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Human Medicines (Amendment) Regulations

Volume 656: debated on Monday 18 March 2019

I beg to move,

That the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62), dated 14 January 2019, a copy of which was laid before this House on 18 January, be revoked.

This motion concerns the serious shortage protocol. I thank the business managers for allowing time for this debate, but it really should not have come about as a result of the Official Opposition tabling a prayer against the regulations. The Government should have brought these proposals to the House for full debate and scrutiny, because the serious shortage protocol is perhaps one of the most far-reaching and contentious of the Government’s changes to medicines regulation in recent times.

The Government are using Henry VIII powers to enable Ministers to issue a serious shortage protocol for pharmacists to follow. The Department of Health and Social Care has stated that the protocol

“could be issued…in instances of serious national shortages and would enable community pharmacists and other dispensers to dispense in accordance with the protocol—rather than the prescription—without contacting a GP.”

These reforms represent a quite extraordinary power grab whereby Ministers can grant themselves the authority to instruct local pharmacists to ration drugs, overrule the GP’s prescription and dispense therapeutic generic equivalents or reduced dosages in the event of a medicines shortage.

Is the hon. Gentleman aware of the particular concern among people with epilepsy, who require absolute consistency of supply and for whom any change in medication can have dire consequences? The brilliant organisation SUDEP Action has raised very specific concerns about the risks to people with epilepsy.

I thank the right hon. Gentleman. He is quite right to raise those concerns about patients with epilepsy, which I will touch on in the course of my remarks, echoing the point that he made with great eloquence.

These changes represent an extraordinary power grab. Ministers should have brought them to the House for proper scrutiny, and then, of course, they should have gone out for proper consultation with patients, patient groups and health stakeholder. That is why the Academy of Medical Royal Colleges stated that it is

“inexplicable and unacceptable that an issue of this importance is not the subject of wide consultation and that medical royal colleges as doctors’ professional bodies were not specifically engaged in the process.”

The British Medical Association said that it

“should have far more time to adequately consider the Government’s proposals for change.”

That is why we have brought this prayer motion and why I am pleased that we have the opportunity to debate these proposals today.

It is worth saying a word about the context in which we debate these proposals. Notwithstanding the confusion on the Government Benches about when we actually do exit the European Union—the Under-Secretary of State for Exiting the European Union, the hon. Member for Spelthorne (Kwasi Kwarteng) has given us no greater guidance today in his remarks at the Dispatch Box—it is worth recalling that, as The Lancet said only last month, Brexit, especially a no-deal Brexit, will affect the healthcare workforce, NHS financing, the availability of medicines and vaccines, the sharing of information and medical research.

Our effective joint working with our European partners has been vital for the NHS over recent years, in everything from infectious disease control to the licensing, sale and regulation of medicines. Developing new medicines depends on the international co-operation that is fundamental to accessing clinical trials. Patients in the UK are currently able to access EU-wide trials for new treatments, and the UK has the highest number of phase 1 clinical trials across the EU.

Thanks to the strength of our pharmaceutical base, every month, 45 million packs of medicine move from the UK to the EU, with 37 million packs going from the EU to the UK. We know that 99% of the insulin used in the United Kingdom is not manufactured in the UK. Current EU legislation allows for the legitimate trading of medicines quickly and swiftly cross-border, but the cost of no deal could see pharmaceutical products subject to 44 separate checks and controls at the borders, hugely delaying access to medicines.

My hon. Friend is making some very important points. I wonder whether he has seen the advice from the UK BioIndustry Association, which knows what is going in the life sciences sector and says:

“Despite the expertise and efforts of the MHRA…with 12 days …until Brexit, being prepared for a ‘no deal’ is an impossible task”.

I thank my hon. Friend. As the Member of Parliament for Cambridge, he works very closely with the life sciences and pharmaceuticals industries and is a great champion for them. He is quite right to raise those concerns—although it is not clear if we are leaving in 12 days because, as I said, the Minister at the Dispatch Box earlier was pretty hopeless in giving the House any clarity on that matter. I suppose we will have to wait for further statements from the Government tomorrow, unless the Health Minister wants to clarify matters for us in a moment.

One of the issues that the organisation my hon. Friend mentioned is concerned about is the parallel trade in medicines, where pharmaceutical exporters seeking to profit from currency fluctuations could see medicines intended to meet UK patient requirements being quickly distributed out to the EU because of the advantage that a fall in sterling, perhaps, could accrue to them in those circumstances. This is why we have seen widespread concerns about medicine shortages in the event of no deal.

This is not something just for the future. I am already getting reports that certain medicines are in short supply, and patients are being advised to go back to their GPs to see if there are alternatives because somebody somewhere is already stockpiling and there is not the flow through. Does my hon. Friend accept that?

My hon. Friend raises a very important point. There have indeed been reports of shortages in certain medicines. In recent weeks, we have heard of shortages of Naproxen, an arthritis medicine, with similar reports about EpiPens a few weeks ago. I have heard from some community pharmacists, directly themselves, that there is even an shortage of aspirin. I emphasise that these are anecdotal reports rather than information based on any national reporting that I have seen—this is what community pharmacists have told me when I have been in their pharmacies discussing this with them—but yes, there are shortages now as a result of the uncertainty in the pharmaceutical market.

Diabetes UK has warned that

“despite reaching out directly to the Department of Health and Social Care in December, we still have not seen the concrete detail needed to reassure us—or people with diabetes—that the UK Government’s plans are robust enough to guarantee no impact on insulin and medicine supplies in the event of a no-deal Brexit.”.

It was a similar story from the epilepsy bodies, who said:

“We do not have confidence in the current arrangements to ensure the continuity of life-saving medications for people with epilepsy.”

