Medicines and Medical Devices Bill

Baroness Watkins of Tavistock Excerpts

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

Relevant documents: 19th Report from the Delegated Powers Committee, and 10th Report from the Constitution Committee

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

A participants list for today’s proceedings has been published by the Government Whips Office, as have lists of Members who have put their name down to the amendments or expressed an interest on each group. I will call Members to speak in the order listed, but ask noble Lords to note that both the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, have had to withdraw. Members are not permitted to intervene spontaneously. The Chair calls each speaker. Interventions before speeches or “Before the noble Lord sits down” are not permitted.

During the debate on each group, I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. Groupings are binding, and it will not be possible to degroup or amend for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Grand Committee Room only.

I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an Amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. The proceeding today will cease at 4.30 pm, earlier than originally planned. We will now resume debate on Amendment 27.

Debate on Amendment 27 resumed.

[Baroness Penn (Con)]

My Lords, I thank noble Lords for their patience in waiting a full week to hear the response to what was a very useful and detailed debate. By way of compensation, I hope my response today reassures them that my time has been put to good effect: I am sure they will let me know if that is not the case.

Amendment 27 was tabled by the noble Lords, Lord Patel and Lord Hunt of Kings Heath. I reassure both noble Lords that the Government and the MHRA remain committed to ongoing international collaboration for the benefit of patients and the life sciences sector in the UK. The noble Lord, Lord Patel, set out some of the work the MHRA is doing to deliver on this commitment after the end of the transition period in his opening remarks on this group. I am pleased that noble Lords had the opportunity to hear from and question the MHRA directly on this and other issues this week. The Government heard the request from noble Lords to ensure that this is part of an ongoing dialogue with the regulator and parliamentarians.

In response to the noble Lord, Lord Hunt, I am reluctant to revisit the debate on alignment with the EU, which we have already had in this Committee, as well as in many previous debates. However, I reassure him that the UK is seeking mutual recognition with the EU on a number of areas, including batch testing, good manufacturing practice and continuing co-operation on pharmacovigilance. Certain aspects of medicine regulations are also harmonised at an international level and we are committed to those international standards in all areas. Indeed, to further support the aim of continued international collaboration, we have tabled Amendment 48, which I will come to shortly.

Turning to Amendment 118, tabled by the noble Baroness, Lady Thornton, I reassure her that this amendment is unnecessary. The MHRA and the VMD are both recognised globally as leading regulators and will retain their regulatory sovereignty regardless of any trade deals agreed. This will include the MHRA’s duty to consider the safety and efficacy of human medicines placed on the UK market. We will ensure that our new FTAs provide flexibility for the Government to protect legitimate domestic priorities; we have made this clear in our published approach to trade negotiations with specific trading partners.

On the price the NHS pays for medicines, the Government have made clear that this is not on the table for negotiations. The prices of branded medicines will continue to be controlled through the 2019 voluntary scheme for branded medicines pricing and access—VPAS. To be absolutely clear, the powers in the Bill do not enable regulations to be made that relate to the pricing of medicines or medical devices. In relation to data, the UK has a strong system to protect health and care data, as set out in the Data Protection Act 2018 and covered by the common law duty of confidentiality. Our objectives for trade negotiations are explicit that we will maintain the UK’s high standards of data protection. Again, to be absolutely clear, it would not be within the scope of the powers in the Bill under Clauses 1, 8 and 12 to create exceptions to or modify the provisions of our data protection legislation.

I heard in last week’s debate that questions of safeguards and data protection were at the heart of noble Lords’ concerns about the government amendments in the name of my noble friend Lord Bethell, to which I will now turn. These amendments would allow us to share information regarding these areas with international regulators or networks where this is required to give effect to international agreements or arrangements. I reassure the noble Lord, Lord Clement-Jones, and others about the motivation behind these amendments, which have been identified as necessary as part of the work to support the future relationship with the European Union, and to protect and preserve existing work that the MHRA does. On his question about source codes and algorithms in medical devices, I make two points. The UK-Japan trade deal, as with the EU-Japan trade deal that came before it, provides for safeguards against IP infringement on the question of source code and algorithms. However, to protect patient safety, and for effective regulation, there remains provision for a regulator or conformity assessment body to request source code and algorithms as part of their regulatory responsibilities.

