Human Medicines (Amendment) Regulations

Jackie Doyle-Price Excerpts

Monday 18th March 2019 Commons Chamber

[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.

[Norman Lamb]

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?

[Jackie Doyle-Price]

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.

[Helen Goodman]

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.

[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.

--- Later in debate ---

[Mr Ivan Lewis (Bury South) (Ind)]

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.

[Jackie Doyle-Price]

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.

[Mr Lewis]

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.

--- Later in debate ---

[Helen Goodman]

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.

[Jackie Doyle-Price]

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.

[Helen Goodman]

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.