The Government have sought to reassure patients that their contingency plans are failsafe, but the report in The Lancet that I referenced earlier also said that

“stockpiling arrangements cannot cope for more than a few weeks.”

It also noted that some affected products, such as radioisotopes needed for treating some types of cancer, simply cannot be stockpiled. This chimes with the Royal College of Radiologists, which last month issued staggering concerns about the supply of medical isotopes, spelling out how the expected disruption would force clinicians to alter treatment plans and mean the prioritisation of some cancer patients over others. That is why the Government are proposing the serious shortages protocol contained in this statutory instrument and effectively using Henry VIII powers to enable Ministers to issue a protocol to pharmacies for them to follow.

As I said, this is an extraordinary power grab. It will effectively mean that a GP’s prescription can be changed by a pharmacist. No longer would a medicine be prescribed by a doctor who knows the medical history of the patient but instead by a pharmacist acting in accordance with a protocol drawn up by the Government. That is why these emergency measures have, quite rightly, raised alarm among various patient groups—because these changes could cause real problems for people with long- term conditions.

Does the hon. Gentleman accept that it would be sensible if there was a sunset clause, because clearly giving that much power to a pharmacist as opposed to a physician who knows the patient is very dangerous if it is to be used for the long term or perpetually and not just to deal with the current crisis?

The hon. Lady makes an entirely reasonable observation. I trust that the Minister took note of it and look forward to her reply to that point.

Does the hon. Gentleman agree that this puts individual pharmacists into quite an invidious position because they may well be having to make decisions that may impact adversely on a patient’s health and wellbeing when they are not necessarily skilled to make those judgments? My concern particularly relates to epilepsy but it applies to other areas as well.

The right hon. Gentleman hits the nail on the head. That is exactly the point that has been put to me when I have visited community pharmacists and discussed this with them. Of course there are other pharmacists who have perhaps done more training and want to work at the top of their licence and believe that there is a role for more autonomy. However, there are real concerns about the way in which these changes are being rushed through without any resource put into education, explanation or wider training that may be needed. In those circumstances, it is appropriate that we raise our concerns, support our motion and oppose the Government’s proposal today. He is absolutely right—I have heard that concern expressed directly. Many community pharmacists do not necessarily want this responsibility, given the wider concerns and implications that he highlighted.

The point made by the right hon. Member for North Norfolk (Norman Lamb) raises two issues. First, what is the point of doctors having all this training if anybody without it is suddenly able to dole out prescriptions? Secondly, are pharmacists insured, and is there an insurance scheme for them if they make mistakes? Doctors have a professional insurance system, and pharmacists presumably have a completely different one.

My hon. Friend is right. That is exactly the point that community pharmacists put to me in Loughborough about three weeks ago when I visited them to discuss this. Echoing her point, the BMA has said that it does not support a “blanket approach” to allowing pharmacists to provide therapeutic equivalents where a prescribed drug is not available. The National AIDS Trust has said:

“The only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant.”

SUDEP Action, alongside a broader coalition of epilepsy charities, is particularly worried about these proposals.

After facing pressure from those groups, the Government accepted that replacement drugs were unsuitable for epilepsy patients, but they have left it open to pharmacists to reduce the strength or dosage of epilepsy medication. I am not convinced that that will eliminate the big risks faced by these patients. As the right hon. Member for North Norfolk (Norman Lamb) said, many patients with epilepsy—especially the elderly—are on other medications, and any changes require careful management because of the interaction between different medicines. Up to 90% of people with epilepsy state that even a deterioration in their mood can have a negative effect on seizure control. Anti-epileptic medications have more significant interactions than any other group of drugs.

There are situations where the specific brand, type, form or strength of a treatment must be carefully tailored to the individual based on their responses, which is done by the prescriber and the patient over time. If that is changed by a professional who does not know the patient or their individual risks, some have warned that the consequences could be a loss of control of the condition, failed treatment and an unnecessary emergency, with very serious consequences indeed.

The hon. Gentleman is making a first-class point. This puts patients at risk, and it is not appropriate for the pharmacist to make that decision. People think that generics are the same thing as branded drugs, but they are not. For some, a particular brand is crucial. I commend him for what he is doing.

I am flattered to receive such commendation from the Conservative Benches, and I commend the hon. Lady for her extremely well-made point, with which I agree entirely. I hope that the Minister will respond to the second good point that the hon. Lady has made.

The stakes are too high to get this wrong, yet there has been no impact assessment or risk assessment undertaken on serious shortage protocols for this statutory instrument. This is an unacceptable risk to anyone with a long-term condition and should be recognised by anyone making contingency plans. I was particularly horrified to read in the explanatory memorandum for this SI—it is quite shocking:

“The main benefits of the protocol would be the NHS cost savings associated with GP time.”

In the same breath, it casually goes on to say:

“There may be some risks to patients”.

That is in the Government’s own paperwork. It is astonishing. How can the Government seriously prioritise NHS cost savings over patients’ lives and allow an explanatory memorandum to go out with that sort of wording in it? I hope that the Minister can explain how that got in there and at least reassure us that it is not the Government’s position. If it is the Government’s position that there may be some risks to patients, that suggests that the Government should have come to the House sooner to explain why they are making this regulatory change and not left it to the official Opposition to table a prayer motion to get this debate.

I would like clarity from the Government on a few things. It is not entirely clear from the legislation exactly when these powers would be used. I would like to hear from the Minister whether these powers will be introduced in a no-deal Brexit scenario only or whether we can expect them to be more permanent. I am also concerned that there will only be a review of new powers one year after a serious shortage protocol is issued by Ministers. This speaks to the point made by the hon. Member for Newton Abbot (Anne Marie Morris). One year is too long to wait if this causes serious problems for patients and the wider sector.

