Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): I welcome Mr Canice Ward, head of medicines regulatory group; Mr Gerard Collins, head of health protection policy; and Mr Martin Coleman, head of COVID-19 vaccination programme. I invite the officials to go ahead and brief the Committee, please.

Mr Canice Ward (Department of Health): Thank you, Chair, for giving me and my colleagues at the Department some of your time this afternoon. We are here primarily to inform the Committee of proposed changes to the Human Medicines Regulations, which are related to the sale, supply and administration of vaccines. Members may well have questions or queries on the legislation that, hopefully, I can answer. We are joined by Martin Coleman and Gerard Collins from the Department's health protection branch, who should be able to answer queries on vaccine policies. Hopefully, we will be able to answer any queries that members have.

The Committee has been made aware of the proposals by a submission from the Minister. The Committee was supposed to have a briefing paper yesterday, and I understand that it has been delayed. I apologise for that. It will be with the Committee as soon as we are able to provide it.

The Minister's briefing paper outlines some of the proposals. It might be helpful if I give a bit of background and context to the regulations and the proposed amendments.

The Chairperson (Mr Gildernew): Yes, go ahead, please.

Mr Ward: The Human Medicines Regulations apply UK-wide. Our Minister is a co-signatory for any amendments to the regulations, alongside the Secretary of State for Health. The Human Medicines Regulations are the primary statute that controls and regulates medicinal products or medicines throughout the UK. The regulations place controls on authorisations, manufacture, import, sale, supply, administration etc. Basically, anything that you want to know about the regulation of human medicines is found in the Human Medicines Regulations.

The regulations set up the Medicines and Healthcare products Regulatory Agency (MHRA) as the body that acts as a licensing authority across the whole of the UK. Many of these proposals or proposed amendments relate to the work of the MHRA. The primary policy intent of these amendments or proposals is to support the effective and rapid roll-out of the flu vaccine and, potentially, a COVID vaccination programme. They are broken down into five main policy areas. I will go through each with a bit of background, if members wish?

The Chairperson (Mr Gildernew): Yes. Members would like you to do that. Go ahead.

Mr Ward: In no particular order, the first amendment relates to the temporary authorisation of vaccines. As they stand, the Human Medicines Regulations allow the MHRA, as the licensing authority, to issue a temporary authorisation or temporary licence to permit the use of an unlicensed medicine, in response to certain specific threats to public health, such as a pandemic, like COVID-19. The proposed amendment will make it explicit that the sale, supply or administration of any product, which could be temporarily authorised under these regulations, may be subject to additional conditions that the MHRA would impose. Such conditions are likely to be similar to those attached to licensed medicines, such as what storage conditions they have to be kept in, who they can be used on, batch testing or quality assurance standards. They are all additional safeguards, and, if any of those areas were not met, the product would not obtain a temporary authorisation or, indeed, if they were breached, it would lose its authorisation.

Members should note that the provisions already exist to permit the supply of an unlicensed medicine in public health emergencies, when a licensed product is not available. These proposals simply strengthen those regulations and raise the standards by allowing the MHRA to impose any additional conditions that it feels to be appropriate. The provisions and the temporary authorisation would be used only by exception and temporarily, pending the issuance or granting of a licence or full marketing authorisation. No COVID vaccine would be used or deployed until it has demonstrated safety, quality and efficacy through robust clinical trials, which the MHRA would approve, and has enough evidence to support its use.

The second proposal is really to bolster and expand the workforce eligible to administer vaccines. Currently, under the Human Medicines Regulations, only appropriate practitioners are permitted, save a few exceptions, to administer vaccines. They are usually parenterally administered, by injection. Appropriate practitioners are defined by the regulations and include doctors, dentists, pharmacists, prescribers, nurse prescribers and some other independent prescribers. These proposals aim to increase the number of persons able to administer flu and, potentially, COVID vaccines. This will be done in three ways.

