Medicines and Medical Devices Bill

Debate between Baroness Finlay of Llandaff and Baroness Wheeler

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

[Baroness Wheeler (Lab)]

My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.

We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for

“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.

If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.

Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.

We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?

Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?

One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.

[Baroness Finlay of Llandaff (CB) [V]]

I thank the Committee for allowing me to come in a bit late; I apologise for that.

Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.

In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.

In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.

Mental Capacity (Amendment) Bill [HL]

Debate between Baroness Finlay of Llandaff and Baroness Wheeler

Report: 2nd sitting (Hansard): House of Lords
Tuesday 27th November 2018 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, Amendments 49, 85 and 87, which are in my name, complement Amendment 29—which, like others, I strongly support. Information to the family and those who care deeply about the welfare of the person is the cared-for person’s safeguard against exploitation or bad care or simply having their needs ignored. It is paramount that families have a role to play in the care planning of their relatives, not least by giving them the option to stay fully informed and to object to the proposed plans if they are unsatisfied.

When an assessment happens at one point it is easy to collate all the information, get it signed off and then forget that every day until the scheduled review is a day to be lived by the cared-for person. If the conditions laid out in the authorisation are not adhered to, if the person is not empowered as much as possible to be both mentally and physically active, gradual inactivity and a slipping decline set in.

The care itself is important. Certainly, quality of care will vary between care homes and within them, but monitoring the care plan is central to ensuring that the cared-for person’s dignity is maintained. Their quality of life depends on how they are treated day in, day out, as well as whether they receive care in a way that enhances their personal dignity or, shamefully, they are treated as though they are of less worth. It is therefore imperative to ensure that the cared-for person is placed at the heart of the LPS authorisation process, which is why I want all those consulted in the initial process, as laid out in paragraph 17(2), to be able to access easily the care and support plan. Being able to apply for it is not enough; many people may not even know that they are able to apply to look at it. Relatives will notice if the care plan states that something is not happening and question why.

The care plan and authorisation record must be available to the cared-for person, enabling them to keep track of what is supposed to be happening. For those with fluctuating capacity or less severe impairments, the sense of control and empowerment that this would give is completely in line with the ethos of the Mental Capacity Act. Where the cared-for person cannot monitor their care plan, they can still know, even in their short-term memory, whether they are getting what they should get. Those with specific responsibilities for the cared-for person’s welfare—such as the nominated representative, the donee of the lasting power of attorney for health and welfare or the court-appointed deputy—must have both the authorisation statement and the accompanying care plan.

The care plan must also be provided to the care team in the cared-for person’s place of residence, because where such a place is supported living, I am concerned that those who provide support and are not on a professional register may find that they are not given all the details. I strongly support Amendment 29, introduced so clearly by my noble friend Lady Watkins. People must know what their rights are and what will happen. This will not be costly; it will be far less costly than the court cases that are likely to come if the requirement to provide information about all aspects of the process and plan is not in the Bill.

Amendment 87 deals with what to do in the event of a dispute. It requires an AMCP to be appointed to explore the reasons for the dispute and assess the situation independently. If agreement cannot be reached, independent mediation must be sought before resorting to the adversarial processes of going to court. A group of family law solicitors has been working for over a year to develop a system of mediation to be used before a court proceeding in the Court of Protection. This type of dispute, where everyone agrees that a solution must be found in the interests of the cared-for person, lends itself well to mediation; it would be swifter, cost less than any court action and be far less traumatic for all concerned. If the principle of dealing with dispute is not in the Bill, can the Minister reassure the House that it will be dealt with in the code of practice?

Before I finish, I urge the Minister to recognise the strength of feeling about people needing to be given information about their rights. If he will not accept these amendments, will he agree to bring the lead amendment in this group back as a government amendment at Third Reading? Requiring adequate information-giving must be in the Bill; it cannot be left to the code of practice, nor deferred to the Commons stages. This is one of the most essential planks in ensuring that the care that should be given is given.

[Baroness Wheeler (Lab)]

My Lords, we on these Benches strongly support the key amendments in this group. Amendment 29, to which my noble friend Lady Thornton added her name, would ensure that the responsible body has a duty to make sure that the cared-for person or the person representing them in an advocacy, professional or other capacity fully understands the rights of the cared-for person for whom deprivation of liberty is proposed, and the rights to challenge. Those rights also include specifically the rights to an independent and professional assessment, to a review of the LPS arrangements, to advocacy and support and to be able to challenge the LPS authorisation in court.