Considering that the stakes are so high, it is be essential that the Government deliver extensive communication and training to GPs, pharmacists, other healthcare professionals and the public, to help them understand any new protocols and manage expectations and any dissatisfaction. I would be grateful if the Minister outlined the Government’s plans. I talk and listen to frontline NHS staff all the time, and I know that there is a well-founded fear about the implications of a no-deal Brexit for hundreds of thousands of people in need of life-saving medicines. I am interested to hear from the Minister what information about these protocols has been shared with the health sector and professionals involved.

When the Secretary of State gave evidence to the Health and Social Care Committee a few weeks ago, he informed it that he will prioritise medicines over food. That glib assertion from the Secretary of State hardly offered the reassurance that patients deserve. Brexit should not compromise patient safety in any way. It is up to the Minister to allay the widespread concerns, but if she is not able to do so, we will test the opinion of the House. I commend our motion.

I am grateful for the opportunity to address the House and reassure Members on both sides of the House about the purposes of the regulations. I have been asked a number of questions, and I will try to answer all of them as best I can.

I want to start by saying that there is considerable misinformation out there about these regulations, which are designed to most efficiently manage the supply of medicines in the event of a shortage. I should also make clear to the House that this is not just a Brexit regulation; it will apply in any case, not just in the case of no deal, not least because recent events have shown the challenge in managing medicines. The regulations on how pharmacists will be able to apply this protocol are designed to minimise not only the demand on GPs but the risk to patients, because pharmacists will only be able to use their powers under these regulations according to very clear criteria, and we will still encourage them to speak to prescribers where there is any element of doubt.

Will the Minister give us some details about what those criteria will be, so that clear decisions can be made by pharmacists and so that when a particular brand is really important for a patient, there is no possibility that a generic will be substituted?

The circumstances will be different from protocol to protocol, which is not a very clear answer—but we would have to look at each incident. The hon. Member for Leicester South (Jonathan Ashworth) mentioned HIV medicine. Another example is antipsychotic medicines, where there is a clear relationship with the patient: obviously, it would not be appropriate to unilaterally change those items of medication.

When a prescription is issued, the pharmacist has to dispense that medicine according to strict instructions under the terms of the prescription. For example, if the prescription was for packets of 200 mg tablets and there was a shortage of those, they could be substituted with a different measurement. All those issues would be dealt with from protocol to protocol, having been considered by a pharmacy panel who can properly and rigorously challenge what an appropriate substitute would be in the event of a shortage of any medicine.

Is the Minister not concerned about the challenge that, however qualified the pharmacist, they do not have the patient’s notes? She has referred to an amount, and I understand how having two smaller pills will equal what should have been prescribed, but when it is a generic versus a specific branded medicine, that is a very difficult and challenging decision to make.

I come back to what I said to my hon. Friend earlier. The terms under which pharmacists will be able to exercise their discretion will be clearly set out in each protocol, and there will be full consultation by an expert panel, with ministerial approval in such an event.

Will the Minister clarify whether, if there are adverse effects as a result of some change that has been made in these circumstances, the prescriber, the dispenser or the Government would ultimately be liable?

The protocol will be very tightly drafted, which will really limit the ability of the pharmacist, who would only be able to prescribe outside the terms of the prescription within the narrow confines of the protocol. As I say, this has been done to secure continuity of supply when there is a potential challenge, but I would expect to take advice from a pharmacy panel, in conjunction with those most affected, to make sure that we put in place appropriate risk management on those occasions.

What kind of timescale is the Minister considering? Let us take people with epilepsy. As my hon. Friend the Member for Leicester South (Jonathan Ashworth) said at the Dispatch Box, if somebody’s condition changes, it might take six months to work out what the right prescription ought to be. The Minister surely cannot say that we will write a protocol in Whitehall in the event of some sudden shortage and implement it across the land because, as we keep saying, different people have different medical needs.

We are talking about a protocol that can deal with an immediate shortage, but we would not expect that shortage to continue indefinitely. It enables us to manage the shortage, while trying to secure the ongoing supply.

Reference has been made to EpiPens, and that is exactly what happened in that context: we knew that we had a shortage and that there was a supply coming, so steps were taken to manage the supply so that everybody who needed EpiPens had a supply of two, with dispensaries managing that supply. We would expect the same to happen. Where we issue a protocol, we would expect prescribers to go back to their normal supply of medication once we had corrected the supply problem, and this is to get us through that period. It is also to encourage people not to stockpile medicines in the event of worries about a shortage. This is about giving people the reassurance that we will manage such shortages effectively.

The hon. Member for Leicester South mentioned that there had been criticism about a lack of consultation. It is worth noting that the Government have been challenged by the Good Law Project on a number of grounds, but it is also worth telling the House that the High Court decided last week that permission for judicial review would not be granted on the issue of lack of consultation.

I want to clarify the purpose of the regulations. First, they implement the EU falsified medicines legislation on certain safety features on the packaging of medicines. They also extend the exemption for the supply of naloxone hydrochloride, so that drug treatment services can supply all dosage forms of that medicine; at the moment, we can only supply injectables, but we now know that nasal administration is more efficient. In addition, and this is obviously the main crux of the debate today, they enable retail pharmacies, where appropriate, to supply against a serious shortage protocol, instead of against prescriptions, if such a protocol has been issued.

