Human Medicines (Amendment) Regulations

Norman Lamb Excerpts

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth (Leicester South) (Lab/Co-op)]

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.

[Norman Lamb (North Norfolk) (LD)]

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.

[Jonathan Ashworth]

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.

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[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.

[Norman Lamb]

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.

[Jonathan Ashworth]

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.

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[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.

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[Dr Whitford]

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.

[Norman Lamb]

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?

[Dr Whitford]

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.

[Norman Lamb]

They do not have the patient’s records.

[Dr Whitford]

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.

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[Norman Lamb (North Norfolk) (LD)]

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.