Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Lord Patel (CB) [V]]

My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.

This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.

Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.

Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.

This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.

The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.

I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.

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

My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.

When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.

The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.

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

I have received a request to speak after the Minister from the noble Lord, Lord Hunt.

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

My Lords, before the noble Lord winds up, I want to thank the Minister. Clearly, the fund is welcome, but it will cover only a limited number of medicines. The debate goes wider than that.

I want to ask the Minister about the financial contribution that her department receives under the current voluntary agreement with pharma for sales of branded health service medicines. Does she not agree that it is a strange position we have reached where, if the cost to the NHS of those branded medicines goes above the agreed rate, her department receives a rebate? That is excellent, but why then does the NHS continue to treat drug costs almost as a pariah and hold down its investment in new medicines? Why cannot that rebate be used as a way to incentivise a switch by the NHS to new medicine?

I have debated this with the noble Lord, Lord O’Shaughnessy, and his predecessor. It is a real issue. The NHS itself believes drug costs to be a major problem, but the department has essentially solved the problem at a national level through the rebate scheme. Somehow, instead of a virtuous circle, we have got the very opposite.

[Baroness Penn (Con)]

The noble Lord speaks with great passion. He is right that the debate goes wider than the innovative medicines fund, but it might also go somewhat wider than the scope of the Bill. I am, however, happy to write to him on the points that he raises.

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[Baroness Thornton (Lab)]

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

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

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

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

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

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

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

That is a legitimate question that needs to be answered.

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

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

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

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

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

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

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

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


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

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

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

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

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

The noble Lords, Lord O’Shaughnessy and Lord Clement-Jones, have withdrawn. I therefore call the noble Baroness, Lady Jolly.

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[Baroness Wheeler (Lab)]

I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.

We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.

The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:

“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,


and yet

“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.


As the DPRRC commented at paragraphs 39 and 42:

“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”


The Constitution Committee concurred and recommended that

“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”

Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.

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

My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.

It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:

“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.