Wednesday 4th November 2020
(3 years, 5 months ago)
Grand CommitteeMedicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Amendment Paper: HL Bill 116-IV(a) Amendment for Grand Committee (for Fifth Marshalled List) - (3 Nov 2020)
Baroness Jolly (LD) [V]
I should apologise to noble Lords: my noble friend Lord Clement-Jones is unable to be part of today’s Committee, so I will be speaking on his behalf—at some length but without, I suspect, his bravura.
Amendment 30 seeks to tighten the provisions in Clause 3 to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. Amendment 31 also seeks to do this, by requiring a framework for data to be used as agreed in consultation with the pharmaceutical industry, and Amendment 33 places a duty on the Secretary of State to
“act with a view to”,
rather than
“have regard to the importance of”,
ensuring that information is retained securely when exercising powers.
There is no doubt that the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and my noble friend Lord Clement-Jones are travelling down the same road, and I have very similar concerns. That is why we signed Amendment 30, and I am grateful to the noble Lord, Lord Hunt, for his support for the amendment tabled by my noble friend Lord Clement-Jones.
As explained at Second Reading, there are grave concerns about the wording of Clause 3(1)(b), relating to the development of a UK system to prevent the supply of falsified medicines. The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines, of information collected”
by such a system. This is an attempt to unreasonably broaden the original data-collection provisions of the Falsified Medicines Directive after the transition period.
The background to the current legislation is very clear. By the early 2000s, pharmaceutical companies were concerned about falsified, counterfeit products entering the legitimate medicines supply chain—especially high-value items such as Viagra. At that time, this was the only real way to distribute such products at scale. Schemes involving pack serialisation were proposed to reduce the risk of reputational and trading losses from counterfeit and falsified medicines entering the supply chain, and to reduce the potential risk of harm to patients.
A stakeholder model was established which is governed by the main groups in the supply chain and funded mainly by manufacturers—branded, generic and parallel trade—with smaller contributions to costs from wholesalers and pharmacies. These proposals became the EU Falsified Medicines Directive 2011/62/EU. In the meantime, the issue of falsified medicines had moved largely to the internet, where they are sold from trading platforms and/or unlicensed pharmacies.
So why is data use so important? As the Company Chemists’ Association has pointed out, data is a very sensitive commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage for the purpose of planning or adjusting manufacturing, marketing, prescribing, buying and stock control. But access to pack information—who is handling which packs—could highlight purchasing decisions, the margins being made and those trading for import/export purposes.
So the principle of “Whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016. As a result, general access to FMD data is restricted to pack information—name, batch, expiry, serial number—and active/inactive status, with some exceptions for investigating incidents and national competent authority use for reports, reimbursement, and pharmacovigilance and pharmacoepidemiology research.
The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.
Given both this access and the known sensitivities around FMD data, it is unclear why the department has included the sweeping provision of Clause 3(1)(b) on the use, retention and disclosure for any purpose of data collected under a falsified medicines system, and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme.
The pharmacy community has concerns not just that the department might accidentally release commercially sensitive data—this is covered by Clause 3(3)—but that it might use such data to gain unfair advantage by abusing its monopoly position as the main purchaser of medicines in the UK. Pharmacies wish to see data use under any future system being part of an agreement that has been subject to discussion with stakeholders and approved by Parliament. My noble friend understands that the department has said that the details of any proposed use under a new falsified medicines system would be contained in a statutory instrument by the affirmative procedure.
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.
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.
Lord Patel (CB) [V]
I thank the Minister for his response, as I thank all other noble Lords who have spoken. A small point was raised, with a good, short debate and the right response. I beg leave to withdraw my amendment.
Lord Bethell
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 5.
Baroness Jolly (LD) [V]
My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to
“conditions set out in the regulations”
or in
“a protocol published by the appropriate authority.”
As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.
Lord Bethell (Con)
My Lords, the lockdown debate later this afternoon brings home the significance of an emergency like Covid. It requires swift, dramatic change to protect public health. Clauses 6 and 15 are essential. They would allow us to make provisions about the disapplication of a medicine or medical devices provision where there is a need to protect the public from a serious risk to health. We would need regulations to do this, because to act in breach of an otherwise applicable provision would be an offence.
Medicines is a highly regulated area. Regulations apply from development of medicines to delivery, right the way down to the pharmacy. It is a complex and overlapping system, designed to protect the end-user, the patient. But there are times when we need to switch off a circuit of the system to respond to an emergency. This is most vividly apparent when we speak of a Covid vaccine. This is end to end, from port arrival, to the logistics of its delivery, to who may administer it. We need to be able to pick this circuit out of the whole and isolate it. Otherwise, to disapply regulation without being highly specific is to disapply regulation not just from the vaccine but from other medicines as well.
