Medicines and Medical Devices Bill

Debate between Baroness Cumberlege and Baroness Masham of Ilton

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

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

My Lords, I am speaking on the telephone, as something went wrong with my iPad.

I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.

Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.

There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.

[Baroness Cumberlege (Con) [V]]

My Lords, I congratulate the noble Baroness, Lady Thornton, on her comprehensive introduction, expressing the urgency of the situation, which was also stressed by the noble Baroness, Lady Masham, in another interesting contribution for which I thank her. This is a difficult and hugely important issue, and it needs serious consideration on two counts. We have to look beyond the present situation with anti-vaccine campaigners and decide very carefully what is information and how we should combat damaging information being spread. Secondly, how do we reserve the right of the individual to use social media to express their personal views?

I spent six years on the Press Council, dealing with complaints. It was taxing, but today the print media is regulated to a greater extent. Even then, accountability for what should be published and what should not lay with not only the journalist who had written the article but with the editor and, in some newspapers, the owner.

NHS Bodies and Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch) Regulations 2012

Debate between Baroness Cumberlege and Baroness Masham of Ilton

Tuesday 5th February 2013 Lords Chamber

[Baroness Masham of Ilton]

My Lords, it is with regret that we are here this evening regretting that the Government have, through restrictions on campaigning, deliberately tied the hands of local Healthwatch bodies from giving public voice to those patients’ interests.

The regulations seem muddled and unclear. I am surprised that the noble Earl, Lord Howe, has not managed to do better. Over the years, he has witnessed the difficulties that the bodies representing patients have had, ever since the closure of the community health councils. This time around, I feel that the Government are missing an opportunity. I support the view—I always have—that it is essential that local Healthwatch be independent and led by the service users and the public if it is to have credibility and influence. It must not be a tool of those whom it monitors and inspects.

With the Francis report to be published tomorrow, I am sure that it will become evident that a clear, independent voice supporting patients and users of care homes is vital. There should be trust. The dangerous culture of cover-up and not listening to family and friends must be rectified. At the moment, the Patients Association is asked to comment when there is a problem. We need good, dynamic Healthwatches to ensure that disasters do not happen. We need people who know the needs of their local population. We need safety and a good standard of all health and social care. Healthwatch England is there to help and support local groups, but the local Healthwatch should have freedom to do the very best for those whom it should be protecting and supporting. I hope that the Government will realise what is needed and do better before it is too late.

[Baroness Cumberlege]

My Lords, I suspect that my noble friend has got the message now that we are not totally enamoured of these regulations. I think back to when we had the White Paper, which was published in July 2010. I remember, as my noble friend Lady Jolly has said, how excited I was then by the fact that in local Healthwatch we were to have an organisation that really would be the collective voice of patients. There was a mechanism so that it would have a very strong infrastructure at the local level.

So far so good, but throughout the passage of the Bill Members of your Lordships’ House fought strongly to get that policy enacted. We were given assurances, as noble Lords have said, and they were given in good faith. Yet now we have the regulations in this statutory instrument, we are not only disappointed but deeply concerned. I share the grave concern of the House’s Secondary Legislation Scrutiny Committee, which says that there is a very real possibility that local Healthwatch is in danger of being manipulated, but our concerns do not stop there.

The Government are right to want local people to have control of local Healthwatch but there is a genuine fear about it being subjected to such complex and draconian restrictions on what it will be able to say and do. It is not entirely clear to us what value local Healthwatch can add to the accountability framework of the NHS. This view is shared by Healthwatch England which, as the noble Lord, Lord Collins, has said, suggests that this could be dealt with by guidance. However, the trouble with guidance is that it does not have any statutory force. However, it could use its powers to sharpen the way in which local Healthwatch operates—as an independent champion through the trademark which all local Healthwatches must have and have to own. I have not given my noble friend any notice of this, but perhaps he might like to think about that and take it away.

Paragraph 36 of the regulations prohibits local Healthwatch from opposing or promoting changes to any national or EU law, any national policy, any policy by a local public authority—including both local authorities, the NHS or “any organ or agency” of either—and any planned or actual changes in any of these. In addition, it prohibits influencing,

“voters in relation to any election or referendum”.

