Human Medicines (Amendment) Regulations

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.

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.