The proposals are for three mechanisms. The first is a national protocol that will allow registered healthcare professionals who do not usually administer vaccines to do so and will allow people who are not registered healthcare professionals to administer licensed or temporarily authorised vaccines. The protocol will set out who is allowed to do it, under what conditions, and what clinical considerations need to be followed. There will be Northern Ireland input to any such protocol. All staff who will issue such vaccines, under the protocol, will usually be health professionals who administer medicines, as part of their work, or non-healthcare professionals. Everyone will undergo a comprehensive training programme and a competency assessment to ensure that they are suitable and able to administer vaccines under the supervision of another healthcare professional.

The second proposal relating to the workforce is the expansion of who can lawfully administer vaccines under occupational health schemes. At present, only nurses are eligible or lawfully entitled to administer vaccines under occupational health schemes. It is proposed to expand that workforce to include other healthcare professionals who routinely administer medicines, such as midwives, paramedics, physios, pharmacists and others, to allow them to administer vaccines under occupational health schemes.

The last proposal, under the workforce arrangements, relates to patient group directions (PGDs). It is a method already contained in the Human Medicines Regulations. It allows for the sale, supply or administration of prescription-only medicines, such as vaccines, without the need for a prescription. PGDs are used in a variety of settings, including community pharmacies and others, where they already administer flu and/or other vaccines, such as travel vaccines. A current restriction in the regulations prohibits the use of medicines or vaccines without a full marketing authorisation from the MHRA. This proposal will allow vaccines that have been temporarily authorised to be included within PGDs. It will enable the cohort of professionals who already administer vaccines under PGDs to deliver vaccines that have been temporarily authorised. On the whole, the proposals will ensure that the workforce comprises enough people who are suitably trained to administer the additional vaccines and will help to deal with additional demand.

The third proposal is a clarification on civil liability relating to vaccines. The Human Medicines Regulations already offer protection from civil liability to manufacturers or healthcare professionals who are asked to supply an unlicensed medicine in response to a public health threat. That is a part of EU legislation that has been transposed. The proposals in these amendments are to extend that civil immunity to drug companies that place the medicine on the market, in recognition that the company that places the vaccine on the market is not necessarily the manufacturer. It balances that up somewhat.

The proposal also extends the protection to non-health professionals who may be asked to administer a vaccine, in line with the previously mentioned national protocol. Essentially, it puts the companies marketing a temporarily authorised product in a no-better-and-no-worse position than they would be if the product were licensed. It also puts non-healthcare professionals who are asked to administer vaccines on the same footing as health professionals administering a vaccine. Any civil immunity would be forfeited if there were breaches in any of the conditions set out by the Government. Any of the breaches would be similar to breaches of the supply or administration of a licensed product and would be subject to the same standard penalties that are currently set out in the regulations.

The fourth proposal relates to wholesale dealing. In its simplest terms, wholesale dealing is the sale or supply of medicines between different entities, persons or companies. Currently, companies or persons can wholesale deal medicines only if they have a wholesale dealer's licence issued by the MHRA. These proposals will permit the wholesale supply of vaccines by persons, companies or entities that currently do not have a MHRA wholesale dealer's licence.

There are already situations that arise during public vaccination campaigns where there may be an excess of a particular vaccine in one healthcare organisation, such as a trust, and too few vaccines in another. If, for example, a trust did not have a wholesale dealer's licence, there are, probably, two options: it could destroy the stock that it has no demand for, or it could ask the wholesaler that provided the vaccine to return and uplift the excess stock, which would then have to be brought back to the wholesaler's warehouse and counted and verified that it could still be used. That stock could, potentially, be sent out to another trust, for example. This amendment bypasses that step and allows the direct transfer between trusts or other healthcare entities if needed, so that the vaccines could be supplied or transferred in a more efficient and timely manner. The wholesale-dealing measures will be time-limited and subject to review — limited until 1 April 2022, when there will be a fuller consideration of whether that should be made permanent.

The last proposal relates to advertising and is to relax some of the restrictions on the advertising of vaccines and unlicensed medicines. We have quite strict controls on the advertising of medicines; there is, generally, a blanket restriction on the advertisement of unlicensed medicines. Vaccines can be promoted as part of a public-health campaign to assist the uptake rate, for obvious reasons. These proposals, put simply, allow the advertisement of a temporarily authorised vaccine to ensure that it can be included in any public-awareness and advertising campaign. Without those, the Government and others could not advertise any temporarily authorised vaccine.