The MHRA and the VMD presently share and receive intelligence from their counterparts through our membership of the European Union, which will come to an end. The MHRA and the VMD will be the UK’s independent, standalone regulators and require appropriate legal powers for their own reciprocal information-sharing arrangements with other nations and forums. Without this, the UK may not be able to comply with its information-sharing obligations under international agreements; nor would it be able to participate in international arrangements facilitating the mutual exchange of intelligence regarding medicines and medical devices. These exchanges of information are of vital interest to UK patient safety. For example, intelligence sourced from international regulators through the EU has ensured access to life-saving medical devices for UK patients during Covid and has enabled the MHRA to trace suppliers of non-compliant testing kits. This is vital and will continue to be so going forward.

Future reciprocal information-sharing agreements with international regulators will help the MHRA and VMD to take swift regulatory action on medicines and medical devices that pose a risk, removing them from the marketplace if necessary. I reassure noble Lords that this data is limited to the data that the MHRA holds. The MHRA will always anonymise patient data before it is shared internationally, under the powers in the Bill. For the purpose of pharmacovigilance, for example, the MHRA might need to share information received through adverse incident reports. However, the information would always be anonymised and is usually kept at a high level—for example, description of the safety signal, or a trend report to identify whether another country has also identified an issue with a particular product or manufacturer.

I appreciate that there has been some concern over the use of the word “person” in the drafting of the amendment. We used that word, rather than specifying particular organisations, because we anticipate that international agreements will require the UK to share information not only with overseas regulators but with other bodies, such as overseas Governments, international organisations such as the World Health Organization, and international networks such as the International Medical Device Regulators Forum.

The wording is necessary because it provides the breadth, for example, to share data with international networks that might not be formalised. If we were to list all the organisations, networks and relationships that might be involved, it would simply not be possible to keep that list live on the face of legislation. Debate has been categorical that the MHRA needs to be a front-footed international regulator, and to limit it to the relationships it has now, rather than being flexible with regard to new regulatory forums or relationships, would restrict that aim.

The noble Lord, Lord Patel, asked pertinent questions about the data protection provisions in the new clauses. I have to admit to noble Lords that I had the same reaction about their potentially circular nature when I first read them, and I hope that I shall be able to unpack their effect here. The GDPR sets out seven key principles for processing personal data, the first of which involves “lawfulness, fairness and transparency”. We are providing a lawful basis for processing personal data by inserting these powers. That does not remove the other protections under the Data Protection Act that apply to the sharing of information under these clauses.

Where personal data are sensitive personal data, which are now called special category data, the GDPR requires further conditions, under Article 9, to be met for the processing to be lawful. Patient health data are a type of special category data. Relevant conditions under the GDPR, of which there are 10 that could be relied on to disclose patient data under the clause, would include “explicit consent”, reasons of “substantial public interest”, health or social care reasons, or public health reasons.

The GDPR also sets out further requirements where personal data are to be shared internationally. There must be an adequacy decision in place confirming that the third country or international organisation ensures an adequate level of data protection. In the absence of an adequacy decision, appropriate safeguards must be put in place that provide enforceable data subject rights and effective legal remedies, which can take the form of a legally binding agreement or contracts between parties. In the absence of an appropriate safeguard, data could be transferred only if it were

“necessary in order to protect the vital interests of the data subject or another natural person where the data subject is … incapable of giving consent.”



Equivalent safeguards for personal data and commercially sensitive information are already in place in Clause 35 for information relating to medical devices. This is solely to facilitate the appropriate sharing of information to give effect to international agreements and arrangements. They are critical to ensuring we can regulate effectively and uphold high standards of patient safety and access.

Amendment 45, in the name of the noble Baroness, Lady Thornton, seeks to achieve what is already standard and long-standing practice. Existing arrangements already ensure that timeliness, openness and transparency are key to the fees regime, and they are published online and available on GOV.UK. We will ensure that the industry and any other interested stakeholders know about any future fee changes in good time. We have laid statutory instruments to implement changes at the end of the transition period, as the cost of providing some regulatory services has fallen, so the fees charged will need to be reduced.

On the basis of the reassurances I have provided on Amendments 27, 45 and 118, I hope the noble Lord, Lord Patel, feels able to withdraw Amendment 27, and that the noble Baroness, Lady Thornton, is similarly assured and will not move her amendment.

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

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

[Baroness Thornton (Lab)]

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

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

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Clause 2 agreed.

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

We now come to the group consisting of Amendment 28. I remind noble Lords that anybody wishing to speak after the Minister should email the clerk during the debate.