These prohibited activities may be undertaken only if they are incidental to what could be called the core purpose of local Healthwatch—that is, giving people a say in local health and social care—unless that core purpose is incidental to the prohibited activities. This is mind-stretching. That seems to be something of a circular definition whereby X is allowed if it is incidental to Y, unless Y is incidental to X. This is pretty difficult. I have said that it is mind-stretching but I really fear that it will be unworkable. What is certain is that it will be incomprehensible to local people, who are expected to participate in local Healthwatch.

The impact of this provision is likely to have a chilling effect and to negate the aims of Healthwatch. Why should any committed volunteer get involved in local Healthwatch, giving freely of their time and energy to try to influence things for the better, if they risk being penalised for doing so?

I shall describe three situations to the Minister to test this with him, and I hope that he will reassure me on these points. First, say that there was a controversial policy to close an A&E department in order to save money. Would local Healthwatch be permitted to provide evidence to campaigners of how good the patient experiences had been at that threatened department? Would that be banned under Regulation 36 as the promotion of changes to a policy that a public authority proposes to adopt? If the Minister says no, how could local Healthwatch be confident that the local NHS decision-makers would share this view?

Secondly, could people who had been active in a national campaign to improve quality and accountability in the NHS be decision-makers in local Healthwatch? Would local Healthwatch have to avoid any connections to an organisation seen as intending,

“to affect public support for a political party”,

that was in power? Again, if the Minister says no, and decisions on such matters are to be delegated to local authorities, how could local Healthwatch be confident of that?

Thirdly, during a local election campaign, would local Healthwatch be subject to purdah, like democratically elected bodies such as local authorities or the Government themselves? Would that apply even if it discovered serious abuses of vulnerable people with learning disabilities in a residential home during this period? Such a discovery would not reflect well on the local authority commissioners, who are “an organ or agency” of local government under the regulations. Would the local Healthwatch have to keep such concerns secret or risk being penalised by that very same local authority?

The very fact that we have to ask these questions demonstrates that we do not have the right set of safeguards for the independence of local Healthwatch. The fact that local Healthwatch is funded and controlled by local authorities, which it is supposed to be scrutinising, is pretty uncomfortable. The added constraints of Regulation 36 threaten its freedom to speak and to act in the interests of patients and the population. These very complex restrictions seem designed to protect those in politics or in the provision of services who have something to hide. They impoverish the debate on health and social care, whether it is about controversial reconfigurations or a Baby P tragedy. Patients could not care less about politics and just want someone to speak up for them when they themselves cannot.

I urge my noble friend to consider modifying, redrafting or, if possible, removing these restrictions, or to find a mechanism to ensure that they are not implemented in the way that I have outlined and the way that I fear. To me, it is not clear whom they are really designed to protect, but I fear that it is certainly not patients.

Health and Social Care Bill

Debate between Baroness Cumberlege and Baroness Masham of Ilton

Thursday 8th March 2012 Lords Chamber

[Baroness Masham of Ilton]

My Lords, with so many changes over the years to volunteers supporting patients, it is important that HealthWatch England and local healthwatches should be effective. First, there were community health councils, most of which did a good job—some did not. Then there were health forums, which lasted only two years. Then there were LINks, which have not been very well supported. The way that these volunteers, who were supposed to be a voice for patients and people using social care, have been treated has not been good. Unless healthwatches have a strong voice and enough support to operate, they will not be able to do a worthwhile job. They need to be independent so that when they see something that needs to be improved they can speak out.

In the Mid Staffordshire Hospital, where the culture was wrong and patients suffered, no one spoke out when they should have done—except the relatives. I hope that lessons will be learnt and strong safeguards put in place, including a strong healthwatch. I know that the noble Earl understands the need for a body supporting patients that is fit for purpose. If the House thinks that HealthWatch England and local healthwatches are not fit for purpose, as suggested in the Bill, and if the amendments are not accepted, perhaps with the help of the Minister there is still time before Third Reading to get it right.

I ask him whether children’s services are to be included in healthwatches. If not, they should be. Just think of what happened to Baby P. We must not forget. It will be very disappointing if we do not get it right in your Lordships' House.

[Baroness Cumberlege]

My Lords, I have several amendments in this group and the next one. There are synergies between the two groups, so I shall speak briefly introducing both groups and go on to those in this group.