The noble Baroness, Lady Watkins, made a strong case for rights to information to be on the face of the Bill, ably following on from the interventions of the noble Baroness, Lady Hollins, during its previous stages. She spoke on the importance of this issue, particularly in respect to people with learning difficulties, and the need, wherever possible, to take steps to increase the cared-for person’s capacity to understand what is happening to them and to have as much involvement as possible to help them determine their wishes and feelings.

Care Bill [HL]

Debate between Baroness Finlay of Llandaff and Baroness Wheeler

Monday 10th June 2013 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, for many years in medicine, there has been a move to try to ensure training in the community, but its implementation has been woeful. It has not been instigated as rapidly as people have been campaigning for over many years. I hope that the Government will look favourably on the spirit behind the amendment, although, in an odd way, the wording may be a little too restrictive. It is a very important move to ensure that, as more patients are moved out to be cared for in the community, community services can deliver what they need. With very sick people in the community, a different skill set will be needed from that which is currently available.

[Baroness Wheeler]

My Lords, I support my noble friend Lord Warner’s amendment. There will of course be further debate on integration in the wider context of the Bill, but the amendment is important because it underlines that Health Education England must have the strategic overview and understanding of the workforce requirements across the boundaries of health and social care if it is to undertake its role effectively.

Our stakeholder meetings have shown that there is considerable concern among stakeholders on that issue. They want the links between HEE and the social care sector to be more explicit. The noble Earl’s reassurances last week in that regard concerning Clause 88 were helpful, and I look forward to hearing from him further on how HEE is to work with integrated care delivery. I hope that he will concede that my noble friend’s cross-reference in his amendment to Clause 85 is necessary, because it links the HEE’s duty in Clause 88 to have regard to promoting integration to its key role of ensuring that there are sufficient skilled healthcare workers available.

The Health Education England mandate acknowledges that the future needs of the NHS, public health and care system will require a greater emphasis on community, primary and integrated health and social care. HEE is essential in that. Staff must be trained and developed in the skills that are transferable between different care settings and in working in cross-disciplinary teams in a range of different health and support settings. It must also work closely with the social care sector by developing common standards and portable qualifications across the NHS, public health and social care systems. The local LETB role, linking up with the health and well-being boards, is particularly important in that respect.

It is worth briefly mentioning two recent reports on integration, both of which, among other things, reinforce how much awareness and understanding of each other’s roles must take place for integrated services to happen and to be delivered. The shared commitment statement under the National Collaboration for Integrated Care and Support was drawn up by an impressive mix of national partner organisations, including government departments, the HEE itself, regulatory bodies, the Association of Directors of Adult Social Services, National Voices and other stakeholder groups. It pledges to help,

“local organisations work towards providing more person-centred, coordinated care for their communities”.

There is not time to go into detail, but National Voices’ A Narrative for Person-centred Coordinated (“Integrated”) Care, which sets out what integrated care and support looks like from an individual perspective, for both the cared-for and for carers, is a powerful vision for the future. It underlines how closely staff across primary, community, NHS and social care will have to work if this is to be achieved. The section of the narrative on communication describes professionals talking to each other, and patients always knowing who is co-ordinating their care, always being informed about what is going on, and having one point of contact. This in itself would be nirvana to most patients, service users and carers.

The recently published Nuffield Trust report, Evaluation of the first year of the Inner North West London Integrated Care Pilot, looks at developing new forms of care planning for people with diabetes and people over the age of 75. It underlines the importance of staff having a high level of commitment to the pilot and to the care planning process in particular. Initial results show that work on care planning and multidisciplinary groups resulted in improved collaboration across the different parts of the local health and social care system.

On public health, the HEE mandate itself states:

“The health of people in England will only improve in line with other comparable developed countries when the entire NHS, public health and social care workforce genuinely understands how their services together can improve the public’s health”.

Does the Minister accept that the HEE mandate supports the case for the Bill to include an explicit reference on the overall strategic context?

HEE’s role is to provide national leadership for workforce training, planning and development, ensuring that we have skilled, committed staff in the right place, in the right specialities and numbers. We need to meet these challenges of the future and of the changing face of healthcare provision. How to ensure an integrated approach to education and training across the NHS, public health and social care is a very strategic issue. I hope that the Minister will reassure the House on this by responding positively to the amendment.