Amendment 28

Moved by

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[Lord O'Shaughnessy (Con)]

My Lords, I thank the noble Lord, Lord Patel, for moving this amendment. I also pay tribute to my noble friend Lord Lansley for laying the amendment and for creating the template for the innovative medicines fund—the Cancer Drugs Fund—in the first place. The noble Lord, Lord Patel, described the tens of thousands of patients who have benefited from that scheme. It has been a fantastic innovation and something I am sure we all want to build on.

It also seems entirely appropriate that I am following the noble Lord, Lord Hunt, who gave a powerful speech. When I was a Minister, he was unrelenting in pointing out the weaknesses in the PPRS when it came to supporting innovation. He was right then and he is right now. That is why I needed no persuading to support this idea and this amendment. It was something that I tried and failed to introduce in the VPAS when I was a Minister, but perhaps a seed was planted then. It was fantastic to see the commitment made in the Conservative party manifesto in 2019 to create an innovative medicines fund.

As the noble Lord, Lord Patel, said, there are many areas, particularly, but not exclusively, rare diseases—and I have a daughter with a rare genetic condition—where experimental drugs seem to offer great hope, whether that is cannabinoids for epilepsy in children, or gene therapies for children with spinal muscular atrophy, or the many other conditions where the promise seems huge but the data does not yet convince. It feels to me that if we accept circumstances in which it is right to give cancer patients access to those kinds of therapies, it should also be right to give all other patients access to those kinds of therapies too. That is really what the innovative medicines fund is about.

I think that we have seen the shape of the future innovative medicines fund and what it would look like. The VPAS allows for confidential, complex deals for the first time. We have seen CAR-T therapies come through that route. We have also seen a deal signed for Inclisiran—originally from the Medicines Company, now Novartis—with testing of that in a real-world situation following a very successful large-scale clinical trial that was largely focused in the UK. This provides a template for how we might go about doing business for common conditions, as well as for rare ones.

I am sure my noble friend the Minister will agree with everything she has heard today, so I want to ask her what the timetable is for introducing the scheme. Questions have been raised by the BIA and ABPI and others, and I very much agree with them that an ambitious definition of innovation is required. The noble Lord, Lord Hunt, made an excellent point when he forcefully said that we must make sure that the rebate is recycled into innovative medicines, rather than just going back to the Treasury—there does not need to be an additional expenditure control mechanism. I will be grateful for my noble friend’s guidance on that.

One other thing that has come up in our debate in Committee so far—and of course this is more difficult because it takes it outside medicines and into other areas—is the exciting potential in devices, digital and diagnostics. There is no rebate scheme or automatic source of third-party funding that could provide for that. Is the Minister prepared to entertain exploring the potential for expanding the innovative medicines fund into something broader, and beyond medicines, perhaps not in its first iteration but in the future? I look forward to hearing what she has to say.

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

I call the noble Baroness, Lady Finlay of Llandaff. Lady Finlay? I think we had better move on and we can come back. I call the noble Baroness, Lady Jolly.

[Baroness Jolly (LD) [V]]

My Lords, this amendment would require the Secretary of State to establish the innovative medicines fund, as promised in the Conservative’s 2019 manifesto. It provides that it is funded from rebates paid to the Government under the terms of the pharmaceutical price regulation scheme.

The Cancer Drugs Fund was a Cameron initiative from the general election of 2010, and the 2019 general election saw a Johnson extension: the innovative medicines fund. He promised that

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

The promise was to increase the funding to £0.5 billion. Can the Minister confirm the figure and clarify how “innovative” will be defined? Importantly, how will the fund address the UK issue of combination pricing, where some new cancer treatments are not cost effective, even when the price is nothing?

There are questions about what drugs outside of cancer drugs could qualify to go into the new fund. Can the Minister help with a response here? There might be candidates from medicines selected for the early access to medicines fund, a pre-licensing indicator of promising innovation given by the MHRA. This would allow 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, which is a prerequisite for any drug to get a full, positive EAMS designation, there looks to be a good fit, and we support it.

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I hope noble Lords are reassured on the timing of the engagement exercise—to be undertaken in the first quarter of next year, and I hope that the noble Lord, Lord Patel, feels able to withdraw the amendment.

[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.

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

I have also received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

I apologise for my email ineptitude.

I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.

I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.

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Amendment 29 not moved.

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

We now come to the group beginning with Amendment 30. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Clause 3: Falsified medicines

Amendment 30

Moved by

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

We now come to the group consisting of Amendment 40. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Amendment 40

Moved by