Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Philippa Whitford Excerpts

Wednesday 6th March 2019 General Committees

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

It is a pleasure to serve under your chairmanship, Mr Robertson. I thank the hon. Member for Ellesmere Port and Neston and I echo many of his points. I certainly echo his points on the complexity and the short time that we have had to go through the draft regulations. I do not feel that it is sufficient scrutiny for something so technical and complex.

The three main groups affected will be the MHRA itself, the industry—both pharmaceutical and device producers and wholesalers and those who are involved in research and trials—and, thirdly, the NHS and the patients that it serves.

The MHRA will have to massively expand its organisation and its staff. It will have to take on people with skills that it does not currently require. As was mentioned by the shadow Minister, it will also have to develop systems to replace what the EMA has been doing. The EMA typifies one of the benefits that we get from the EU, because we will have to duplicate massive amounts of systems, and we are asking pharmaceutical companies to duplicate staff in the UK and the EU.

The immediate and urgent challenge the MHRA faces is grandfathering the central market authorisations, of which there are about 1,000 from 1995 to 2017. They are central authorisations, and only about a third are held in the UK. It will also have to transfer parallel import licences for similar drugs. The explanatory memorandum cites 21 days. How many of those licences exist? Is it remotely feasible to expect the MHRA to transfer them over within three weeks?

Data access will become more difficult, as this often involves looking at commercially sensitive data. As the UK will not be covered by the European Court of Justice in the future, many companies will be more wary, as they will be asking what their recourse to law will be if they feel that their data has been misused.

In the longer term, the MHRA will have to treble the number of new drug and new agent assessments to produce market authorisations for the UK. It will have to replace the pharmacovigilance work that the EMA does, both the major work and the regular reviews and updates. It will have to replace new data systems, because the UK will no longer have access to EudraVigilance data. That is the key loss—a loss of collaboration.

Although I have tried to raise it, one point that has been overlooked a lot in the past couple of years is the issue of quality control and batch release authorisation. The National Institute for Biological Standards and Control will be leaving the EU shared group of official control authorities on batch release, which means it is losing access to a collaborative network. It will have to ensure that all that work is replaced in the UK. That also means losing mutual recognition.

The MHRA will also have to license people. We heard that there will have to be marketing authority holders and qualified persons for pharmacovigilance for every single company here in the UK, as well as this new creation, the responsible person for import. What will their qualifications be? Exactly how will they be judged and licensed?

I recognise that it is a practical thing just to say that drugs that will be certified in the EU should be recognised in the UK, but this is not driven by our wanting to stay close to Europe; it is driven by the fact that the UK simply does not have enough qualified persons to do it any other way. That shows the threat. This is demanding a big increase in staff and skills, both for pharmaceutical industries and for the MHRA.

Under “Responsible Person”, the explanatory memorandum says that a licence holder must

“put in place an assurance system”.

Why is it not the Government putting in a single assurance system? Do they really want every drug company to come up with their own assurance system for licences?

MHRA funding has been based on the work that it has done for the European Medicines Agency in the past and on statutory fees. We are told that that will all be replaced through fees: more than £60,000 for a major assessment, more than £50,000 for a major pharmacovigilance assessment and smaller fees for some of the reviews and updates. When we hear so much about a Brexit dividend, why are the Government not looking at putting some funding into the MHRA, particularly in relation to set-up, but also in relation to maintaining these things?

For the pharmaceutical industry, the issue is duplication —having a legal marketing authority holder in the UK and a qualified person. It will mean the time involved in processing the grandfathering of marketing authorities. It will mean the costs of the additional fees, and as I said, those are substantial fees. It will mean a disincentive to launch medicines in the UK when a fee has to be paid to the EMA and then another fee has to be paid within the UK.

The aim is to negotiate bilateral recognition for batch-testing. How long will that take, and how many jobs are likely to go to the EU? What the paper that I am discussing focuses on is purely drugs being made available in the UK market. Although that is understandable, because it is about the MHRA, there is no talk about what support and help there will be for the industry. Forty-one million packets of drugs go to the EU, and the EU rules are that they need to be batch-tested within the EU. At the moment, 10% of batch-testing is UK only; three quarters is EU only; and only 13% of batch-testing is in both places. There is no talk about what support there will be for the industry. We risk losing those jobs, and the problem is that although those jobs might go first, other jobs tend to follow. Will a big, multinational drugs firm that is opening a new production unit in Europe pick the UK? The chances are that it will not, so the issue is future jobs as well.