Not implementing this statutory instrument would have dire consequences. Not only would the Government lose this tool to manage shortages of medicines, but we would also deny drug treatment services the ability to supply all dosage forms of naloxone hydrochloride. Without this SI, we would not be able to introduce UK-specific flexibilities for the falsified medicines safety features scheme, meaning that a disproportionate burden would be put on the supply chain.

On the safety features, I would like to say that we are committed to stopping falsified medicines from reaching patients. Our No. 1 priority is safe access to medicines in the most efficient way. I can also say that we want to retain a close working partnership with the EU on medicines regulation, for all the reasons the hon. Gentleman outlined, and we wish to ensure that patients continue to have timely access to safe medicines and medical innovations.

The new safety features measures under the EU delegated safety features regulation are directly applicable, and they already require UK manufacturers to place a unique identifier and tamper-evident features on packaging for almost all prescription-only medicines. These medicines need to be scanned on supply to the patient to verify their authenticity. Our position is clear that, as a member state, we were obliged to implement these requirements. We worked extensively with stakeholders to understand the detail and to develop the best approach on the flexibilities and enforcement specifically for the UK, and this was tested through a formal consultation process.

It is worth noting that the UK has a very complex supply chain. Without the national flexibilities in this statutory instrument, the burden on industry would be disproportionate and it would risk patients not getting timely access to medicines; nor would we be able to enforce the requirements already in place. The reputation of UK medicines, the UK pharmaceutical industry and regulators could be seriously undermined. I have already mentioned the issue of naloxone hydrochloride. It is administered in the event of a heroin overdose, so we clearly want to make that available in the most efficient way possible.

To come back to the serious shortage protocol provisions, these will provide the Government with an additional tool to deal with a shortage of medicines. Over 2.5 million prescription items are dispensed in primary care in England alone every day, and the vast majority are not subject to supply problems. However, we must have a robust system in place for when they are. We work closely with the Medicines and Healthcare Products Regulatory Agency, the pharmaceutical industry and NHS England in operating and managing the supply chain to help prevent shortages, and to ensure that the risks to patients are minimised when shortages do arise.

The issue of EpiPens is a very good example. Last autumn, we faced a serious international shortage of EpiPens. That shortage had a knock-on effect on other adrenaline auto-injectors and, despite efforts by the Department and the industry, there was not enough supply to meet the demand in the country. We were therefore forced to ration the available injectors so that the available supply could be spread out across all patients who needed them until more stock became available. To be able to do that, we put in place a dispensing protocol.

The protocol required pharmacists to check with patients how many adrenaline injectors, including expired ones, they had so that pharmacists could decide on the number of injectors to supply. Patients below a certain weight had to be referred back to their prescriber. Again, another risk management tool that we would apply in issuing a protocol would be to make sure that pharmacists were referring people back to their prescriber if there was such a question. This ensured that, throughout the duration of the shortage, we managed the available stock in such a way that each patient had access to at least two injectors. It was this incident with the adrenaline injectors, as well as our EU exit preparations, that led the Government to formalise that what was done in the EpiPen situation should be put in place to manage other serious shortages, should they arise.

I say again that this is not the Government’s plan for dealing with medicine shortages in a no-deal exit. That is simply not the case at all. We wanted to introduce these provisions before 29 March so that we would have the option of issuing protocols, but only as part of our multi-layered approach to minimise any supply disruption in a no-deal exit. We are confident that our other management plans will deal with that. These include securing additional roll-on roll-off freight capacity for goods; buffer stocks and stockpiling; extra warehouse space; and space on aeroplanes for products with a short shelf life or specific storage conditions. The questions raised about radioisotopes are clearly relevant to that. These regulations will ensure that companies can continue to sell their products in the UK. They will strengthen the process and resources used to deal with shortages in the event, despite everyone’s best efforts, that they do occur.

The Minister is being generous with her time. Will she explain what currently happens when there is a shortage? Of course I realise that patients need medicines, but why do we need this specific piece of legislation when, so far, the Government have dealt with many other shortages reasonably adequately, I should have thought?

As I explained, it was the issues regarding EpiPens that brought home to us the need to have a suitable protocol in place.

Hon. Members have expressed concern about the role of pharmacists in the system. At the moment, where the prescriber has prescribed a specific medicine, including a specific strength and quantity, the retail pharmacist must supply exactly what is on the prescription and cannot deviate from that. The pharmacist has no flexibility if the exact order cannot be supplied, for example, because of supply issues. The pharmacist has to send the patient back to their GP. Clearly that would not be an efficient use of GPs’ time if we could put in place a protocol that would enable the application of alternative medicines.

The serious shortage protocol enables retail pharmacists to supply in accordance with a strict protocol for a specific prescription-only medicine, rather than against a prescription, without going back to the prescriber. That will be done only in exceptional circumstances, in the event of a serious shortage of a medicine, when all other mitigation measures have been exhausted or would be likely to be ineffective, and all the clinical community think it is appropriate to issue such a protocol. The protocol may prescribe one of the following options: an alternative quantity, an alternative pharmaceutical form, an alternative strength, a therapeutic equivalent or a generic equivalent. However, as I said, each case will be considered on its merits, and of course the risk of various health conditions. We believe that therapeutic substitution will be extremely rare. It would need to be clinically appropriate, and a sufficient stock of any alternative would be required.

As I have said, any serious shortage protocol will be developed with clinician input. Which clinicians are involved will depend on the expertise required, but we would involve, for example, the relevant royal colleges and societies. We would also work closely with patient representative groups, as we did in the EpiPen shortage. Each protocol would clearly set out what action can be taken by the retail pharmacy, in what circumstances, for which patients, and during which period. I re-emphasise that this is not about pharmacists acquiring prescribing rights by the back door. It is entirely about ensuring that patients have access to the medicine they need by making the best possible use of highly qualified pharmacists and freeing up GP time for patients who need to see their GP. If a pharmacist is in any doubt about what they are prescribing, they can always exercise their professional judgment to refer an individual patient back to the GP, and if patients do not want the alternative under the protocol, they can always go back to their prescriber.