In conclusion, the proposals, put simply, expand the workforce who are able to administer vaccines in a variety of ways, permit the advertising of vaccines to aid public awareness, and allow for the wholesale supply of vaccines, all of which will ensure that the public are aware of the vaccines, that there are enough trained people to administer the vaccines to meet any anticipated demand, and that there is a stock of vaccines located where and when they can be utilised. The other amendments simply clarify and strengthen regulations that already exist.

There was a three-week consultation, as you mentioned, Chair. It closed on Friday 18 September. The Committee has asked for specific feedback: we are working with the HSC, which led the consultation, to obtain consultation outcomes with a specific reference to Northern Ireland.

The Committee will be provided with an additional paper on that. Following that, we anticipate receiving a further draft statutory instrument for our consideration. We will liaise with the Departmental Solicitor's Office (DSO) and, assuming that the proposals are implemented without any substantive changes following the consultation, the amendments will likely come into force at some date in October, which is yet to be determined. Again, we will, of course, update the Committee when that date falls or when the regulations are laid.

Thank you. That is the end of my brief. I am happy to take any questions. Hopefully, Gerard and Marty can join in with their expertise, where appropriate.

The Chairperson (Mr Gildernew): Thank you, Canice. I have to say that that has certainly improved my understanding of the proposed amendments. You elaborated to some degree on the issue of immunity from civil liability for manufacturers and marketing organisations and, indeed, health professionals or non-health professionals who are administering. If someone should become seriously ill as a result of being vaccinated, where would the liability lie?

Mr Ward: Marty, do you want to come in on that one?

Mr Martin Coleman (Department of Health): My understanding is that the COVID-19 disease has now been added to the vaccine damage liability scheme. That is not a compensation scheme, but it means that there would be liability. If it was proven or suspected that it resulted from the vaccine, the person would be entitled to funding from that scheme. That has been put in place across the UK; it applies to all four Administrations. Where the person would go beyond that would probably be with the Government as opposed to the manufacturer.

The Chairperson (Mr Gildernew): OK. You have said that it is your "understanding" and "probably". Can we get some clarity on that issue in writing?

Mr Coleman: I heard it verbally at a meeting, but I can follow that up and get it in writing from them.

The Chairperson (Mr Gildernew): Yes. I think that that would be important.

As we understand it, the amendments are to allow for a temporary authorisation for an unlicensed vaccine. Can you talk us through the rationale for that, the risks attached to that and the mitigations of the potential impacts of that that have been considered? Are we going back to Canice or, Canice, do you want to bring in some of the other gentlemen?

Mr Ward: Marty, do you want to deal with that one?

Mr Coleman: Sorry. Could you repeat the question, Chair?

The Chairperson (Mr Gildernew): What is the overarching rationale for undertaking this exercise? What are the risks to doing it in this way? What mitigations are in place around those risks?

Mr Coleman: The rationale behind it is obviously to try to get the vaccine in place as quickly as possible. It is important to point out that, if it was unlicensed, it would certainly not be untested. It would have to go through all the normal rigorous processes. It would have to pass all those tests as normal before it was ever used on any member of the public. It is purely a timing issue. The process of getting a licence takes a considerable length of time. A balance would have to be weighed up between a vaccine possibly being available that could be given to people in order to protect them against COVID-19, and that vaccine not having the paperwork with it to make it licensed. That would be the decision.

It would be the Joint Committee on Vaccination and Immunisation (JCVI) that would make that decision. It would not be us in Belfast, London or Edinburgh. The JCVI is a UK-wide body of experts. It would weigh up all the scientific information that it is privy to and make a decision as to how effective the vaccine appears to be, when it can be available from and the amount that can be available. It would decide whether to go ahead and, under certain circumstances, use an unlicensed vaccine. The risk would be having a vaccine available that is not licensed and people continuing to get COVID-19 and possibly suffering the consequences, as opposed to using that vaccine for a certain period while the licensing process goes through. However, I emphasise again that the testing of the vaccine would be exactly the same as normal. It would have passed all the tests. It would not be an untested vaccine; it would just be unlicensed.