I have tried hard throughout our debates to ensure that we have a more robust accountability framework. As I see it, the framework is in three parts. First, there is the local authority. Secondly, there is HealthWatch England. Thirdly, there is the local community. I will not go into the independence of HealthWatch England, because I debated it very fully in Committee, but I understand the passion that has been expressed on that issue. For me, those three elements balance each other, and it is important that they do, because that will improve transparency.

To give an example, if HealthWatch England makes recommendations to local authorities on how they commission local healthwatch, local healthwatch and the community can hold the local authority to account for how it commissions. That gives it a yardstick by a third party, HealthWatch England, against which to measure the local authority commissioning arrangements. The policy document produced by the Government on Friday, Local Healthwatch—The Policy Explained, states that the Government are considering how the constitution and governance of local healthwatch needs to ensure that it operates for the benefit of and is accountable principally to its local community.

The third element is local people. They are critical to the accountability framework. As the noble Baroness, Lady Masham, said, in many eyes, they are the most important.

The government amendments, including those laid on Friday, go some way to addressing that, but they also introduce fresh concerns, which I shall refer to later. The loss of statutory structure is a great threat to independence. The value for money and rationale still have to be adequately explained, but I am sure that my noble friends on the Front Bench will do that shortly.

My noble friend Lady Jolly and I tabled Amendment 224, which improves accountability nationally by linking the perspectives of HealthWatch England more closely to the grassroots by electing the members of local healthwatch to the HealthWatch England statutory committee. The noble Lord, Lord Harris, gave that a warmish welcome, although I say to him that that is not a sub-committee, it is a committee. It is not subservient to a committee, it is a committee.

The Government have sought broader opinion with their public consultation on that and other topics which closed on Friday. That elected membership would serve two functions: first, as a counterweight to the influence of the Care Quality Commission, making HealthWatch England more independent; and, secondly, as an agent for the accountability of HealthWatch England, keeping it in touch with the patient and user reality. If local healthwatch does not think that HealthWatch England is really speaking out for people, it can say so through its elected representatives. They would be elected against a skill specification to ensure that they were the right people to fulfil that important role. Without that, HealthWatch England is a free-floating organisation with no local connection, a mere national harvester of local data. I hope that the Minister can reassure me again that that accountability gap will be dealt with.

Government Amendment 226 is very much welcomed. I strongly support it, because it responds to my amendment in Committee. It provides for the majority of the members of HealthWatch England to be made up of non-CQC members, making it independent of the CQC, which therefore cannot dominate HealthWatch England. My Amendment 226A stitches the accountability framework together transparently, by providing for local healthwatch to have regard to the standards set by HealthWatch England. I hope that my noble friend can give me some assurances as to how that last element can be covered.

The introduction of the HealthWatch trademark under government Amendment 235C is a very interesting device and may well help. Amendment 228 was also tabled by my noble friend Lady Jolly and me. It enhances independence and transparency nationally by providing for the Secretary of State to issue conflicts guidance to which both the CQC and HealthWatch England must have regard. I hope that the Minister finds that sensible. Amendment 229 is another government amendment which I support. It includes a risk management strategy, so that what may have gone wrong in one place may stimulate vigilance in another. I strongly support that.

I am sure that my noble friend will wish to speak to her amendments, but I have introduced mine and hope that some of them find some favour with those on the Front Bench.

Health and Social Care Bill

Debate between Baroness Cumberlege and Baroness Masham of Ilton

Wednesday 7th December 2011 Lords Chamber

[Baroness Masham of Ilton]

My Lords, I, too, would like to support what has been said about the HPA. It is so well thought of across the world, and infections spread across the world. Infections are getting much more complicated, with drug resistance, and we need the HPA more than ever. I ask the Minister one question: whatever happens to it, will it have an independent chairman?

[Baroness Cumberlege]

My Lords, I speak to Amendment 260, in the name of the noble Lord, Lord Patel. It is probably not the time to go around memory lane, but I want to draw on some experiences that I have had. I was the hapless Minister responsible for the Health Education Authority. Some people may remember the Health Education Authority. It was largely independent and its funding came through the department. I should not speak ill of the dead, but it really was a nightmare. One of my lasting memories of my modest ministerial career was when we had a Starred Question in this House, asking why government money and very scarce resources should be spent on a leaflet, produced by the Health Education Authority, entitled, I think, 69 Ways for Better Sex. It was the first that I or the department had ever heard of it. Perhaps one of the interesting things was the number of noble Lords who said they could not take part in the debate unless they had seen a copy of the leaflet.