Let me be very clear: patients will not be given alternative medicines where this is not medically appropriate. This includes patients with complex medication regimes or conditions such as epilepsy or HIV. However, that does not mean that they are exempt from the protocols. For example, a protocol for a reduced quantity of anti-epilepsy medication could be issued, as we did for EpiPen. That would have to be considered against a backdrop of all the available stock being spread out across all patients, and there being time for patients to see their prescriber if the supply issues become long- term. Without the protocol, some patients would receive the medicines prescribed to them, but some would leave the pharmacy empty-handed. Clearly, we need to make sure that all patients have timely access to their medicines.

In the event of a serious shortage of any medicine, it is vital that patients continue to receive the treatment they need. The introduction of strict protocols, developed with specialist doctors, is a sensible step that will, in exceptional circumstances, allow highly trained pharmacists to provide an appropriate alternative or quantity, as set out in the protocol, to reduce the impact on patients. This ensures a co-ordinated response to a shortage and timely access to medicines.

Of course, I hope that we never have to introduce a serious shortage protocol, but there may be times when we have no other options, because all other measures have been exhausted or are likely to be ineffective. Not implementing the statutory instrument would put patients’ timely access to medicines at risk, first, by not enabling drug treatment services to supply all dosage forms of naloxone hydrochloride; secondly, by imposing much more burdensome implementation of safety features of packs of medicines with flexibilities to accommodate the specific characteristics of the UK supply chain; and thirdly, by denying the Government an important tool to manage shortages of medicines and to ensure that patients continue to get the right medicines in a timely manner. I hope that the motion is defeated.

We are discussing changes to the Human Medicines Regulations 2012. I welcome the implementation of the falsified medicines directive, with its provisions on unique identifiers and anti-tampering devices. I also welcome the change to allow nasal naloxone to be used to deal with opioid overdose. But snuck in among those perfectly reasonable measures is the serious shortage protocol. That deals with prescription-only medicines and highlights what we face with Brexit coming in 11 days.

Forty-one million packets of drugs a month go from the UK to the EU, and 37 million are imported into the UK, including almost all insulin—the UK does not produce insulin to a large extent. There are many other drugs that the UK does not produce. We have previously and in this debate raised the issue of radioisotopes, although this clearly does not apply to that. There will also be problems with the supply chain of raw chemicals to produce drugs in the UK and with processes such as batch testing for UK exports into the EU, because the EU will not recognise batch testing not carried inside the EU. One of the key words missing from the withdrawal Act that was scattered throughout the Chequers deal, if we can call it that, is “frictionless”. Do a word search. It is not there. We have been discussing this matter in the context of no deal, but there will be issues regarding the supply chains in making drugs and moving drugs around even if the Government’s withdrawal agreement goes through.

Bizarrely, section 8 of the explanatory memorandum to the regulations claims:

“This instrument does not relate to withdrawal from the European Union.”

As we would say in Scotland, “Aye, right.” It continues that:

“if withdrawal from the European Union were a contributing factor to a serious shortage…a serious shortage protocol could be used”.

That is the thinnest fig leaf I have ever seen in my whole life.

The documents talk about the Minister or Ministers being able to add drugs to the serious shortage protocol list. Who is meant by “Ministers”? Is it the devolved Ministers in Edinburgh and Cardiff, or are we merely talking about all the junior Ministers and the Secretary of State here in Westminster? Health is devolved, and the use of drugs and the diseases dealt with vary across the UK. It is important that health is not pulled back away from devolution. I would like that to be clarified, particularly when the Minister suggests that this is not a short-term solution, but envisaged as a long-term solution for shortages.

I accept that shortages can arise, but normally they are few; normally it is possible to get access to information about what is causing them, making it easier to come up with solutions. However, as has been said, the review will take place only after a year, which is quite a long time for a protocol to be in place. It would be useful to send information on what replacements could be used to the GP or prescriber, rather than to the pharmacist. If it is known that there is a national shortage, why wait until the point of dispensing the drug? Tell GPs. Tell non-GP prescribers. Do not leave it to the last minute, when someone is in the pharmacy. That is the issue: the shortage protocol gives pharmacists the power to override the prescriber. Predominantly, that is a GP, but not necessarily.

I say to other Members that pharmacists can change the strength, but not the dose. If someone is on a 10 mg tablet and is used to taking one 10 mg tablet, they may be given two 5 mg tablets. That may seem innocuous, but an elderly, vulnerable or slightly confused patient who knows that they take one tablet every morning might end up taking half the dose they require. Even worse is if they are given a larger dose that they are meant to cut in half. That is much more complex. The number of tablets patients have to take could cause confusion.

The statutory instrument talks about quantity. At the moment, patients are usually given eight weeks of a prescription and pay a prescription charge. If they only get four weeks of their medication, will they get the second four weeks without paying another prescription charge or will prescription charges be doubled? That is not an issue in Scotland, but it is certainly an issue here in England.

My hon. Friend is speaking very knowledgably about dosage. Many of my constituents are on methadone prescriptions. They need to get the correct amount of prescription or it can have very real consequences for relapse and how they are able to live their lives. Does she agree that protections need to be put in place for groups for whom removing the dose could have severe consequences?

It is critical that the patient’s dose is not changed or put in danger. The management of any condition is dose sensitive. We cannot go down to homeopathic doses of antibiotics or blood pressure medication—that would be crazy.