Then we come to the NHS and patients. We hear, obviously, about costs for the NHS, because it will have more paperwork to do. There will be delays in accessing new drugs for patients; Australia and Canada have significant delays—sometimes as much as three years. That means that patients will lose access, and there will be an impact on future trials. Trials are always carried out on the best available versus the brand-new. If the UK is not able to deliver the best available drug to patients, it will not be able to take part in future trials.

The papers to which I am referring state that the UK Government will incentivise innovation in relation to rare diseases, but in fact the big step forward in the past 10 or 15 years was collaboration across a population of 500 million people. If we are talking about incredibly rare diseases, the bigger the population from which we recruit people to take part in the trials, the sooner we will find the answer.

As was mentioned, there is also the issue of leaving the falsified medicines directive and the safety packet measures therefore not being required in the UK. Similarly, it is stated that UK producers will not have to register, or to register their products, if they sell online. The worry about devices is that the sheer pressure of all this on the MHRA could lead to shortcuts and to rushing things through to try to keep up.

We have had multiple debates and discussions in the House about the impact of vaginal mesh. That was automatically passed on, because there was no recognition that the device was changing and that the operation to use the device was changing. Unless we have people with expertise looking at these devices, it will be very easy to think that they are exactly the same, but there might be substantial changes in how they work, the materials they are made of and how it is proposed that they will be used. Again, I come back to collaboration. Not sharing pharmacovigilance information through the EudraVigilance database is a real concern to patients in the EU and here.

On shortages, the documentation simply mentions that Ministers will have new powers if there are significant shortages after leaving the EU. I have raised the issue of the Human Medicines (Amendment) Regulations 2019, regarding the serious shortage protocol, which would allow a pharmacist to change a patient’s medication without consulting their GP. They do not have access to the patient’s medical records, only their prescription. A patient might have been on multiple drugs in the past to reach one that controls their condition. They will not remember all the drugs they were on over the years. They will not necessarily remember which drug caused them to have blackouts or other side effects. Those regulations were put through as a negative SI with no scrutiny and no debate. This measure proposes exactly the same powers.

When I came across the serious shortage protocol, I was shocked to find that there was no consultation with the General Medical Council, even though it would be a significant reversal of medical legal responsibility. I have concerns that in the future such moves on shortages will be simply rushed through, with insufficient cognisance taken of the impact they will have on patients. What other changes does the Minister envisage that Ministers will have powers to enact? Does she not recognise that doing things through the negative procedure does not allow for any scrutiny or debate, and does not allow us to protect our constituents?

[Jackie Doyle-Price]

I thank the hon. Members for Ellesmere Port and Neston and for Central Ayrshire for their probing questions. They have both made compelling arguments. I recognise their concerns about scrutiny, but we are where we are. The Government have to make provision for a no-deal scenario, even though we remain determined to leave the EU on 29 March with a deal. None the less, we need to put these statutory instruments in place to deal with the event that that does not happen. Both hon. Members asked probing questions, and I shall try to address all of them. I am sure I will miss some, but I promise to write to them both with full answers to the points they have raised.

Overall, there are concerns about the costs to businesses, patients and taxpayers, all of which need to be addressed. However, I should be up front about this. Clearly, there will be a cost to business. One reason why Margaret Thatcher was such a big believer in the single market was that a single-market regime would reduce costs to business. Therefore, unilaterally leaving the single market will increase costs. We need to be frank and honest about that. We also need to be frank and honest that some of those costs will be passed on to taxpayers and patients. That is a given, but it underlines why we are determined to leave with a deal and minimise any disruption, recognising that we want to make the best out of this scenario for Great Britain.

Some issues were also raised about resources and personnel in respect of the MHRA, which I will come on to. I appreciate that hon. Members feel that they have not had sufficient opportunity to scrutinise this. However, I can assure the Committee that the proposals have been taken forward by MHRA in full consultation with business with a desire to minimise disruption and additional cost, and with a full view to planning to ensure that MHRA is equipped to deal with it. Much of the machinery is in place, given MHRA’s role in being such a key player within the EMA.