The HEA went completely off the rails. It was only when we were reading or listening to the media that we found out what it was up to. In the end, it not only alienated the Department of Health and the Government, it alienated local health authorities, with their responsibilities for public health. It was they in the end who asked us to close it down. Well, we did. Listening to the current proposal for Public Health England to be an agency, I think that is a good idea, although I know it is very unpopular with the Faculty of Public Health and others. An executive agency, although not totally independent, will operate with a degree of autonomy from Ministers on a day-to-day basis. While not as independent perhaps as a health authority, it will be recognisable as an entity and have its own identity.

The only model that we have got in health of an executive agency is the MHRA. Its chairman, noble Lords will know, is Professor Sir Alasdair Breckenridge, who has been the chair since its inception. Sir Alasdair is a very strong individual and somebody people really respect highly. In the vernacular, he is the sort of person you do not mess with because you know you will not win; you do not even try because he is somebody with enormous integrity and presence, and runs a very good organisation. It seems a good idea to look at the MHRA model and see how it is organised. Sir Alasdair tells me that there are eight non-executives on the agency board, who form the majority and are the board. They have a very good chief executive who is a civil servant but the non-executives are not. They are drawn from right across the country with different experiences and, again, they are people of huge distinction who are very much respected.

Here is an example or model that actually works. It has been tried and tested, and is a model we could certainly adapt for Public Health England. However, I suggest to my noble friend that the important thing is to keep the public health constituency with us on this. It is important that it has a real involvement in choosing the chairman of this new agency. If it is involved, that will go someway to ensuring the agency will be a success. It should also be involved in the recruitment and appointment of the non-executive members. We have a highly credible organisation here that could be a very good model for Public Health England and I hope my noble friend will consider those points about the appointment of the chairman and the non-executives, and the formation of that board.

Health and Social Care Bill

Debate between Baroness Cumberlege and Baroness Masham of Ilton

Tuesday 22nd November 2011 Lords Chamber

[Baroness Masham of Ilton]

My Lords, I spoke on this subject at Second Reading, and I want to go back in history for a few minutes. I remember that when the community health councils were closed down, the noble Earl, Lord Howe, and I felt strongly that the health forums which were put in their place should be independent. If a local healthwatch organisation is linked too closely to its local authority, it will be difficult for it to be able to speak out if it finds that both health and social care facilities are not up to scratch. What happens if they disagree with the CQC? Patients often need help, so an independent body would be much better to help them with their problems. It is vital that HealthWatch is adequately funded to do a useful job, otherwise it will fail. Perhaps I may give an example concerning a rural area. What happens if there are not adequate funds for the payment of members’ travel expenses? That has been found with the local LINks. I hope that the Minister will give this serious consideration.

[Baroness Cumberlege]

My Lords, I have listened to the debate, and some powerful arguments have been put forward for an independent HealthWatch England. However, I am not sure that that is the right answer. The noble Lord, Lord Harris, said that he feels that the Bill is setting up the new arrangements, and of course he is right. However, when one is setting up new arrangements, it is a good idea to look at what has happened in the past. Looking back to the confederation of CHCs, one sees that it never actually made an impact. I think that that was probably because the initiative for setting up that body came from the CHCs themselves, and so the confederation had no formal legitimacy, no clout and few resources.

--- Later in debate ---

[Baroness Masham of Ilton]

My Lords, I want to ask the noble Baroness, Lady Cumberlege, about her safeguarding amendments, which are very interesting. Would she not also put down a safeguarding amendment about the funds? Jobs will not be able to be done unless funds are safeguarded.

[Baroness Cumberlege]

I will think about that. Having dealt with the Treasury in the past, I know how difficult it is to get anything ring-fenced. However, the noble Baroness’s suggestion is very interesting and I will take it on board.

We have examples of other consumer groups being very effective within their parent organisation. I think in particular of NICE, which has done a lot to get views on its work from the general public. The Council for Healthcare Regulatory Excellence has also done that.