Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

[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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Moved by

[Baroness Thornton]

30: Clause 3, page 2, line 39, leave out “, for any purpose to do with human medicines,”
Member’s explanatory statement
This amendment tightens the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe.

[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.

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[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.

We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.

I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.

Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.

We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.

The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.

We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.

I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.

I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.

[Baroness Thornton (Lab)]

I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.

The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.

Amendment 30 withdrawn.

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[Baroness Jolly (LD) [V]]

My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.

[Baroness Thornton (Lab)]

My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.

[Lord Bethell (Con)]

My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.

I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.

I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.

It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.

The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.

I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.