As I mentioned in my opening remarks, the Government’s approach has been to minimise burdens on business while enabling the most robust action for the UK to protect public health. As I have said, I acknowledge that that will place costs on business. The hon. Member for Central Ayrshire explained the disproportionality of EMA costs with regard to what might be replicated with the MHRA. She is absolutely right about that. I can tell her that the fees have been developed based on existing processes. For example, the targeted assessment fee is based on the existing MHRA incoming mutual recognition fee. Furthermore, the MHRA regularly reviews its fee levels and will continue to do so. There is a commitment from the MHRA to review the overall system of fees to the industry following exit with no deal so that we can maintain that they are fair and proportionate to business.

[Dr Whitford]

Obviously, the MHRA uses a trading fund now and must basically wash its own face financially. Will the Government provide more direct funding to the MHRA or is it envisaged that all of the costs will still be recouped from fees?

[Jackie Doyle-Price]

On day one of exit under this scenario, the MHRA will, as the hon. Lady says, continue to wash its own face. As to what might materialise subsequently, that would be subject to further discussion. I would not rule out anything at this stage. We are trying to ensure that the business can continue as usual on 30 March if we leave without a deal, but—let us set this in stone—that is if that is the result on 30 March. If we end up in that scenario, we will of course want to make sure that we have got things working effectively. It is also true that we will have to see how relationships work in practice. We can already see that some market practices are preparing for a no deal; others are not. We have said what we are prepared to do to recognise what has happened and what is licensed and goes through the regulatory system in Europe. We are being quite open about accepting that.

The hon. Lady mentioned batch testing, for example. We cannot be sure the same will happen in Europe. We will have to monitor how that works out in practice before setting in stone what the future regulatory regime will be. I come back to my original point: this is for day one of exit to keep the show on the road.

[Dr Whitford]

The Minister talks about preparing for a no deal, but as the EMA does not have associate membership, most of what is being put in place will be required, deal or no deal.

[Jackie Doyle-Price]

That is right. As I have said, we are seeing that some parts of industry are preparing for that scenario on the basis that there will be no associate membership. Having left in that scenario, if we look broadly at how the MHRA discharges its functions and how it is funded, at this stage we are looking at it continuing as usual and washing its own face. The hon. Lady mentioned that we could use some of the Brexit dividend to meet the cost. All of that is completely wide open at this stage. This measure is really just to keep the show on the road.

We have put some expectations down in terms of review. Most of the commitments we have made are to review all of the operations within two years. As for any conclusions we reach, we will come back to Parliament to institute any change if that is what we wish to do, but that would be done very much in consultation with industry and in a transparent way, recognising that all Opposition Members are not entirely satisfied. Clearly, we will go back to business as usual when it comes to scrutiny of these matters. Again, I cannot say often enough that I do not want that eventuality to materialise. It is my determination that we leave with a deal.

There was a reference to the impact on SMEs. The MHRA is taking steps to ensure that the burden on them is minimised. It will look at things such as fee waivers for some products to encourage further research and innovation. Again, that recognises the real concern about that.

[Jackie Doyle-Price]

I trust the MHRA to manage its own finances and take a proportionate view as to what is an appropriate fee, because it has the day-to-day contact with businesses. Overall, it will still be expected to settle its budget on the basis of the fee income that it incurs. That still gives it the freedom to do that, if that is in the sector’s strategic interest.

We have responded to some of the representations made by business about the potential additional costs. One reason that we introduced the responsible person for import assurance procedure was to minimise, as effectively as possible, the burden on the trading of the wholesale sector. Again, that recognises that where things have been checked and have gone through an appropriate European regulatory procedure, we should be satisfied that that is good enough for us. I am confident that that pragmatic approach will be repeated as the MHRA takes the matter forward.

Several points were made about the MHRA’s ability to take on new roles. The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The MHRA has real expertise in many areas, including pharmaco- vigilance and clinical trials regulation, which provides benefits to patients across the EU. I am confident that the EU will want to retain access to that expertise. That also shows that the MHRA has the expertise and human resources to discharge those roles. It has 30 years of experience as a lead regulator, it has led on the registration of more than 3,500 medicines, and it is globally recognised for its expertise. None the less, it will manage the demands on its service and I have every confidence in its ability to do so.