Pharmacists can give a different form, such as liquid, solid or capsule. Again, for some patients that will not be a problem; for others, it will. The hon. Member for Newton Abbot (Anne Marie Morris) mentioned generic drugs. Generally, NHS prescribers use generic drugs as the default to save money. However, I have had patients who had appalling side effects from the generic form of tamoxifen, but not from the non-generic brand. There always has to be a right for GPs to say, “In this case, I will use the brand.”

The most important bit of this statutory instrument is that it allows a change to a completely different drug. It may be a drug that is approved by a panel sitting somewhere in London with the colleges, who say that it is a reasonable replacement for the other drug, but that does not take into account the fact that patients are all individuals. I can tell you that they are all individuals.

Pharmacists are very knowledgeable—in Scotland, we have had community pharmacists for over a decade and they contribute massively—but they work to their own protocol, they work within limits and they do not have access to the patient’s notes. Therefore, they cannot see that the patient has been on a drug in the past and had terrible side effects. They will replace with a protocol drug, but what about the responsibility? Why is this happening right now?

It suggests to me that the Department of Health and Social Care is expecting massive shortages, to the point where the simple act of picking up the phone and saying to the GP, “I don’t have drug A. Would drug B be reasonable for Mrs Smith?”, is somehow impractical. I find that very worrying. It may be that Mrs Smith has had six drugs to control her blood pressure. Drug 2 and drug 5 caused her to faint or have blackouts, but the pharmacist does not know that.

Epileptics have been mentioned. The issue with epileptics is that any change can destabilise their epilepsy. They are therefore never prescribed by generic, but are prescribed by brand to avoid precisely that.

The hon. Lady makes a very good point. Does she agree that there is often an interaction between epilepsy drugs and other drugs that the patient may be on and that any interruption of that relationship may cause problems?

The right hon. Gentleman makes a very good point, and one that applies to many drugs. When we prescribe, we sit and look at the interactions. I would expect a pharmacist to look at that. They will have the patient’s full prescription and should, therefore, be able to look at interactions.

That is the key thing: they do not have the patient’s records and they do not know what problems a drug may have caused in the past.

This change could have a real impact on epileptics. It brings the danger of a fit, and the fit itself may be a threat to them. Obviously epileptics are exposed to sudden unexpected death in epilepsy and can suffer from trauma, depending on where they are when they take the fit. They can even lose their driving licence for a year because they have one fit. The social impact of that on epileptics is enormous.

It says in the explanatory notes that, because of that, epilepsy drugs and biological drugs would not be considered suitable for the protocol. However, it does not say that in the SI—they are not excluded. It is important that such people are protected.

I have been listening closely to the hon. Lady. This is already happening. A friend of mine went to her chemist to pick up some drugs and the dosage was halved by the pharmacist, not by her doctor. She had enough drugs to keep her going until she went to the doctor again, who reinstated the original drug. I just think it is really scary at the moment; people do not understand why this is happening. It cannot be about Brexit, because it is happening now.

I am just coming on to that issue. I reiterate that it is the strength, rather than the dose, so I imagine the hon. Lady’s friend would be expected to take two smaller tablets, not to reduce her dose.

As I have said, the obvious thing would be to share the protocol with the prescribers, not to aim it at the pharmacists who are right at the end of the process.

Why is it that we are seeing the shortages now? Quite simply, there are two ways to stockpile: either by forcing increased production, which it is not necessarily within the gift of the Department or even the Secretary of State to do, or by setting aside some of the drugs within normal production. When I talk to my GP friends, they talk about a massive surge in shortages over the past nine months. That coincides almost exactly with the acceleration of stockpiling. My concern is that drugs are being set aside into the stockpile and that is causing shortages right now.

There should be publication of the list of drugs that are at risk of shortage, so that a GP can say, “For this lady or gentleman it is not that important, so if it is a shortage drug I won’t use it, but for this other patient I will have to use it.” Apparently, that is currently hidden behind commercial sensitivity.

It is important that a consultation and an impact assessment are carried out. I was shocked that the BMA was given a week to respond and the General Medical Council was not even consulted. This statutory instrument totally reverses medical and prescriber legal responsibility, so who is legally responsible? How do pharmacists feel about the fact that they might be held answerable for changing the drug, or will the Government underwrite that? I think that this has been appallingly handled and has been snuck in with no scrutiny and no debate.

The hon. Member for Leicester South (Jonathan Ashworth) talked about cost and time saving for GPs and, secondary to that, the impact on patient safety. If we look at the basis for the review in a year, it says that No. 1 will be the function of the market and that No. 2 will be the impact on patients, so again we see that patient safety is not being put at the heart of this. This proposal has not been properly thought through, particularly if it is envisaged as a long-term solution to drug shortages. No deal should now be off the table, as of last week. There should be time to look at this issue properly, consult properly and come up with something that will not endanger patients.

I very much agree with the concerns that were raised by the Scottish National party spokesperson, the hon. Member for Central Ayrshire (Dr Whitford). Let me make a general point first. I recognise that this statutory instrument is not being introduced purely for no-deal planning, but clearly, there is a recognition that the risk of shortages increases in a no-deal scenario. To me, it absolutely beggars belief that Cabinet Ministers in this Government were willing last Thursday purposefully to vote against an extension and therefore in favour of the risk of no deal in just a few days’ time, knowing that the risk to patients would increase as a result. It is extraordinary that Ministers in a Government could choose to vote in that way knowing that patients would be put at greater risk.