The Chairperson (Mr Gildernew): Could there be additional population-level or individual screening? Is it part of the normal process for the vaccines to be tracked? Do their effectiveness or any potential issues continue to be assessed?

Mr Ward: Marty head the nail on the head when he said that unlicensed does not mean untested. Any vaccine is deployed only after it demonstrates safety, quality and efficacy through a robust clinical trial programme. As with any medicine, there will be post-marketing and ongoing pharmacal vigilance to ensure that the vaccine remains effective and safe to use.

The Chairperson (Mr Gildernew): That is helpful. I will go across to members.

Ms Bradshaw: Thank you, gentlemen, for being here today. I have a few quick questions. The first relates to the concern about the vaccine among the more vulnerable, such as those who live with multiple morbidities. Canice, you used the term "pharma control", or something like that. How will the vaccine be tested for people who are taking other medicine? How rigorous is that process? Obviously, those people are coming through the pandemic and are very fearful of maybe getting the vaccine.

Mr Ward: I am not sure that I can fully answer that, Paula, but any testing by MHRA will take into account comorbidities and people using other medications and medicines. That is part of the routine testing and clinical trial process.

Ms Bradshaw: The point that I am making is that there was a very quick consultation process — it lasted three weeks — and, obviously, there is a race around the world to get the vaccine out as soon as possible. I suppose that people are fearful when things seem to be rushed through. There is a bit of a communications issue for the Department of Health about reassuring people on the extent to which there has been rigorous testing. I will leave the communication going forward with you.

What prior engagement did you have with the DHSC in the lead-up to the three-week consultation and what groups in Northern Ireland did you engage with before you made your official DH submission to the consultation process?

Mr Ward: Officials have ongoing engagement. We engage with DHSC officials at least weekly if not more frequently on a number of areas of legislation and SIs, which the Committee is partly aware of due to EU exit and other ongoing health matters. We have a set of standard organisations and bodies as stakeholders that we include in any consultation, including the Patient and Client Council, Community Pharmacy NI, the BMA and similar groups.

Ms Bradshaw: OK, so you are confirming that you engaged with them prior to making the formal submission under this consultation exercise.

Mr Ward: No. We do not make formal consultation responses.

Ms Bradshaw: In the Minister's letter to the Committee, he talked about engaging on it. Sorry; I am struggling to find it now, but I read a minute ago about DOH providing a response to the consultation process. I will find it and come back to you.

The Chairperson (Mr Gildernew): We will come back to you.

Mrs Cameron: I want to ask you whether the amended 2012 regulations will still apply in Northern Ireland after the transition period. Will the changes be reflected instead in the Medicines and Medical Devices Bill? That is my first question. My second question is this: will the Department and the Government fight to ensure that the impact of the NI protocol does not cause a disjointed approach to Northern Ireland consumers receiving doses of the vaccine as part of a national coordinated effort?

Mr Ward: Yes, the amendments and the Human Medicines Regulations will apply, post-transition.

Your second query was about the medicines and medical devices Bill. Can you elaborate on that, please?

Mrs Cameron: So you are saying that they will still apply after the transition period. I was asking whether the changes would instead be reflected in the forthcoming medicines and medical devices Bill, but that is not the case.

Mr Ward: No. The Bill will, if and when it becomes an Act, give the Department and DHSC regulation-making powers. If we wanted to make legislation post-transition, we would do so under the medicines and medical devices Act, if that becomes law, but that has no bearing on these proposals or amendments.

Mrs Cameron: OK. The second part was about whether the Department and the Government will fight to ensure that the impact of the NI protocol does not cause a disjointed approach to NI consumers receiving doses of the vaccine as part of the national, coordinated effort.

Mr Ward: I am not best placed to comment on that. I can check with colleagues, but I would take it as a given that the Department will fight to ensure that the Northern Ireland population has equal access to vaccines.

Mr Coleman: I can confirm that that has been discussed at the UK-wide vaccination implementation board. It has been flagged up as a potential issue, and we have been in regular contact with the Department of Health and Social Care in England and Public Health England to work out exactly what may be required and how we can militate against it becoming an issue under those circumstances.

Mrs Cameron: OK. Thank you.

The Chairperson (Mr Gildernew): I will go back to Paula.