The hon. Member for Ellesmere Port and Neston raised the issues of continued access to medicines and of reviewing the fees. The statutory instrument provides continuity for patients and businesses by providing for existing EU licences to be automatically converted into UK licences, which should give continued access to medicines and will be done at no cost to industry. It also puts in place a new licensing route that will allow the MHRA to accept the same information from companies that apply for an EMA licence and that will allow the UK to grant a licence in the same timeframe as one would be received today.

Effectively, we will follow and replicate what the EMA does. There has been much talk of the UK being rule takers and hon. Members might suggest that there is no change here. That recognises, however, that we are in a global marketplace for medicines and that we all want to have access to the best medicines. In practice, there is much shadowing and sharing of expertise in this area. That raises a question that we do not have time to debate this afternoon, but there is much to be gained from international co-operation in this area.

Obviously, we want to make sure that the UK remains an attractive market for new medicines and for innovation. As I said earlier, we will review the fees set out in the SI within two years to make sure that they remain competitive and fit for purpose, and that they deliver the objectives that we want to achieve through the regulatory system.

The hon. Gentleman laid down a challenge; he said that the regulations go beyond a simple technical implementation of the directives into UK law and raise new powers for the Secretary of State. Clearly, the regulations are made under section 8 of the European Union (Withdrawal) Act 2018, which gives Ministers powers, where appropriate, to take additional powers. However, the changes are the minimum necessary to maintain continuity while protecting the health of UK patients while we are outside the EU, although clearly there is concern about issues of supply, as the hon. Member for Central Ayrshire mentioned.

We do not anticipate needing to use the Henry VIII power. We are confident that the regime that we have set out will ensure continuity of supply. However, in the event that that did not happen, provision would be needed. The power is a safeguard to be used in the case of serious shortages. I would not choose to describe it as a Henry VIII power, but I recognise the right of Opposition Members to do so. It is limited to temporarily modifying the effects of the human medicines regulations, for a limited time or purpose. As has been mentioned, the statutory instrument would use the negative procedure, but it could obviously be annulled. However, it would be used only where existing processes had been exhausted.

The hon. Member for Ellesmere Port and Neston raised the question whether any particular medicines would be at risk, and also mentioned prices in that regard—a concern that I think the hon. Member for Central Ayrshire will share. Clearly the MHRA consulted on the issue, and that informed its analysis. Any potential increase in medicine prices will depend on the extent to which costs are passed on to the consumer; but we shall bear the matter in mind, with regard to future medicines price negotiations. It is something that we shall have to keep an eye on at this stage. It is difficult to quantify. None the less, we have made clear commitments to the public about what they can expect, and about ensuring a continuous supply of medicines, and we shall have to find ways to deliver on those commitments.

[Dr Whitford]

Is the Minister aware that the Royal College of Radiologists has now produced emergency guidance to nuclear medicine departments, simply because the UK Government did not, on the potential threat of shortage of radionuclides and radiopharmaceuticals, both for scanning and for cancer treatment?

[Jackie Doyle-Price]

I was not aware of that, but I encourage everyone to participate in the dialogue, because in such an event the whole system would need to be ready. I shall perhaps come back to the hon. Lady on that specific point because, although much of our no-deal preparation is happening within the confines of Whitehall, it is not all being shared publicly.

I emphasise that there have been massive conversations with industry, including those in the life sciences industry—and with charities—about the changes, to make sure that everyone is prepared.

[Dr Whitford]

The Minister says that preparation is happening in Whitehall that is not being shared with the public, but we are talking about the president of the Royal College of Radiologists. The people who actually deliver scans have not had any guidance from the Government. That is not scaremongering. They have to be ready for something that could happen in a few weeks. They are talking about delaying patients, planning light weeks, and when the molybdenum will arrive, because those things cannot be stockpiled. Why has there not been guidance to the NHS about how to prepare to deal with shortages of radionuclides?

[Jackie Doyle-Price]

My understanding is that those conversations have been taking place. However, the hon. Lady is right that the very nature of those products, which cannot be stockpiled, has brought complications. I fully expect the president to be involved in those conversations. I do not have that knowledge to hand now, but I will write to her afterwards, to give her some reassurance.