I want in particular to address the concerns of patients with epilepsy, including the concerns raised by the really good organisation, SUDEP Action. For those who are unaware, SUDEP means sudden unexpected death in epilepsy, so we are talking here about all those people who lose their lives as a result of epilepsy. There are very real and legitimate concerns about the impacts that the measure will have on those people. To bring this into really sharp focus, Simon Lees, one of the trustees of SUDEP Action, who has epilepsy, was today refused the supply of one of his three epilepsy medications because of a shortage. His brother died from epilepsy shortly after his medication was changed, so the risk to patients is very real.

As others have said, pharmacists are highly skilled professionals, but they are not specialist prescribers or skilled in assessing the risk of unexpected death through epilepsy. There is a particular concern about people with a learning disability who may also have epilepsy, who are particularly at risk. As the SNP spokesperson said, pharmacists do not have access to the full patient record. The need for consistency for these patients in the supply, dosing, timing and formulation of anti-epileptic drugs is absolutely critical. There is a real risk when medications change. That is why specialist prescribers play such an important role in any change for a patient with epilepsy. Person-centred prescribing and medication management is the most effective way to keep these patients safe, so it is little wonder that those people and the organisation that supports them are so concerned about this issue.

I also want to make some particular points that SUDEP Action has raised. The current documentation on the protocol indicates that there is no requirement for patients to be made aware of medication changes—that seems extraordinary to me—or a recognition of the channels available to them should they wish to challenge or question those changes. Without those safeguards, people with epilepsy may be unaware of medication changes that have occurred, putting them at significant risk, particularly if these changes result in increased side effects or changing seizure control. It is also unclear whether the pharmacist, the original prescriber or the Government are ultimately accountable for adverse effects—I made this point in my challenge to the Minister—caused by one of the protocols being activated. Should a death occur following a lack of consistency of supply of the usual medication, who will be held to account for that change? As others have said, it seems essential that the Government make publicly available a list of the medications that are at risk of shortage. There should be an early warning system for prescribers so that they are aware of the risks of medications running short in supply.

In conclusion, there are legitimate and serious concerns here, and that is why I will be joining others in voting in favour of the motion to revoke the regulations.

I am glad we have had the opportunity to have this debate. Like other hon. Members, I want to focus on the impact these changes could have on those with epilepsy. I thank SUDEP Action, which the right hon. Member for North Norfolk (Norman Lamb) mentioned, for the work it has done to bring concerns about this issue to the fore. I also agree with many of the concerns my hon. Friend the Member for Leicester South (Jonathan Ashworth) expressed in his opening remarks.

The Secretary of State was unable to address bereaved families and clinicians at the recent summit held by SUDEP Action, but will he meet me, other hon. Members and representatives of SUDEP Action and talk directly to families about the concerns they have? If he could agree to do that, it would be very helpful.

Medicines shortages pose a serious risk to people with epilepsy. As hon. Members are aware, it is a high-risk condition, requiring complex, tailored care. As other hon. Members have said, many people with epilepsy are particularly vulnerable to changes to that care. I have recently met families, such as that of Rachel Shah, whose daughter Emily died aged 19 shortly after a non-specialist prescriber made an error with her medication. The family and the non-specialist were entirely unaware of the risks of sudden unexpected death in epilepsy, and the error was not noticed. That is quite shocking.

Studies show that people on existing medications are put at risk when those medicines are changed. Tried and tested systems mean that, when there is a medicines shortage, specialist prescribers with expertise and access to the full patient record are involved in any changes. There are known risk factors that can increase the risk of death among people with epilepsy. However, those can be carefully managed through open, positive relationships between clinicians and patients. Those clinicians have often had responsibility for the patients’ medication schedule, which has often been worked up with the patient over many years.

The serious shortage protocols, passed under the Human Medicines (Amendment) Regulations 2019 give pharmacists the right to supply a different quantity or pharmaceutical quality of medicine in the event of the country experiencing a serious shortage of prescription-only medicines. As other hon. Members have said, pharmacists are skilled professionals in medicines and medicines management, but they are not specialist prescribers. Nor are they specialists in assessing SUDEP or other epilepsy risks in individuals, and they do not have access to full patient records.

With your indulgence, Madam Deputy Speaker, I would just like to reassure the right hon. Member for North Norfolk (Norman Lamb) and the hon. Member for Bury South (Mr Lewis). We do not consider that treatment for epilepsy would be appropriately covered by a serious shortage protocol, for exactly the reasons that they have both outlined: this is specialist prescribing and very bespoke to the patient. In the event of a shortage of epilepsy drugs, the clear guidance would be for the pharmacist to refer the patient back to their prescriber. The shortage protocols will be very tightly defined, within given circumstances, as to what drug will be an appropriate alternative treatment; they are by no means meant to be very one size fits all.

I think the Minister for that reassurance. I think we will want to see that in writing. Having that clarity is incredibly important, so that when the guidance is published, the reassurance is there for people with epilepsy and their families. That is incredibly important.

We should remember that laws that sought to allow change in the prescription of epilepsy medications were rejected in 2010 after a public consultation that highlighted major patient safety concerns. MHRA guidance in 2017 included vital safeguards against switching medication for people with epilepsy. These issues have therefore been interrogated in the past.

A precautionary approach concerned with patient safety would include analysis and openness about the causes of medical shortages; include an impact and risk assessment; aim to avoid any risk of worsening medical shortages; follow good practice in the regulation of medical shortages; include training and communication arrangements for all affected; and include clear, robust and timely accountability to patients and the public for adverse events and avoidable deaths. Nurses and clinicians are currently unable to gain access to a number of medications. They need to know which are on the list of likely shortages, and whether all the possibilities of measures to prevent such shortages have been exhausted.

