower legislation whenever they raise a concern, even if, for whatever reason, it does not proceed to initiating a review. I was grateful that during our meetings the Minister openly discussed the possibility of vexatious triggers, although I estimate that these would be very few and that triggers for reviews would involve legitimate concerns about a person’s welfare.

I also seek assurance that in its inspections the Care Quality Commission will be asked specifically to check that all staff know that they can request a review to be triggered and that they know that they will be protected. In addition, the responsible body, whenever asked to undertake a review, will need to keep a register of all such requests so that an emerging pattern of several requests coming from an institution will trigger a more major review into the type of care provided for everyone there.

One of the difficulties I anticipate arising at the interface between the Mental Health Act and the Mental Capacity Act is over the principle of objection. Among this cohort of people, objection may not be active; it may be passive. Sitting quietly, being withdrawn and being unhappy should be enough objection for people to consider whether the person should have been placed somewhere different or whether the conditions of their liberty protection safeguards should be altered. I have the impression that the type of objection envisaged in the Mental Health Act review was much more active than this type of passive objection, which could be interpreted as consent.

The other worrying aspect relating to this Bill and to the entire mental health review is the acute shortage of accommodation for people, both in the short and long terms. There is a shortage of suitable accommodation for people in crisis and of long-term accommodation that can meet people’s needs. Some are therefore accommodated in places not really adequate for their needs, but there seems to be no other option.

I repeat my gratitude to the Minister for having listened and brought forward this government amendment, and for all the other amendments that have gone into the Bill and brought about substantive changes. I look forward to hearing those reassurances in his response.