We had two waves of consultations on the draft instruments. For the last, in October, we issued a consultation that received 170 responses, through which we ended up with the proposals before us. Again, these are subject to further consultation with the industry.

It is obviously a priority for us to make sure that Britain remains a competitive location for life sciences companies, and we are committed to maintaining our renowned strength in science and research. Since the referendum, we have seen many signs of the industry’s continued confidence in the UK. In 2017, we received the highest level of life science investment in Europe, and were second globally only to the US. That illustrates the confidence in our regulatory system, which is why we are confident that the MHRA is well up to the task given to it by the draft statutory instruments.

The hon. Member for Ellesmere Port and Neston gave an impressive illustration of what he described as the confusion regarding the various dates at which parts of the draft regulations will come into effect and the complexity of some of the references within them, and he posed legitimate questions on how business would understand and prepare for them. However, as I say, we have produced detailed guidance to support everyone in interpreting the draft instruments, and the MHRA does not expect anyone to navigate this alone and will be there to give advice. That support is partly reflected in the length of time that businesses will have to prepare for and implement these measures. We will ensure that that dialogue continues.

The hon. Gentleman also raised questions about market access and legal accountability, and whether we will have sufficient people to discharge that role for the industry. We believe that those skills are already in place, bearing in mind that a lot of companies will already have to fulfil these functions with the EMA, particularly when exporting. We do not anticipate that this change will be disproportionately onerous on business. However, we have given the industry 21 months to implement that aspect. To make sure that only genuinely qualified people undertake that role, anyone who vouches for a medicine that is then potentially harmful to patients faces a maximum two years’ imprisonment. The sector has sufficient integrity to engage only properly qualified people; to do otherwise would be foolhardy.

Questions were asked about the degree to which UK consumers could be protected from false medicines. To reassure Committee members, the falsified medicines directive, implemented in 2013, will remain in UK law, even in the event of a no-deal exit. We will make sure that we continue to apply the same protections as before. We obviously want to retain a close working partnership with the EU on medicines regulation, and I think that we will be able to share expertise and information on such issues over and above any potential mutual recognition of regulations. We will all benefit from that information sharing. Issues were also raised about the wholesale sector. We will obviously continue to ensure that the MHRA keeps a good eye on that and makes sure that that regulatory regime is fit for purpose.

Turning to some of the comments about the devices, we will continue to recognise the CE mark on medical devices. It is also fair to say that the existing regulatory regime has perhaps been seen as rather liberal in its approach—the hon. Member for Central Ayrshire alluded to this when she referred to mesh—and it has been subject to some revision at EU level. Certainly, we want to follow what is happening with that review and consider whether there are any further improvements we would wish to make to that CE mark system.

To those colleagues who thought that leaving the EU might lead to a bonfire of regulation, I say that, clearly, when it comes to medical devices, some of which remain within the body for a length of time, we should not stint in our approach to the protection of patients. Patient safety should be the primary objective, notwithstanding the importance of maintaining a competitive marketplace. Patient safety is crucial.

There are estimated to be around 600,000 medical devices available on the EU market, many of which have not been produced in the UK or approved by UK-notified bodies. It would be quite a big undertaking for the MHRA to license those products, but we will increase our market surveillance by requiring all new devices being placed on the UK market to be registered with the MHRA after exit day by the manufacturer or a UK responsible person, in accordance with the transitional timetable. Our emphasis is patient safety first and foremost, while doing our best to improve access to the market. We will require, as the hon. Member for Ellesmere Port and Neston said, all overseas manufacturers to register those products here with the MHRA themselves.

We have also had some discussion about the RP-I. That is a new role; the hon. Gentleman asked how many will be required and where we will find them. We are giving the industry a two-year transition period, to give it the opportunity to register those persons with the MHRA, and it will depend on the number of wholesalers who intend to import products from the EEA. We are satisfied on the basis of the discussions we have had with the industry that that two-year implementation period is appropriate, and there has been consultation on exactly what sorts of skills those persons should have, with the intention that they should fill the regulatory gap caused by our removal from the EMA, but without putting undue burdens on the industry.