People with epilepsy are recognised to be a high-risk group in current legislation. They must be protected against shortages of any medications that they take—not just their epilepsy medication—by a requirement in the legislation, and in any accompanying guidance, for the involvement of a specialist prescriber at all times. To be fair, that is the assurance that the Minister sought to give this evening.

It is not good enough to say in the explanatory memorandum that protocols will not apply to certain epilepsy treatments for which a brand is required. Any change in the 2017 MHRA guidance on epilepsy medication should be avoided, although, if such a change is required owing to a serious shortage, it must follow public consultation with the involvement of the third sector and patients. I think that patient groups feel they have been excluded from the process thus far. I urge the Minister to agree—in the spirit in which she has engaged with the House this evening—to meet SUDEP Action along with me, and other Members, if the Secretary of State is not willing or does not have time to do so.

The Government should make publicly available the list of medications that are at risk of shortage. If people living with long-term health conditions, and their clinicians, know about serious shortages that may affect them, they should have opportunities to contribute to any consultations and debates. An early-warning system for prescribers is essential, but it must be extended to all specialist prescribers. Many are on the front line, trying to ensure continuity of medication for patients, and they will be able to provide the necessary reassurance for those patients if they are aware of potential shortages.

We should not forget the anxiety that this will cause among people who are already extremely vulnerable, and the fact that that anxiety could lead to further health problems. All who are involved in the chain need to be able—where appropriate—to offer the maximum clarity, information and reassurance. The Government should also publish an operational framework and guidance to ensure that there is good practice and medicine shortages can be managed safely. They should commit themselves to patient-centred and shared care decision-making.

Perhaps this is the most important point that has been made so far: it is still not clear where accountability lies in the event of an adverse event—worst of all, a death—when there has been a failure of continuity of supply lines. That issue has been highlighted by the Pharmacists’ Defence Association. Obviously the association is very concerned about the potential negative effect on pharmacists, but a greater concern relates to the potential impact on patients and families.

This legislation is not simply another complication caused by Brexit. It may present serious challenges for many years to come. It is first and foremost about patient safety, and in those circumstances, the Government need to take appropriate time and care when making their decisions.

I am pleased to have an opportunity to make a short contribution to the debate.

It is ironic, given that one of the main Brexit campaign slogans, on the side of a bus, promised £350 million for the NHS, that one of the most serious problems we are having to consider is the problem of medicine shortages in the event of Brexit. The Minister has still not made clear the extent to which those shortages are related to Brexit. Common sense suggests that this is a Brexit statutory instrument, and I am assuming that it went through the usual Brexit process of being dealt with by the European Statutory Instruments Committee, but the Minister has not made clear why we are having these shortages in medicines, which are happening already. I have a constituent with a child with epilepsy who is finding it difficult to get their child’s prescription. If this is not Brexit-related, how come all these shortages are suddenly happening now, at a time when the pharmaceutical industry is being told it needs to stockpile?

I wholeheartedly support the points my hon. Friend is making and the concern she is raising about the potential link to Brexit, which would seem to many Members to be an obvious connection. Does she agree that Brexit is not only threatening the NHS through these potential shortages of medicines, but threatening the staffing of our NHS? I represent a seat where 13% of the staff at the local hospital come from EU countries, and many are leaving and going home, which is of deep concern to our residents.

Of course what my hon. Friend says about staff shortages and Brexit is absolutely right.

I was going on to say that I have a GlaxoSmithKline factory in my constituency, and obviously I have discussed this issue with it. It is extremely underwhelmed by the Government’s no-deal planning, and extremely under- whelmed by the fact that it is having to pay for these extra stockpiles. All these Brexit costs that are being put on to the industrialists mean that there is less money for research and development, investment, job creation and all the things we would all like to see.

It is notable that there are very high numbers of people with the conditions most likely to be affected. There are 4 million people in this country with diabetes, 500,000 people with epilepsy, and 250,000 people whose allergies are so serious that they need an EpiPen. Given that we clearly have 5 million, 6 million or perhaps 10 million people whose health is likely to be at risk if there are medicine shortages, I would have thought that the Government would have not just done a full risk and impact assessment but produced for us today, alongside the statutory instrument, the protocols. The Minister knows which drugs and conditions we are talking about; surely, given all the problems we have had with the industry, doctors and patient groups not being properly consulted, it would have been sensible to make those protocols at this moment, so we could look at them alongside the statutory instrument. I hope the Minister will come to the Dispatch Box and answer some of these points. She is shaking her head.

This is a tool to manage serious medicine shortages. I do not expect any medicine shortages, but this tool exists in the event of them arising. As for the idea that we could bring together a list, we do not anticipate that there will need to be a list.

Brexit is now 11 days away. Collapsing out of Europe with no deal is obviously far less likely following the votes of last week, but it is still a possibility, and at that point the possibility—the probability—of these medicine shortages will increase very significantly. Here we are, less than a fortnight away, and the Minister has not got these protocols in draft at the moment. [Interruption.] The Minister is still chuntering; I am sorry, but she has not provided us with the reassurance that we want. I speak as someone who carries an EpiPen; I am not very taken with the idea that I will not be able to get an EpiPen, and my husband will not be very taken with the idea that he cannot get his epilepsy tablets. If the Minister and Department of Health and Social Care officials think that this is a way to save money, they could not be more wrong.

When things go wrong—when a person has a fit, or goes into anaphylactic shock—they are taken into A&E, and they might be there for 12 hours. That is not cheap; that is not a saving. Of course, it is extremely dangerous, too. The rate of death for people with epileptic fits is one in 100; one in 100 fits leads to death. Ministers are taking much too great a risk with their fellow citizens’ lives.

Question put.