Human Medicines (Amendment) Regulations

Anne Marie Morris Excerpts

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth]

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.

[Anne Marie Morris (Newton Abbot) (Con)]

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?

[Jonathan Ashworth]

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.

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[Jonathan Ashworth]

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.

[Anne Marie Morris]

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.

[Jonathan Ashworth]

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.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

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.

[Anne Marie Morris]

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?

[Jackie Doyle-Price]

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.

[Anne Marie Morris]

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.

[Jackie Doyle-Price]

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.

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[Jackie Doyle-Price]

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.

[Anne Marie Morris]

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?

[Jackie Doyle-Price]

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.