Ms Bradshaw: Thank you. Sorry for the confusion. There is a paper in members' packs from Philip Bell, who is from the medicines policy branch in the Department of Health. In it, he says:

Did the Department of Health consolidate the responses from stakeholders here, or did it encourage the individual groups that Canice outlined earlier to respond directly?

Mr Ward: They were asked to respond directly.

Ms Bradshaw: Are you getting sight of a read-out of what was fed in from Northern Ireland?

Mr Ward: We are hoping to get that, but the consultation only closed on Friday. We have asked for, and are hoping to get, a read-out of the whole response and the response specifically from NI.

Ms Bradshaw: Thank you.

Mr Easton: I accept that these amendments have to be brought forward.

On the campaign to promote a vaccine, there is quite a lot of scepticism among those in a certain quarter of the community who are afraid of the side effects, or worse, of a vaccine. It is vital that the campaign be promoted well and that everybody knows the consequences. It does not help the campaign if somebody is using an unlicensed vaccine. I know that you are saying that it is safe, but the fact that it has been declared unlicensed will not help to sell it. You need to think about that. Will everybody be told of any potential side effects before they get the vaccine?

Mr Ward: Martin, do you want to come in on that one?

Mr Coleman: The fact that it might be an unlicensed vaccine has been considered. There will be further marketing and promotion to emphasise that, while it may be unlicensed, it certainly will not be untested. We will try to reassure people that that has been considered and that there is no concern about the vaccine. Could you repeat your next question for me?

Mr Easton: If you are using a vaccine and it has known side effects in some cases — not necessarily for everybody — will it be made clear to everybody beforehand?

Mr Coleman: My understanding is that the same thing would apply as applies to any other vaccine. The patient information leaflet (PIL), which lists the ingredients and possible side effects of any vaccine would normally be given to an individual when they receive a vaccine. The same procedures would also apply, and the vaccinator would speak to the individual and record if they felt dizzy afterwards, had a sore arm or whatever else. That would be recorded and reported through the normal procedures. That is called the yellow-card procedure and that information would eventually work its way back to the MHRA, which would gather and assess all that information. Those normal procedures would be in place.

My understanding is that the MHRA is putting enhanced procedures in place to make sure that any issues that arise are identified very quickly and that people who suffer from additional sore arms, sore heads, or whatever else, are identified very early on. That applies to all vaccines, but extra precautions or procedures will be put in place with this vaccine to make sure that those issues are flagged up should they arise.

Mr Carroll: Following on from Alex's points, I am not normally a fan of advertising, but I think that advertising the benefits of the vaccine will be essential. I know that it is not my job, but, in a friendly way, I would suggest that we could advertise it by relating it to smallpox and other diseases that have been eliminated by vaccination. That would help to quell some of the nonsense that is out there.

There is a contradiction in that we need the vaccine quickly, but we do not want it to be rushed through in an unsafe way. I know that some countries are trying to rush it out competitively. Are you convinced that everything is being done to make sure that the vaccine will be safe to administer?

Mr Ward: As I said, Gerry, no COVID-19 vaccine or any vaccine would be authorised for use unless there was evidence of safety, quality and efficacy from the usual clinical trial routes. If there were questions about its safety, quality or efficacy, it would not be given a temporary authorisation.

The Chairperson (Mr Gildernew): Alan, quickly.

Mr Chambers: It is a quick question. If a vaccine comes from somewhere like Russia and a number of clinical trials were carried out in Russia, would the UK conduct any trials to satisfy itself that the vaccine was safe, or would it take it that the Russian tests were sufficient?

Mr Coleman: The vaccines that the UK has signed up to do not include the Russian vaccine. The UK Government have signed up to, I think, six potential vaccines over four different types of vaccines. Those could deliver 340 million doses for the UK. Not all those vaccines will probably pass all the tests or whatever else, but none of them is the Russian vaccine at this point. The six companies involved are publicly known, but none of them is involved in making the Russian vaccine. My understanding is that we expect to use one of those vaccines and are not looking elsewhere at this stage.

The Chairperson (Mr Gildernew): I thank the officials for briefing the meeting and answering members' questions. We can let you go now.