This is the point of conditions that go alongside the disapplication. Where we know what the conditions will be, of course it should be in the regulations. But often we cannot know what the specific conditions are. That is where the protocol comes in that the noble Baroness, Lady Thornton, with her Amendments 46, 47, 93 and 94, would like to remove. I acknowledge that the Delegated Powers and Regulatory Reform Committee objected to the use of a protocol. I note that its condemnation was not limited to this Bill but was a broader point about other legislation as well. I hope that I can explain why such a protocol is necessary here.
Protocols are a last resort in any emergency that provides critical flexibility in highly regulated areas. They would be time limited to provide flexibility and administrative detail, tailored to the professional audience that requires it and in language which they are familiar with. A protocol will be used only where it is not be possible to determine all the necessary conditions of disapplication at the pace needed to deal with an urgent threat. The protocol allows for the finer details to be sketched in, while giving Parliament the structure of the regulations to consider. We can debate the principle of disapplying certain provisions of the regulations, without always having the specific names of medicines or vaccines in front of us.
There are existing provisions in the Human Medicines Regulations 2012 that allow for the disapplication of regulatory provisions on how prescription, pharmacy and over-the-counter medicines may lawfully be supplied. These are limited to circumstances in the event or anticipation of a pandemic disease. This formed part of the response to the swine flu pandemic in 2009. Six protocols were issued in relation to specific antivirals for the treatment of swine flu, enabling them to be supplied by authorised staff who would not normally be able to supply prescription-only medicines. This involved separate protocols for different strengths of oseltamivir, a demonstration of just how specific we would expect the protocols to be.
We have made an SI this month introducing provision for the use of protocols in relation to coronavirus and influenza vaccinations. That SI seeks to anticipate the certain flexibilities that might be needed but it is not possible to cover all eventualities. It anticipates the need for rapid supply and the potential mass administration of medicines, since the anticipated vaccine may be delivered by injection.
However, until we are presented with a vaccine, we cannot know how many injections are required, for example. That is a finer point of detail that has implications for the scale of operation required. The SI makes clear that the disapplication of existing regulatory provisions about supply and administration of medicines will be subject to conditions set out in the protocol. These conditions of disapplication will include specifics around the class of persons permitted to administer the vaccines, and the protocol would specify the process by which a person in that class is designated as a person authorised to do so. It will provide for supervision and recording requirements that must be met when the vaccine is administered. These requirements will change depending on the necessities of the specific vaccine. Parliament can debate the regulation, but until we know the detail of that vaccine, we simply cannot establish how this operation will run.
The emergency powers allow us to go broader in terms of disapplications than what is currently available, a reflection of the type of emergency we face. In the illustrative SI published on introduction we have provided some clarity on our intent. It gives an example of what might be needed to ensure the disapplication could be relied upon in response to other circumstances, including a spread of toxins, pathogenic agents, and so on, that give rise to the risk of serious harm to health. This too would operate alongside a protocol.
Amendments 93 and 97 in the name of the noble Baroness, Lady Thornton, relate to emergencies involving medical devices. Provisions already exist in the Medical Devices Regulations 2002. These provisions allow particular devices to be put into service without being subject to CE marking, following a duly justified request if the Secretary of State considers this to be in the interests of the protection of health.
The ventilator challenge allowed us to fulfil the clinical need for ventilators through a combination of CE-marked devices, and devices which were granted an exemption from the requirement. They were required to conform to bespoke technical specifications as a condition of the exemption being granted, and the technical specifications evolved as they needed to. That ensured that the only devices in service without a CE mark were those that met the highest possible standards.
Online publication will also support dissemination to the required audience, to whom it will be targeted, such as operators in the supply chain, enabling conditions to be quickly understood by those who must use them, referring to concepts, processes and so on that they are familiar with from their field.
Protocols are a last-resort power. Where we can anticipate what the conditions of disapplication will be, we will put these into regulations, but I cannot say now how many injections will be required for a Covid vaccine or how many staff will be needed to deliver it. Parliament has our intent, our plans and our proactive preparations now, but not technical specifications—nor do we. I commend the noble Baroness, Lady Thornton, and her team for all they do to hold us to account. It is right that they look at how we can write good legislation, although we need legislation that allows for practicality in a crisis. Therefore, I hope I have provided enough assurances for her to feel able to withdraw her amendment.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.
Lord Bethell (Con)
I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.
Baroness Wheeler (Lab)
I thank noble Lords for their contributions in supporting the amendment—the noble Lord, Lord Hunt, reinforced by the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. I was particularly interested to hear the quote from the Leader of the House on this matter, and I am glad that that has now gone on record. I certainly echo the comments by the noble Lord, Lord Patel, about what he calls smokescreens, and his underlining of the powers the Government already have for dealing with such situations.
I thank the Minister for the very detailed explanation he offered on this issue, and for telling us why the Government feel that they do not need to address the DPRR Committee’s concern and table amendments. He also talked about protocols being a last resort, and I was grateful for that—and also for the fact that they would be time limited. I note those two things. This is a complex issue, not least for me. I need to look carefully at the Minister’s response, and, if necessary, come back to this issue on Report. I beg leave to withdraw the amendment.
Lord Bethell
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with human medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines. (3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—(a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Health in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.